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contraceptives, postcoital

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Description

Contraceptives, Postcoital: Contraceptive substances to be used after COITUS. These agents include high doses of estrogenic drugs; progesterone-receptor blockers; ANTIMETABOLITES; ALKALOIDS, and PROSTAGLANDINS. [Medical Subject Headings (MeSH), National Library of Medicine, extracted Dec-2023]

Cross-References

ID SourceID
PubMed CID73346591
CHEMBL ID2447915
MeSH IDM0005121

Synonyms (4)

Synonym
contraceptives, postcoital
postcoital contraceptives
CHEMBL2447915
O029200000

Research Excerpts

Toxicity

ExcerptReferenceRelevance
" Some of these concerns include potentially increased risks of cardiovascular events (including arterial and venous disease), worries about possible effects on future fertility, feared teratogenic consequences following method failure or inadvertent use during pregnancy, exaggerated or extreme fears of adverse tolerability, and concerns about drug interactions with other medications."( How safe is emergency contraception?
Ellertson, C; Norris Turner, A, 2002
)
0.31
" DES is considered safe only as an emergency contraceptive measure."( FDA considers DES safe as 'morning-after' pill.
, 1973
)
0.25
"During a 1996 hearing, the US Food and Drug Administration (FDA) Reproductive Health Drugs Advisory Committee reached the unanimous conclusion that certain oral contraceptives (OCs) are safe and effective for use in an emergency postcoital regimen."( FDA finds emergency postcoital contraception safe and effective.
, 1996
)
0.29
" A specialist conference in January this year concluded that the technique is safe and effective and would be particularly valuable in resource-poor countries."( Cutting unsafe abortions.
, 1998
)
0.3
"Ulipristal acetate (UPA), a selective progesterone receptor modulator, when taken as a single 30-mg dose, is safe and effective for emergency contraception up to 5 days (120 h) following unprotected intercourse."( Ulipristal acetate: a new emergency contraceptive that is safe and more effective than levonorgestrel.
Fine, PM, 2011
)
0.37
" The most commonly (>10%) reported adverse events included headache, nausea, and abdominal pain."( Ulipristal acetate: review of the efficacy and safety of a newly approved agent for emergency contraception.
Maltz, FN; Richardson, AR, 2012
)
0.38
" We revised the literature to concern most of the data available on the role of EC and moreover clarifying the available methods, the action windows of the accessible devices, the adverse events and the controindications."( Nowadays which emergency contraception? Comparison between past and present: latest news in terms of clinical efficacy, side effects and contraindications.
D'Antona, D; Di Gangi, S; Fanelli, T; Gizzo, S; Nardelli, GB; Omar, A; Patrelli, TS; Saccardi, C; Zambon, A, 2012
)
0.38
" The main side effect was frequent menstrual irregularities."( A systematic review of effectiveness and safety of different regimens of levonorgestrel oral tablets for emergency contraception.
Al-Amin, MM; Rahman, MM; Reza, HM; Shohel, M; Uddin, MM; Zaman, A, 2014
)
0.4
"This review will evaluate all the information about the potential adverse effects and tolerability of each method of EC by putting them in balance with their safety and effectiveness."( Consequences of emergency contraceptives: the adverse effects.
Chabbert-Buffet, N; Daraï, E; Keller, V; Thomin, A, 2014
)
0.4
"Different means of EC have been demonstrated to be generally safe and well tolerated."( Consequences of emergency contraceptives: the adverse effects.
Chabbert-Buffet, N; Daraï, E; Keller, V; Thomin, A, 2014
)
0.4
" An easy access could diminish unwanted pregnancies; however, there is a risk of misuse and, in any case, of developing some adverse events."( Emergency contraceptive pill safety profile. Comparison of the results of a follow-up study to those coming from spontaneous reporting.
Carvajal, A; García Ortega, P; García Sevillano, L; Martín Arias, LH; Pellón, M; Sáinz, M; Treceño, C; Velasco, V, 2015
)
0.42
"Out of 139 women surveyed, 113 developed any adverse event--two considered as severe; the most frequently reported events were menstrual disturbances, which accounted for 21% of all events."( Emergency contraceptive pill safety profile. Comparison of the results of a follow-up study to those coming from spontaneous reporting.
Carvajal, A; García Ortega, P; García Sevillano, L; Martín Arias, LH; Pellón, M; Sáinz, M; Treceño, C; Velasco, V, 2015
)
0.42
" To determine whether LNG, UPA or COC (Yuzpe) ECPs are safe for women with certain characteristics or medical conditions, we searched the PubMed and Cochrane databases for articles published from date of inception until May 2015 pertaining to the safety of LNG, UPA or Yuzpe ECP use."( Safety data for levonorgestrel, ulipristal acetate and Yuzpe regimens for emergency contraception.
Curtis, KM; Jatlaoui, TC; Riley, H, 2016
)
0.43
", ulipristal acetate pills, levonorgestrel pills, and the copper-IUD), carry only mild side effects and serious adverse events are essentially unknown."( The safety of available and emerging options for emergency contraception.
Lee, JK; Schwarz, EB, 2017
)
0.46
"9%; menstrual irregularity is the most common adverse effect (strength of recommendation [SOR]: B, Cochrane review of lower-quality trials)."( Are oral emergency contraceptives a safe and effective form of long-term birth control?
Hooper-Lane, C; Kraus, C, 2017
)
0.46
" Main outcome measure The survey focused on the utilization of emergency contraceptives without a prescription in Germany, and on the pharmacists' experiences with (potential) problems and concerns regarding safe use."( Trends in dispensing oral emergency contraceptives and safety issues: a survey of German community pharmacists.
Freudewald, L; Ganso, M; Said, A; Schulz, M, 2019
)
0.51
"This systematic review and meta-analysis aimed to summarize current evidence regarding the adverse events, and their prevalence, reported during the use of oral levonorgestrel emergency contraceptives."( A Systematic Review and Meta-analysis of the Adverse Effects of Levonorgestrel Emergency Oral Contraceptive.
Leelakanok, N; Methaneethorn, J, 2020
)
0.56
"Four electronic databases and the US FDA Adverse Event Reporting System (FAERS) Public Dashboard were searched."( A Systematic Review and Meta-analysis of the Adverse Effects of Levonorgestrel Emergency Oral Contraceptive.
Leelakanok, N; Methaneethorn, J, 2020
)
0.56
"A total of 47 articles were included in this systematic review, from which it was shown that most of the adverse reactions were common and not serious."( A Systematic Review and Meta-analysis of the Adverse Effects of Levonorgestrel Emergency Oral Contraceptive.
Leelakanok, N; Methaneethorn, J, 2020
)
0.56
"The most common adverse effects of levonorgestrel were not serious."( A Systematic Review and Meta-analysis of the Adverse Effects of Levonorgestrel Emergency Oral Contraceptive.
Leelakanok, N; Methaneethorn, J, 2020
)
0.56

Pharmacokinetics

ExcerptReferenceRelevance
"A pharmaceutical and pharmacokinetic study was carried out on levonorgestrel tablets from two different sources (Hungarian- and Chinese-made)."( Comparative cross-over pharmacokinetic study on two types of postcoital contraceptive tablets containing levonorgestrel.
Fotherby, K; He, CH; Liao, DL; Matlin, SA; Shi, YE; Van Look, PF; Vince, PM; Xu, JQ; Zhu, YH, 1990
)
0.28
" In view of the vast clinical applications and interactions of steroidal oral contraceptives with commonly used therapeutic agents, the interaction potential of certain concomitantly administered therapeutic agents was investigated in terms of postcoital contraceptive efficacy (pharmacological) and the pharmacokinetic profile of centchroman in female Sprague-Dawley rats."( Effect of concurrently coadministered drugs on the pharmacokinetic/pharmacodynamic profile of centchroman, a nonsteroidal oral contraceptive, in rats.
Gupta, RC; Kumar, V; Lal, J; Singh, MM, 2006
)
0.33
" Pharmacokinetic interaction was studied in normal female rats with or without coadministered drugs."( Effect of concurrently coadministered drugs on the pharmacokinetic/pharmacodynamic profile of centchroman, a nonsteroidal oral contraceptive, in rats.
Gupta, RC; Kumar, V; Lal, J; Singh, MM, 2006
)
0.33
" In pharmacokinetic interaction studies, most of the therapeutic agents affected the rate and extent of absorption of centchroman."( Effect of concurrently coadministered drugs on the pharmacokinetic/pharmacodynamic profile of centchroman, a nonsteroidal oral contraceptive, in rats.
Gupta, RC; Kumar, V; Lal, J; Singh, MM, 2006
)
0.33
"The study was intended to investigate the effect of concomitant administration of antimalarial drug (pyrimethamine or arteether) on pharmacokinetic and post coitus contraceptive efficacy of ormeloxifene in female Sprague-Dawley rats."( Effect of arteether and pyrimethamine coadministration on the pharmacokinetic and pharmacodynamic profile of ormeloxifene.
Jaiswal, S; Lal, J; Sharma, A; Shukla, M, 2017
)
0.46
" Mean bioavailable LNG Cmax was lower in obese (7."( Pharmacokinetics of the 1.5 mg levonorgestrel emergency contraceptive in women with normal, obese and extremely obese body mass index.
Jusko, WJ; Molins, EAG; Natavio, M; Nelson, A; Stanczyk, FZ, 2019
)
0.51

Compound-Compound Interactions

ExcerptReferenceRelevance
"The availability of a medical mode of termination of early pregnancy by the administration of RU486, an antiprogesterone alone, or in combination with one of the PG analogues significantly reduces the maternal morbidity and mortality associated with the classical surgical abortion."( Mifepristone (RU486) alone or in combination with a prostaglandin analogue for termination of early pregnancy: a review.
Avrech, OM; Bukovsky, I; Caspi, E; Golan, A; Weinraub, Z, 1991
)
0.28
"5 mg/kg combined with anordrin 2 mg/kg when given on d 6-8 of pregnancy."( [Antifertility effects of RU-486 in combination with anordrin in rats].
Lin, ZM; Liu, GM; Qian, YX; Shen, PJ; Shen, QC; Xu, RY, 1989
)
0.28
"The study purpose was to obtain additional clinical experience with 200 mcg of ethinyl estradiol combined with 2 mg dl-norgestrel as an emergency postcoital contraceptive."( A multicenter clinical investigation employing ethinyl estradiol combined with dl-norgestrel as postcoital contraceptive agent.
Rademaker, AW; Smith, RP; Yuzpe, AA, 1982
)
0.26
"The effectiveness of mifepristone, onapristone, and ORG 31806 alone or in combination with anordiol to terminate pregnancy in the rat was evaluated."( Comparative effectiveness of three antiprogestins alone and in combination with anordiol in terminating pregnancy in the rat.
Bardin, CW; Dao, B; Koide, SS; Li, XJ; Vanage, G, 1997
)
0.3
"The pregnancy termination potency of varying doses of mifepristone, onapristone, and ORG 3806--alone and in combination with the estrogenic/antiestrogenic compound anordiol--was evaluated in adult rats."( Comparative effectiveness of three antiprogestins alone and in combination with anordiol in terminating pregnancy in the rat.
Bardin, CW; Dao, B; Koide, SS; Li, XJ; Vanage, G, 1997
)
0.3
" In 2016, the label of LNG was updated based on a drug-drug interaction (DDI) study showing a significant decrease in LNG exposure when co-administered with efavirenz, a known CYP3A4 inducer."( Drug interactions between emergency contraceptive drugs and cytochrome inducers: literature review and quantitative prediction.
Bourguignon, L; Capelle, A; France, M; Goutelle, S; Le Corvaisier, C; Tod, M, 2021
)
0.62

Bioavailability

ExcerptReferenceRelevance
" Absorption and bioavailability of the Hungarian-made tablets were greater as evidenced by higher serum concentrations of levonorgestrel, a greater area under the concentration-time curve during the first 24 hours, and a more marked suppressive effect on SHBG levels."( Comparative cross-over pharmacokinetic study on two types of postcoital contraceptive tablets containing levonorgestrel.
Fotherby, K; He, CH; Liao, DL; Matlin, SA; Shi, YE; Van Look, PF; Vince, PM; Xu, JQ; Zhu, YH, 1990
)
0.28
" Following this initial explorative phase, keeping in mind that an antifertility agent must be highly effective over a period of time sufficiently long to block a dynamic process such as pregnancy, selected compounds were studied in depth in order to determine the relationships between their bioavailability and their effectiveness."( A new class of non-hormonal contragestational agents: pharmacodynamic-pharmacokinetic relationships.
Assandri, A; Galliani, G; Omodei-Salé, A, 1982
)
0.26
" In other pharmacokinetic parameters, clearance (CL) remained unchanged; however, there was decrease in bioavailability (F) and volume of distribution (V(d)) in some situations."( Effect of concurrently coadministered drugs on the pharmacokinetic/pharmacodynamic profile of centchroman, a nonsteroidal oral contraceptive, in rats.
Gupta, RC; Kumar, V; Lal, J; Singh, MM, 2006
)
0.33
" Moreover, the area under the curve of EE and MPA revealed an increase in bioavailability after transdermal administration as compared to oral route."( Development and evaluation of matrix type transdermal patch of ethinylestradiol and medroxyprogesterone acetate for anti-implantation activity in female Wistar rats.
Agrawal, SS; Pruthi, JK, 2011
)
0.37

Dosage Studied

ExcerptRelevanceReference
" This dosage schedule called for 4 tablets over 12 hours, and the clinician claims that this schedule avoids some of the semantic difficulties associated with the usual treatment of 50-60 tablets of estrogen over 5 days."( An alternative to the use of high-dose estrogens for postcoital contraception.
Schilling, LH, 1979
)
0.26
" This task calls for chronic dosing and the accompanying problem of eventual liver involvement and hypertrophy of the secondary accessory sex organs."( Contraceptive technology in the future.
Corbin, A, 1979
)
0.26
" High dosage of progestins are in common use in the treatment of abortus imminens."( [Current status of gestagen administration. 2. Gestagen therapy in the area of reproduction].
Völker, W, 1977
)
0.26
" 189 campus women received the dosage of 2 tablets in 12 hours, given within 72 hours of unprotected intercourse."( Post-coital contraception using d1-norgestrel/ethinyl estradiol combination.
Ross, A; Smith, RP, 1978
)
0.26
" All compounds were active anti-implantational agents, varying in required dosage from 4 mug to 2000 mug (total dosage over 4 days)."( Post-coital contraceptive activity and estrogen receptor binding affinity of phenolic steroids.
Müller, RE; Wotiz, HH, 1977
)
0.26
"5 mg/kg body weight) of the compound administered on days 1, 2 or 3 of pregnancy or multiple dosing (0."( Biological profile of 2-[4-(2-N-piperidinoethoxy) phenyl]-3-phenyl (2H) benzo (b) pyran--a potent antiimplantation agent in rat.
Dhar, JD; Duran, S; Kapil, RS; Setty, BS, 1991
)
0.28
" Teichmann, who indicates that 3-phase preparations under proper dosage prevent conception by hindering ovulation."( [Headlines].
Uhl, D, 1989
)
0.28
" The recommended dosage is 2 tablets taken 12 hours apart, preferably within 12-24 hours, and no later that 72 hours, after intercourse."( Ovral as a "morning-after" contraceptive.
, 1989
)
0.28
"The effects of two cyclically administered, triphasic, combined low dosage oestrogen and progestogen oral contraceptives on haemostasis have been compared in a longitudinal study, over 6 months, in 26 healthy females aged 16-30 years."( A comparison of the effects of two triphasic oral contraceptives on haemostasis.
Cohen, H; Gillmer, MD; Machin, SJ; Mackie, IJ; Walshe, K, 1988
)
0.27
" Thus, the fact of adding on the 4th day of the RU 486 treatment a weak dosage of synthetic prostaglandin equal to 1/6 of that used alone when inducing abortions made a clear improvement in the results possible."( Fertility control in women: results with RU 486 by the end of 1985.
Baulieu, E, 1986
)
0.27
"Ethinylestradiol (EE), at a dosage of 5 mg/day for 5 consecutive days (5 mg EE), has generally been used for interception."( A comparison of high-dose estrogens versus low-dose ethinylestradiol and norgestrel combination in postcoital interception: a study in 493 women.
Haspels, AA; Van Santen, MR, 1985
)
0.27
"Ethinyl estradiol (EE), at a dosage of 5 mg/day for 5 consecutive days (5 mg EE) has generally been used for interception."( A comparison of high-dose estrogens versus low-dose ethinylestradiol and norgestrel combination in postcoital interception: a study in 493 women.
Haspels, AA; Van Santen, MR, 1985
)
0.27
" In certain postcoital dosing regimens, 2 analogs were more active in preventing or terminating pregnancy in rats than would have been predicted on the basis of their estrogenicity."( Potential antifertility agents. 3. Substituted dibenzothiophenecarboxylic acids and derivatives.
Bialy, G; Bierwagen, ME; Crenshaw, RR; Jenks, TA; Luke, GM, 1972
)
0.25
" The recommended oral dosage is 25 mg twice daily for 5 consecutive days, begun within 72 hours after sexual exposure."( Diethylstilbestrol as a "morning after" contraceptive.
, 1973
)
0.25
" With an increase in the dosage of the extract, the percentage of implantation failure increased."( Flowers of Hibiscus rosa-sinensis, a potential source of contragestative agent: I. effect of benzene extract on implantation of mouse.
Bhattacharya, K; Kabir, SN; Pakrashi, A; Pal, AK, 1984
)
0.27
" Half the dosage was administered immediately upon entry into the study and the remainder 12 hours later."( A multicenter clinical investigation employing ethinyl estradiol combined with dl-norgestrel as postcoital contraceptive agent.
Rademaker, AW; Smith, RP; Yuzpe, AA, 1982
)
0.26
" Dose-response curves can be prepared from these average results, and the relative in vivo effectiveness of the spermicides can be determined."( Postcoital, Vaginal, spermicidal potency of formulations: the Macaca arctoides (stumptailed macaque) as animal model.
Hahn, DW; Zaneveld, LJ; Zatuchni, B, 1981
)
0.26
" Most of the clinical trials have studied its efficacy in the termination of early pregnancy when used in conjunction with a low dosage of a prostaglandin analogue."( Mifepristone. A review of its pharmacodynamic and pharmacokinetic properties, and therapeutic potential.
Brogden, RN; Faulds, D; Goa, KL, 1993
)
0.29
" If indeed it has occurred, and the patient has given written consent, the clinicians administers 2 times the dosage of 1 OC to the patient and a repeat dose 12 hours later."( Six years of clinical experience using postcoital contraception in college women.
Buttermore, S; Nolan, C, 1993
)
0.29
" In our case, we describe a CVA due to occlusion of the common carotid artery after an acute massive overdose of estrogens due to error of dosage when using Yuzpe's system or emergency post-coital therapy."( [Occlusion of the right common carotid artery due to oral estrogen overdose].
Escudero, D; Sánchez-Ojanguren, J; Zapata, A, 1998
)
0.3
"Emergency contraceptive devices are most often applied either in combination with estrogen and progesterone or only progesterone in high dosage (0."( [Emergency contraception].
Draca, P,
)
0.13
" Serial blood samples were drawn over 72 h after dosing in a fasting state."( Pharmacokinetics of levonorgestrel 0.75 mg tablets.
Duncan, G; Gabelnick, H; Kook, K, 2002
)
0.31
"The observation that estrogens in sufficient dosage given postcoitally may prevent implantation of the ovum have led to studies regarding practical clinical application."( Post-coital oral contraception.
Morris, JM; Van Wagenen, G, 1966
)
0.24
" The dosage schedule is 2 tablets at once followed by 2 tablets after 12 hours."( Statement on postcoital contraception.
, 1981
)
0.26
" The dosage was either 5 mg of stilboestrol 5 times daily for 5 days, or 1 mg of ethinyloestradiol twice daily for 5 days."( The "morning-after pill"--a preliminary report.
Haspels, AA, 1969
)
0.25
" The recommended regimen consists of six tablets of Ovral (two taken immediately, two more in 12 hours) or 12 tablets of Lo/Ovral, Nordette, or Levlen (four taken immediately, repeat dosage in 12 hours)."( Emergency contraceptive pills (ECP) protocol.
, 1994
)
0.29
" The other OCs require a dosage of four pills each time."( FDA finds emergency postcoital contraception safe and effective.
, 1996
)
0.29
" Administration and dosage of the various agents is to be specified by a doctor according to the particular method, and to the state of health of the patient."( [Pharmacological aspects of oral contraceptives (author's transl)].
Simon, P; Soubrie, C; Weil-levy, C, 1980
)
0.26
" Among new preparations, the combination of 2 mg cyproterone acetate and 50 mcg of ethinyl estradiol (EE) has been shown in multicenter European studies to have good effects on acne and satisfactory acceptance despite some hyperestrogenic secondary effects, which may be improved by a new dosage schedule."( [Current issues in contraception].
Audebert, AJ, 1985
)
0.27
" In countries where emergency contraception is only available by prescription, providers should offer an advance prescription or supply (where available), and use newer dosing regimens for levonorgestrel-only emergency contraception to increase adherence and efficacy."( Emergency contraceptive pills: a review of the recent literature.
Conard, LA; Gold, MA, 2004
)
0.32
" Although most had accurate knowledge about the method's dosing schedule, side effects and mechanism(s) of action, more than half erroneously believed that repeated use posed health risks."( Pharmacists' knowledge and perceptions of emergency contraceptive pills in Soweto and the Johannesburg Central Business District, South Africa.
Blanchard, K; Harrison, T; Sello, M, 2005
)
0.33
" Women refrained from nursing for 72 h after dosing and fed their infants with milk frozen beforehand."( Levonorgestrel pharmacokinetics in plasma and milk of lactating women who take 1.5 mg for emergency contraception.
Bouyer, J; Caviedes, R; Forcelledo, ML; Gainer, E; Lillo, S; Massai, R; Reyes, V; Villarroel, C, 2007
)
0.34
" The vast majority (97%) of the respondents were aware of the dosing schedule of the available ECP."( Knowledge and attitudes of pharmacists regarding over-the-counter emergency contraception in South-Eastern Hungary.
Bártfai, G; Szöllosi, AP; Szucs, M, 2010
)
0.36
" Both Phase III clinical trials found that UPA does not lose efficacy within the 120-h dosing interval."( Ulipristal acetate: a new emergency contraceptive.
Bulloch, MN; Sullivan, JL, 2011
)
0.37
"UPA, at the dosage used for EC, does not affect human embryo implantation process, in vitro."( Effects of ulipristal acetate on human embryo attachment and endometrial cell gene expression in an in vitro co-culture system.
Berger, C; Boggavarapu, NR; Gemzell-Danielsson, K; Lalitkumar, PG; Menezes, J, 2015
)
0.42
"This study provides new insights on the mechanism of action of UPA on human embryo implantation, demonstrating that UPA in a dosage used for EC does not affect embryo viability and the implantation process of embryo."( Effects of ulipristal acetate on human embryo attachment and endometrial cell gene expression in an in vitro co-culture system.
Berger, C; Boggavarapu, NR; Gemzell-Danielsson, K; Lalitkumar, PG; Menezes, J, 2015
)
0.42
" Different methods have varying modes of action, time frame of efficacy, dosage schedule and unwanted effects."( Emergency contraception: which is the best?
Mittal, S, 2016
)
0.43
" We also included data from 2 subjects who experienced rupture prior to COC dosing in the analysis."( Combined oral contraceptive interference with the ability of ulipristal acetate to delay ovulation: A prospective cohort study.
Edelman, AB; Hennebold, JD; Jensen, JT; McCrimmon, S; Messerle-Forbes, M; O'Donnell, A, 2018
)
0.48
" Moderate to severe DDI were predicted in 17 cases with CYP3A4 inducers, and dosage adjustments were suggested."( Drug interactions between emergency contraceptive drugs and cytochrome inducers: literature review and quantitative prediction.
Bourguignon, L; Capelle, A; France, M; Goutelle, S; Le Corvaisier, C; Tod, M, 2021
)
0.62
[information is derived through text-mining from research data collected from National Library of Medicine (NLM), extracted Dec-2023]

Research

Studies (1,792)

TimeframeStudies, This Drug (%)All Drugs %
pre-1990477 (26.62)18.7374
1990's339 (18.92)18.2507
2000's640 (35.71)29.6817
2010's276 (15.40)24.3611
2020's60 (3.35)2.80
[information is prepared from research data collected from National Library of Medicine (NLM), extracted Dec-2023]

Study Types

Publication TypeThis drug (%)All Drugs (%)
Trials72 (3.67%)5.53%
Reviews276 (14.07%)6.00%
Case Studies33 (1.68%)4.05%
Observational3 (0.15%)0.25%
Other1,577 (80.42%)84.16%
[information is prepared from research data collected from National Library of Medicine (NLM), extracted Dec-2023]

Clinical Trials (203)

Trial Overview

TrialPhaseEnrollmentStudy TypeStart DateStatus
A Open-label Study to Investigate the Potential Pharmacokinetic Interaction of Perampanel With Oral Contraceptives in Healthy Female Subjects [NCT01209858]Phase 148 participants (Actual)Interventional2010-03-31Completed
Bioavailability of a Formulation of Levonorgestrel and Ethinyl Estradiol 15.0 mg/0.03 mg Coated Tablets With Regards to the Marketed Reference Product [NCT05282940]Phase 136 participants (Actual)Interventional2022-02-26Completed
Phase II Study of Pembrolizumab and Mifepristone in Patients With Advanced HER2-negative Breast Cancer [NCT03225547]Phase 274 participants (Anticipated)Interventional2018-02-12Active, not recruiting
An Open Label Study of 400 mcg Sublingual Misoprostol Following Mifepristone 200 mg for Abortion up to 63 Days LMP [NCT01173003]688 participants (Actual)Interventional2009-06-30Completed
Pharmacokinetics of Levonorgestrel and Ulipristal Acetate Emergency Contraception in Women With Normal and Obese Body Mass Index [NCT02689804]Phase 434 participants (Actual)Interventional2015-07-10Completed
A RANDOMIZED, PHASE II STUDY OF ENZALUTAMIDE, ENZALUTAMIDE WITH MIFEPRISTONE, and TREATMENT OF PHYSICIAN'S CHOICE IN PATIENTS WITH AR+ METASTATIC TRIPLE-NEGATIVE OR ER-LOW BREAST CANCER [NCT06099769]Phase 2201 participants (Anticipated)Interventional2023-10-18Recruiting
A Prospective, Randomized Controlled Trial Comparing the Use of Dienogest and Combined Oral Contraceptive Pills (Microgynon) to Reduce the Risk of Recurrence of Endometriotic Cyst After Conservative Surgery [NCT02385448]Phase 4144 participants (Anticipated)Interventional2015-02-28Recruiting
Short-Term Oral Mifepristone for Central Serous Chorioretinopathy. A Placebo-controlled Dose Ranging Study of Mifepristone in the Treatment of CSC (STOMP-CSC) [NCT02354170]Phase 216 participants (Actual)Interventional2015-01-31Completed
Mifepristone and Misoprostol Versus Misoprostol Alone for Missed Abortion: A Randomized-controlled Trial [NCT02342002]Phase 4416 participants (Anticipated)Interventional2015-01-31Terminated(stopped due to lack of funding)
Alternative Provision of Medication Abortion Via Pharmacy Dispensing [NCT03320057]Phase 4326 participants (Actual)Interventional2018-06-01Completed
A Non-randomised, Open-label Phase I Trial to Evaluate the Effect of BI 456906 at Different Dose Levels of Multiple Subcutaneous Doses in a Titration Scheme on the Single Dose Pharmacokinetics of a Combination of Ethinylestradiol and Levonorgestrel in Oth [NCT05896384]Phase 124 participants (Anticipated)Interventional2023-12-07Not yet recruiting
An Outpatient Medical Abortion Regimen With Mifepristone and Two Doses of Misoprostol at 71-77 and 78-84 Days of Pregnancy [NCT05119439]Phase 423 participants (Actual)Interventional2022-10-07Terminated(stopped due to Enrollment)
A Prospective, Randomized, Double-blind Parallel-arm, Placebo-controlled Study to Assess the Effects on Ovarian Activity of a Combined Oral Contraceptive Pill When Preceded by the Intake of ellaOne® (Ulipristal Acetate 30 mg) or Placebo. [NCT01569113]Phase 476 participants (Actual)Interventional2012-03-31Completed
Improving Access to Abortion in the Republic of Georgia [NCT04458558]Phase 4120 participants (Anticipated)Interventional2020-06-30Recruiting
A Phase I Adaptive Dose, Double-Blind, Placebo-Controlled, SAD and MAD Study to Measure the Safety, Tolerability, Pharmacokinetics and Pharmacological Effects of Orally Administered CORT125134 in Healthy Subjects [NCT03508635]Phase 1130 participants (Actual)Interventional2014-09-30Completed
Acceptability and Feasibility of a Simplified Medical Abortion Regimen in Georgia: A Study of 400 mcg Buccal Misoprostol Following 200 mg Mifepristone for Abortion up to 63 Days Gestation [NCT02398838]622 participants (Actual)Interventional2009-12-31Completed
A Randomized, Placebo-Controlled, Double-Blind, Phase II Trial of Nanoparticle Albumin-Bound Paclitaxel (Nab-Paclitaxel, Abraxane®) With or Without Mifepristone for Advanced, Glucocorticoid Receptor-Positive, Triple-Negative Breast Cancer [NCT02788981]Phase 264 participants (Anticipated)Interventional2017-03-28Active, not recruiting
A Pilot Study on the Safety and Efficacy of Mifepristone for the Prevention of Relapses of Alcohol Drinking [NCT02243709]Phase 1/Phase 232 participants (Actual)Interventional2014-09-30Completed
Outpatient Medical Abortion With Mifepristone and Misoprostol Through 77 Days of Gestation: A Non-inferiority Trial [NCT02314754]Phase 4719 participants (Actual)Interventional2014-12-31Completed
Study of Hypercortisolism in Patients With Difficult to Control Type 2 Diabetes Despite Receiving Standard-of-Care Therapies: Prevalence and Treatment With Korlym® (Mifepristone) (CATALYST) [NCT05772169]Phase 41,000 participants (Anticipated)Interventional2023-03-31Recruiting
Open Label, One-way Crossover Study to Assess the in Vivo Formation of Ethinylestradiol Following Single Intramuscular Administration of 200 mg Norethisterone Enantate Compared to Ethinylestradiol Pharmacokinetics After Multiple Doses of a Combined Oral C [NCT02170038]Phase 116 participants (Actual)Interventional2014-06-30Completed
A Randomized, Double-blind, 2-Period, 2-Sequence Crossover Phase I Study With a 1 Month run-in Period to Examine the Effect of Cladribine Tablets on the PK of a Monophasic Oral Contraceptive Containing Ethinyl Estradiol and Levonorgestrel (Microgynon®) in [NCT03745144]Phase 124 participants (Actual)Interventional2019-01-17Completed
An Open, Two-period, Fixed-sequence, Phase I Trial to Evaluate the Effect of Multiple Doses of BI 1356 on the Multiple-dose Pharmacokinetics of a Combination of Ethinylestradiol and Levonorgestrel [NCT02175394]Phase 118 participants (Actual)Interventional2008-07-31Completed
Randomized Controlled Trial of Mifepristone Versus Laminaria for Cervical Ripening In Midtrimester Induction [NCT00383032]72 participants Interventional2004-01-31Completed
Investigation of the Effect of Subcutaneously Co-administered Semaglutide and NNC0480-0389 on Pharmacokinetics of an Oral Combination Contraceptive (Ethinylestradiol and Levonorgestrel) in Healthy Postmenopausal Females [NCT05153564]Phase 127 participants (Actual)Interventional2021-12-13Completed
A Multicenter Randomized Clinical Trial of Mifepristone Versus GnRHa for the Treatment of Adenomyosis [NCT05151016]Early Phase 1140 participants (Anticipated)Interventional2021-12-01Not yet recruiting
The Effect of a Progesterone Receptor Modulator on Breast Tissue in Women With BRCA-1 and -2 Mutations - a Placebo Controlled RCT. [NCT01898312]Phase 245 participants (Actual)Interventional2013-09-30Completed
Cervical Prostaglandin EP3 Receptor mRNA Expression 48 Hours After Administration of Mifepristone [NCT01224509]18 participants (Actual)Interventional2004-09-30Terminated(stopped due to Longer than expected recruitment period.)
A Biomarker Study of Mifepristone in Early Stage Breast Cancer [NCT01138553]Early Phase 14 participants (Actual)Interventional2010-06-30Terminated(stopped due to Inadequate subject accrual)
Efficacy of Mifepristone in Males With Type 2 Diabetes Mellitus [NCT03052400]Phase 28 participants (Actual)Interventional2017-02-03Terminated(stopped due to End of Funding)
The Effect of Multiple Doses of BI 425809 on the Pharmacokinetics of Multiple Doses of a Combination of Ethinylestradiol and Levonorgestrel Following Oral Administration in Healthy Premenopausal Female Subjects (an Open-label, Two-period, Fixed Sequence D [NCT05613777]Phase 119 participants (Actual)Interventional2022-11-24Completed
Evaluation of Efficacy of Two Therapeutic Strategies for Cervical Maturation Before Medical Termination: Mechanical Plus Medicinal Maturation vs Medicinal Maturation Alone [NCT03194126]120 participants (Actual)Interventional2018-02-11Completed
A Pilot Study of the Effect of a Glucocorticoid Receptor Antagonist in Patients With Subclinical Cushings [NCT00721201]Phase 1/Phase 26 participants (Anticipated)Interventional2008-11-30Completed
A Multicenter, Randomized, Double-blind, Active-controlled, Parallel Group, 2-arm Study to Show Superiority of the Oral Contraceptive SH T00658ID Over Microgynon on Hormone Withdrawal-associated Symptoms After 6 Cycles of Treatment [NCT00778609]Phase 3449 participants (Actual)Interventional2008-12-31Completed
"Evaluating the Safety, Acceptability and Feasibility of an Outpatient Day Procedure Service Documenting the Roles of Health Workers in the Provision of Medical Abortion at 13-18 Weeks Gestation" [NCT03346629]Phase 4230 participants (Actual)Interventional2017-12-01Completed
Comparison of Efficacy and Safety of Sequential Use of Mifepristone and Misoprostol vs Misoprostol Alone in Women With Early Pregnancy Loss: Randomized Controlled Trial [NCT05124314]Phase 4220 participants (Anticipated)Interventional2021-10-27Recruiting
Compassionate Use Protocol for the Administration of CORLUX® (Mifepristone) in the Treatment of the Signs and Symptoms of Endogenous Cushing's Syndrome [NCT01371565]Phase 34 participants (Actual)Interventional2010-11-30Completed
RESET-medication: Glucocorticoid Receptor (GR) Blockade as Diseasemodifying Treatment for Depression With Childhood Trauma [NCT05217758]Phase 2158 participants (Anticipated)Interventional2021-12-09Recruiting
A Randomised Placebo-controlled Trial of Mifepristone and Misoprostol Versus Misoprostol Alone in the Medical Management of Missed Miscarriage [NCT03065660]Phase 3711 participants (Actual)Interventional2017-09-20Completed
Mifepristone 5 mg Versus 10 mg for the Treatment of Uterine Leiomyomata. A Randomized, Double Blinded Clinical Trial. [NCT00712595]Phase 2/Phase 3200 participants (Actual)Interventional2007-01-31Completed
A Phase I, Open-Label, Fixed-Sequence Study to Determine the Effect of Single and Multiple Oral Doses of CORLUX (TM) (Mifepristone) on the Pharmacokinetics of a Single Oral Dose of Fluvastatin (a CYP2C9 Probe) in Healthy Volunteers [NCT00752843]Phase 120 participants (Actual)Interventional2008-09-30Completed
Uptake and Acceptability of Home-use of Mifepristone for Medical Abortion [NCT00994734]615 participants (Actual)Interventional2009-05-31Completed
Mifepristone 5 mg Versus 10 mg During 6 Months for the Treatment of Uterine Leiomyomata. A Randomized, Double Blinded Clinical Trial. [NCT00886873]Phase 2/Phase 3100 participants (Actual)Interventional2008-05-31Completed
Single Center, Double Blind, Randomized, Crossover Study to Investigate the Impact of the Oral Contraceptive Yasmin (30 µg EE / 3 mg DRSP) Compared to Microgynon (30 µg / 150 LNG) on Hemostasis Parameters in 40 Female Volunteers [NCT00651846]Phase 443 participants (Actual)Interventional2003-06-30Completed
Mifepristone Versus Osmotic Dilators in Conjunction With Misoprostol for Cervical Preparation Prior to D&E at 14-19 Weeks [NCT02679092]0 participants (Actual)Interventional2016-04-30Withdrawn(stopped due to Funding changes.)
Comparing Two Regimens for Medical Abortion: Mifepristone+Misoprostol Versus Misoprostol Alone [NCT00680394]440 participants (Actual)Interventional2007-07-31Completed
Novel Therapeutics in PTSD: A Randomized Clinical Trial of Mifepristone [NCT00833339]Phase 280 participants (Anticipated)Interventional2008-05-31Recruiting
A Single-Center, Open-Label, Crossover, Randomized Study to Investigate the Impact of the Transdermal Contraceptive Patch Containing 0.55 mg Ethinylestradiol and 2.1 mg Gestodene (Material no. 80876395) in a 21-day Regimen as Compared to a Monophasic Cont [NCT00933179]Phase 230 participants (Actual)Interventional2009-06-30Completed
Evaluation of the Efficacy, Tolerance of the Treatment, and Patient Satisfaction During the Management of an Arrested Pregnancy in the First Trimester According to the New Toulouse University Hospital Protocol [NCT05049980]52 participants (Actual)Interventional2021-11-01Completed
Microgynon Riociguat Drug Interaction Study to Investigate the Effect of Riociguat 2.5 mg 3 Times Daily Multiple-dose Treatment on the Plasma Concentrations of / Exposure to Levonorgestrel and Ethinyl Estradiol in Healthy Postmenopausal Women in a 2-fold [NCT02159326]Phase 131 participants (Actual)Interventional2014-06-30Completed
A Phase II Study of Treatment With Oral Mifepristone as Salvage Therapy in Patients With Advanced or Metastatic Non-Small Cell Lung Cancer Who Have Failed Two or More Previous Chemotherapy Regimens [NCT02642939]Phase 23 participants (Actual)Interventional2015-12-31Terminated(stopped due to Lack of enrollment)
Glucocorticoid Antagonists in Heavy Drinkers: Effects on fMRI Connectivity, Withdrawal and Drinking [NCT02989662]150 participants (Anticipated)Interventional2016-02-29Recruiting
A Randomized, Double-blind Placebo-controlled Crossover Trial of Mifepristone in Gulf War Veterans With Chronic Multisymptom Illness [NCT00691067]Phase 465 participants (Actual)Interventional2008-05-31Completed
Mifepristone and Misoprostol Versus Misoprostol Alone for Mid-trimester Termination of Pregnancy (14 - 21 Weeks LMP): A Randomized-controlled Double-blinded Trial [NCT00784186]120 participants (Actual)Interventional2008-08-31Completed
Comparison Between Misopristol and Pitocin After Mifepristone Preparation for Second Trimeter Abortion [NCT00784797]Phase 4145 participants (Actual)Interventional2009-01-31Completed
Understanding Gulf War Illness: An Integrative Modeling Approach [NCT04255498]Phase 120 participants (Anticipated)Interventional2017-10-30Recruiting
Pilot Study of an Ambulatory Medical Abortion Service at 13-18 Weeks of Gestation in Colombia [NCT04063904]Phase 416 participants (Actual)Interventional2019-10-16Terminated(stopped due to Difficulties with recruitment, COVID 19 pandemic)
Mifepristone and Misoprostol Versus Misoprostol Alone for Treatment of Fetal Death at 14-28 Weeks of Pregnancy: A Randomized, Placebo-controlled Double-blinded Trial [NCT02633761]Phase 3200 participants (Anticipated)Interventional2015-04-01Terminated(stopped due to Lack of funding)
The Effect of Vaginal Mifepristone on Reduction of Uterine Fibroids Size and the Symptoms Associated With the Fibroids - Pilot Study (Phase IIa) [NCT00881140]Phase 230 participants (Actual)Interventional2009-04-30Completed
Medical Termination of Pregnancy Due to Emergency Contraception Failure: A Randomized Trial Comparing Mifepristone Combined Misoprostol and Misoprostol Alone. [NCT00677755]394 participants (Actual)Interventional2004-10-31Completed
A Randomized Controlled Trial to Compare Sublingual and Buccal Misoprostol Regimens After Mifepristone for Termination of Pregnancy 13 - 21 Weeks From Last Menstrual Period (LMP) [NCT02708446]Phase 4320 participants (Anticipated)Interventional2014-05-31Recruiting
Mifepristone and Misoprostol Versus Misoprostol Alone for Mid-trimester Termination of Pregnancy (14-21 Weeks LMP): A Randomized-controlled Double-blinded Trial [NCT00957346]Phase 320 participants (Anticipated)Interventional2011-02-28Terminated
Mifepristone and Misoprostol Versus Misoprostol Alone for Mid-trimester Termination of Pregnancy (14 - 21 Weeks LMP): A Randomized-controlled Double-blinded Trial [NCT00969982]238 participants (Actual)Interventional2009-06-30Completed
Multi-center, Double-blind, Randomized Study to Investigate the Impact of a Sequential Oral Contraceptive Containing Estradiol Valerate and Dienogest (SH T00658ID) Compared to a Monophasic Contraceptive Containing Ethinylestradiol and Levonorgestrel (Micr [NCT00764881]Phase 3217 participants (Actual)Interventional2009-01-31Completed
The Effectiveness, Safety, and Acceptability of Home-administered Medical Abortion at Gestational Age of 8 to ≤9 Weeks Versus >9 to ≤12 Weeks: A Prospective Cohort Study in Mexico City [NCT02745093]Phase 4648 participants (Anticipated)Interventional2016-09-30Not yet recruiting
A Pilot Study of the Acceptability and Feasibility of an Out-patient Regimen of Medical Abortion With Mifepristone and 400 mcg Sublingual Misoprostol at 71-77 and 78-84 Days Gestation [NCT02720991]Phase 450 participants (Actual)Interventional2014-07-31Completed
Pre-treatment With Mifepristone in Patients With Mirena for Optimizing Bleeding Pattern in Pre-menopausal Women [NCT01931657]Phase 260 participants (Anticipated)Interventional2013-08-31Completed
Carboplatin, Gemcitabine, and Mifepristone for Advanced Breast Cancer and Recurrent or Persistent Epithelial Ovarian Cancer [NCT02046421]Phase 131 participants (Actual)Interventional2013-11-30Completed
An Open-label Study of the Efficacy and Safety of CORLUX (Mifepristone) in the Treatment of the Signs and Symptoms of Endogenous Cushing's Syndrome [NCT00569582]Phase 350 participants (Actual)Interventional2007-12-31Completed
A Phase II Evaluation of Mifepristone in the Treatment of Recurrent or Persistent Epithelial Ovarian or Primary Peritoneal Carcinoma [NCT00459290]Phase 224 participants (Actual)Interventional2007-05-31Completed
Assessing Acceptability and Use of Medical Menstrual Regulation in the United States [NCT03972358]Phase 2284 participants (Anticipated)Interventional2020-02-12Recruiting
Treatment of Early Pregnancy Failure [NCT00468299]16 participants (Actual)Interventional2007-04-30Terminated(stopped due to poor enrollment)
A Double-blind, Placebo-controlled Study of Mifepristone in Patients With Non-psychotic Major Depressive Disorder Referred for Bilateral Electroconvulsive Therapy (ECT) [NCT00285818]11 participants (Actual)Interventional2003-01-31Completed
Cervical Preparation With Mifepristone Prior to Osmotic Dilators: A Randomized, Double-blind, Placebo-controlled Pilot Study [NCT03714880]Phase 244 participants (Actual)Interventional2019-04-26Terminated(stopped due to Slow recruitment compounded by COVID-19)
Effects of Mifepristone on Biomarkers of Metabolic Function and Neuropsychological Performance Among Middle-Aged and Older Individuals [NCT01988610]Phase 123 participants (Actual)Interventional2013-10-31Completed
Phase 1 Study of Mifepristone in Combination With Eribulin in Patients With Locally Advanced/Metastatic Breast or Other Specified Solid Tumors, With a Dose Expansion Cohort in Patients With Triple Negative Breast Cancer. [NCT02014337]Phase 137 participants (Actual)Interventional2014-01-31Completed
Acceptability and Feasibility of a Simplified Medical Abortion Regimen in Kazakhstan: A Study of 600 µg Sublingual Misoprostol Following 200 mg Mifepristone for Abortion up to 70 Days Gestation [NCT02018796]290 participants (Actual)Observational2013-10-31Completed
Acceptability and Feasibility of a Demedicalized Medical Abortion Regimen in the Caucasus [NCT02219100]613 participants (Actual)Interventional2010-11-30Completed
Early Versus Delayed Insertion of Nexplanon® at Medical Abortion - a Randomized Controlled Equivalence Trial. [NCT01920022]Phase 4551 participants (Actual)Interventional2013-10-31Completed
A Pilot Study of Mifepristone Followed by Misoprostol in Women Undergoing Second Trimester Abortion [NCT00592215]Phase 10 participants (Actual)Interventional2008-03-31Withdrawn
Hypothalamic-Pituitary-Adrenal (HPA)/Dopamine Axis in Psychotic Depression [NCT00867360]Phase 310 participants (Actual)Interventional2005-08-31Terminated(stopped due to Insufficient recruitment.)
Non-surgical Alternatives to Treatment of Failed Medical Abortion: A Randomized Controlled Double-blind Trial [NCT02704481]Phase 416 participants (Actual)Interventional2016-06-01Terminated(stopped due to Funding mechanism compromised)
The Effect of Atazanavir/Cobicistat on the Pharmacokinetics of an Oral Contraceptive Containing Ethinylestradiol and Levonorgestrel (Microgynon 30®) in Healthy Women [NCT02697851]Phase 113 participants (Actual)Interventional2016-07-31Terminated(stopped due to "Insufficient enrolment and business reasons")
A Trial Investigating the Influence of Oral Semaglutide on Pharmacokinetics of Ethinylestradiol and Levonorgestrel in an Oral Contraceptive Combination Drug in Healthy Postmenopausal Females [NCT02845219]Phase 125 participants (Actual)Interventional2016-07-31Completed
Mifepristone and Misoprostol for the Treatment of Early Pregnancy Failure: a Pilot Clinical Trial [NCT00177372]Phase 430 participants (Actual)Interventional2005-01-31Completed
Feasibility and Acceptability of Dispensing Mifepristone Via Mail Order Pharmacy [NCT03913104]Phase 4538 participants (Actual)Interventional2020-01-05Active, not recruiting
Comparison of the Effectiveness of Abortive Measures From the Administration of Mifegyne and Cytotec at One and Two Visits [NCT00920465]Phase 3200 participants (Anticipated)Interventional2009-06-30Recruiting
The Extended Gestational Age Medical Abortion Study: The Effectiveness of Medical Abortion With Mifepristone and Misoprostol at 57-63 Days Versus 64-70 Days Gestation [NCT00997347]Phase 41,400 participants (Actual)Interventional2009-07-31Completed
A Randomised, Double-blind, Two-way Crossover Study to Determine the Effects of Co-administration of AZD6140 and Nordette® (Combination of Levonorgestrel and Ethinyl Estradiol) After Multiple Oral Doses in Healthy Female Volunteers [NCT00685906]Phase 124 participants (Anticipated)Interventional2008-04-30Completed
[NCT00206193]0 participants ObservationalRecruiting
The Effect of Preoperative Treatment With Mifepristone on Uterine Fibroids and Breast Tissue [NCT00579475]Phase 130 participants (Actual)Interventional2004-11-30Completed
The Acceptability of an Out-patient Regimen of Medical Abortion With Mifepristone and 800 Mcg Misoprostol Administered Buccally or Sublingually at 78-84 Days Gestation: Two Pilot Studies [NCT01856985]Phase 450 participants (Actual)Interventional2013-04-30Completed
Mifepristone and Misoprostol for Undesired Pregnancy of Unknown Location: A Randomized Pilot Study of Misoprostol Dosing [NCT05839899]Phase 350 participants (Anticipated)Interventional2023-08-30Recruiting
COMPARATIVE STUDY OF EFFECTS BETWEEN LETROZOLE PLUS MISOPROSTOL AND MIFEPRISTONE PLUS MISOPROSTOL IN TERMINATING NON-VIABLE FIRST TRIMESTER PREGNANCIES [NCT05304273]Phase 3120 participants (Anticipated)Interventional2022-05-05Recruiting
Mifepristone Treatment for Breast Cancer Patients Expressing Levels of Progesterone Receptor Isoform A (PRA) Higher Than Those of Isoform B (PRB): Neoadjuvant Therapy. [NCT02651844]20 participants (Actual)Interventional2016-04-30Completed
A Randomized Phase I Trial of Nanoparticle Albumin Bound Paclitaxel (Nab-paclitaxel, Abraxane) With or Without Mifepristone for Advanced Breast Cancer [NCT01493310]Phase 19 participants (Actual)Interventional2011-11-30Completed
Phase II Study of Mifepristone (RU-486) in the Treatment of PR Positive Advanced/Recurrent Endometrioid Adenocarcinoma and Low Grade Endometrial Stromal Sarcoma (LGESS) [NCT00505739]Phase 213 participants (Actual)Interventional2001-09-30Completed
Mifepristone Outpatient Labour Induction [NCT05177510]Phase 3400 participants (Anticipated)Interventional2023-08-25Recruiting
Mifepristone After Trauma to Enhance Resilience [NCT00554177]Phase 15 participants (Actual)Interventional2007-09-30Completed
The Use of Letrozole or Mifepristone for Pretreatment of Medical Termination of Pregnancy: a Randomized, Non-inferiority Trial [NCT05341817]Phase 4144 participants (Anticipated)Interventional2022-11-22Recruiting
An Open Label Extension Study of the Efficacy and Safety of CORLUX® (Mifepristone) in the Treatment of the Signs and Symptoms of Endogenous Cushing's Syndrome [NCT00936741]Phase 330 participants (Actual)Interventional2009-07-31Completed
A Randomized, Double-blind, Parallel-group, Multi-center Study to Investigate the Pharmacodynamics and Pharmacokinetics of a Combined Oral Contraceptive Containing Levonorgestrel (LNG) and Ethinylestradiol (EE) When Given Together With Vilaprisan Over 3 M [NCT03210246]Phase 171 participants (Actual)Interventional2017-07-17Completed
Mifepristone Tablets in the Treatment of Symptomatic Uterine Fibroids With Safety and Efficacy in Open, Multicenter Phase IV Clinical Studies [NCT03210324]Phase 4434 participants (Actual)Interventional2017-06-01Terminated(stopped due to It is difficult to recruit enough participants)
A Pilot Study on the Combined Use of Letrozole, Miferpristone and Misoprostol in Termination of First Trimester Pregnancy up to 63 Days Gestation [NCT01475318]50 participants (Anticipated)Interventional2011-10-31Recruiting
Pharmacodynamic Assessment to Drug Ciclo 21 (Levonorgestrel + Ethinyl Estradiol) Market by União Química Farmacêutica Nacional S/A Compared to Drug Nordette of Wieth Indústria Farmacêutica Ltda. [NCT01480778]Phase 362 participants (Actual)Interventional2014-07-31Completed
A Randomized, Placebo-Controlled, Phase I/II Trial of the Anti-HIV Activity and Safety of VGX-410 (Mifepristone) at Three Dose Levels in HIV-1 Infected Subjects [NCT00099645]Phase 1/Phase 248 participants InterventionalCompleted
A Double-blind, Placebo-controlled Trial of the Safety and Efficacy of C-1073 (Mifepristone) as Adjunctive Therapy in Alzheimer's Disease [NCT00105105]Phase 2160 participants Interventional2003-04-30Terminated
Medication Enhanced Rapid Therapy [NCT02099825]Phase 115 participants (Actual)Interventional2014-01-13Terminated(stopped due to COVID and staffing issues)
[NCT00482209]1,220 participants (Anticipated)Interventional2007-05-31Completed
An International, Double-Blind, Placebo-Controlled, Study of the Efficacy and Safety of CORLUX™ (Mifepristone) vs. Placebo in the Treatment of Psychotic Symptoms in Patients With Psychotic Major Depression (PMD) [NCT00146523]Phase 3247 participants (Actual)Interventional2005-05-31Completed
A Randomized, Double-Blind, Placebo-Controlled Study of Safety and Efficacy of CORLUX™ (Mifepristone) in the Treatment of Psychotic Symptoms in Patients With Major Depressive Disorder With Psychotic Features [NCT00130676]Phase 3257 participants (Actual)Interventional2004-09-30Completed
A Phase II Study of Mifepristone (RU-486) in Androgen Independent Prostate Cancer With Correlative Assessment of Androgen Receptor Co-Repressor Proteins [NCT00140478]Phase 248 participants (Anticipated)Interventional2005-02-28Completed
A Double-Blind, Placebo-Controlled Study of the Efficacy and Safety of Mifepristone vs. Placebo in the Treatment of Psychotic Symptoms in Patients With Major Depressive Disorder With Psychotic Features [NCT00637494]Phase 3292 participants (Actual)Interventional2008-03-31Terminated(stopped due to DRC recommended stopping study as it had missed its primary endpoint)
Investigation of the Effects of Mifepristone (RU486) on Stress Sensitivity and Relapse Prevention in Cocaine Dependent Patients [NCT01134198]Phase 2/Phase 358 participants (Actual)Interventional2010-05-31Completed
An Open-label, Two-period, Fixed-sequence Trial to Evaluate the Effect of Multiple Doses of BI 10773 on the Multiple-dose Pharmacokinetics of a Combination of Ethinylestradiol and Levonorgestrel in Healthy Premenopausal Female Volunteers [NCT01328184]Phase 118 participants (Actual)Interventional2011-04-30Completed
Antiglucocorticoid Therapy for Cognitive Impairment in Late-life Anxiety Disorders [NCT01333098]Phase 1/Phase 215 participants (Actual)Interventional2012-09-30Completed
"Assessing Use Of Mifepristone After Progestin Priming For Use As Missed Period Pills" [NCT04676776]Phase 2139 participants (Anticipated)Interventional2021-01-25Recruiting
Preliminary, Double Blind, Placebo Controlled Trial of the Effect of Glucocorticoid Receptor Antagonist Treatment on Biologic and Symptom Outcomes in Patients With Borderline Personality Disorder and Histories of Childhood Abuse [NCT01212588]Phase 222 participants (Actual)Interventional2010-09-30Terminated(stopped due to Funding ended)
A Two-Week, Double-Blind, Placebo-Controlled Study of the Efficacy and Safety of Mifepristone in the Prevention of Olanzapine-Induced Weight Gain in Healthy Male Volunteers [NCT00455442]Phase 257 participants (Actual)Interventional2007-03-31Completed
Randomized Control Trial Of Mifepristone for Fibroids [NCT00133705]Phase 370 participants (Actual)Interventional2003-07-31Completed
A Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study of the Safety and Efficacy of Three Dose Levels of CORLUX™ (Mifepristone) Plus an Antidepressant vs. Placebo Plus an Antidepressant in the Treatment of Psychotic Symptoms in Patients Wit [NCT00128479]Phase 3443 participants (Actual)Interventional2004-09-30Completed
Antiglucocorticoid Therapy in Bipolar Depression With Mifepristone (RU486) [NCT00043654]Phase 2110 participants Interventional2002-08-07Completed
Increased Access to Emergency Contraceptive Pills [NCT00060463]1,490 participants Interventional2002-10-31Active, not recruiting
An International, Open-Label Extension Study of the Safety and Tolerability of CORLUX™ (Mifepristone) for Recurrent Psychotic Symptoms in Patients With Major Depressive Disorder With Psychotic Features [NCT00128505]Phase 3104 participants (Actual)Interventional2005-08-31Completed
Mifepristone vs. Laminaria Insertion for Cervical Preparation Prior to Surgical Abortion at 14-16 Weeks [NCT00986921]50 participants (Actual)Interventional2009-10-31Completed
An Open-Label Extension Study of the Safety and Tolerability of CORLUX™ (Mifepristone) for Recurrent Psychotic Symptoms in Patients With Major Depressive Disorder With Psychotic Features [NCT00208156]Phase 387 participants (Actual)Interventional2005-05-31Completed
A Placebo Controlled Study on the Efficacy of 10 mg Oral Mifepristone for the Treatment of Symptomatic Uterine Leiomyomas [NCT00219778]Phase 220 participants (Anticipated)Interventional2004-12-31Terminated
Prospective, Multicenter, Open-label, Uncontrolled Study to Investigate the Contraceptive Efficacy, Bleeding Patterns, and Safety of an Oral Contraceptive Containing 0.03 mg Ethinylestradiol and 0.125 mg Levonorgestrel (SH D00342A) Applied for 13 Cycles t [NCT00220324]Phase 3840 participants (Actual)Interventional2004-02-29Completed
Glucocorticoid and Mineralocorticoid Receptor Function in Post Traumatic Stress Disorder [NCT00046553]97 participants Observational2002-09-30Completed
A Single-center, Open-label, Controlled, Randomized Study to Investigate the Impact of a Sequential Oral Contraceptive (SH T00658ID) as Compared to a Sequential Oral Contraceptive Containing Ethinylestradiol and Levonorgestrel (SH D00264A) on Plasma Lipid [NCT00185224]Phase 258 participants (Actual)Interventional2005-03-31Completed
Comparison Expectant With Immediate Medical Management for the Evacuation of the no Evolutionary Pregnancies Before 13 GW [NCT00190294]Phase 4200 participants (Actual)Interventional2003-04-30Completed
Prospective, Open-Label, Multicenter, International Study of Mifepristone for Symptomatic Treatment of Cushing's Syndrome Caused by Ectopic Adrenal Corticotrophin Hormone (ACTH) Secretion [NCT00422201]Phase 218 participants (Actual)Interventional2007-05-15Terminated
INST 0817: Compassionate Use of Mifepristone [NCT00832871]4 participants (Actual)Interventional2008-11-30Terminated(stopped due to Low accrual; 4 patients enrolled between 2008-2015)
Psychophysiology of Delayed Extinction and Reconsolidation in Humans [NCT01631682]Phase 4186 participants (Actual)Interventional2010-11-30Completed
Cervical Rippening With Antiprogesterone in Midtrimester Abortions [NCT00410345]Phase 4145 participants (Actual)Interventional2004-08-31Completed
An Open-label Study to Evaluate the Contraceptive Efficacy and Safety of the Transdermal Contraceptive System of 17-deacetylnorgestimate and Ethinyl Estradiol With the Oral Contraceptive Triphasil. [NCT00236795]Phase 31,494 participants (Actual)Interventional1997-01-31Completed
A Multicenter, Randomized Comparison of Mifepristone and Misoprostol Administered Simultaneously Versus 24 Hours Apart for Abortion Through 63 Days [NCT00269568]Phase 41,128 participants (Actual)Interventional2004-06-30Completed
Mifepristone 2.5, 5, 10 mg Versus Placebo in the Treatment of Endometriosis [NCT02271958]Phase 2/Phase 3360 participants (Actual)Interventional2010-11-30Completed
A Randomized Study of Sublingual Versus Oral Misoprostol Administration Following Mifepristone 200 mg for Abortion up to 63 Days Gestation [NCT00286208]1,443 participants (Actual)Interventional2005-08-31Completed
Oral Mifepristone and Buccal Misoprostol Administered Simultaneously for Abortion Through 63 Days Gestation [NCT00330993]Phase 2120 participants Interventional2006-03-31Completed
A Single Centre Open-label Randomised Controlled Trial of Long Term Pituitary Down-regulation Before in Vitro Fertilisation for Women With Endometriosis: a Pilot Study [NCT01757249]Phase 45 participants (Actual)Interventional2013-01-31Terminated(stopped due to Unable to recruit sufficient participants)
Medical Abortion With Mifepristone + Misoprostol (13 - 22 Weeks): A Double-blind Randomized-controlled Trial [NCT01768299]Phase 4504 participants (Actual)Interventional2013-02-28Completed
Treatment of Uterine Myoma With 2.5 or 5 mg Mifepristone Daily During 3 Months With 9 Months Post-treatment Follow-up. Randomized Clinical Trial. [NCT01786226]Phase 2/Phase 3220 participants (Actual)Interventional2010-03-31Terminated
Exploring a Patient-centered Approach to Mifepristone Administration in Medical Abortion [NCT01811056]401 participants (Actual)Interventional2013-04-30Completed
Acceptability and Feasibility of a Simplified Medical Abortion Service Delivery in Western Ukraine: A Demonstration Study of 800 mcg Buccal Misoprostol Following 200 mg Mifepristone for Abortion up to 70 Days Gestation [NCT02981030]Phase 4102 participants (Actual)Interventional2016-11-23Completed
An Open-label, Two-period, Fixed-sequence, Phase I Trial to Evaluate the Effect of Multiple Doses of BI 207127 + Faldaprevir on the Multiple-dose Pharmacokinetics of a Combination of Ethinylestradiol and Levonorgestrel in Healthy Premenopausal Female Subj [NCT01941615]Phase 118 participants (Actual)Interventional2013-11-30Terminated
Mifepristone Versus Misoprostol for Cervical Preparation Prior to Surgical Abortion Between 11 to 15 Weeks [NCT01636063]42 participants (Actual)Interventional2012-06-30Terminated(stopped due to Poor subject enrollment)
Comparative Effectiveness of Pregnancy Failure Management Regimens [NCT02012491]Phase 3300 participants (Actual)Interventional2014-01-31Completed
Double Blind Randomized Trial of the Anti-Progestational Agent Mifepristone In The Treatment of Unresectable Meningioma [NCT03015701]Phase 3193 participants (Actual)Interventional1992-08-31Completed
Value of Mifepristone in Eliminating the Need for a Second Set of Osmotic Dilators Prior to Dilation and Evacuation Between 19-24 Weeks: A Randomized Trial [NCT01615731]50 participants (Actual)Interventional2012-05-31Completed
A Randomized, Open-label Phase II Trial of the Anti-HCV Activity and Safety of VGX-410 (Mifepristone) at 3 Dose Levels in HCV Infected Patients [NCT00255177]Phase 244 participants (Actual)Interventional2005-11-30Completed
Mifepristone Versus Osmotic Dilator Insertion for Cervical Preparation Prior to Surgical Abortion at 15-18 Weeks [NCT01436279]Phase 350 participants (Actual)Interventional2011-07-31Completed
Glucocorticoid Antagonist Treatment of Alcohol Use Disorder [NCT02179749]Phase 2103 participants (Actual)Interventional2014-09-30Completed
Single-Center, Randomized, Double-Blind, Placebo Controlled, Crossover Study to Assess the Effect of Aleglitazar on the Pharmacokinetics and Pharmacodynamics of Ethinyl Estradiol and Levonorgestrel as Components of the Oral Contraceptive Microgynon® [NCT01615354]Phase 118 participants (Actual)Interventional2012-07-31Completed
Cervical Preparation of Abortions Under Paracervical Block in the First Trimester: A Randomized Clinical Trial [NCT03043014]110 participants (Actual)Interventional2017-06-01Completed
Mifepristone Induction for Fetal Demise, a Randomized Control Trial [NCT02620904]Phase 49 participants (Actual)Interventional2016-07-14Terminated(stopped due to unable to recruit. Projected completion was 2018 however, enrollment and recruitment were difficult. The study was terminated due to inability to enroll.)
An Open-Label, Randomized, Two-Way Crossover Study to Investigate the Potential Pharmacokinetic Interaction of Padsevonil With Oral Contraceptives in Healthy Female Participants [NCT04131517]Phase 114 participants (Actual)Interventional2019-10-23Terminated(stopped due to Based on available data, UCB has decided to stop development of padsevonil as adjunctive treatment of focal-onset seizures)
A Randomized Trial of Mifepristone Antagonization With High-Dose Progesterone to Prevent Medical Abortion [NCT03774745]Phase 1/Phase 212 participants (Actual)Interventional2019-02-11Terminated(stopped due to Safety)
A Randomized, Placebo-Controlled, Double-Blinded Study of Mifepristone in Midtrimester Termination of Pregnancy [NCT00382538]64 participants Interventional2005-03-31Completed
Acceptability and Feasibility of Medical Abortion in Mexico, Puerto Rico, Armenia and Azerbaijan: A Study of Buccal Misoprostol Administration Following Mifepristone 200 mg for Abortion up to 63 Days' Gestation [NCT00386282]1,250 participants (Actual)Interventional2006-09-30Completed
Glucocorticoid Receptor Blockade With Mifepristone in Patients With Mild Adrenal Hypercortisolism [NCT01990560]Phase 48 participants (Actual)Interventional2013-11-30Completed
Prospective Non Interventional Phase IV Multi-centre Canadian Study on the Effectiveness and Safety of Combination Mifepristone/Misoprostol for Medical Abortion Under 63 Days Gestation [NCT04905251]3,000 participants (Anticipated)Observational2022-02-22Recruiting
The HYsteroscopic Miscarriage MaNagement (HYMMN) Trial [NCT04751500]149 participants (Actual)Interventional2021-01-31Completed
A Phase I Trial to Investigate the Effect of Nintedanib on the Pharmacokinetics of a Combination of Ethinylestradiol and Levonorgestrel in Female Patients With Systemic Sclerosis Associated Interstitial Lung Disease (SSc-ILD) [NCT03675581]Phase 117 participants (Actual)Interventional2018-11-08Completed
Efficacy of Mifepristone (RU-486) in the Treatment of Bipolar Depression. [NCT00359125]Phase 20 participants (Actual)Interventional2006-07-31Withdrawn
A Phase I Trial to Investigate the Effect of Nintedanib on the Pharmacokinetics of a Combination of Ethinylestradiol and Levonorgestrel in Patients With Non-small Cell Lung Cancer [NCT02751385]Phase 12 participants (Actual)Interventional2016-05-20Terminated(stopped due to Terminated- Study halted due to low recruitment.)
Simultaneous Mifepristone and Misoprostol Versus Misoprostol Alone for Induction of Labor of Nonviable Second Trimester Pregnancy: a Pilot Randomized Controlled Trial [NCT05322252]Phase 430 participants (Anticipated)Interventional2022-07-01Recruiting
A Randomized, Placebo-controlled, Dose Escalating, Phase II Trial of the Anti -HIV-Activity and Safety of VGX-410 (Mifepristone) in HIV-1 Infected Subjects [NCT00352911]Phase 219 participants (Actual)Interventional2006-07-31Completed
Cervical Preparation for Surgical Abortion at 12-14 Weeks: a Prospective, Randomized, Evaluator-blinded, Multicenter, Controlled Comparison Between Mifepristone, Misoprostol and Their Combination [NCT01795599]Phase 3198 participants (Anticipated)Interventional2013-05-31Recruiting
Acceptability and Feasibility of Medical Abortion in Singapore: A Study of 800 μg Buccal Misoprostol Following 200 mg Mifepristone for Abortion Through 70 Days Gestation [NCT02985229]Phase 3130 participants (Actual)Interventional2016-10-31Completed
Mifepristone and Misoprostol for 2nd Trimester Termination of Pregnancy (13-22 Weeks LMP) in Burkina Faso [NCT03269279]Phase 3100 participants (Anticipated)Interventional2017-05-20Recruiting
A Study to Investigate the Pharmacokinetic Drug-drug Interaction Following Oral Administration of Ethinylestradiol/Levonorgestrel (Microgynon®) and BI 409306 in Healthy Korean Premenopausal Female Subjects (an Open-label, Two-period, Fixed-sequence Study) [NCT03193307]Phase 116 participants (Actual)Interventional2017-06-29Completed
A Phase I/II Trial of Enzalutamide Plus the Glucocorticoid Receptor Antagonist Mifepristone for Patients With Metastatic Castration Resistant Prostate Cancer (CRPC) [NCT02012296]Phase 1/Phase 288 participants (Actual)Interventional2013-12-13Completed
A Multicenter,Prospective Clinical Trial for Reducing Remaining Submucous Fibroids Volume and Preventing Recurrence by Treating With GnRH Analogues or Mifepristone After Transcervical Resection of Type I-II Myoma [NCT05898321]294 participants (Anticipated)Interventional2023-06-01Not yet recruiting
Mifepristone Dynamic Testing for Diagnosis for Central Adrenal Insufficiency [NCT04588688]Phase 23 participants (Actual)Interventional2021-05-05Terminated(stopped due to low recruitment)
"A Study of Acceptability and Feasibility of an Outpatient Day Procedure for Medical Abortion at 13-18 Weeks Gestation in Two Public Sector Hospitals in Nepal" [NCT05046041]Phase 4120 participants (Actual)Interventional2020-11-25Completed
Introducing Mifepristone-Misoprostol for Menstrual Regulation in Public Sector Facilities in Bangladesh [NCT01798017]Phase 41,738 participants (Actual)Interventional2012-11-30Completed
Effects of the Glucocorticoid Antagonist, Mifepristone, on Glucose Intolerance in Obese and Overweight Individuals [NCT01419535]Phase 1/Phase 219 participants (Actual)Interventional2011-11-29Completed
Mifepristone in Refractory Depression [NCT00186056]31 participants (Actual)Interventional2003-01-31Completed
A Randomized Comparison of Same-Day Oral Mifepristone-Misoprostol to Misoprostol Only for Cervical Preparation in Second Trimester Surgical Abortion [NCT02412618]Phase 4100 participants (Actual)Interventional2012-09-30Completed
Medication Development in Alcoholism: Investigating Glucocorticoid Antagonists [NCT01548417]Phase 256 participants (Actual)Interventional2012-03-31Completed
An Open-label Study of the Safety, Pharmacokinetics and Pharmacodynamics of Mifepristone in Children With Refractory Cushing's Disease [NCT01925092]Phase 30 participants (Actual)Interventional2013-08-31Withdrawn(stopped due to Lack of enrollment)
Alternative Provision of Medication Abortion Via Advance Provision [NCT03829696]Phase 40 participants (Actual)Interventional2020-01-31Withdrawn(stopped due to The study is not proceeding at this time.)
Mifepristone as an Adjunct to Transcervical Balloon for Labor Induction (MiLI): A Randomized Clinical Trial [NCT05097326]Phase 330 participants (Actual)Interventional2022-06-27Completed
Developing Memory Reconsolidation Blockers as Novel PTSD Treatments [NCT01490697]Phase 434 participants (Actual)Interventional2009-03-31Completed
Novel Therapeutics in PTSD: A Randomized Clinical Trial of Mifepristone [NCT01739335]Phase 281 participants (Actual)Interventional2012-11-19Completed
Mifepristone and Misoprostol Compared With Misoprostol Alone for Second Trimester Abortion [NCT03044093]Phase 4200 participants (Anticipated)Interventional2017-01-31Recruiting
Why Antiprogestrone (Mifepristone) and Cyp 26 Inhibitor Must be Combined With Tamoxifen or ( Tamoxifen and Retinoic Acid) for Treating Early Breast Cancer [NCT05016349]Phase 3160 participants (Anticipated)Interventional2021-08-31Not yet recruiting
The Effects of Multiple Doses of Baricitinib on the Pharmacokinetics of a Single Dose of an Oral Contraceptive in Healthy Female Subjects [NCT01896726]Phase 120 participants (Actual)Interventional2013-07-31Completed
Evaluation of Cortisol Resistance in Young Sedentary and Endurance-trained Men and Elderly Sedentary Men [NCT01294319]Phase 251 participants (Actual)Interventional2011-01-24Completed
A Single-blind, Placebo-controlled, 2-period, Fixed Sequence Study to Determine the Effects of Coadministration of Fostamatinib 100 mg Twice Daily on the Pharmacokinetics of an Oral Contraceptive in Healthy Female Subjects [NCT01276262]Phase 122 participants (Actual)Interventional2011-03-31Completed
Treatment of Schizoaffective Disorder Using Mifepristone [NCT00725270]Phase 2/Phase 312 participants (Actual)Interventional1998-04-30Terminated(stopped due to Lack of funding.)
Mifepristone Versus Placebo to Treat Adenomyosis: a Double-blind, Multicentre,Randomized Clinical Trial [NCT03520439]Phase 2/Phase 3134 participants (Actual)Interventional2018-05-19Completed
Cervical Preparation Before Dilation and Evacuation in the Second Trimester: A Multicenter Randomized Trial Comparing Osmotic Dilators Alone to Dilators Plus Adjunctive Misoprostol or Adjunctive Mifepristone. [NCT01751087]300 participants (Actual)Interventional2013-01-31Completed
A Phase 1, Open-Label, Drug-Drug Interaction Study in Healthy Subjects to Determine the Effects of a Strong Inhibitor (Itraconazole) of Cytochrome P450 3A on Exposure to Mifepristone and Its Metabolites [NCT03259542]Phase 133 participants (Actual)Interventional2017-08-09Completed
A Phase 1, Open-Label, Fixed-Sequence, Crossover Drug-Drug Interaction Study in Healthy Subjects to Determine the Effects of a Strong Inducer of Cytochrome P450 3A on Exposure to Mifepristone and Its Metabolites [NCT03258372]Phase 148 participants (Actual)Interventional2017-08-16Completed
Targeting Progesterone Signaling for Breast Cancer Prevention in BRCA1 Carriers: a Pilot Study [NCT05062174]0 participants (Actual)Observational2021-11-01Withdrawn(stopped due to PI decision to cancel research)
A 4-week, Double-blind, Placebo-controlled Study of the Efficacy and Safety of Mifepristone in the Prevention of Risperidone-induced Weight Gain in Healthy Male Volunteers [NCT00698022]Phase 176 participants (Actual)Interventional2008-11-30Completed
Protocol Title: Reducing Complications and Patient Barriers in Second Trimester Abortion: Pre-Operative Effects of Mifepristone (POEM) on Dilatation and Evacuation Services [NCT01862991]80 participants (Actual)Interventional2013-07-31Completed
Tumor Necrosis Factor (TNF) and Glucocorticoid Antagonist for Gulf War Illness (GWI)-Associated Multi-symptom Disease Homeostasis Reset [NCT04254627]Phase 120 participants (Anticipated)Interventional2021-09-24Recruiting
Glucocorticoid Antagonist Treatment for Tobacco Use Disorder [NCT03248713]Early Phase 18 participants (Actual)Interventional2017-11-29Terminated(stopped due to Lack of recruitment)
Mifepristone and Misoprostol Versus Misoprostol Alone for Uterine Evacuation After Early Pregnancy Failure: a Randomized Double Blind Placebo-controlled Comparison (Triple M Trial) [NCT03212352]Phase 4342 participants (Actual)Interventional2018-06-27Terminated(stopped due to Advised by DSMB based on interim-analysis, highly significant difference.)
An Open-Label, Randomized Crossover Study to Evaluate the Acceptability and Preference for Contraceptive Options in Healthy HIV-Uninfected Female Adolescents, 16-17 Years of Age, as Proxy for HIV Prevention Methods [NCT02404038]131 participants (Actual)Interventional2015-07-31Active, not recruiting
[information is prepared from clinicaltrials.gov, extracted Sep-2024]

Trial Outcomes

TrialOutcome
NCT00133705 (1) [back to overview]Uterine Volume
NCT00186056 (1) [back to overview]Hamilton Depression Rating Scale
NCT00255177 (1) [back to overview]Mean Log Change in Viral Load From Baseline (Day 1) to Day 28
NCT00285818 (1) [back to overview]Hamilton Depression Rating Scale Score
NCT00352911 (1) [back to overview]Mean Log Change in Viral Load From Baseline (Day 1) to Day 56
NCT00422201 (2) [back to overview]Glycemic Disorders Improved or Normalized
NCT00422201 (2) [back to overview]Features of Cushing's Syndrome
NCT00459290 (8) [back to overview]Overall Survival
NCT00459290 (8) [back to overview]Progression-free Survival
NCT00459290 (8) [back to overview]Progression-free Survival at 6 Months
NCT00459290 (8) [back to overview]Progression-free Survival by Age (y)
NCT00459290 (8) [back to overview]Progression-free Survival by Performance Status
NCT00459290 (8) [back to overview]Progression-free Survival by Platinum Sensitivity
NCT00459290 (8) [back to overview]Proportion of Patients With Objective Tumor Response
NCT00459290 (8) [back to overview]Number of Participants With Adverse Effects (Grade 3 or Higher) as Assessed by Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0
NCT00468299 (2) [back to overview]Complete Abortion at One Week
NCT00468299 (2) [back to overview]Number of Women With Complete Abortion 24-48hrs After Receiving Medical Treatment for Early Pregnancy Failure.
NCT00569582 (2) [back to overview]Decrease in Diastolic Blood Pressure.
NCT00569582 (2) [back to overview]Improvement in Diabetes and/or Glucose Intolerance.
NCT00637494 (2) [back to overview]Proportion of Mifepristone Treated Patients With Plasma Drug Concentrations Equal to or Above 1637 ng/mL vs. Placebo Treated Patients Who Achieve a ≤ 50% Reduction in BPRS-PSS at Days 7 and 56
NCT00637494 (2) [back to overview]Proportion of Mifepristone vs. Placebo Treated Patients With at Least a 50% Reduction From Baseline in Brief Psychiatric Rating Scale-Positive Symptom Subscale (BPRS-PSS) at Days 7 and 56
NCT00698022 (4) [back to overview]Percentage of Participants With <5% and <7% Increase From Baseline in Body Weight
NCT00698022 (4) [back to overview]Percentage of Participants With One or More Adverse Events
NCT00698022 (4) [back to overview]Percentage of Participants Discontinued From the Study Due to an Adverse Event
NCT00698022 (4) [back to overview]Change From Baseline in Body Weight
NCT00725270 (2) [back to overview]Change in Mood Symptoms
NCT00725270 (2) [back to overview]Change in Positive Psychotic Symptoms Over the Course of Treatment
NCT00764881 (110) [back to overview]Maximum Intensity of Withdrawal Bleeding Episodes at Cycle 1
NCT00764881 (110) [back to overview]The Mean Absolute Values of Psychological General Well-Being Index (PGWBI) - Anxiety at Cycle 6
NCT00764881 (110) [back to overview]The Mean Absolute Values of Psychological General Well-Being Index (PGWBI) - Depressed Mood at Baseline
NCT00764881 (110) [back to overview]The Mean Absolute Values of Psychological General Well-Being Index (PGWBI) - Depressed Mood at Cycle 6
NCT00764881 (110) [back to overview]The Mean Absolute Values of Psychological General Well-Being Index (PGWBI) - General Health at Baseline
NCT00764881 (110) [back to overview]The Mean Absolute Values of Psychological General Well-Being Index (PGWBI) - General Health at Cycle 6
NCT00764881 (110) [back to overview]The Mean Absolute Values of Psychological General Well-Being Index (PGWBI) - Positive Well-being at Baseline
NCT00764881 (110) [back to overview]The Mean Absolute Values of Psychological General Well-Being Index (PGWBI) - Positive Well-being at Cycle 6
NCT00764881 (110) [back to overview]The Mean Absolute Values of Psychological General Well-Being Index (PGWBI) - Self-control at Baseline
NCT00764881 (110) [back to overview]The Mean Absolute Values of Psychological General Well-Being Index (PGWBI) - Self-control at Cycle 6
NCT00764881 (110) [back to overview]The Mean Absolute Values of Psychological General Well-Being Index (PGWBI) - Vitality at Baseline
NCT00764881 (110) [back to overview]The Mean Absolute Values of Psychological General Well-Being Index (PGWBI) - Vitality at Cycle 6
NCT00764881 (110) [back to overview]The Mean Absolute Values of Psychological General Well-Being Index (PGWBI) Global Score at Baseline
NCT00764881 (110) [back to overview]The Mean Absolute Values of Psychological General Well-Being Index (PGWBI) Global Score at Cycle 6
NCT00764881 (110) [back to overview]Vaginal Effects Evaluated by the Mean Absolute Values of Atrophy Symptom Questionnaire (ASQ) at Baseline
NCT00764881 (110) [back to overview]Vaginal Effects Evaluated by the Mean Absolute Values of Atrophy Symptom Questionnaire (ASQ) at Cycle 6
NCT00764881 (110) [back to overview]Vaginal Effects Evaluated by the Mean Absolute Values of Vaginal Health Assessment (VHA) at Baseline
NCT00764881 (110) [back to overview]Vaginal Effects Evaluated by the Mean Absolute Values of Vaginal Health Assessment (VHA) at Cycle 6
NCT00764881 (110) [back to overview]Vaginal Effects Evaluated by the Mean Change From Baseline to Cycle 6 in Vaginal Health Assessment (VHA)
NCT00764881 (110) [back to overview]Percentage of Participants by Maximum Intensity of Intracyclic Bleeding Episodes at Cycle 1
NCT00764881 (110) [back to overview]Percentage of Participants by Maximum Intensity of Intracyclic Bleeding Episodes at Cycle 3
NCT00764881 (110) [back to overview]Percentage of Participants by Maximum Intensity of Intracyclic Bleeding Episodes at Cycle 6
NCT00764881 (110) [back to overview]Percentage of Participants by Maximum Intensity of Withdrawal Bleeding Episodes at Cycle 1
NCT00764881 (110) [back to overview]Percentage of Participants by Maximum Intensity of Withdrawal Bleeding Episodes at Cycle 3
NCT00764881 (110) [back to overview]Percentage of Participants by Maximum Intensity of Withdrawal Bleeding Episodes at Cycle 6
NCT00764881 (110) [back to overview]Percentage of Participants With / Without Withdrawal Bleeding at Cycle 1
NCT00764881 (110) [back to overview]Percentage of Participants With / Without Withdrawal Bleeding at Cycle 3
NCT00764881 (110) [back to overview]Percentage of Participants With / Without Withdrawal Bleeding at Cycle 6
NCT00764881 (110) [back to overview]Percentage of Participants With at Least 1 Intracyclic Bleeding Episode
NCT00764881 (110) [back to overview]Percentage of Participants With Presence or Absence of Intracyclic Bleeding at Cycle 1
NCT00764881 (110) [back to overview]Percentage of Participants With Presence or Absence of Intracyclic Bleeding at Cycle 3
NCT00764881 (110) [back to overview]Percentage of Participants With Presence or Absence of Intracyclic Bleeding at Cycle 6
NCT00764881 (110) [back to overview]Vaginal Effects Evaluated by Vaginal pH at Cycle 6
NCT00764881 (110) [back to overview]Change From Baseline to Cycle 6 in the Total of Questions 1 to 6 of the Female Sexual Function Index (FSFI) - Full Analysis Set (FAS)
NCT00764881 (110) [back to overview]Change From Baseline to Cycle 6 in the Total of Questions 1 to 6 of the Female Sexual Function Index (FSFI) - Per Protocol Set (PPS)
NCT00764881 (110) [back to overview]Difference in Duration Between Longest and Shortest Bleeding / Spotting Episodes in Reference Period 1
NCT00764881 (110) [back to overview]Difference in Duration Between Longest and Shortest Bleeding / Spotting Episodes in Reference Period 2
NCT00764881 (110) [back to overview]Difference in Duration Between Longest and Shortest Spotting-only Episodes in Reference Period 1
NCT00764881 (110) [back to overview]Difference in Duration Between Longest and Shortest Spotting-only Episodes in Reference Period 2
NCT00764881 (110) [back to overview]Length of Withdrawal Bleeding Episodes at Cycle 1
NCT00764881 (110) [back to overview]Length of Withdrawal Bleeding Episodes at Cycle 3
NCT00764881 (110) [back to overview]Length of Withdrawal Bleeding Episodes at Cycle 6
NCT00764881 (110) [back to overview]Number of Spotting Only Episodes in Reference Period 1
NCT00764881 (110) [back to overview]Maximum Intensity of Withdrawal Bleeding Episodes at Cycle 3
NCT00764881 (110) [back to overview]Maximum Intensity of Withdrawal Bleeding Episodes at Cycle 6
NCT00764881 (110) [back to overview]Maximum Length of Bleeding / Spotting Episodes in Reference Period 1
NCT00764881 (110) [back to overview]Maximum Length of Bleeding / Spotting Episodes in Reference Period 2
NCT00764881 (110) [back to overview]Maximum Length of Intracyclic Bleeding Episodes at Cycle 1
NCT00764881 (110) [back to overview]Maximum Length of Intracyclic Bleeding Episodes at Cycle 3
NCT00764881 (110) [back to overview]Maximum Length of Intracyclic Bleeding Episodes at Cycle 6
NCT00764881 (110) [back to overview]Maximum Length of Spotting-only Episodes in Reference Period 1
NCT00764881 (110) [back to overview]Maximum Length of Spotting-only Episodes in Reference Period 2
NCT00764881 (110) [back to overview]Mean Change From Baseline to Cycle 6 in Female Sexual Distress Scale (FSDS-R) Total Score
NCT00764881 (110) [back to overview]Mean Change From Baseline to Cycle 6 in FSFI Domain Score (Arousal)
NCT00764881 (110) [back to overview]Mean Change From Baseline to Cycle 6 in FSFI Domain Score (Desire)
NCT00764881 (110) [back to overview]Mean Change From Baseline to Cycle 6 in FSFI Domain Score (Lubrication)
NCT00764881 (110) [back to overview]Mean Change From Baseline to Cycle 6 in FSFI Domain Score (Orgasm)
NCT00764881 (110) [back to overview]Mean Change From Baseline to Cycle 6 in FSFI Domain Score (Pain)
NCT00764881 (110) [back to overview]Mean Change From Baseline to Cycle 6 in FSFI Domain Score (Satisfaction)
NCT00764881 (110) [back to overview]Mean Change From Baseline to Cycle 6 in FSFI Total Score
NCT00764881 (110) [back to overview]Mean Change From Baseline to Cycle 6 in Psychological General Well-Being Index (PGWBI) - Anxiety
NCT00764881 (110) [back to overview]Mean Change From Baseline to Cycle 6 in Psychological General Well-Being Index (PGWBI) - Depressed Mood
NCT00764881 (110) [back to overview]Mean Change From Baseline to Cycle 6 in Psychological General Well-Being Index (PGWBI) - General Health
NCT00764881 (110) [back to overview]Mean Change From Baseline to Cycle 6 in Psychological General Well-Being Index (PGWBI) - Positive Well-being
NCT00764881 (110) [back to overview]Mean Change From Baseline to Cycle 6 in Psychological General Well-Being Index (PGWBI) - Self-control
NCT00764881 (110) [back to overview]Mean Change From Baseline to Cycle 6 in Psychological General Well-Being Index (PGWBI) - Vitality
NCT00764881 (110) [back to overview]Mean Change From Baseline to Cycle 6 in Psychological General Well-Being Index (PGWBI) Global Score
NCT00764881 (110) [back to overview]Mean Change From Baseline to Cycle 6 in Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) (Short Version) Total Score
NCT00764881 (110) [back to overview]Mean Length of Bleeding / Spotting Episodes in Reference Period 1
NCT00764881 (110) [back to overview]Mean Length of Bleeding / Spotting Episodes in Reference Period 2
NCT00764881 (110) [back to overview]Mean Length of Spotting-only Episodes in Reference Period 1
NCT00764881 (110) [back to overview]Mean Length of Spotting-only Episodes in Reference Period 2
NCT00764881 (110) [back to overview]Number of Bleeding / Spotting Days in Reference Period 1
NCT00764881 (110) [back to overview]Number of Bleeding / Spotting Days in Reference Period 2
NCT00764881 (110) [back to overview]Number of Bleeding / Spotting Episodes in Reference Period 1
NCT00764881 (110) [back to overview]Number of Bleeding / Spotting Episodes in Reference Period 2
NCT00764881 (110) [back to overview]Number of Intracyclic Bleeding Days at Cycle 1
NCT00764881 (110) [back to overview]Number of Intracyclic Bleeding Days at Cycle 3
NCT00764881 (110) [back to overview]Number of Intracyclic Bleeding Days at Cycle 6
NCT00764881 (110) [back to overview]Number of Intracyclic Bleeding Episodes at Cycle 1
NCT00764881 (110) [back to overview]Number of Intracyclic Bleeding Episodes at Cycle 3
NCT00764881 (110) [back to overview]Number of Intracyclic Bleeding Episodes at Cycle 6
NCT00764881 (110) [back to overview]Number of Spotting Only Days in Reference Period 1
NCT00764881 (110) [back to overview]Number of Spotting Only Days in Reference Period 2
NCT00764881 (110) [back to overview]Vaginal Effects Evaluated by the Mean Change From Baseline to Cycle 6 in Atrophy Symptom Questionnaire (ASQ)
NCT00764881 (110) [back to overview]Number of Spotting Only Episodes in Reference Period 2
NCT00764881 (110) [back to overview]Onset of Withdrawal Bleeding Episodes at Cycle 1
NCT00764881 (110) [back to overview]Onset of Withdrawal Bleeding Episodes at Cycle 3
NCT00764881 (110) [back to overview]Onset of Withdrawal Bleeding Episodes at Cycle 6
NCT00764881 (110) [back to overview]Percentage of Participants With Improvement in Participant's Assessment in Clinical Global Impression (CGI) at Cycle 6
NCT00764881 (110) [back to overview]Percentage of Participants With Improvement in the Investigator's Assessment in Clinical Global Impression (CGI) at Cycle 6
NCT00764881 (110) [back to overview]The Mean Absolute Values of Female Sexual Distress Scale (FSDS-R) Total Score at Baseline
NCT00764881 (110) [back to overview]The Mean Absolute Values of Female Sexual Distress Scale (FSDS-R) Total Score at Cycle 6
NCT00764881 (110) [back to overview]The Mean Absolute Values of FSFI Domain Score (Arousal) at Baseline
NCT00764881 (110) [back to overview]The Mean Absolute Values of FSFI Domain Score (Arousal) at Cycle 6
NCT00764881 (110) [back to overview]The Mean Absolute Values of FSFI Domain Score (Desire) at Baseline
NCT00764881 (110) [back to overview]The Mean Absolute Values of FSFI Domain Score (Desire) at Cycle 6
NCT00764881 (110) [back to overview]The Mean Absolute Values of FSFI Domain Score (Lubrication) at Baseline
NCT00764881 (110) [back to overview]The Mean Absolute Values of FSFI Domain Score (Lubrication) at Cycle 6
NCT00764881 (110) [back to overview]The Mean Absolute Values of FSFI Domain Score (Orgasm) at Baseline
NCT00764881 (110) [back to overview]The Mean Absolute Values of FSFI Domain Score (Orgasm) at Cycle 6
NCT00764881 (110) [back to overview]The Mean Absolute Values of FSFI Domain Score (Pain) at Baseline.
NCT00764881 (110) [back to overview]The Mean Absolute Values of FSFI Domain Score (Pain) at Cycle 6
NCT00764881 (110) [back to overview]The Mean Absolute Values of FSFI Domain Score (Satisfaction) at Baseline
NCT00764881 (110) [back to overview]The Mean Absolute Values of FSFI Domain Score (Satisfaction) at Cycle 6
NCT00764881 (110) [back to overview]The Mean Absolute Values of FSFI Total Score at Baseline
NCT00764881 (110) [back to overview]The Mean Absolute Values of FSFI Total Score at Cycle 6
NCT00764881 (110) [back to overview]The Mean Absolute Values of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) (Short Version) Total Score at Baseline
NCT00764881 (110) [back to overview]The Mean Absolute Values of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) (Short Version) Total Score at Cycle 6
NCT00764881 (110) [back to overview]The Mean Absolute Values of Psychological General Well-Being Index (PGWBI) - Anxiety at Baseline
NCT00832871 (3) [back to overview]Toxicity Associated With Adrenal Insufficiency
NCT00832871 (3) [back to overview]Overall Survival
NCT00832871 (3) [back to overview]Duration of Response
NCT00867360 (3) [back to overview]Change in Psychotic Symptoms Subscale (PSS) of the Brief Psychiatric Rating Scale (BPRS)
NCT00867360 (3) [back to overview]Change in Mean Cortisol Level
NCT00867360 (3) [back to overview]% Change in Mean Evening Pre- and Post- Florinef Cortisol After Treatment With Either Mifepristone or Placebo
NCT00936741 (2) [back to overview]Number of Participants With Adverse Events
NCT00936741 (2) [back to overview]The Long-term Benefit of Mifepristone Treatment in Cushing's Syndrome as Measured by Changes in the Score on the Physician's Global Assessment of Disease Severity
NCT00986921 (3) [back to overview]Time for Completion of Procedure
NCT00986921 (3) [back to overview]Moderate or Severe Pain Overnight
NCT00986921 (3) [back to overview]Assessment of Ease of Procedure by Operator
NCT01134198 (1) [back to overview]Number of Participants With Relapse by Days 10 and 28
NCT01212588 (15) [back to overview]Symptom Change - SCL-90-R
NCT01212588 (15) [back to overview]Symptom Change - BPDSI Subscales
NCT01212588 (15) [back to overview]Symptom Change - BPDSI Subscales
NCT01212588 (15) [back to overview]Symptom Change - SCL-90-R
NCT01212588 (15) [back to overview]Symptom Change - BPDSI Subscales
NCT01212588 (15) [back to overview]Symptom Change - SCL-90-R
NCT01212588 (15) [back to overview]Symptom Change - CGI-I
NCT01212588 (15) [back to overview]Symptom Change - CGI-S
NCT01212588 (15) [back to overview]Symptom Change - BPRS
NCT01212588 (15) [back to overview]Durable Symptom Change
NCT01212588 (15) [back to overview]Levels of Cortisol
NCT01212588 (15) [back to overview]Metacognitive Capacity
NCT01212588 (15) [back to overview]Number of Participants With Possibly and Probably Related Adverse Events
NCT01212588 (15) [back to overview]Rapid Symptom Change
NCT01212588 (15) [back to overview]Symptom Change - Borderline Checklist
NCT01294319 (2) [back to overview]Proportion of Suppressors After Dexamethasone
NCT01294319 (2) [back to overview]Post-dexamethasone Cortisol Level
NCT01328184 (18) [back to overview]Number of Participants With Clinically Relevant Abnormalities in Physical Examination, Vital Signs, ECG and Clinical Laboratory Tests.
NCT01328184 (18) [back to overview]Levonorgestrel: Terminal Half-life at Steady State (t1/2,ss)
NCT01328184 (18) [back to overview]Levonorgestrel: Terminal Rate Constant at Steady State (λz,ss)
NCT01328184 (18) [back to overview]Levonorgestrel: Time From Last Dosing to Maximum Measured Concentration (Tmax,ss)
NCT01328184 (18) [back to overview]Assessment of Tolerability
NCT01328184 (18) [back to overview]Ethinylestradiol: Apparent Clearance at Steady State (CL/Fss)
NCT01328184 (18) [back to overview]Ethinylestradiol: Apparent Volume of Distribution During the Terminal Phase at Steady State (Vz/Fss)
NCT01328184 (18) [back to overview]Ethinylestradiol: Area Under the Curve at Steady State Over the Uniform Dosing Interval τ (AUCτ,ss)
NCT01328184 (18) [back to overview]Ethinylestradiol: Maximum Measured Concentration (Cmax,ss)
NCT01328184 (18) [back to overview]Ethinylestradiol: Mean Residence Time at Steady State (MRTpo,ss)
NCT01328184 (18) [back to overview]Ethinylestradiol: Terminal Half-life at Steady State (t1/2,ss)
NCT01328184 (18) [back to overview]Ethinylestradiol: Terminal Rate Constant at Steady State (λz,ss)
NCT01328184 (18) [back to overview]Ethinylestradiol: Time From Last Dosing to Maximum Measured Concentration (Tmax,ss)
NCT01328184 (18) [back to overview]Levonorgestrel: Apparent Clearance at Steady State (CL/Fss)
NCT01328184 (18) [back to overview]Levonorgestrel: Apparent Volume of Distribution During the Terminal Phase at Steady State (Vz/Fss)
NCT01328184 (18) [back to overview]Levonorgestrel: Area Under the Curve at Steady State Over the Uniform Dosing Interval τ (AUCτ,ss)
NCT01328184 (18) [back to overview]Levonorgestrel: Maximum Measured Concentration (Cmax,ss)
NCT01328184 (18) [back to overview]Levonorgestrel: Mean Residence Time at Steady State (MRTpo,ss)
NCT01333098 (4) [back to overview]Cognitive Changes Over Time, as Measured by Between Group and Within-subjects Comparison of Neuropsychological Measures.
NCT01333098 (4) [back to overview]Number of Participants With Self-reported Side Effects
NCT01333098 (4) [back to overview]Drug Acceptability, as Measured by Number of Participants With Dose-limiting Side Effects
NCT01333098 (4) [back to overview]Anxiety Symptoms
NCT01371565 (1) [back to overview]Number of Participants With Adverse Events
NCT01419535 (6) [back to overview]Homeostatic Model Assessment of Insulin Resistance (HOMA-IR)
NCT01419535 (6) [back to overview]Change in Insulin Sensitivity Index
NCT01419535 (6) [back to overview]Change in Fasting Plasma Glucose
NCT01419535 (6) [back to overview]Change in Fasting Insulin Levels
NCT01419535 (6) [back to overview]Adipose-tissue Insulin Sensitivity Index (Adipo-SI)
NCT01419535 (6) [back to overview]Adipose-tissue Insulin Resistance Index (Adipo-IR)
NCT01436279 (8) [back to overview]Acceptability to Patient
NCT01436279 (8) [back to overview]Cervical Dilation Achieved
NCT01436279 (8) [back to overview]Operative Time
NCT01436279 (8) [back to overview]Difficulty of Procedure
NCT01436279 (8) [back to overview]Pain Medication (Fentanyl) During the Abortion
NCT01436279 (8) [back to overview]Pain Medication (Midazolam) During the Abortion
NCT01436279 (8) [back to overview]Subject Discomfort Before the Abortion
NCT01436279 (8) [back to overview]Length of Procedure
NCT01490697 (2) [back to overview]Change From Baseline in the Impact of Event Scale-Revised (IES-R) Total Score
NCT01490697 (2) [back to overview]Physiological Posttraumatic Stress Disorder (PTSD) Probability as Determined From Psychophysiologic Responses to Traumatic Recollection
NCT01548417 (2) [back to overview]Drinking
NCT01548417 (2) [back to overview]Craving to Drink
NCT01615731 (8) [back to overview]Total Procedure Time
NCT01615731 (8) [back to overview]Adverse Events
NCT01615731 (8) [back to overview]Maximum Cervical Dilation
NCT01615731 (8) [back to overview]Pain Perceived by Patient
NCT01615731 (8) [back to overview]Procedure Time
NCT01615731 (8) [back to overview]Adverse Events (EBL)
NCT01615731 (8) [back to overview]Ease of Procedure by Blinded Surgeon
NCT01615731 (8) [back to overview]Overall Patient Experience
NCT01631682 (1) [back to overview]Change From Baseline Skin Conductance Response
NCT01636063 (1) [back to overview]Initial Cervical Dilation at the Time of Surgical Abortion
NCT01739335 (12) [back to overview]Change in CAPS Total Score From Baseline to 4-week and 12-week
NCT01739335 (12) [back to overview]Change in Sleep Quality (Measured by the PSQI Total Score) From Baseline to 4-Week and 12-Week
NCT01739335 (12) [back to overview]Changes in PTSD Symptom Severity (Measured by the Stressful Life Total Score From the PTSD Checklist) From Baseline to 4-Week and 12-Week
NCT01739335 (12) [back to overview]Change in Anger Level (Measured by the STAXI Total Score) From Baseline to 4-Week and 12-Week
NCT01739335 (12) [back to overview]Change in Depression (Measured by the BDI Total Score) From Baseline to 4-Week and 12-Week
NCT01739335 (12) [back to overview]Change in Adrenocorticotropic Hormone (ACTH) From Baseline to 1-week
NCT01739335 (12) [back to overview]Change in Adrenocorticotropic Hormone (ACTH) From Baseline to 4-week
NCT01739335 (12) [back to overview]Change in Plasma Cortisol From Baseline to 1-Week
NCT01739335 (12) [back to overview]Change in Plasma Cortisol From Baseline to 4-Week
NCT01739335 (12) [back to overview]Change in CAPS Avoidance Symptom Scores From Baseline to 4-Week and 12-Week
NCT01739335 (12) [back to overview]Change in CAPS Hyperarousal Symptom Scores From Baseline to 4-Week and 12-Week
NCT01739335 (12) [back to overview]Change in CAPS Intrusive Symptom Scores From Baseline to 4-Week and 12-Week
NCT01751087 (9) [back to overview]Complications From Procedure
NCT01751087 (9) [back to overview]Chills (Any) After Day 2 Medication Administration
NCT01751087 (9) [back to overview]Ability to Complete the D&E on the First Attempt
NCT01751087 (9) [back to overview]Initial Cervical Dilation
NCT01751087 (9) [back to overview]Patient Satisfaction With Cervical Prep
NCT01751087 (9) [back to overview]Operative Time
NCT01751087 (9) [back to overview]Need for Mechanical Dilation
NCT01751087 (9) [back to overview]Ease of Mechanical Dilation
NCT01751087 (9) [back to overview]Physician Satisfaction With Cervical Preparation
NCT01862991 (2) [back to overview]Adverse Events
NCT01862991 (2) [back to overview]Procedure Time
NCT01896726 (4) [back to overview]PK: Cmax of Levonorgestrel
NCT01896726 (4) [back to overview]PK: AUC(0-∞) of Levonorgestrel
NCT01896726 (4) [back to overview]PK: Area Under the Concentration Versus Time Curve From Time Zero to Infinity [AUC(0-∞)] of Ethinyl Estradiol
NCT01896726 (4) [back to overview]Pharmacokinetics (PK): Maximum Concentration (Cmax) of Ethinyl Estradiol
NCT01990560 (11) [back to overview]Waist Circumference
NCT01990560 (11) [back to overview]State Trait Anxiety Inventory (STAI)
NCT01990560 (11) [back to overview]Quality of Life
NCT01990560 (11) [back to overview]Hospital Anxiety and Depression Scale (HADS)
NCT01990560 (11) [back to overview]HOMA-IR
NCT01990560 (11) [back to overview]Fasting Lipid Profile
NCT01990560 (11) [back to overview]CushingQoL
NCT01990560 (11) [back to overview]Nottingham Health Profile (NHP)
NCT01990560 (11) [back to overview]Body Mass Index (BMI)
NCT01990560 (11) [back to overview]Weight
NCT01990560 (11) [back to overview]A1C Level
NCT02012296 (7) [back to overview]Cortisol
NCT02012296 (7) [back to overview]Radiographic PFS
NCT02012296 (7) [back to overview]Thyroid Stimulating Hormone
NCT02012296 (7) [back to overview]Testosterone
NCT02012296 (7) [back to overview]PSA Progression-free Survival
NCT02012296 (7) [back to overview]Number of Participants With Positive GR Expression Within Circulating Tumor Cells (CTCs)
NCT02012296 (7) [back to overview]Number of Participants With Positive AR Expression Within Circulating Tumor Cells (CTCs)
NCT02012491 (6) [back to overview]Uterine Asperation
NCT02012491 (6) [back to overview]Frequency of Serious Adverse Events Between Study Arms.
NCT02012491 (6) [back to overview]Gestational Sac Expulsion by the 30-day Telephone Call
NCT02012491 (6) [back to overview]Gestational Sac Expulsion by the Second Follow-up Visit at Day 8
NCT02012491 (6) [back to overview]Gestational Sac Expulsion With One Treatment Dose on Day 3 (Visit 2) and no Need for Additional Medical or Surgical Intervention Within 30 Days of Treatment.
NCT02012491 (6) [back to overview]Adverse Event Reported by Participants
NCT02179749 (2) [back to overview]Drinking Quantity Per Day
NCT02179749 (2) [back to overview]Craving
NCT02243709 (3) [back to overview]Number of Participants Experiencing Adverse Events in the Mifepristone Versus Placebo Group as a Measure of Safety and Tolerability
NCT02243709 (3) [back to overview]Alcohol Craving Score on the Alcohol Craving Questionnaire in the Mifepristone Versus Placebo Group
NCT02243709 (3) [back to overview]Drinking Consumption in the Mifepristone Verses Placebo Group
NCT02412618 (2) [back to overview]Initial Cervical Dilation
NCT02412618 (2) [back to overview]Patient Acceptability and Assessment of Pain and Side Effects (5-point Likert Scale)
NCT02620904 (1) [back to overview]Time to Delivery of Fetus
NCT02689804 (10) [back to overview]Area Under the Curve From Time 0 to 24 Hours of Serum LNG Concentration
NCT02689804 (10) [back to overview]Area Under the Curve From Time 0 to 24 Hours of Serum UPA Concentration
NCT02689804 (10) [back to overview]Clearance of Serum LNG
NCT02689804 (10) [back to overview]Clearance of Serum UPA
NCT02689804 (10) [back to overview]Elimination Half-life of Serum LNG
NCT02689804 (10) [back to overview]Elimination Half-life of Serum UPA
NCT02689804 (10) [back to overview]Maximum Concentration of Serum LNG
NCT02689804 (10) [back to overview]Maximum Concentration of Serum UPA
NCT02689804 (10) [back to overview]Time to Maximum Concentration of Serum LNG
NCT02689804 (10) [back to overview]Time to Maximum Concentration of Serum UPA
NCT02751385 (3) [back to overview]Maximum Measured Concentration (Cmax) of Ethinylestradiol and Levonorgestrel
NCT02751385 (3) [back to overview]Area Under the Concentration-time Curve of the the Ethinylestradiol and Levonorgestrel in Plasma Over the Time Interval From 0 to the Last Quantifiable Data Point (AUC0-tz)
NCT02751385 (3) [back to overview]Area Under the Concentration-time Curve of the Ethinylestradiol and Levonorgestrel in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC0-infinity).
NCT03052400 (13) [back to overview]LDL-cholesterol
NCT03052400 (13) [back to overview]PSA
NCT03052400 (13) [back to overview]Hemoglobin A1c
NCT03052400 (13) [back to overview]Systolic BP
NCT03052400 (13) [back to overview]Uric Acid
NCT03052400 (13) [back to overview]Weight
NCT03052400 (13) [back to overview]Hypoglycemic Events
NCT03052400 (13) [back to overview]Diastolic BP
NCT03052400 (13) [back to overview]Cortisol
NCT03052400 (13) [back to overview]Body Mass Index
NCT03052400 (13) [back to overview]Basal Insulin Dose
NCT03052400 (13) [back to overview]Adverse Events
NCT03052400 (13) [back to overview]ACTH
NCT03320057 (6) [back to overview]Number of Pharmacists Who Report Being Satisfied With Pharmacy Dispensing of Mifeprex
NCT03320057 (6) [back to overview]Number of Pharmacists Who Objected to Participate in Dispensing Mifeprex
NCT03320057 (6) [back to overview]Number of Participants With an Adverse Event
NCT03320057 (6) [back to overview]Number of Participants With a Complete Abortion With Medication Alone and Who do Not Require a Surgical Procedure to Complete the Abortion
NCT03320057 (6) [back to overview]Number of Participants Who Report Being Satisfied With Obtaining Mifeprex in the Pharmacy
NCT03320057 (6) [back to overview]Difference in Pharmacists' Mean Knowledge Score Related to Medication Abortion
NCT03675581 (6) [back to overview]Area Under the Concentration-time Curve of Ethinylestradiol in Plasma Over the Time Interval From 0 to the Last Quantifiable Data Point (AUC0-tz)
NCT03675581 (6) [back to overview]Area Under the Concentration-time Curve of Levonorgestrel in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC0-∞)
NCT03675581 (6) [back to overview]Area Under the Concentration-time Curve of Levonorgestrel in Plasma Over the Time Interval From 0 to the Last Quantifiable Data Point (AUC0-tz)
NCT03675581 (6) [back to overview]Maximum Measured Concentration of Levonorgestrel in Plasma (Cmax)
NCT03675581 (6) [back to overview]Maximum Measured Concentration of Ethinylestradiol in Plasma (Cmax)
NCT03675581 (6) [back to overview]Area Under the Concentration-time Curve of Ethinylestradiol in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC0-∞)
NCT03714880 (7) [back to overview]Number of Participants That Required Mechanical Dilation
NCT03714880 (7) [back to overview]Number of Participants That Required Mechanical Dilation
NCT03714880 (7) [back to overview]Pain Dilator Placement Using Visual Analog Scale
NCT03714880 (7) [back to overview]Number of Participants That Had Placement of Expected Dilators or More
NCT03714880 (7) [back to overview]Number of Participants That Experienced Complications
NCT03714880 (7) [back to overview]Cervical Dilation
NCT03714880 (7) [back to overview]"Provider Assessment of Procedure as Very Easy or Easy"
NCT03774745 (5) [back to overview]Expulsion During Follow-up Evaluation
NCT03774745 (5) [back to overview]Continuing Pregnancy Based on Ultrasound Examination
NCT03774745 (5) [back to overview]Number of Participants With Change in Serum Progesterone and hCG During Follow-up
NCT03774745 (5) [back to overview]Number of Participants With Adverse Events During Follow-up Evaluation
NCT03774745 (5) [back to overview]Medical Safety During Treatment and Follow-up
NCT04131517 (8) [back to overview]Area Under the Concentration-time Curve From Time 0 to Infinity (AUC[0-inf]) of Levonorgestrel in Part 1
NCT04131517 (8) [back to overview]Steady State Plasma Concentration (Cmax,ss) of Padsevonil in Part 1
NCT04131517 (8) [back to overview]Percentage of Participants With Treatment-emergent Adverse Events (TEAEs) in Part 1
NCT04131517 (8) [back to overview]Percentage of Participants With Serious TEAEs in Part 1
NCT04131517 (8) [back to overview]Maximum Observed Plasma Concentration (Cmax) of Ethinylestradiol in Part 1
NCT04131517 (8) [back to overview]Area Under the Concentration-time Curve From Time 0 to Time Tau (AUC[0-tau]) of Padsevonil in Part 1
NCT04131517 (8) [back to overview]Maximum Observed Plasma Concentration (Cmax) of Levonorgestrel in Part 1
NCT04131517 (8) [back to overview]Area Under the Concentration-time Curve From Time 0 to Infinity (AUC[0-inf]) of Ethinylestradiol in Part 1
NCT04588688 (4) [back to overview]Number of Study Participants With Complete Study Data Captured
NCT04588688 (4) [back to overview]Peak Cortisol Measured After Mifepristone
NCT04588688 (4) [back to overview]Absolute ACTH After Mifepristone
NCT04588688 (4) [back to overview]Number of Study Participants Recruited

Uterine Volume

Uterine volume is measured in mLs (NCT00133705)
Timeframe: 6 months

InterventionmL (Mean)
Treatment Group719
Placebo Group449

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Hamilton Depression Rating Scale

"Hamilton Depression Rating Scale. Minimum score of 0 (no depressive symptoms) to maximum of 68 (very severely depressed).~Outcome Measure is reporting a Change from Baseline in HAMD scores, i.e., scores at Day 35 minus scores at Baseline." (NCT00186056)
Timeframe: Baseline and Day 35 HAMD scores

Interventionunits on a scale (Mean)
Mifepristone18.75
Placebo19.68

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Mean Log Change in Viral Load From Baseline (Day 1) to Day 28

Mean log change in HCV RNA viral load (significant reduction is considered >0.5 log 10) from baseline (Day 1) following once or twice daily dosing for 28 days at the 28 day timepoint (NCT00255177)
Timeframe: Baseline (Day 1) to Day 28

Interventioncopies/mL on log scale (Log Mean)
Placebo0.30
VGX-410 150mg Daily0.00
VGX-410 300mg Daily0.18
VGX-410 300mg Twice Daily0.04

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Hamilton Depression Rating Scale Score

The Hamilton Depression Scale measures the severity of depression. There are 17 items rated 0 to 4. A total score of 0 indicates that the patient does not endorse any symptoms of depression. The maximum score (the most severe depression) is 68. The outcome measure is the difference between Visit 1 and Visit 4 Hamilton Depression Rating Scale scores of the mifepristone and placebo groups. (NCT00285818)
Timeframe: Screening to Final Visit

,
Interventionunits on a scale (Mean)
BaselineVisit 4; 4 weeks
Mifepristone28.520.5
Placebo23.019.0

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Mean Log Change in Viral Load From Baseline (Day 1) to Day 56

Mean log change in HIV RNA viral load (significant reduction is considered >0.5 log 10) from baseline (Day 1) to Day 56 following 150mg twice daily for 14 days, dose escalation to 300mg twice daily for 14 days and then 28 days off treatment. (NCT00352911)
Timeframe: Baseline (Day 1) to Day 56

Interventioncopies/mL on log scale (Log Mean)
VGX-410 (Mifepristone)0.18
Placebo for VGX-410 (Mifepristone)0.42

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Glycemic Disorders Improved or Normalized

"Criteria for improvement or normalization of glycemic disorders:~A. For diabetic patients (known or diagnosed at pre-inclusion visit)~Decrease in HbA1c > 0.3% B. For patients with IGT~Normalization of OGTT (2-hour glucose plasma level after 75 g OGTT < 7.8 mmol/L (140 mg/dL) D. For patients with IFG~If impaired fasting glucose is also associated with impaired glucose tolerance during OGTT at pre-inclusion:~- Normalization of OGTT (2-hour glucose plasma level after 75 g OGTT < 7.8 mmol/L (140 mg/dL)~If impaired fasting glycemia is associated with normal OGTT at pre-inclusion (except at T0):~- Normalization of fasting plasma glucose (fasting plasma glucose < 5.5 mmol/L (100 mg/dL)" (NCT00422201)
Timeframe: 8 weeks at steady dose

Interventionparticipants (Number)
Mifepristone2

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Features of Cushing's Syndrome

"Criteria for secondary glycemic disorder improvement of clinical symptoms attributable to the Cushing's syndrome A. For diabetic patients~Improvement of the following parameters: glycemic profile, fasting blood glucose, fructosamine, 2-hour OGTT (for diabetics diagnosed at screening)~Number of anti-diabetics treatment or dose of anti-diabetics treatment for diabetic patients already on diabetes treatment at inclusion~Doses of insulin for insulin-treated patients B. For patients with IGT~HbA1c~Fructosamine C. For patients with IFG~HbA1c~Fructosamine D. For all patients~Fasting plasma insulin~Area Under the Curve of OGTT results when OGTT performed~HOMA index" (NCT00422201)
Timeframe: 8 weeks at steady dose

Interventionparticipants (Number)
Prospective, Open-label, Study of Mifepristone2

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Overall Survival

(NCT00459290)
Timeframe: Five years

Interventionmonths (Median)
MifepristoneNA

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Progression-free Survival

"Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter (LD) of target lesions taking as reference the smallest sum LD recorded since study entry, or unequivocal progression of existing non-target lesions, or the appearance of one or more new lesions.~CT scan or MRI is used to follow lesion for measurable disease every other cycle for the first 6 months; every three months thereafter; and at any time if clinically indicated based on symptoms or physical signs suggestive of progressive disease or rising serum tumor marker levels. Responses must be confirmed by repeat imaging 4 weeks following documentation of response." (NCT00459290)
Timeframe: Every other cycle, for the first 6 months; every three months thereafter; and at any time if clinically indicated based on symptoms or physical signs suggestive of progressive disease or rising serum tumor marker levels.

Interventionmonths (Median)
Mifepristone1.8

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Progression-free Survival at 6 Months

"Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter (LD) of target lesions taking as reference the smallest sum LD recorded since study entry, or unequivocal progression of existing non-target lesions, or the appearance of one or more new lesions.~CT scan or MRI is used to follow lesion for measurable disease every other cycle for the first 6 months; every three months thereafter; and at any time if clinically indicated based on symptoms or physical signs suggestive of progressive disease or rising serum tumor marker levels. Responses must be confirmed by repeat imaging 4 weeks following documentation of response." (NCT00459290)
Timeframe: Every other cycle, for the first 6 months; every three months thereafter; and at any time if clinically indicated based on symptoms or physical signs suggestive of progressive disease or rising serum tumor marker levels.

Interventionpercentage of participants (Number)
Mifepristone13.6

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Progression-free Survival by Age (y)

"Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter (LD) of target lesions taking as reference the smallest sum LD recorded since study entry, or unequivocal progression of existing non-target lesions, or the appearance of one or more new lesions.~CT scan or MRI is used to follow lesion for measurable disease every other cycle for the first 6 months; every three months thereafter; and at any time if clinically indicated based on symptoms or physical signs suggestive of progressive disease or rising serum tumor marker levels. Responses must be confirmed by repeat imaging 4 weeks following documentation of response." (NCT00459290)
Timeframe: Every other cycle, for the first 6 months; every three months thereafter; and at any time if clinically indicated based on symptoms or physical signs suggestive of progressive disease or rising serum tumor marker levels.

Interventionmonths (Median)
< 601.7
60 <704.0
>=701.7

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Progression-free Survival by Performance Status

(NCT00459290)
Timeframe: Every other cycle, for the first 6 months; every three months thereafter; and at any time if clinically indicated based on symptoms or physical signs suggestive of progressive disease or rising serum tumor marker levels.

Interventionmonths (Median)
GOG Performance Status 01.8
GOG Performance Status 11.7

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Progression-free Survival by Platinum Sensitivity

Platinum Senstive defined as treatment free interval >6 months on most recent platinum (NCT00459290)
Timeframe: Every other cycle, for the first 6 months; every three months thereafter; and at any time if clinically indicated based on symptoms or physical signs suggestive of progressive disease or rising serum tumor marker levels.

Interventionmonths (Median)
Not Platinum Sensitive1.7
Platinum Sensitive1.9

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Proportion of Patients With Objective Tumor Response

"Complete and Partial Tumor Response by Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0). Per RECIST v1.0 for target lesions and assessed by MRIor CT scan: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest dimensions (LD) of all target measurable lesions taking as reference the baseline sum of LD.~CT scan or MRI is used to follow lesion for measurable disease every other cycle for the first 6 months; every three months thereafter; and at any time if clinically indicated based on symptoms or physical signs suggestive of progressive disease or rising serum tumor marker levels. Responses must be confirmed by repeat imaging 4 weeks following documentation of response." (NCT00459290)
Timeframe: Every other cycle, for the first 6 months; every three months thereafter; and at any time if clinically indicated based on symptoms or physical signs suggestive of progressive disease or rising serum tumor marker levels.

Interventionpercentage of participants (Number)
Mifepristone4.5

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Number of Participants With Adverse Effects (Grade 3 or Higher) as Assessed by Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0

(NCT00459290)
Timeframe: Every cycle, during treatment (average of 3 months).

InterventionParticipants (Count of Participants)
AnemiaCoagulationDermatologicGastrointestinalHemorrhage
Mifepristone12111

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Complete Abortion at One Week

Complete abortion at one week; uterus demonstrated to be empty on transvaginal ultrasound (NCT00468299)
Timeframe: 3 weeks

Interventionparticipants (Number)
Misoprostol and Placebo6
Mifepristone and Misoprostol7

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Number of Women With Complete Abortion 24-48hrs After Receiving Medical Treatment for Early Pregnancy Failure.

(NCT00468299)
Timeframe: 24-48 hrs

Interventionparticipants (Number)
Misoprostol and Placebo5
Mifepristone and Misoprostol5

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Decrease in Diastolic Blood Pressure.

Responder is defined as subject with a decrease greater than or equal to 5mm Hg in diastolic blood pressure from baseline to week 24 or last visit. (NCT00569582)
Timeframe: Baseline to Week 24

Interventionparticipants (Number)
Mifepristone8

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Improvement in Diabetes and/or Glucose Intolerance.

Responder is defined as subject with a decrease greater than or equal to 25% in area under the curve for glucose on 2-hour oral glucose test from baseline to week 24 or last visit, for Cushing's patients with type-2 diabetes mellitus/impaired glucose tolerance. (NCT00569582)
Timeframe: Baseline to Week 24

Interventionparticipants (Number)
Mifepristone15

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Proportion of Mifepristone Treated Patients With Plasma Drug Concentrations Equal to or Above 1637 ng/mL vs. Placebo Treated Patients Who Achieve a ≤ 50% Reduction in BPRS-PSS at Days 7 and 56

Response as measured by 50% reduction in psychosis at Days 7 and 56 was compared between the group administered placebo and the group who achieved a sufficiently high plasma level of mifepristone (NCT00637494)
Timeframe: 56 days

Interventionparticipants (Number)
Active37
Placebo48

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Proportion of Mifepristone vs. Placebo Treated Patients With at Least a 50% Reduction From Baseline in Brief Psychiatric Rating Scale-Positive Symptom Subscale (BPRS-PSS) at Days 7 and 56

Response as measured by 50% reduction in psychosis at Days 7 and 56 was compared between the group administered placebo and the group administered mifepristone (NCT00637494)
Timeframe: 56 days

Interventionparticipants (Number)
Active51
Placebo48

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Percentage of Participants With <5% and <7% Increase From Baseline in Body Weight

(NCT00698022)
Timeframe: Baseline and 28 days

,,
InterventionParticipants (Count of Participants)
<5% increase in body weight<7% increase in body weight
Mifepristone Plus Risperidone913
Risperidone Plus Mifepristone-matched Placebo310
Risperidone-matched Placebo Plus Mifepristone811

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Percentage of Participants With One or More Adverse Events

(NCT00698022)
Timeframe: Up to 28 days

InterventionParticipants (Count of Participants)
Mifepristone Plus Risperidone29
Risperidone Plus Mifepristone-matched Placebo27
Risperidone-matched Placebo Plus Mifepristone13

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Percentage of Participants Discontinued From the Study Due to an Adverse Event

(NCT00698022)
Timeframe: Up to 28 days

InterventionParticipants (Count of Participants)
Mifepristone Plus Risperidone5
Risperidone Plus Mifepristone-matched Placebo4
Risperidone-matched Placebo Plus Mifepristone1

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Change From Baseline in Body Weight

(NCT00698022)
Timeframe: Baseline and 28 days

Interventionkilograms (Mean)
Mifepristone Plus Risperidone2.32
Risperidone Plus Mifepristone-matched Placebo4.23
Risperidone-matched Placebo Plus Mifepristone2.87

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Change in Mood Symptoms

Utilized the Hamilton Depression Rating Scale, 21-item version to assess depressive symptoms, with a range of 0-63, with higher scores indicating greater levels of depression. (NCT00725270)
Timeframe: Baseline and Day 9

,
Interventionunits on a scale (Mean)
BaselineDay 9
Mifepristone24.8613.57
Placebo26.219.0

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Change in Positive Psychotic Symptoms Over the Course of Treatment

Utilized the Positive Symptoms Subscale of the Brief Psychiatric Rating Scale is assess psychotic symptoms. Range for the subscale is 4-28, with 4 = no positive symptoms (NCT00725270)
Timeframe: 8 days

,
Interventionunits on a scale (Mean)
Baseline PSS ScoresDay 9 PSS scores
Mifepristone7.576.0
Placebo12.011.0

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Maximum Intensity of Withdrawal Bleeding Episodes at Cycle 1

Intensity was rated as 1=spotting; 2=light; 3=normal or 4=heavy. (NCT00764881)
Timeframe: At Cycle 1 (28 days per Cycle)

InterventionScores on a scale (Mean)
EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)3.1
EE/LNG (Microgynon) + Placebo3.7

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The Mean Absolute Values of Psychological General Well-Being Index (PGWBI) - Anxiety at Cycle 6

Anxiety is 1 of 6 dimensions of the PGWBI self-report questionnaire used to measure the subjective well-being or distress of the participant. The response format used a 6-grade Likert scale and the range of PGWBI scores were normalized from 0 to 100. The higher the score, the better the wellbeing of the participant. (NCT00764881)
Timeframe: At Cycle 6 (28 days per Cycle)

InterventionScores on a scale (Mean)
EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)74.8
EE/LNG (Microgynon) + Placebo74.1

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The Mean Absolute Values of Psychological General Well-Being Index (PGWBI) - Depressed Mood at Baseline

Depressed mood is 1 of 6 dimensions of the PGWBI self-report questionnaire used to measure the subjective well-being or distress of the participant. The response format used a 6-grade Likert scale and the range of PGWBI scores were normalized from 0 to 100. The higher the score, the better the wellbeing of the participant. (NCT00764881)
Timeframe: At Baseline

InterventionScores on a scale (Mean)
EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)86.20
EE/LNG (Microgynon) + Placebo85.79

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The Mean Absolute Values of Psychological General Well-Being Index (PGWBI) - Depressed Mood at Cycle 6

Depressed mood is 1 of 6 dimensions of the PGWBI self-report questionnaire used to measure the subjective well-being or distress of the participant. The response format used a 6-grade Likert scale and the range of PGWBI scores were normalized from 0 to 100. The higher the score, the better the wellbeing of the participant. (NCT00764881)
Timeframe: At Cycle 6 (28 days per Cycle)

InterventionScores on a scale (Mean)
EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)87.24
EE/LNG (Microgynon) + Placebo89.94

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The Mean Absolute Values of Psychological General Well-Being Index (PGWBI) - General Health at Baseline

General health is 1 of 6 dimensions of the PGWBI self-report questionnaire used to measure the subjective well-being or distress of the participant. The response format used a 6-grade Likert scale and the range of PGWBI scores were normalized from 0 to 100. The higher the score, the better the wellbeing of the participant. (NCT00764881)
Timeframe: At Baseline

InterventionScores on a scale (Mean)
EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)79.12
EE/LNG (Microgynon) + Placebo81.00

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The Mean Absolute Values of Psychological General Well-Being Index (PGWBI) - General Health at Cycle 6

General health is 1 of 6 dimensions of the PGWBI self-report questionnaire used to measure the subjective well-being or distress of the participant. The response format used a 6-grade Likert scale and the range of PGWBI scores were normalized from 0 to 100. The higher the score, the better the wellbeing of the participant. (NCT00764881)
Timeframe: At Cycle 6 (28 days per Cycle)

InterventionScores on a scale (Mean)
EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)80.22
EE/LNG (Microgynon) + Placebo81.17

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The Mean Absolute Values of Psychological General Well-Being Index (PGWBI) - Positive Well-being at Baseline

Positive well-being is 1 of 6 dimensions of the PGWBI self-report questionnaire used to measure the subjective well-being or distress of the participant. The response format used a 6-grade Likert scale and the range of PGWBI scores were normalized from 0 to 100. The higher the score, the better the wellbeing of the participant. (NCT00764881)
Timeframe: At Baseline

InterventionScores on a scale (Mean)
EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)47.88
EE/LNG (Microgynon) + Placebo48.46

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The Mean Absolute Values of Psychological General Well-Being Index (PGWBI) - Positive Well-being at Cycle 6

Positive well-being is 1 of 6 dimensions of the PGWBI self-report questionnaire used to measure the subjective well-being or distress of the participant. The response format used a 6-grade Likert scale and the range of PGWBI scores were normalized from 0 to 100. The higher the score, the better the wellbeing of the participant. (NCT00764881)
Timeframe: At Cycle 6 (28 days per Cycle)

InterventionScores on a scale (Mean)
EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)49.41
EE/LNG (Microgynon) + Placebo49.26

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The Mean Absolute Values of Psychological General Well-Being Index (PGWBI) - Self-control at Baseline

Self-control is 1 of 6 dimensions of the PGWBI self-report questionnaire used to measure the subjective well-being or distress of the participant. The response format used a 6-grade Likert scale and the range of PGWBI scores were normalized from 0 to 100. The higher the score, the better the wellbeing of the participant. (NCT00764881)
Timeframe: At Baseline

InterventionScores on a scale (Mean)
EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)66.40
EE/LNG (Microgynon) + Placebo66.66

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The Mean Absolute Values of Psychological General Well-Being Index (PGWBI) - Self-control at Cycle 6

Self-control is 1 of 6 dimensions of the PGWBI self-report questionnaire used to measure the subjective well-being or distress of the participant. The response format used a 6-grade Likert scale and the range of PGWBI scores were normalized from 0 to 100. The higher the score, the better the wellbeing of the participant. (NCT00764881)
Timeframe: At Cycle 6 (28 days per Cycle)

InterventionScores on a scale (Mean)
EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)66.95
EE/LNG (Microgynon) + Placebo67.18

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The Mean Absolute Values of Psychological General Well-Being Index (PGWBI) - Vitality at Baseline

Vitality is 1 of 6 dimensions of the PGWBI self-report questionnaire used to measure the subjective well-being or distress of the participant. The response format used a 6-grade Likert scale and the range of PGWBI scores were normalized from 0 to 100. The higher the score, the better the wellbeing of the participant. (NCT00764881)
Timeframe: At Baseline

InterventionScores on a scale (Mean)
EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)60.27
EE/LNG (Microgynon) + Placebo60.93

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The Mean Absolute Values of Psychological General Well-Being Index (PGWBI) - Vitality at Cycle 6

Vitality is 1 of 6 dimensions of the PGWBI self-report questionnaire used to measure the subjective well-being or distress of the participant. The response format used a 6-grade Likert scale and the range of PGWBI scores were normalized from 0 to 100. The higher the score, the better the wellbeing of the participant. (NCT00764881)
Timeframe: At Cycle 6 (28 days per Cycle)

InterventionScores on a scale (Mean)
EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)61.83
EE/LNG (Microgynon) + Placebo63.58

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The Mean Absolute Values of Psychological General Well-Being Index (PGWBI) Global Score at Baseline

The PGWBI measured at Baseline self-representations over the past 4 weeks of intrapersonal affective or emotional states reflecting a sense of subjective well-being or distress. The response format used a 6-grade Likert scale and the range of PGWBI scores were normalized from 0 to 100. The higher the score, the better the well-being of the participant (NCT00764881)
Timeframe: At Baseline

InterventionScores on a scale (Mean)
EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)67.75
EE/LNG (Microgynon) + Placebo67.98

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The Mean Absolute Values of Psychological General Well-Being Index (PGWBI) Global Score at Cycle 6

The PGWBI measured at Cycle 6 self-representations over the past 4 weeks of intrapersonal affective or emotional states reflecting a sense of subjective well-being or distress. The response format used a 6-grade Likert scale and the range of PGWBI scores were normalized from 0 to 100. The higher the score, the better the well-being of the participant (NCT00764881)
Timeframe: At Cycle 6 (28 days per Cycle)

InterventionScores on a scale (Mean)
EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)69.20
EE/LNG (Microgynon) + Placebo69.86

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Vaginal Effects Evaluated by the Mean Absolute Values of Atrophy Symptom Questionnaire (ASQ) at Baseline

ASQ consists of 5 items which define the status of the vagina. The response format uses a 4-point scale from 0 (none) to 3 (severe). (NCT00764881)
Timeframe: At Baseline

InterventionScores on a scale (Mean)
EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)0.54
EE/LNG (Microgynon) + Placebo0.47

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Vaginal Effects Evaluated by the Mean Absolute Values of Atrophy Symptom Questionnaire (ASQ) at Cycle 6

ASQ consists of 5 items which define the status of the vagina. The response format uses a 4-point scale from 0 (none) to 3 (severe). (NCT00764881)
Timeframe: At Cycle 6 (28 days per Cycle)

InterventionScores on a scale (Mean)
EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)0.27
EE/LNG (Microgynon) + Placebo0.25

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Vaginal Effects Evaluated by the Mean Absolute Values of Vaginal Health Assessment (VHA) at Baseline

The VHA, performed by the Investigator during gynecological exam, is the average of 5 individual scores related to composition and appearance of the vagina (secretions, epithelial integrity, epithelial surface thickness, color, and pH) scored from 0 (no atrophy or pH<4) to 3 (severe or pH5). (NCT00764881)
Timeframe: At Baseline

InterventionScores on a scale (Mean)
EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)0.33
EE/LNG (Microgynon) + Placebo0.38

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Vaginal Effects Evaluated by the Mean Absolute Values of Vaginal Health Assessment (VHA) at Cycle 6

The VHA, performed by the Investigator during gynecological exam, is the average of 5 individual scores related to composition and appearance of the vagina (secretions, epithelial integrity, epithelial surface thickness, color, and pH) scored from 0 (no atrophy or pH<4) to 3 (severe or pH5). (NCT00764881)
Timeframe: At Cycle 6 (28 days per Cycle)

InterventionScores on a scale (Mean)
EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)0.34
EE/LNG (Microgynon) + Placebo0.31

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Vaginal Effects Evaluated by the Mean Change From Baseline to Cycle 6 in Vaginal Health Assessment (VHA)

The VHA, performed by the Investigator during gynecological exam, is the average of 5 individual scores related to composition and appearance of the vagina (secretions, epithelial integrity, epithelial surface thickness, color, and pH) scored from 0 (no atrophy or pH<4) to 3 (severe or pH5). The change in average score ranges from -3 (best) to 3 (worst). (NCT00764881)
Timeframe: Baseline up to Cycle 6 (28 days per Cycle)

InterventionScores on a scale (Mean)
EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)0.01
EE/LNG (Microgynon) + Placebo-0.06

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Percentage of Participants by Maximum Intensity of Intracyclic Bleeding Episodes at Cycle 1

Intracyclic bleeding is any unexpected bleeding episode occurring in cyclical treatment regimens. Intensity rated on 4-point scale where 1=spotting; 2=light; 3=normal; and 4=heavy. (NCT00764881)
Timeframe: At Cycle 1 (28 days per Cycle)

,
InterventionPercentage of participants (Number)
spottinglightnormalheavy
EE/LNG (Microgynon) + Placebo80.020.00.00.0
EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)75.06.312.56.3

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Percentage of Participants by Maximum Intensity of Intracyclic Bleeding Episodes at Cycle 3

Intracyclic bleeding is any unexpected bleeding episode occurring in cyclical treatment regimens. Intensity rated on 4-point scale where 1=spotting; 2=light; 3=normal; and 4=heavy. (NCT00764881)
Timeframe: At Cycle 3 (28 days per Cycle)

,
InterventionPercentage of participants (Number)
spottinglightnormalheavy
EE/LNG (Microgynon) + Placebo75.025.00.00.0
EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)64.723.511.80.0

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Percentage of Participants by Maximum Intensity of Intracyclic Bleeding Episodes at Cycle 6

Intracyclic bleeding is any unexpected bleeding episode occurring in cyclical treatment regimens. Intensity rated on 4-point scale where 1=spotting; 2=light; 3=normal; and 4=heavy. (NCT00764881)
Timeframe: At Cycle 6 (28 days per Cycle)

,
InterventionPercentage of participants (Number)
spottinglightnormalheavy
EE/LNG (Microgynon) + Placebo100.00.00.00.0
EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)66.78.316.78.3

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Percentage of Participants by Maximum Intensity of Withdrawal Bleeding Episodes at Cycle 1

Withdrawal bleeding is bleeding that occurs when using oral contraceptives (OCs) caused by falling levels and/or taking away external source of estrogen and progestogen toward cycle end. Intensity rated on 4-point scale from 1=spotting to 4=heavy. (NCT00764881)
Timeframe: At Cycle 1 (28 days per Cycle)

,
InterventionPercentage of participants (Number)
spottinglightnormalheavy
EE/LNG (Microgynon) + Placebo7.725.053.813.5
EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)22.444.730.32.6

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Percentage of Participants by Maximum Intensity of Withdrawal Bleeding Episodes at Cycle 3

Withdrawal bleeding is bleeding that occurs when using oral contraceptives (OCs) caused by falling levels and/or taking away external source of estrogen and progestogen toward cycle end. Intensity rated on 4-point scale from 1=spotting to 4=heavy. (NCT00764881)
Timeframe: At Cycle 3 (28 days per Cycle)

,
InterventionPercentage of participants (Number)
spottinglightnormalheavy
EE/LNG (Microgynon) + Placebo4.025.361.69.1
EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)26.533.737.32.4

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Percentage of Participants by Maximum Intensity of Withdrawal Bleeding Episodes at Cycle 6

Withdrawal bleeding is bleeding that occurs when using oral contraceptives (OCs) caused by falling levels and/or taking away external source of estrogen and progestogen toward cycle end. Intensity rated on 4-point scale from 1=spotting to 4=heavy. (NCT00764881)
Timeframe: At Cycle 6 (28 days per Cycle)

,
InterventionPercentage of participants (Number)
spottinglightnormalheavy
EE/LNG (Microgynon) + Placebo13.026.147.813.0
EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)38.927.827.85.6

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Percentage of Participants With / Without Withdrawal Bleeding at Cycle 1

Withdrawal bleeding is bleeding that occurs when using oral contraceptives (OCs) caused by falling levels and/or taking away external source of estrogen and progestogen toward cycle end (NCT00764881)
Timeframe: At Cycle 1 (28 days per Cycle)

,
InterventionPercentage of participants (Number)
without withdrawal bleedingwith withdrawal bleeding
EE/LNG (Microgynon) + Placebo2.897.2
EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)24.875.2

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Percentage of Participants With / Without Withdrawal Bleeding at Cycle 3

Withdrawal bleeding is bleeding that occurs when using oral contraceptives (OCs) caused by falling levels and/or taking away external source of estrogen and progestogen toward cycle end (NCT00764881)
Timeframe: At Cycle 3 (28 days per Cycle)

,
InterventionPercentage of participants (Number)
without withdrawal bleedingwith withdrawal bleeding
EE/LNG (Microgynon) + Placebo0.0100.0
EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)13.586.5

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Percentage of Participants With / Without Withdrawal Bleeding at Cycle 6

Withdrawal bleeding is bleeding that occurs when using oral contraceptives (OCs) caused by falling levels and/or taking away external source of estrogen and progestogen toward cycle end (NCT00764881)
Timeframe: At Cycle 6 (28 days per Cycle)

,
InterventionPercentage of participants (Number)
without withdrawal bleedingwith withdrawal bleeding
EE/LNG (Microgynon) + Placebo8.092.0
EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)51.448.6

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Percentage of Participants With at Least 1 Intracyclic Bleeding Episode

Intracyclic bleeding is any unexpected bleeding episode occurring in cyclical treatment regimens. (NCT00764881)
Timeframe: Up to Cycle 6 (28 days per Cycle)

,
InterventionPercentage of participants (Number)
noyes
EE/LNG (Microgynon) + Placebo87.912.1
EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)63.136.9

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Percentage of Participants With Presence or Absence of Intracyclic Bleeding at Cycle 1

Intracyclic bleeding is any unexpected bleeding episode occurring in cyclical treatment regimens. (NCT00764881)
Timeframe: At Cycle 1 (28 days per Cycle)

,
InterventionPercentage of participants (Number)
with absence of intracyclic bleedingwith presence of intracyclic bleeding
EE/LNG (Microgynon) + Placebo95.34.7
EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)84.215.8

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Percentage of Participants With Presence or Absence of Intracyclic Bleeding at Cycle 3

Intracyclic bleeding is any unexpected bleeding episode occurring in cyclical treatment regimens. (NCT00764881)
Timeframe: At Cycle 3 (28 days per Cycle)

,
InterventionPercentage of participants (Number)
with absence of intracyclic bleedingwith presence of intracyclic bleeding
EE/LNG (Microgynon) + Placebo96.04.0
EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)82.317.7

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Percentage of Participants With Presence or Absence of Intracyclic Bleeding at Cycle 6

Intracyclic bleeding is any unexpected bleeding episode occurring in cyclical treatment regimens. (NCT00764881)
Timeframe: At Cycle 6 (28 days per Cycle)

,
InterventionPercentage of participants (Number)
with absence of intracyclic bleedingwith presence of intracyclic bleeding
EE/LNG (Microgynon) + Placebo94.75.3
EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)83.816.2

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Vaginal Effects Evaluated by Vaginal pH at Cycle 6

Vaginal pH (0 to 6) measured by subject using a pH indicator dipstick (NCT00764881)
Timeframe: At Cycle 6 (28 days per Cycle)

,
InterventionProportion of participants (Number)
Vaginal pH < 4.0Vaginal pH 4.0 - 4.4Vaginal pH 4.5 - 5.0Vaginal pH > 5.0
EE/LNG (Microgynon) + Placebo0.0390.2940.6370.029
EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)0.0530.2980.5210.117

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Change From Baseline to Cycle 6 in the Total of Questions 1 to 6 of the Female Sexual Function Index (FSFI) - Full Analysis Set (FAS)

Change from Baseline FSFI domains in desire and arousal component scores at Cycle 6. The change in score ranges from -28 (worst) to 28 (best). (NCT00764881)
Timeframe: Baseline up to Cycle 6 (28 days per Cycle)

Interventionscores on a scale (Mean)
EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)6.45
EE/LNG (Microgynon) + Placebo5.98

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Change From Baseline to Cycle 6 in the Total of Questions 1 to 6 of the Female Sexual Function Index (FSFI) - Per Protocol Set (PPS)

Change from Baseline FSFI domains in desire and arousal component scores at Cycle 6. The change in score ranges from -28 (worst) to 28 (best). (NCT00764881)
Timeframe: Baseline up to Cycle 6 (28 days per Cycle)

Interventionscores on a scale (Mean)
EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)6.43
EE/LNG (Microgynon) + Placebo6.37

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Difference in Duration Between Longest and Shortest Bleeding / Spotting Episodes in Reference Period 1

Reference Period 1 is defined as Day 1 to Day 90 during study treatment and includes the initial bleeding episode that triggered the first intake of study medication, meaning that the first treatment cycle includes 2 bleeding episodes. (NCT00764881)
Timeframe: From Day 1 to Day 90

InterventionDays (Mean)
EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)3.8
EE/LNG (Microgynon) + Placebo2.2

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Difference in Duration Between Longest and Shortest Bleeding / Spotting Episodes in Reference Period 2

Reference Period 2 is defined as Day 91 to Day 180 during study treatment. (NCT00764881)
Timeframe: From Day 91 to Day 180

InterventionDays (Mean)
EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)2.3
EE/LNG (Microgynon) + Placebo1.3

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Difference in Duration Between Longest and Shortest Spotting-only Episodes in Reference Period 1

Reference Period 1 is defined as Day 1 to Day 90 during study treatment and includes the initial bleeding episode that triggered the first intake of study medication, meaning that the first treatment cycle includes 2 bleeding episodes. (NCT00764881)
Timeframe: From Day 1 to Day 90

InterventionDays (Mean)
EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)1.1
EE/LNG (Microgynon) + Placebo1.0

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Difference in Duration Between Longest and Shortest Spotting-only Episodes in Reference Period 2

Reference Period 2 is defined as Day 91 to Day 180 during study treatment. (NCT00764881)
Timeframe: From Day 91 to Day 180

InterventionDays (Mean)
EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)1.3
EE/LNG (Microgynon) + Placebo0.8

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Length of Withdrawal Bleeding Episodes at Cycle 1

Withdrawal bleeding is bleeding that occurs when using oral contraceptives (OCs) caused by falling levels and/or taking away external source of estrogen and progestogen toward cycle end (NCT00764881)
Timeframe: At Cycle 1 (28 days per Cycle)

InterventionDays (Mean)
EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)4.3
EE/LNG (Microgynon) + Placebo4.6

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Length of Withdrawal Bleeding Episodes at Cycle 3

Withdrawal bleeding is bleeding that occurs when using oral contraceptives (OCs) caused by falling levels and/or taking away external source of estrogen and progestogen toward cycle end (NCT00764881)
Timeframe: At Cycle 3 (28 days per Cycle)

InterventionDays (Mean)
EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)4.3
EE/LNG (Microgynon) + Placebo4.4

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Length of Withdrawal Bleeding Episodes at Cycle 6

Withdrawal bleeding is bleeding that occurs when using oral contraceptives (OCs) caused by falling levels and/or taking away external source of estrogen and progestogen toward cycle end (NCT00764881)
Timeframe: At Cycle 6 (28 days per Cycle)

InterventionDays (Mean)
EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)3.4
EE/LNG (Microgynon) + Placebo4.0

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Number of Spotting Only Episodes in Reference Period 1

Reference Period 1 is defined as Day 1 to Day 90 during study treatment and includes the initial bleeding episode that triggered the first intake of study medication, meaning that the first treatment cycle includes 2 bleeding episodes. (NCT00764881)
Timeframe: From Day 1 to Day 90

Interventionepisodes (Mean)
EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)1.1
EE/LNG (Microgynon) + Placebo0.4

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Maximum Intensity of Withdrawal Bleeding Episodes at Cycle 3

Intensity was rated as 1=spotting; 2=light; 3=normal or 4=heavy. (NCT00764881)
Timeframe: At Cycle 3 (28 days per Cycle)

InterventionScores on a scale (Mean)
EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)3.2
EE/LNG (Microgynon) + Placebo3.8

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Maximum Intensity of Withdrawal Bleeding Episodes at Cycle 6

Intensity was rated as 1=spotting; 2=light; 3=normal or 4=heavy. (NCT00764881)
Timeframe: At Cycle 6 (28 days per Cycle)

InterventionScores on a scale (Mean)
EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)3.0
EE/LNG (Microgynon) + Placebo3.6

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Maximum Length of Bleeding / Spotting Episodes in Reference Period 1

Reference Period 1 is defined as Day 1 to Day 90 during study treatment and includes the initial bleeding episode that triggered the first intake of study medication, meaning that the first treatment cycle includes 2 bleeding episodes. (NCT00764881)
Timeframe: From Day 1 to Day 90

InterventionDays (Mean)
EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)6.6
EE/LNG (Microgynon) + Placebo5.6

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Maximum Length of Bleeding / Spotting Episodes in Reference Period 2

Reference Period 2 is defined as Day 91 to Day 180 during study treatment. (NCT00764881)
Timeframe: From Day 91 to Day 180

InterventionDays (Mean)
EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)5.3
EE/LNG (Microgynon) + Placebo4.7

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Maximum Length of Intracyclic Bleeding Episodes at Cycle 1

Intracyclic bleeding is any unexpected bleeding episode occurring in cyclical treatment regimens. (NCT00764881)
Timeframe: At Cycle 1 (28 days per Cycle)

InterventionDays (Mean)
EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)3.5
EE/LNG (Microgynon) + Placebo2.4

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Maximum Length of Intracyclic Bleeding Episodes at Cycle 3

Intracyclic bleeding is any unexpected bleeding episode occurring in cyclical treatment regimens. (NCT00764881)
Timeframe: At Cycle 3 (28 days per Cycle)

InterventionDays (Mean)
EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)5.0
EE/LNG (Microgynon) + Placebo2.8

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Maximum Length of Intracyclic Bleeding Episodes at Cycle 6

Intracyclic bleeding is any unexpected bleeding episode occurring in cyclical treatment regimens. (NCT00764881)
Timeframe: At Cycle 6 (28 days per Cycle)

InterventionDays (Mean)
EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)3.5
EE/LNG (Microgynon) + Placebo5.0

[back to top]

Maximum Length of Spotting-only Episodes in Reference Period 1

Reference Period 1 is defined as Day 1 to Day 90 during study treatment and includes the initial bleeding episode that triggered the first intake of study medication, meaning that the first treatment cycle includes 2 bleeding episodes. (NCT00764881)
Timeframe: From Day 1 to Day 90

InterventionDays (Mean)
EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)3.9
EE/LNG (Microgynon) + Placebo3.3

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Maximum Length of Spotting-only Episodes in Reference Period 2

Reference Period 2 is defined as Day 91 to Day 180 during study treatment. (NCT00764881)
Timeframe: From Day 91 to Day 180

InterventionDays (Mean)
EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)3.9
EE/LNG (Microgynon) + Placebo3.7

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Mean Change From Baseline to Cycle 6 in Female Sexual Distress Scale (FSDS-R) Total Score

Change from Baseline to Cycle 6 in the validated, 13-item scale (0=never to 4=always) that assesses subjective distress associated with sexual dysfunction in women. A decrease in the total score=decrease in frequency of the subjective distress symptom. The change in total score ranges from -52 (best) to 52 (worst). (NCT00764881)
Timeframe: Baseline up to Cycle 6 (28 days per Cycle)

InterventionScores on a scale (Mean)
EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)-10.0
EE/LNG (Microgynon) + Placebo-9.6

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Mean Change From Baseline to Cycle 6 in FSFI Domain Score (Arousal)

Mean change from Baseline to Cycle 6 in the sum of questions 3 to 6 on sexual arousal on the FSFI Questionnaire. The change in the normalized score for those 4 questions ranges from -6 (worst) to 6 (best). (NCT00764881)
Timeframe: Baseline up to Cycle 6 (28 days per Cycle)

Interventionscores on a scale (Mean)
EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)1.43
EE/LNG (Microgynon) + Placebo1.24

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Mean Change From Baseline to Cycle 6 in FSFI Domain Score (Desire)

Mean change from Baseline to Cycle 6 in the sum of questions 1 and 2 on sexual desire on the FSFI Questionnaire. The change in the normalized score for those 2 questions ranges from -4.8 (worst) to 4.8 (best). (NCT00764881)
Timeframe: Baseline up to Cycle 6 (28 days per Cycle)

Interventionscores on a scale (Mean)
EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)1.02
EE/LNG (Microgynon) + Placebo1.11

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Mean Change From Baseline to Cycle 6 in FSFI Domain Score (Lubrication)

Mean change from Baseline at Cycle 6 in the sum of questions 7 to 10 on the FSFI Questionnaire. The change in the normalized score for those 4 questions ranges from -6 (worst) to 6 (best). (NCT00764881)
Timeframe: Baseline up to Cycle 6 (28 days per Cycle)

InterventionScores on a scale (Mean)
EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)1.36
EE/LNG (Microgynon) + Placebo1.04

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Mean Change From Baseline to Cycle 6 in FSFI Domain Score (Orgasm)

Mean change from Baseline to Cycle 6 in the sum of questions 11 to 13 on orgasm on the FSFI Questionnaire. The change in the normalized score for those 3 questions ranges from -6 (worst) to 6 (best). (NCT00764881)
Timeframe: Baseline up to Cycle 6 (28 days per Cycle)

InterventionScores on a scale (Mean)
EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)1.26
EE/LNG (Microgynon) + Placebo1.06

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Mean Change From Baseline to Cycle 6 in FSFI Domain Score (Pain)

Mean change from Baseline to Cycle 6 in the sum of questions 17 to 19 on pain on the FSFI Questionnaire. The change in the normalized score for those 3 questions ranges from -6 (worst) to 6 (best). (NCT00764881)
Timeframe: Baseline up to Cycle 6 (28 days per Cycle)

InterventionScores on a scale (Mean)
EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)0.69
EE/LNG (Microgynon) + Placebo0.22

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Mean Change From Baseline to Cycle 6 in FSFI Domain Score (Satisfaction)

Mean change from Baseline to Cycle 6 in the sum of questions 14 to 16 on satisfaction on the FSFI Questionnaire. The change in the normalized score for those 3 questions ranges from -5.2 (worst) to 5.2 (best). (NCT00764881)
Timeframe: Baseline up to Cycle 6 (28 days per Cycle)

InterventionScores on a scale (Mean)
EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)1.03
EE/LNG (Microgynon) + Placebo1.03

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Mean Change From Baseline to Cycle 6 in FSFI Total Score

The change in the normalized FSFI total score ranges from -34 (worst) to 34 (best). (NCT00764881)
Timeframe: Baseline up to Cycle 6 (28 days per Cycle)

InterventionScores on a scale (Mean)
EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)6.7
EE/LNG (Microgynon) + Placebo5.7

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Mean Change From Baseline to Cycle 6 in Psychological General Well-Being Index (PGWBI) - Anxiety

Anxiety is 1 of 6 dimensions of the PGWBI self-report questionnaire used to measure the subjective well-being or distress of the participant. The response format used a 6-grade Likert scale and the change in the normalized PGWBI - Anxiety score ranges from -100 (worst) to 100 (best). (NCT00764881)
Timeframe: Baseline up to Cycle 6 (28 days per Cycle)

InterventionScores on a scale (Mean)
EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)4.9
EE/LNG (Microgynon) + Placebo2.6

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Mean Change From Baseline to Cycle 6 in Psychological General Well-Being Index (PGWBI) - Depressed Mood

Depressed mood is 1 of 6 dimensions of the PGWBI self-report questionnaire used to measure the subjective well-being or distress of the participant. The response format used a 6-grade Likert scale and the change in the normalized PGWBI - depressed mood score ranges from -100 (worst) to 100 (best). (NCT00764881)
Timeframe: Baseline up to Cycle 6 (28 days per Cycle)

InterventionScores on a scale (Mean)
EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)1.75
EE/LNG (Microgynon) + Placebo4.25

[back to top]

Mean Change From Baseline to Cycle 6 in Psychological General Well-Being Index (PGWBI) - General Health

General health is 1 of 6 dimensions of the PGWBI self-report questionnaire used to measure the subjective well-being or distress of the participant. The response format used a 6-grade Likert scale the change in the normalized PGWBI general health score ranges from -100 (worst) to 100 (best). (NCT00764881)
Timeframe: Baseline up to Cycle 6 (28 days per Cycle)

InterventionScores on a scale (Mean)
EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)0.93
EE/LNG (Microgynon) + Placebo-0.15

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Mean Change From Baseline to Cycle 6 in Psychological General Well-Being Index (PGWBI) - Positive Well-being

Positive well-being is 1 of 6 dimensions of the PGWBI self-report questionnaire used to measure the subjective well-being or distress of the participant. The response format used a 6-grade Likert scale and the change in the normalized PGWBI - positive well-being score ranges from -100 (worst) to 100 (best). (NCT00764881)
Timeframe: Baseline up to Cycle 6 (28 days per Cycle)

InterventionScores on a scale (Mean)
EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)0.91
EE/LNG (Microgynon) + Placebo0.98

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Mean Change From Baseline to Cycle 6 in Psychological General Well-Being Index (PGWBI) - Self-control

Self-control is 1 of 6 dimensions of the PGWBI self-report questionnaire used to measure the subjective well-being or distress of the participant. The response format used a 6-grade Likert scale and the change in the normalized PGWBI - self-control score ranges from -100 (worst) to 100 (best). (NCT00764881)
Timeframe: Baseline up to Cycle 6 (28 days per Cycle)

InterventionScores on a scale (Mean)
EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)0.02
EE/LNG (Microgynon) + Placebo0.71

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Mean Change From Baseline to Cycle 6 in Psychological General Well-Being Index (PGWBI) - Vitality

Vitality is 1 of 6 dimensions of the PGWBI self-report questionnaire used to measure the subjective well-being or distress of the participant. The response format used a 6-grade Likert scale and the change in the normalized PGWBI - vitality score ranges from -100 (worst) to 100 (best). (NCT00764881)
Timeframe: Baseline up to Cycle 6 (28 days per Cycle)

InterventionScores on a scale (Mean)
EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)1.42
EE/LNG (Microgynon) + Placebo2.65

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Mean Change From Baseline to Cycle 6 in Psychological General Well-Being Index (PGWBI) Global Score

Change from Baseline to Cycle 6 in the PGWBI Questionnaire's assessment of the participant's overall sense of well-being or distress. The response format used a 6-grade Likert scale and the change in the normalized PGWBI global score ranges from -100 (worst) to 100 (best). (NCT00764881)
Timeframe: Baseline up to Cycle 6 (28 days per Cycle)

InterventionScores on a scale (Mean)
EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)1.93
EE/LNG (Microgynon) + Placebo1.90

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Mean Change From Baseline to Cycle 6 in Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) (Short Version) Total Score

Change from Baseline to Cycle 6 in the overall enjoyment and satisfaction experienced during the past week as scored on the QLES-Q (short version - 16 items). 1-5 scale (very poor, poor, fair, good, very good). The normalized score ranges from 0 (worst) to 100 (best). The change in the normalized score ranges from -100 (worst) to 100 (best). (NCT00764881)
Timeframe: Baseline up to Cycle 6 (28 days per Cycle)

InterventionScores on a scale (Mean)
EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)2.60
EE/LNG (Microgynon) + Placebo4.12

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Mean Length of Bleeding / Spotting Episodes in Reference Period 1

Reference Period 1 is defined as Day 1 to Day 90 during study treatment and includes the initial bleeding episode that triggered the first intake of study medication, meaning that the first treatment cycle includes 2 bleeding episodes (NCT00764881)
Timeframe: From Day 1 to Day 90

InterventionDays (Mean)
EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)4.47
EE/LNG (Microgynon) + Placebo4.42

[back to top]

Mean Length of Bleeding / Spotting Episodes in Reference Period 2

Reference Period 2 is defined as Day 91 to Day 180 during study treatment. (NCT00764881)
Timeframe: From Day 91 to Day 180

InterventionDays (Mean)
EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)4.13
EE/LNG (Microgynon) + Placebo4.03

[back to top]

Mean Length of Spotting-only Episodes in Reference Period 1

Reference Period 1 is defined as Day 1 to Day 90 during study treatment and includes the initial bleeding episode that triggered the first intake of study medication, meaning that the first treatment cycle includes 2 bleeding episodes. (NCT00764881)
Timeframe: From Day 1 to Day 90

InterventionDays (Mean)
EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)3.38
EE/LNG (Microgynon) + Placebo2.79

[back to top]

Mean Length of Spotting-only Episodes in Reference Period 2

Reference Period 2 is defined as Day 91 to Day 180 during study treatment. (NCT00764881)
Timeframe: From Day 91 to Day 180

InterventionDays (Mean)
EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)3.18
EE/LNG (Microgynon) + Placebo3.23

[back to top]

Number of Bleeding / Spotting Days in Reference Period 1

Reference Period 1 is defined as Day 1 to 90 during study treatment and includes the initial bleeding episode that triggered the first intake of study medication, meaning that the first treatment cycle includes 2 bleeding episodes. (NCT00764881)
Timeframe: From Day 1 to Day 90

InterventionDays (Mean)
EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)16.3
EE/LNG (Microgynon) + Placebo15.3

[back to top]

Number of Bleeding / Spotting Days in Reference Period 2

Reference Period 2 is defined as Day 91 to 180 during study treatment (NCT00764881)
Timeframe: From Day 91 to Day 180

InterventionDays (Mean)
EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)12.2
EE/LNG (Microgynon) + Placebo12.6

[back to top]

Number of Bleeding / Spotting Episodes in Reference Period 1

Reference Period 1 is defined as Day 1 to Day 90 during study treatment and includes the initial bleeding episode that triggered the first intake of study medication, meaning that the fist treatment cycle includes 2 bleeding episodes (NCT00764881)
Timeframe: From Day 1 to Day 90

Interventionepisodes (Mean)
EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)3.5
EE/LNG (Microgynon) + Placebo3.3

[back to top]

Number of Bleeding / Spotting Episodes in Reference Period 2

Reference Period 2 is defined as Day 91 to Day 180 during study treatment (NCT00764881)
Timeframe: From Day 91 to Day 180

Interventionepisodes (Mean)
EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)3.0
EE/LNG (Microgynon) + Placebo3.1

[back to top]

Number of Intracyclic Bleeding Days at Cycle 1

Intracyclic bleeding is any unexpected bleeding episode occurring in cyclical treatment regimens. (NCT00764881)
Timeframe: At Cycle 1 (28 days per Cycle)

InterventionDays (Mean)
EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)0.6
EE/LNG (Microgynon) + Placebo0.1

[back to top]

Number of Intracyclic Bleeding Days at Cycle 3

Intracyclic bleeding is any unexpected bleeding episode occurring in cyclical treatment regimens. (NCT00764881)
Timeframe: At Cycle 3 (28 days per Cycle)

InterventionDays (Mean)
EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)0.9
EE/LNG (Microgynon) + Placebo0.1

[back to top]

Number of Intracyclic Bleeding Days at Cycle 6

Intracyclic bleeding is any unexpected bleeding episode occurring in cyclical treatment regimens. (NCT00764881)
Timeframe: At Cycle 6 (28 days per Cycle)

InterventionDays (Mean)
EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)0.6
EE/LNG (Microgynon) + Placebo0.3

[back to top]

Number of Intracyclic Bleeding Episodes at Cycle 1

Intracyclic bleeding is any unexpected bleeding episode occurring in cyclical treatment regimens. (NCT00764881)
Timeframe: At Cycle 1 (28 days per Cycle)

Interventionepisodes (Mean)
EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)0.2
EE/LNG (Microgynon) + Placebo0.1

[back to top]

Number of Intracyclic Bleeding Episodes at Cycle 3

Intracyclic bleeding is any unexpected bleeding episode occurring in cyclical treatment regimens. (NCT00764881)
Timeframe: At Cycle 3 (28 days per Cycle)

Interventionepisodes (Mean)
EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)0.2
EE/LNG (Microgynon) + Placebo0.1

[back to top]

Number of Intracyclic Bleeding Episodes at Cycle 6

Intracyclic bleeding is any unexpected bleeding episode occurring in cyclical treatment regimens. (NCT00764881)
Timeframe: At Cycle 6 (28 days per Cycle)

Interventionepisodes (Mean)
EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)0.2
EE/LNG (Microgynon) + Placebo0.1

[back to top]

Number of Spotting Only Days in Reference Period 1

Reference Period 1 is defined as Day 1 to Day 90 during study treatment and includes the initial bleeding episode that triggered the first intake of study medication, meaning that the first treatment cycle includes 2 bleeding episodes. (NCT00764881)
Timeframe: From Day 1 to Day 90

InterventionDays (Mean)
EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)7.6
EE/LNG (Microgynon) + Placebo3.8

[back to top]

Number of Spotting Only Days in Reference Period 2

Reference Period 2 is defined as Day 91 to Day 180 during study treatment. (NCT00764881)
Timeframe: From Day 91 to Day 180

InterventionDays (Mean)
EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)6.1
EE/LNG (Microgynon) + Placebo3.3

[back to top]

Vaginal Effects Evaluated by the Mean Change From Baseline to Cycle 6 in Atrophy Symptom Questionnaire (ASQ)

ASQ consists of 5 items which define the status of the vagina. The response format uses a 4-point scale from 0 (none) to 3 (severe). The change in average score ranges from -3 (best) to 3 (worst). (NCT00764881)
Timeframe: Baseline up to Cycle 6 (28 days per Cycle)

InterventionScores on a scale (Mean)
EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)-0.27
EE/LNG (Microgynon) + Placebo-0.18

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Number of Spotting Only Episodes in Reference Period 2

Reference Period 2 is defined as Day 91 to Day 180 during study treatment. (NCT00764881)
Timeframe: From Day 91 to Day 180

Interventionepisodes (Mean)
EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)1.1
EE/LNG (Microgynon) + Placebo0.4

[back to top]

Onset of Withdrawal Bleeding Episodes at Cycle 1

Onset of withdrawal bleeding was calculated from the end of the exposure to the progestogen component (Day 24 for EV/DNG and Day 21 for EE/LNG). Therefore the count for the onset started at each Cycle on Day 25 for EV/DNG and Day 22 for EE/LNG. (NCT00764881)
Timeframe: From Day 24 for EV/DNG and Day 21 for EE/LNG to Day 28 for Cycle 1

InterventionDays (Mean)
EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)3.5
EE/LNG (Microgynon) + Placebo3.4

[back to top]

Onset of Withdrawal Bleeding Episodes at Cycle 3

Onset of withdrawal bleeding was calculated from the end of the exposure to the progestogen component (Day 24 for EV/DNG and Day 21 for EE/LNG). Therefore the count for the onset started at each Cycle on Day 25 for EV/DNG and Day 22 for EE/LNG. (NCT00764881)
Timeframe: From Day 24 for EV/DNG and Day 21 for EE/LNG to Day 28 for Cycle 3

InterventionDays (Mean)
EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)4.2
EE/LNG (Microgynon) + Placebo3.6

[back to top]

Onset of Withdrawal Bleeding Episodes at Cycle 6

Onset of withdrawal bleeding was calculated from the end of the exposure to the progestogen component (Day 24 for EV/DNG and Day 21 for EE/LNG). Therefore the count for the onset started at each Cycle on Day 25 for EV/DNG and Day 22 for EE/LNG. (NCT00764881)
Timeframe: From Day 24 for EV/DNG and Day 21 for EE/LNG to Day 28 for Cycle 6

InterventionDays (Mean)
EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)1.1
EE/LNG (Microgynon) + Placebo3.3

[back to top]

Percentage of Participants With Improvement in Participant's Assessment in Clinical Global Impression (CGI) at Cycle 6

In 1 section of the CGI the subject rates their total improvement and rate of satisfaction with sexuality during treatment. The assessment scale ranges from 0 to 7: (0=not assessed; 1=very much improved; 2=much improved; 3=minimally improved; 4=no change; 5=minimally worse; 6=much worse; 7=very much worse). The scale of 1, 2, and 3 were categorized as improvement. (NCT00764881)
Timeframe: At Cycle 6 (28 days per Cycle)

InterventionPercentage of participants (Number)
EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)70.3
EE/LNG (Microgynon) + Placebo62.7

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Percentage of Participants With Improvement in the Investigator's Assessment in Clinical Global Impression (CGI) at Cycle 6

CGI is used to collect information regarding the subject's total clinical experience. The assessment scale ranges from 0 to 7: (0=not assessed; 1=very much improved; 2=much improved; 3=minimally improved; 4=no change; 5=minimally worse; 6=much worse; 7=very much worse). The scale of 1, 2, and 3 were categorized as improvement. (NCT00764881)
Timeframe: At Cycle 6 (28 days per Cycle)

InterventionPercentage of participants (Number)
EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)68.1
EE/LNG (Microgynon) + Placebo70.5

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The Mean Absolute Values of Female Sexual Distress Scale (FSDS-R) Total Score at Baseline

Validated, 13-item scale (0=never to 4=always) that assesses subjective distress associated with sexual dysfunction in women. A decrease in the total score=decrease in frequency of the subjective distress symptom. The total score ranges from 0 (worst) to 52 (best). (NCT00764881)
Timeframe: At Baseline

InterventionScores on a scale (Mean)
EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)25.6
EE/LNG (Microgynon) + Placebo27.5

[back to top]

The Mean Absolute Values of Female Sexual Distress Scale (FSDS-R) Total Score at Cycle 6

Validated, 13-item scale (0=never to 4=always) that assesses subjective distress associated with sexual dysfunction in women. A decrease in the total score=decrease in frequency of the subjective distress symptom. The total score ranges from 0 (worst) to 52 (best). (NCT00764881)
Timeframe: At Cycle 6 (28 days per Cycle)

InterventionScores on a scale (Mean)
EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)14.8
EE/LNG (Microgynon) + Placebo17.6

[back to top]

The Mean Absolute Values of FSFI Domain Score (Arousal) at Baseline

Sum of questions 3 to 6 on sexual arousal on the FSFI Questionnaire at Baseline. The normalized score for those 4 questions ranges from 0 (worst) to 6 (best). (NCT00764881)
Timeframe: At Baseline

Interventionscores on a scale (Mean)
EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)2.65
EE/LNG (Microgynon) + Placebo2.77

[back to top]

The Mean Absolute Values of FSFI Domain Score (Arousal) at Cycle 6

Sum of questions 3 to 6 on sexual arousal on FSFI Questionnaire at Cycle 6. The normalized score for those 4 questions ranges from 0 (worst) to 6 (best). (NCT00764881)
Timeframe: At Cycle 6 (28 days per Cycle)

Interventionscores on a scale (Mean)
EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)4.03
EE/LNG (Microgynon) + Placebo4.05

[back to top]

The Mean Absolute Values of FSFI Domain Score (Desire) at Baseline

Sum of questions 1 and 2 on sexual desire on the FSFI Questionnaire at Baseline. The normalized score for those 2 questions ranges from 1.2 (worst) to 6 (best). (NCT00764881)
Timeframe: At Baseline

Interventionscores on a scale (Mean)
EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)2.51
EE/LNG (Microgynon) + Placebo2.39

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The Mean Absolute Values of FSFI Domain Score (Desire) at Cycle 6

Sum of questions 1 and 2 on sexual desire on the FSFI Questionnaire at Cycle 6. The normalized score for those 2 questions ranges from 1.2 (worst) to 6 (best). (NCT00764881)
Timeframe: At Cycle 6 (28 days per Cycle)

Interventionscores on a scale (Mean)
EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)3.53
EE/LNG (Microgynon) + Placebo3.52

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The Mean Absolute Values of FSFI Domain Score (Lubrication) at Baseline

Sum of questions 7 to 10 on lubrication on the FSFI Questionnaire at Baseline. The normalized score for those 4 questions ranges from 0 (worst) to 6 (best). (NCT00764881)
Timeframe: At Baseline

InterventionScores on a scale (Mean)
EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)3.56
EE/LNG (Microgynon) + Placebo3.73

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The Mean Absolute Values of FSFI Domain Score (Lubrication) at Cycle 6

Sum of questions 7 to 10 on lubrication on the FSFI Questionnaire at Cycle 6. The normalized score for those 4 questions ranges from 0 (worst) to 6 (best). (NCT00764881)
Timeframe: At Cycle 6 (28 days per Cycle)

Interventionscores on a scale (Mean)
EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)4.90
EE/LNG (Microgynon) + Placebo4.81

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The Mean Absolute Values of FSFI Domain Score (Orgasm) at Baseline

Sum of questions 11 to 13 on orgasm on FSFI Questionnaire at Baseline. The normalized score for those 3 questions ranges from 0 (worst) to 6 (best). (NCT00764881)
Timeframe: At Baseline

InterventionScores on a scale (Mean)
EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)2.97
EE/LNG (Microgynon) + Placebo2.93

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The Mean Absolute Values of FSFI Domain Score (Orgasm) at Cycle 6

Sum of questions 11 to 13 on orgasm on the FSFI Questionnaire at Cycle 6. The normalized score for those 3 questions ranges from 0 (worst) to 6 (best). (NCT00764881)
Timeframe: At Cycle 6 (28 days per Cycle)

InterventionScores on a scale (Mean)
EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)4.22
EE/LNG (Microgynon) + Placebo4.05

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The Mean Absolute Values of FSFI Domain Score (Pain) at Baseline.

Sum of questions 17 to 19 on pain on the FSFI Questionnaire at Baseline. The normalized score for those 3 questions ranges from 0 (worst) to 6 (best). (NCT00764881)
Timeframe: At Baseline

InterventionScores on a scale (Mean)
EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)4.34
EE/LNG (Microgynon) + Placebo4.74

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The Mean Absolute Values of FSFI Domain Score (Pain) at Cycle 6

Sum of questions 17 to 19 on pain on the FSFI Questionnaire at Cycle 6. The normalized score for those 3 questions ranges from 0 (worst) to 6 (best). (NCT00764881)
Timeframe: At Cycle 6 (28 days per Cycle)

InterventionScores on a scale (Mean)
EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)5.04
EE/LNG (Microgynon) + Placebo5.01

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The Mean Absolute Values of FSFI Domain Score (Satisfaction) at Baseline

Sum of Questions 14 to 16 on satisfaction on the FSFI Questionnaire at Baseline. The normalized score for those 3 questions ranges from 0.8 (worst) to 6 (best). (NCT00764881)
Timeframe: At Baseline

InterventionScores on a scale (Mean)
EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)3.16
EE/LNG (Microgynon) + Placebo3.20

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The Mean Absolute Values of FSFI Domain Score (Satisfaction) at Cycle 6

Sum of questions 14 to 16 on satisfaction on the FSFI Questionnaire at Cycle 6. The normalized score for those 3 questions ranges from 0.8 (worst) to 6 (best). (NCT00764881)
Timeframe: At Cycle 6 (28 days per Cycle)

InterventionScores on a scale (Mean)
EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)4.19
EE/LNG (Microgynon) + Placebo4.26

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The Mean Absolute Values of FSFI Total Score at Baseline

The normalized FSFI total score was the weighted sum of the domain scores covering a range from 2 (worst) to 36 (best). (NCT00764881)
Timeframe: At Baseline

Interventionscores on a scale (Mean)
EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)19.2
EE/LNG (Microgynon) + Placebo19.8

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The Mean Absolute Values of FSFI Total Score at Cycle 6

The normalized FSFI total score was the weighted sum of the domain scores covering a range from 2 (worst) to 36 (best). (NCT00764881)
Timeframe: At Cycle 6 (28 days per Cycle)

InterventionScores on a scale (Mean)
EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)25.8
EE/LNG (Microgynon) + Placebo25.7

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The Mean Absolute Values of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) (Short Version) Total Score at Baseline

Q-LES-Q (short version - 16 items) assessed at Baseline the degree of enjoyment and satisfaction during the past week taking everything into consideration on a 1-5 scale (very poor, poor, fair, good, very good). The normalized score ranges from 0 (worst) to 100 (best). (NCT00764881)
Timeframe: At Baseline

InterventionScores on a scale (Mean)
EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)69.76
EE/LNG (Microgynon) + Placebo68.47

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The Mean Absolute Values of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) (Short Version) Total Score at Cycle 6

Q-LES-Q (short version - 16 items) assessed at Cycle 6 the degree of enjoyment and satisfaction during the past week taking everything into consideration on a 1-5 scale (very poor, poor, fair, good, very good). The normalized score ranges from 0 (worst) to 100 (best). (NCT00764881)
Timeframe: At Cycle 6 (28 days per Cycle)

InterventionScores on a scale (Mean)
EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)71.63
EE/LNG (Microgynon) + Placebo72.48

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The Mean Absolute Values of Psychological General Well-Being Index (PGWBI) - Anxiety at Baseline

Anxiety is 1 of 6 dimensions of the PGWBI self-report questionnaire used to measure the subjective well-being or distress of the participant. The response format used a 6-grade Likert scale and the range of PGWBI scores were normalized from 0 to 100. The higher the score, the better the wellbeing of the participant. (NCT00764881)
Timeframe: At Baseline

InterventionScores on a scale (Mean)
EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)70.3
EE/LNG (Microgynon) + Placebo71.5

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Toxicity Associated With Adrenal Insufficiency

Toxicity will be evaluated per National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE), version 3.0. Frequency and severity of adverse events will be tabulated using counts the following events of interest, which are related to possible adrenal insufficiency: nausea, vomiting, lethargy, dizziness, fatigue, anorexia, and skin rash. Any grade of these events that are self-reported by patients as well as events identified by physician assessment (e.g. physical exam) will be included. (NCT00832871)
Timeframe: Up to 8 weeks after the end of study treatment or until any adverse events are resolved (whichever is longest)

Interventionpercentage of participants (Number)
NauseaVomitingLethargyDizzinessFatigueAnorexiaSkin Rash
Mifepristone0000000

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Overall Survival

The time from patient entry into the protocol to death by any cause. (NCT00832871)
Timeframe: 5 years

InterventionMonths (Median)
Mifepristone24.2

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Duration of Response

The time from the date of response (not the beginning of treatment unless there is stable disease) to disease progression. Response and progression are evaluated according to Response Evaluation Criteria in Solid Tumors (RECIST) (version 1.0). Target lesions are assessed by computerized tomography (CT) or magnetic resonance imaging (MRI): Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Stable Disease (SD), neither sufficient decrease in the sum of the longest diameter of target lesions to qualify for PR nor sufficient increase in the sum of the longest diameter of target lesions to qualify for Progressive Disease; Progressive Disease (PD), 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions (NCT00832871)
Timeframe: 5 years

Interventiondays (Median)
Mifepristone44

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Change in Psychotic Symptoms Subscale (PSS) of the Brief Psychiatric Rating Scale (BPRS)

"The BRPS is a rating scale of various psychiatric symptoms. Each item is rated on a scale of 1 to 7, with 1 being not present. The PSS is the sum of 4 items from the BPRS, which indicates the level of positive psychotic symptoms.. Thus, the range for the PSS is 4 to 28, with higher scores indicating greater levels of positive psychotic symptoms.~For ease of interpretation, the sum of the PSS then has 4 items subtracted so that a score of 0 (instead of 4) indicates that there are no psychotic symptoms. In doing this, the range for the PSS becomes 0 to 24), with larger values indicating more positive psychotic symptoms.~The measure is the change score of PSS total day 1 less PSS total Day 9. 0 indicates no change, where as positive numbers indicate a decrease in psychotic symptoms." (NCT00867360)
Timeframe: baseline to day 9

Interventionunits on a scale (Mean)
Mifepristone.000
Placebo1.00

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Change in Mean Cortisol Level

The reported value is the difference in mean evening cortisol from baseline to Day 9 The mean evening cortisol is calculated from the hourly cortisol value taken from 1800 hrs to 0100 hrs for both time points. The outcome measure is the difference of mean evening cortisol from Day 9 less the mean evening cortrisol from baseline. Negative values indicate a reduction in cortisol levels at Day 9, whereas positive values indicate an increase in cortisol at Day 9. Serum cortisol levels are reported in ug/dL (NCT00867360)
Timeframe: Day 1 to Day 9 difference

Interventionug/dL (Mean)
Mifepristone-3.96
Placebo.285

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% Change in Mean Evening Pre- and Post- Florinef Cortisol After Treatment With Either Mifepristone or Placebo

"Time 1 (baseline) = Difference in cortisol level from Day 1 (pre-florinef mean evening cortisol) at Baseline less Day 2 (post-florinef mean evening cortisol) at baseline~Time 2 (post- mife or placebo treatment) = Difference in cortisol level from Day 22 (pre-florinef mean evening cortisol) and Day 23 (post-florinef mean evening cortisol level).~All measurements were the percent change in mean cortisol level from 6 pm to 10 pm. Cortisol levels are expressed as ug/dL~Percent change in cortisol decrease between Time 2 and Time 1 post florinef should be greater with mifepristone than placebo, reflecting enhanced mineralocorticoid receptor activity." (NCT00867360)
Timeframe: Day 23

Interventionpercentage change (Mean)
Mifepristone14
Placebo-.04

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Number of Participants With Adverse Events

Subjects who received at least one dose of mifepristone were included in the safety analysis. (NCT00936741)
Timeframe: Up to three years.

Interventionparticipants (Number)
Open-label30

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The Long-term Benefit of Mifepristone Treatment in Cushing's Syndrome as Measured by Changes in the Score on the Physician's Global Assessment of Disease Severity

"The mean Investigator's rating of the change in subject's signs and symptoms of Cushing's syndrome from Baseline (Entry into C1073-415) to Endpoint on the Physician's Global Assessment of Disease Severity was ranked on a 9-point scale (9 = much worse, 7 = worse, 5 = no change, 3 = better, 1 = much better). Higher scores indicate more severe illness. Scoring was done at all visits except the 6 Week Follow-up visit; the final visit result (Endpoint) is reported here.~The instruction was Rate the change in the subject's signs and symptoms of Cushing's from Baseline (1 = much better to 9 = much worse)." (NCT00936741)
Timeframe: Up to three years.

Interventionunits on a scale (Mean)
Open-label3.3

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Time for Completion of Procedure

Minutes, from the time of the start of the procedure (speculum insertion) to the conclusion of the procedure (speculum removal) (NCT00986921)
Timeframe: Performance and completion of the abortion procedure takes 10-20 minutes. The length of the procedure is measured. The procedure occurs approximately 24 hours after enrollment.

InterventionMinutes (Mean)
Standard Osmotic Dilators8.0
Mifepristone9.87

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Moderate or Severe Pain Overnight

Women wer asked to rank their amount of pain on a catergorical scale. The outcome measure is the number of women experiencing moderate or severe pain overnight (after mifepristone or osmotic dilators, and before the abortions procedure) (NCT00986921)
Timeframe: Overnight

Interventionpercentage of participants (Number)
Standard Osmotic Dilators52
Mifepristone8

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Assessment of Ease of Procedure by Operator

"The operator for each procedure rated the ease of procedure on a categorical scale. The categories were collapsed into two: easy or very easy and average or difficult." (NCT00986921)
Timeframe: It is administered shortly after the primary outcome, which is one day after enrollment. The study is complete at that point.

Interventionpercentage of participants (Number)
Standard Osmotic Dilators46
Mifepristone36

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Number of Participants With Relapse by Days 10 and 28

assessed percent of sample with documented cocaine use by days 10 and 28 based on self reported use and urine toxicology. Those with documented use were considered to have relapsed. (NCT01134198)
Timeframe: assessed during 8 weeks of trial, but reported for days 10 and 28 of trial

InterventionParticipants (Count of Participants)
Day 1072243148Day 1072243149Day 2872243148Day 2872243149
relapsedabstinent
Mifepristone3
Mifepristone6
Mifepristone5
Placebo8
Mifepristone4
Placebo3

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Symptom Change - SCL-90-R

The Symptom Checklist-90-Revised (SCL-90-R) instrument helps evaluate a broad range of psychological problems and symptoms of psychopathology. The instrument is also useful in measuring patient progress or treatment outcomes. The SCL-90-R contains 90 items on a 5-point rating scale, with a higher score indicating more severity. The items are categorized into 12 domains (9 scores along primary symptom dimensions and 3 scores among global distress indices). A t-score for each domain is then obtained by norming by sex and ranges between 19-81, with a higher score indicating more severity. (NCT01212588)
Timeframe: 21 days after discontinuation of study medication (Visit 6)

,
InterventionScores on a scale (Mean)
SCl-90-R - SomatizationSCL-90-R - Obsessive-ComplusiveSCL-90-R - Interpersonal SensitivitySCL-90-R - DepressionSCL-90-R - AnxietySCL-90-R - HostilitySCL-90-R - Phobic AnxietySCL-90-R - Paranoid IdeationSCL-90-R - PsychoticismSCL-90-R - Global Severity IndexSCL-90-R - Positive Symptom TotalSCL-90-R - Positive Symptom Distress Index
Mifepristone49.7851.3348.8949.0048.4450.1146.0050.3345.4449.0049.5651.67
Placebo47.6044.6045.3044.0042.7048.8050.1046.8045.7045.1044.8046.60

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Symptom Change - BPDSI Subscales

Borderline Personality Disorder Severity Index (BPDSI) symptom domain subscales scores. The BPDSI is a semi-structured clinical interview assessing the frequency and severity of manifestations of Borderline Personality Disorder (BPD) during a circumscribed period of the previous 7 days. The BPDSI measures 9 symptoms associated with BPD on a Likert scale ranging from 0-7 (0 = never; 7 = daily). Each symptom measure produces a mean score ranging from 0-7, with a higher score indicating more prevalent symptoms. (NCT01212588)
Timeframe: 7 days of study medication (Visit 4)

,
InterventionScores on a scale (Mean)
BPDSI Subscale Score - AbandonmentBPDSI Subscale Score - Interpersonal RelationshipsBPDSI Subscale Score - IdentityBPDSI Subscale Score - ImpulsivityBPDSI Subscale Score - Parasuicidal BehaviorBPDSI Subscale Score - Affective InstabilityBPDSI Subscale Score - EmptinessBPDSI Subscale Score - Outbursts of AngerBPDSI Sub. Score-Dissociation & Paranoid Ideation
Mifepristone0.900.801.640.660.373.672.761.081.63
Placebo1.270.581.340.110.192.891.510.790.77

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Symptom Change - BPDSI Subscales

Borderline Personality Disorder Severity Index (BPDSI) symptom domain subscales scores. The BPDSI is a semi-structured clinical interview assessing the frequency and severity of manifestations of Borderline Personality Disorder (BPD) during a circumscribed period of the previous 7 days. The BPDSI measures 9 symptoms associated with BPD on a Likert scale ranging from 0-7 (0 = never; 7 = daily). Each symptom measure produces a mean score ranging from 0-7, with a higher score indicating more prevalent symptoms. (NCT01212588)
Timeframe: Baseline (Visit 2)

,
InterventionScores on a scale (Mean)
BPDSI Subscale Score - AbandonmentBPDSI Subscale Score - Interpersonal RelationshipsBPDSI Subscale Score - IdentityBPDSI Subscale Score - ImpulsivityBPDSI Subscale Score - Parasuicidal BehaviorBPDSI Subscale Score - Affective InstabilityBPDSI Subscale Score - EmptinessBPDSI Subscale Score - Outbursts of AngerBPDSI Sub. Score-Dissociation & Paranoid Ideation
Mifepristone1.461.342.760.780.484.403.961.451.45
Placebo1.360.701.490.320.304.482.351.531.14

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Symptom Change - SCL-90-R

The Symptom Checklist-90-Revised (SCL-90-R) instrument helps evaluate a broad range of psychological problems and symptoms of psychopathology. The instrument is also useful in measuring patient progress or treatment outcomes. The SCL-90-R contains 90 items on a 5-point rating scale, with a higher score indicating more severity. The items are categorized into 12 domains (9 scores along primary symptom dimensions and 3 scores among global distress indices). A t-score for each domain is then obtained by norming by sex and ranges between 19-81, with a higher score indicating more severity. (NCT01212588)
Timeframe: Baseline (Visit 2)

,
InterventionScores on a scale (Mean)
SCl-90-R - SomatizationSCL-90-R - Obsessive-ComplusiveSCL-90-R - Interpersonal SensitivitySCL-90-R - DepressionSCL-90-R - AnxietySCL-90-R - HostilitySCL-90-R - Phobic AnxietySCL-90-R - Paranoid IdeationSCL-90-R - PsychoticismSCL-90-R - Global Severity IndexSCL-90-R - Positive Symptom TotalSCL-90-R - Positive Symptom Distress Index
Mifepristone55.8056.2056.5054.4052.6053.7050.0056.4052.2055.2055.9054.50
Placebo50.2551.5051.5849.7547.1753.0054.5848.4547.6750.0049.0052.25

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Symptom Change - BPDSI Subscales

Borderline Personality Disorder Severity Index (BPDSI) symptom domain subscales scores. The BPDSI is a semi-structured clinical interview assessing the frequency and severity of manifestations of Borderline Personality Disorder (BPD) during a circumscribed period of the previous 7 days. The BPDSI measures 9 symptoms associated with BPD on a Likert scale ranging from 0-7 (0 = never; 7 = daily). Each symptom measure produces a mean score ranging from 0-7, with a higher score indicating more prevalent symptoms. (NCT01212588)
Timeframe: 21 days after discontinuation of study medication (Visit 6)

,
InterventionScores on a scale (Mean)
BPDSI Subscale Score - AbandonmentBPDSI Subscale Score - Interpersonal RelationshipsBPDSI Subscale Score - IdentityBPDSI Subscale Score - ImpulsivityBPDSI Subscale Score - Parasuicidal BehaviorBPDSI Subscale Score - Affective InstabilityBPDSI Subscale Score - EmptinessBPDSI Subscale Score - Outbursts of AngerBPDSI Sub. Score-Dissociation & Paranoid Ideation
Mifepristone1.060.841.920.530.433.272.940.971.62
Placebo0.630.640.630.110.252.961.790.620.56

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Symptom Change - SCL-90-R

The Symptom Checklist-90-Revised (SCL-90-R) instrument helps evaluate a broad range of psychological problems and symptoms of psychopathology. The instrument is also useful in measuring patient progress or treatment outcomes. The SCL-90-R contains 90 items on a 5-point rating scale, with a higher score indicating more severity. The items are categorized into 12 domains (9 scores along primary symptom dimensions and 3 scores among global distress indices). A t-score for each domain is then obtained by norming by sex and ranges between 19-81, with a higher score indicating more severity. (NCT01212588)
Timeframe: 7 days of study medication (Visit 4)

,
InterventionScores on a scale (Mean)
SCl-90-R - SomatizationSCL-90-R - Obsessive-ComplusiveSCL-90-R - Interpersonal SensitivitySCL-90-R - DepressionSCL-90-R - AnxietySCL-90-R - HostilitySCL-90-R - Phobic AnxietySCL-90-R - Paranoid IdeationSCL-90-R - PsychoticismSCL-90-R - Global Severity IndexSCL-90-R - Positive Symptom TotalSCL-90-R - Positive Symptom Distress Index
Mifepristone53.0054.3053.0052.6049.1052.8049.6053.8048.8052.3053.4054.20
Placebo46.2747.9148.4547.8243.0952.0049.5547.9147.2745.8246.9151.91

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Symptom Change - CGI-I

The Clinical Global Impressions Improvement (CGI-I) scale is used to assess the clinical change as compared to symptoms at baseline using a 7-point Likert scale, ranging from very much improved (1) to very much worse (7), with a higher score indicating more severity. (NCT01212588)
Timeframe: 7 days of study medication (Visit 4), 21 days after discontinuation of study medication (Visit 6)

,
InterventionScores on a scale (Mean)
CGI-I - 7 days of study medCGI-I - 21 days after disc of study med
Mifepristone3.303.44
Placebo3.362.80

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Symptom Change - CGI-S

The Clinical Global Impressions Severity Scale (CGI-S) is used for repeated evaluations of global psychopathology. The CGI-S scale is widely used in schizophrenia research and is a single 7-point Likert scale rating severity of psychopathology on a scale of 1 (normal, not ill) to 7 (very severely ill), with a higher score indicating more severity. (NCT01212588)
Timeframe: Baseline, 7 days of study medication (Visit 4), 21 days after discontinuation of study medication (Visit 6)

,
InterventionScores on a scale (Mean)
CGI-S - BaselineCGI-S - 7 days of study medCGI-S - 21 days after disc of study med
Mifepristone4.304.203.89
Placebo4.424.093.70

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Symptom Change - BPRS

The Brief Psychiatric Rating Scale (BPRS) is an 19-item scale measuring positive symptoms, general psychopathology and affective symptoms during the last 7 days. The BPRS measures symptoms with scores ranging from 0-7, with a higher score indicating more severity. A total score is then calculated by adding all the item scores, ranging from 0-133, with a higher score indicating more severity. (NCT01212588)
Timeframe: Baseline (Visit 2), 7 days of study medication (Visit 4), 7 days after discontinuation of study medication (Visit 5), 21 days after discontinuation of study medication (Visit 6)

,
InterventionScores on a scale (Mean)
BPRS - BaselineBPRS - 7 days of study medicationBPRS - 7 days after disc of study medBPRS - 21 days after disc study med
Mifepristone37.7033.9035.7835.22
Placebo37.5033.3633.5030.50

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Durable Symptom Change

To evaluate whether seven days of mifepristone treatment will result in a durable change in symptoms persisting after active treatment discontinuation, as measured by Borderline Personality Disorder Severity Index (BPDSI) total score. The BPDSI is a semi-structured clinical interview assessing the frequency and severity of manifestations of Borderline Personality Disorder (BPD) during a circumscribed period of the previous 7 days. The BPDSI measures 9 symptoms associated with BPD on a Likert scale ranging from 0-7 (0 = never; 7 = daily). Each symptom measure produces a mean score ranging from 0-7, with a higher score indicating more prevalent symptoms. A total score is then calculated using the summed symptom mean scores, ranging from 0-63, with a higher score indicating more prevalent symptoms. (NCT01212588)
Timeframe: 7 days of study medication to 21 days after discontinuation of study medication

,
InterventionScores on a scale (Mean)
BPDSI Total Score after 7 days of medicationBPDSI Total Score 21 days after discont. study med
Mifepristone13.5013.58
Placebo9.458.17

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Levels of Cortisol

To assess cortisol levels as a potential biomarker of hypothalamic-pituitary-adrenal (HPA)-axis engagement (NCT01212588)
Timeframe: Baseline (Visit 2), 7 days of study medication (Visit 4), 7 days after discontinuation of study medication (Visit 5), 21 days after discontinuation of study medication (Visit 6)

,
Interventionmcg/dL (Mean)
Cortisol Level - BaselineCortisol Level - 7 days of study medCortisol Level - 7 days after disc of study medCortisol Level - 21 days after disc study med
Mifepristone13.8835.0120.9111.90
Placebo14.3816.3314.3015.73

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Metacognitive Capacity

The Indiana Psychiatric Illness Interview (IPII) is a semi-structured interview developed to assess illness narratives. Responses are audio taped and later transcribed. It is scored using the Metacognition Assessment Scale- Abbreviated (MAS-A), which has four domains of metacognition: i) Self-Reflectivity ranging from 0-9; ii) Understanding the Mind of Other ranging from 0-7; iii) Decentration ranging from 0-3; and iv) Mastery ranging from 0-9. Lower scores indicate metacognitive deficits, higher scores indicate more integrated and nuanced metacognition. MAS-A total score is the sum of the scores on each of the domains of metacognition, ranging from 0-28, with a lower score indicating metacognitive deficits and a higher score indicating more integrated and nuanced metacognition. (NCT01212588)
Timeframe: Baseline, 21 days after discontinuation of study medication

,
InterventionScores on a scale (Mean)
IIPI - Self-Reflectivity - BaselineIIPI-Self-Reflectivity-21 days after dis study medIIPI - Understanding Others - BaselineIIPI-Understanding Others-21 days after dis medsIIPI - Decentration - BaselineIIPI-Decentration-21 days after dis medsIIPI - Mastery - BaselineIIPI-Mastery-21 days after dis medsIIPI - Total - BaselineIIPI-Total-21 days after dis meds
Mifepristone5.085.253.252.750.500.382.672.7511.5011.13
Placebo4.633.902.882.500.380.203.882.8011.759.40

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Rapid Symptom Change

To evaluate whether mifepristone will produce rapid symptom change after seven days of active treatment, as measured by Borderline Personality Disorder Severity Index (BPDSI) total score. The BPDSI is a semi-structured clinical interview assessing the frequency and severity of manifestations of Borderline Personality Disorder (BPD) during a circumscribed period of the previous 7 days. The BPDSI measures 9 symptoms associated with BPD on a Likert scale ranging from 0-7 (0 = never; 7 = daily). Each symptom measure produces a mean score ranging from 0-7, with a higher score indicating more prevalent symptoms. A total score is then calculated using the summed symptom mean scores, ranging from 0-63, with a higher score indicating more prevalent symptoms. (NCT01212588)
Timeframe: Baseline to 7 days of study medication

,
InterventionScores on a scale (Mean)
BPDSI Total Score after 7 days of medicationBPDSI Total Score at Baseline
Mifepristone13.517.99
Placebo9.4513.66

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Symptom Change - Borderline Checklist

The Borderline Personality Checklist (BPD Checklist) is a 47-item DSM-IV based self-report questionnaire, designed to assess the experienced burden of specific BPD symptoms during the previous week. The BPD Checklist measures symptoms with scores ranging from 1-5, with a higher score indicating more severity. A total score is then calculated by adding all the item scores, ranging from 47-235, with a higher score indicating more severity. (NCT01212588)
Timeframe: Baseline (Visit 2), 7 days of study medication (Visit 4), 7 days after discontinuation of study medication (Visit 5), 21 days after discontinuation of study medication (Visit 6)

,
InterventionScores on a scale (Mean)
BPD Checklist - BaselineBPD Checklist - 7 days of study medBPD Checklist - 7 days after disc of study medBPD Checklist - 21 days after disc study med
Mifepristone103.6098.1091.5687.89
Placebo96.9288.3682.8078.80

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Proportion of Suppressors After Dexamethasone

"All subjects will take 0.25mg dexamethasone as an outpatient between 2300 and 2400h and will then report to the clinic by 0800h next day for the final visit.~At the final visit, cortisol response to dexamethasone suppression was assessed. The cortisol response was dichotomized (suppression vs. non-suppression, using 1.8 ug/dL as the cutoff point) and compared between the two groups,Sedentary Young Adults and Endurance-trained Young Athletes." (NCT01294319)
Timeframe: cortisol measured between 8 and 9 after dexamethasone was taken between 11 PM and midnight

InterventionParticipants (Count of Participants)
Endurance-trained Young Athletes0
Sedentary Young Adults1

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Post-dexamethasone Cortisol Level

(NCT01294319)
Timeframe: Cortisol obtained at 8-9 AM after dexamethasone taken between 11 pm and midnight

Interventionmcg/dL (Mean)
Endurance-trained Young Athletes11.98
Sedentary Young Adults9.98

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Number of Participants With Clinically Relevant Abnormalities in Physical Examination, Vital Signs, ECG and Clinical Laboratory Tests.

Number of participants with clinically relevant abnormalities in physical examination, vital signs and clinical laboratory tests. Relevant findings or worsenings of baseline conditions were reported as adverse events. (NCT01328184)
Timeframe: Day 1 to day 17

Interventionparticipants (Number)
Microgynon0
Microgynon Plus Empa0

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Levonorgestrel: Terminal Half-life at Steady State (t1/2,ss)

Terminal half-life of levonorgestrel in plasma at steady state (NCT01328184)
Timeframe: Pre-dose, 30 min, 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, and 24h after administration of Microgynon on Days 14 and 21. In addition, pre-dose samples were collected on Days 12, 13, 19, and 20.

Interventionhours(h) (Geometric Mean)
Microgynon36.7
Microgynon Plus Empa37.6

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Levonorgestrel: Terminal Rate Constant at Steady State (λz,ss)

Terminal rate constant of levonorgestrel in plasma at steady state (NCT01328184)
Timeframe: Pre-dose, 30 min, 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, and 24h after administration of Microgynon on Days 14 and 21. In addition, pre-dose samples were collected on Days 12, 13, 19, and 20.

Intervention1/h (Geometric Mean)
Microgynon0.0189
Microgynon Plus Empa0.0184

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Levonorgestrel: Time From Last Dosing to Maximum Measured Concentration (Tmax,ss)

Time from last dosing to the maximum measured concentration of levonorgestrel in plasma at steady state (NCT01328184)
Timeframe: Pre-dose, 30 min, 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, and 24h after administration of Microgynon on Days 14 and 21. In addition, pre-dose samples were collected on Days 12, 13, 19, and 20.

Interventionhours(h) (Median)
Microgynon1.00
Microgynon Plus Empa1.00

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Assessment of Tolerability

Tolerability will be assessed by the investigator according to the categories good, satisfactory, not satisfactory, bad and not assessable. (NCT01328184)
Timeframe: Within Day 24 to Day 31

,
Interventionpercentage of participants (Number)
GoodSatisfactoryNot satisfactoryBadNot assessable
Microgynon94.45.60.00.00.0
Microgynon Plus Empa94.45.60.00.00.0

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Ethinylestradiol: Apparent Clearance at Steady State (CL/Fss)

Apparent clearance of ethinylestradiol in the plasma at steady state after oral administration (NCT01328184)
Timeframe: Pre-dose, 30 min, 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, and 24h after administration of Microgynon on Days 14 and 21. In addition, pre-dose samples were collected on Days 12, 13, 19, and 20.

InterventionmL/min (Geometric Mean)
Microgynon552
Microgynon Plus Empa536

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Ethinylestradiol: Apparent Volume of Distribution During the Terminal Phase at Steady State (Vz/Fss)

Apparent volume of distribution during the terminal phase at steady state after oral administration (NCT01328184)
Timeframe: Pre-dose, 30 min, 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, and 24h after administration of Microgynon on Days 14 and 21. In addition, pre-dose samples were collected on Days 12, 13, 19, and 20.

InterventionL (Geometric Mean)
Microgynon729
Microgynon Plus Empa757

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Ethinylestradiol: Area Under the Curve at Steady State Over the Uniform Dosing Interval τ (AUCτ,ss)

Area under the concentration-time curve of ethinylestradiol in plasma at steady state over the uniform dosing interval τ. (NCT01328184)
Timeframe: Pre-dose, 30 min, 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, and 24h after administration of Microgynon on Days 14 and 21. In addition, pre-dose samples were collected on Days 12, 13, 19, and 20.

Interventionpg*h/mL (Geometric Mean)
Microgynon907
Microgynon Plus Empa932

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Ethinylestradiol: Maximum Measured Concentration (Cmax,ss)

Maximum measured concentration of ethinylestradiol in plasma at steady state over the uniform dosing interval τ. (NCT01328184)
Timeframe: Pre-dose, 30 min, 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, and 24h after administration of Microgynon on Days 14 and 21. In addition, pre-dose samples were collected on Days 12, 13, 19, and 20.

Interventionpg/mL (Geometric Mean)
Microgynon97.6
Microgynon Plus Empa96.8

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Ethinylestradiol: Mean Residence Time at Steady State (MRTpo,ss)

Mean residence time of ethinylestradiol in the body at steady state after oral administration (NCT01328184)
Timeframe: Pre-dose, 30 min, 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, and 24h after administration of Microgynon on Days 14 and 21. In addition, pre-dose samples were collected on Days 12, 13, 19, and 20.

Interventionhours(h) (Geometric Mean)
Microgynon18.6
Microgynon Plus Empa19.5

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Ethinylestradiol: Terminal Half-life at Steady State (t1/2,ss)

Terminal half-life of ethinylestradiol in plasma at steady state (NCT01328184)
Timeframe: Pre-dose, 30 min, 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, and 24h after administration of Microgynon on Days 14 and 21. In addition, pre-dose samples were collected on Days 12, 13, 19, and 20.

Interventionhours(h) (Geometric Mean)
Microgynon15.3
Microgynon Plus Empa16.3

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Ethinylestradiol: Terminal Rate Constant at Steady State (λz,ss)

Terminal rate constant of ethinylestradiol in plasma at steady state (NCT01328184)
Timeframe: Pre-dose, 30 min, 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, and 24h after administration of Microgynon on Days 14 and 21. In addition, pre-dose samples were collected on Days 12, 13, 19, and 20.

Intervention1/h (Geometric Mean)
Microgynon0.0454
Microgynon Plus Empa0.0425

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Ethinylestradiol: Time From Last Dosing to Maximum Measured Concentration (Tmax,ss)

Time from last dosing to the maximum measured concentration of ethinylestradiol in plasma at steady state (NCT01328184)
Timeframe: Pre-dose, 30 min, 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, and 24h after administration of Microgynon on Days 14 and 21. In addition, pre-dose samples were collected on Days 12, 13, 19, and 20.

Interventionhours(h) (Median)
Microgynon1.26
Microgynon Plus Empa1.50

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Levonorgestrel: Apparent Clearance at Steady State (CL/Fss)

Apparent clearance of levonorgestrel in the plasma at steady state after oral administration (NCT01328184)
Timeframe: Pre-dose, 30 min, 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, and 24h after administration of Microgynon on Days 14 and 21. In addition, pre-dose samples were collected on Days 12, 13, 19, and 20.

InterventionmL/min (Geometric Mean)
Microgynon26.6
Microgynon Plus Empa26.1

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Levonorgestrel: Apparent Volume of Distribution During the Terminal Phase at Steady State (Vz/Fss)

Apparent volume of distribution during the terminal phase at steady state after oral administration (NCT01328184)
Timeframe: Pre-dose, 30 min, 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, and 24h after administration of Microgynon on Days 14 and 21. In addition, pre-dose samples were collected on Days 12, 13, 19, and 20.

InterventionL (Geometric Mean)
Microgynon84.6
Microgynon Plus Empa85.0

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Levonorgestrel: Area Under the Curve at Steady State Over the Uniform Dosing Interval τ (AUCτ,ss)

Area under the concentration-time curve of levonorgestrel in plasma at steady state over the uniform dosing interval τ. (NCT01328184)
Timeframe: Pre-dose, 30 min, 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, and 24h after administration of Microgynon on Days 14 and 21. In addition, pre-dose samples were collected on Days 12, 13, 19, and 20.

Interventionng*h/mL (Geometric Mean)
Microgynon94.0
Microgynon Plus Empa95.9

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Levonorgestrel: Maximum Measured Concentration (Cmax,ss)

Maximum measured concentration of levonorgestrel in plasma at steady state over the uniform dosing interval τ. (NCT01328184)
Timeframe: Pre-dose, 30 min, 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, and 24h after administration of Microgynon on Days 14 and 21. In addition, pre-dose samples were collected on Days 12, 13, 19, and 20.

Interventionng/mL (Geometric Mean)
Microgynon7.98
Microgynon Plus Empa8.44

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Levonorgestrel: Mean Residence Time at Steady State (MRTpo,ss)

Mean residence time of levonorgestrel in the body at steady state after oral administration (NCT01328184)
Timeframe: Pre-dose, 30 min, 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, and 24h after administration of Microgynon on Days 14 and 21. In addition, pre-dose samples were collected on Days 12, 13, 19, and 20.

Interventionhours(h) (Geometric Mean)
Microgynon48.8
Microgynon Plus Empa49.6

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Cognitive Changes Over Time, as Measured by Between Group and Within-subjects Comparison of Neuropsychological Measures.

Memory composite z-score: The two memory measures were a 16-word list recall similar to the Rey auditory verbal learning test, which has been used by the Washington University Alzheimer's Disease Research Center; and two paragraphs from a set of paragraph recall tests validated as sensitive to effects of stress-level glucocorticoids. For each memory variable, a z score was computed for each participant, where z score = (participant score mean)/standard deviation. Then a single composite memory variable was created by summing up these z scores. Summed Z-scores range from -6 to 6, with scores above 0 being higher than the mean. (NCT01333098)
Timeframe: Baseline, Week 4, Week 12

,
Interventionz-score (Mean)
BaselineWeek 4Week 12
High Baseline Cortisol0.931.853.00
Without High Baseline Corisol-0.59-0.45-0.26

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Number of Participants With Self-reported Side Effects

(NCT01333098)
Timeframe: 4 weeks

Interventionparticipants with reported side effects (Number)
dizzinessfatiguenausea
Mifepristone532

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Drug Acceptability, as Measured by Number of Participants With Dose-limiting Side Effects

number of participants with dose-limiting side effects (NCT01333098)
Timeframe: Baseline, Week 2, Week 4

InterventionParticipants (Count of Participants)
Mifepristone1

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Anxiety Symptoms

Self-report assessment of worry using Penn State Worry Questionnaire- Abbreviated, an 8-item measure (range 8-40 with high scores indicating higher levels of anxiety and worry symptoms.The average score for older adults with generalized anxiety disorder is 22, while the mean score for healthy older adults is 15. (NCT01333098)
Timeframe: baseline, week 4, week 12

,
InterventionScores on a scale (Mean)
BaselineWeek 4Week 12
High Baseline Cortisol30.8022.4023.0
Without High Baseline Corisol27.8827.0025.29

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Number of Participants With Adverse Events

Safety was assessed at all visits and adverse events were recorded. (NCT01371565)
Timeframe: 6 months

Interventionparticipants (Number)
Mifepristone4

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Homeostatic Model Assessment of Insulin Resistance (HOMA-IR)

HOMA-IR is an index of insulin resistance, measured as glucose in mmol/L x insulin in mIU/mL)/22.5. HOMA-IR > 2.5 indicates insulin resistance. (NCT01419535)
Timeframe: 9 days

Interventionunits on a scale (Mean)
Post-mifepristone3.58
Post-placebo5.78

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Change in Insulin Sensitivity Index

insulin sensitivity index based on the effect of insulin on glucose during frequently sampled intravenous glucose tolerance test (FSIVGTT) (NCT01419535)
Timeframe: Nine days

Interventionmin-1·μU·ml-1 (Mean)
Post-mifepristone1.49
Post-placebo1.41

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Change in Fasting Plasma Glucose

fasting plasma glucose after study agent compared to baseline (NCT01419535)
Timeframe: Nine days

Interventionmg/dL (Mean)
Post-mifepristone100.4
Post-placebo107.8

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Change in Fasting Insulin Levels

Fasting insulin after study agent administration compared to baseline (NCT01419535)
Timeframe: 9 days

Interventionpmol/L (Mean)
Post-mifepristone95.6
Post-placebo142.8

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Adipose-tissue Insulin Sensitivity Index (Adipo-SI)

The Adipo-SI was calculated as ratio of the slope of the linear decrease in natural log transformed FFA [Ln (FFA) slope] during the first 90 minutes of the FSIVGTT and the area under the curve (AUC) of insulin during that 90-minute period (AUC Insulin 0-90 min). (NCT01419535)
Timeframe: 9 days

Interventionln(mmol /uU/mL*min)*10^8 (Mean)
Post-mifepristone61.7
Post-placebo42.8

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Adipose-tissue Insulin Resistance Index (Adipo-IR)

The adipose tissue insulin resistance index (Adipo-IR), a surrogate measure for fasting adipose-tissue insulin resistance, was calculated as the product of fasting insulin and fasting free fatty acids (FFA) (NCT01419535)
Timeframe: 9 days

Interventionmmol/l·μU/l (Mean)
Post-mifepristone49.9
Post-placebo65.5

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Acceptability to Patient

"Patient was asked whether they would choose to be in the same group again if they had a similar procedure again. The number of participants whose response was yes is being reported." (NCT01436279)
Timeframe: After procedure completion

InterventionParticipants (Count of Participants)
Mifepristone + Misoprostol26
Osmotic Dilators11

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Cervical Dilation Achieved

Cervical dilation at start of procedure (NCT01436279)
Timeframe: At time of abortion

Interventionmm (Mean)
Mifepristone + Misoprostol42
Osmotic Dilators56

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Operative Time

Interval from initiation of vacuum aspiration to speculum removal (NCT01436279)
Timeframe: Subjects will be followed from the administration of mifepristone/misoprostol, or laminaria, until the end of their procedure, a total of two days.

Interventionminutes (Median)
Mifepristone + Misoprostol9
Osmotic Dilators8.5

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Difficulty of Procedure

"Outcome measure is the number and percentage of participants where the provider rated the procedure as difficult or very difficult. Provider assessment of difficulty of procedure categories were: very easy, easy, moderate, difficult, or very difficult." (NCT01436279)
Timeframe: After completion of procedure

InterventionParticipants (Count of Participants)
Mifepristone + Misoprostol5
Osmotic Dilators3

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Pain Medication (Fentanyl) During the Abortion

Amount of pain medication used during the procedure: reported as micrograms of fentanyl (NCT01436279)
Timeframe: Subjects will be followed from the administration of mifepristone/misoprostol, or laminaria, until the end of their procedure, a total of two days.

Interventionmcg (Mean)
Mifepristone + Misoprostol3.1
Osmotic Dilators2.9

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Pain Medication (Midazolam) During the Abortion

Amount of pain medication used during the procedure: reported as milligrams of midazolam (NCT01436279)
Timeframe: Subjects will be followed from the administration of mifepristone/misoprostol, or laminaria, until the end of their procedure, a total of two days.

Interventionmg (Mean)
Mifepristone + Misoprostol104
Osmotic Dilators105

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Subject Discomfort Before the Abortion

Pain was subjectively described by the subjects as : None, Mild, Moderate, Severe (NCT01436279)
Timeframe: Subjects will be followed from the administration of mifepristone/misoprostol, or laminaria, until the end of their procedure, a total of two days.

,
Interventionparticipants (Number)
NoneMildModerateSevere
Mifepristone + Misoprostol18750
Osmotic Dilators7634

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Length of Procedure

Interval from speculum insertion to speculum removal (NCT01436279)
Timeframe: Subjects will be followed from the administration of mifepristone/misoprostol or laminaria, until the end of their procedure, a total of two days.

Interventionminutes (Mean)
Mifepristone + Misoprostol14
Osmotic Dilators13.5

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Change From Baseline in the Impact of Event Scale-Revised (IES-R) Total Score

IES-R is a 22-item patient reported measure of PTSD symptoms. Each question is answered using a 5-point scale where 0=not at all to 4=extremely for a total possible score of 0 to 88. Lower scores represent less severe symptoms and higher scores representing more severe symptoms. IES-R change scores were calculated by subtracting the Day 14 IES-R total score from the Day 7 IES-R total score. A negative change from Baseline indicates improvement of symptoms and a positive change from Baseline indicates a worsening of symptoms. (NCT01490697)
Timeframe: Day 7 (Baseline) and Day 14

,
Interventionscore on a scale (Mean)
BaselineChange from Baseline at Day 14
Mifepristone Plus d-Cycloserine (DCS)52.4-8.9
Placebo Plus Placebo55.3-5.0

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Physiological Posttraumatic Stress Disorder (PTSD) Probability as Determined From Psychophysiologic Responses to Traumatic Recollection

The posterior probability of developing PTSD was determined for each participant from a composite of psychophysiological responses to script-driven imagery of traumatic events that included assessments of heart rate response in beats per minute, skin conductance response in microSiemens, and corrugator electromyogram (EMG) responses of the left lateral frontalis facial muscle in microVolts. Responses for the traumatic scripts were averaged and square-root transformed for analysis. Responses during personal traumatic imagery of previously studied individuals with and without current PTSD was used to calculate each participant's posterior probability of being classified as PTSD. (NCT01490697)
Timeframe: 1 week following treatment (Day 14)

Interventionpercent probability (Mean)
Placebo Plus Placebo44
Mifepristone Plus d-Cycloserine (DCS)45

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Drinking

Number of standard drinks per week using the Timeline Followback Interview. Total number of alcoholic drinks consumed per week with a minimum value of 0 and a maximum value of 70. (NCT01548417)
Timeframe: 2 weeks

Interventionalcoholic drinks per week (Mean)
Korlym (Mifepristone)27.661
Sugar Pill38.175

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Craving to Drink

Visual Analog Scale (VAS) scores of craving severity in response to in vivo alcohol cues. Higher scores indicate greater craving severity with a minimum score of 0 and a maximum score of 80. (NCT01548417)
Timeframe: 1 week

Interventionunits on a scale (Mean)
Korlym (Mifepristone)36.5
Sugar Pill42.9

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Total Procedure Time

(NCT01615731)
Timeframe: Measured at clinic visits and on OR day, over a 3 day period

Interventionhours (Mean)
Two Sets of Dilators165
Mifepristone Plus One Set of Dilators86

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Adverse Events

uterine perforation, uterine injury, etc. (NCT01615731)
Timeframe: Intraoperatively and 2 weeks post operatively

,
Interventionparticipants (Number)
Pre-Procedure DeliveryCervical InjuryRUpture of Membranes with Subsequent Fever
Mifepristone Plus One Set of Dilators110
Two Sets of Dilators201

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Maximum Cervical Dilation

Measured by estimate with bimanual exam and passage of largest dilator immediately prior to procedure. (NCT01615731)
Timeframe: Measured intra-operatively

,
Interventionparticipants (Number)
Pre-op Cervical Dilation 2 cmPre-op Cervical Dilation 3 cmPre-Op Cervical Dilation 4 cmPre-Op Cervical Dilation 5 cm
Mifepristone Plus One Set of Dilators31451
Two Sets of Dilators2982

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Pain Perceived by Patient

Used a Visual Analogue Scale to determine the pain perceived by the patient pre-operatively (after misoprostol, immediately before transport to OR) and post-operatively (in recovery room, on average 1.5 hours post-operatively). The VAS ranges from 0-100. 0 being no pain felt by the patient and 100 being the worst pain imaginable felt by the patient. (NCT01615731)
Timeframe: Measured pre-operatively (after misoprostol, immediately before transport to OR) and post-operatively (in recovery room, on average 1.5 hours post-operatively)

,
Interventionunits on a scale (Median)
Subject Pain Pre-OpSubject Pain Post-Op
Mifepristone Plus One Set of Dilators6316
Two Sets of Dilators133

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Procedure Time

Measured as time from speculum insertion to removal (NCT01615731)
Timeframe: Intraoperative Time

Interventionminutes (Mean)
Two Sets of Dilators10.9
Mifepristone Plus One Set of Dilators11.8

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Adverse Events (EBL)

One adverse event: Estimated Blood Loss (NCT01615731)
Timeframe: Intraoperatively

InterventionmL (Mean)
Two Sets of Dilators57
Mifepristone Plus One Set of Dilators63

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Ease of Procedure by Blinded Surgeon

Used a Visual Analogue Scale to determine the ease of procedure by blinded surgeon. The VAS ranges from 0-100. 0 being the easiest procedure the surgeon felt they had every performed and 100 being the most difficult procedure imaginable by the surgeon. (NCT01615731)
Timeframe: Measured Immediately after procedure

Interventionunits on a scale (Median)
Two Sets of Dilators29
Mifepristone Plus One Set of Dilators30

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Overall Patient Experience

Used a Visual Analogue Scale to determine the patient's overall satisfaction with her experience. The VAS ranges from 0-100. 0 being a worse than expected experience, 50 being what the patient expected and 100 being a better than expected experience. (NCT01615731)
Timeframe: Measured post operatively (at least 30 minutes, on average 1.5 hours) prior to discharge

Interventionunits on a scale (Median)
Two Sets of Dilators72
Mifepristone Plus One Set of Dilators79

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Change From Baseline Skin Conductance Response

Skin conductance response (SCR) is the change in skin conductance level in response to a stimulus. We compared the SCR to a non-treated conditioned stimulus (CS+N) with the SCR to a treated conditioned stimulus (CS+R) by creating a difference score (CS+R - CS+N) for the day 3 data. Day 3 is 48 hours after the fear-conditioning procedure and serves as the primary measure of whether the treatment had an effect. SCR was measured in microSiemens; the SCR difference score reflects a change in microSiemens. (NCT01631682)
Timeframe: 48hrs

InterventionmicroSiemens (Mean)
Propranolol.06
Reactivation With Time Delay.17
Mifepristone-1.27
Intranasal Oxytocin-.04

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Initial Cervical Dilation at the Time of Surgical Abortion

Initial cervical dilation as measured in French units by a Pratt cervical dilator prior to surgical abortion. The dilation was measured in French units with each French unit being equivalent to 0.33 mm. (NCT01636063)
Timeframe: 24 to 48 hours after enrollment

InterventionFrench units (Mean)
Mifepristone30.8
Misoprostol31.1

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Change in CAPS Total Score From Baseline to 4-week and 12-week

The Clinical Administered PTSD Scale (CAPS) was used to assess the diagnosis of PTSD symptoms. The CAPS total score ranges 0 to 136, which is the sum of 17 PTSD symptoms (each symptom is the sum of the frequency score (ranges 0-4) and the intensity score (ranges 0-4)) in the three different symptom subcategories (intrusive/re-experiencing (0-40), avoidance/numbing (0-56) and hyperarousal (0-40)). A higher CAPS total score indicates worse PTSD symptoms. A positive change score indicates an increased CAPS total score (i.e., worse PTSD symptoms) at 4-week (12-week) compared to its baseline value, while a negative change score indicates an opposite direction. (NCT01739335)
Timeframe: baseline to 4-week

,
Interventionunits on a scale (Least Squares Mean)
Change Score from Baseline to 4-weekChange Score from Baseline to 12-week
Mifepristone (600 mg/Day)-13.96-15.15
Sugar Pill-15.83-18.06

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Change in Sleep Quality (Measured by the PSQI Total Score) From Baseline to 4-Week and 12-Week

The Pittsburgh Sleep Quality Index (PSQI) assesses self-report sleep quality and disturbances. Nineteen individual items generate 7 component scores: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medication and daytime dysfunction. Each component is scored from 0=better to 3=worse. The sum of the 7 component scores yields the PSQI total score (range 0-21) with a higher score indicating a worse sleep quality. A positive change score indicates an increased PSQI total score (i.e., worse sleep quality) at 4-week (or 12-week) compared to its baseline value, while a negative change score indicates an opposite direction. (NCT01739335)
Timeframe: baseline to 4-Week and 12-Week

,
Interventionunits on a scale (Least Squares Mean)
Change Score from Baseline to 4-weekChange Score from Baseline to 12-week
Mifepristone (600 mg/Day)-1.63-0.86
Sugar Pill-1.27-2.04

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Changes in PTSD Symptom Severity (Measured by the Stressful Life Total Score From the PTSD Checklist) From Baseline to 4-Week and 12-Week

"Stressful life total score (ranges 17-85) is the sum of the severity ratings of the 17 PTSD-related symptoms (each symptom is rated on a 5-point scale of 1=not at all to 5=extremely) over the past week. It evaluates the extent to which responders have been bothered by the symptoms of PTSD. The higher stressful life score indicates more stressful life events. A positive change score indicates an increased stressful life total score (i.e., more stressful life events) at 4-week (or 12-week) compared to its baseline value, while a negative change score indicates an opposite direction." (NCT01739335)
Timeframe: baseline to 4-Week and 12-Week

,
Interventionunits on a scale (Least Squares Mean)
Change Score from Baseline to 4-weekChange Score from Baseline to 12-week
Mifepristone (600 mg/Day)-6.84-6.84
Sugar Pill-8.65-8.12

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Change in Anger Level (Measured by the STAXI Total Score) From Baseline to 4-Week and 12-Week

The State-Trait Anger Expression Inventory (STAXI) total score is the sum of 10 items assessing intensity of anger as an emotional state (State Anger) and the disposition to experience angry feelings as a personality trait (Trait Anger). Each item consists of a 4-point scale (1=not at all, 4=very much) that assess intensity of anger at a particular moment and the frequency of anger experience, expression and control. The STAXI total score ranges from 10 to 40, with a higher score indicating a higher intensity of anger.The sum of the 7 component scores yields the PSQI total score (range 0-21) with a higher score indicating a worse sleep quality. A positive change score indicates an increased STAXI total score (i.e., higher intensity of anger) at 4-week (or 12-week) compared to its baseline value, while a negative change score indicates an opposite direction. (NCT01739335)
Timeframe: Baseline to 4-week and 12-week

,
Interventionunits on a scale (Least Squares Mean)
Change Score from Baseline to 4-weekChange Score from Baseline to 12-week
Mifepristone (600 mg/Day)-0.61-1.73
Sugar Pill-1.83-3.20

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Change in Depression (Measured by the BDI Total Score) From Baseline to 4-Week and 12-Week

The Beck Depression Inventory (BDI) total score (ranges 0-63) is the sum of 21 items (each item rated on a 4-point scale of 0 to 3) relating to symptoms of depression, cognitions, and physical symptoms. The BDI total score measures the overall severity of depression. The higher the BDI total score, the more severe the depression. A positive change score indicates an increased BDI total score (i.e., more severe depression) at 4-week (or 12-week) compared to its baseline value, while a negative change score indicates an opposite direction. (NCT01739335)
Timeframe: baseline to 4-Week and 12-Week

,
Interventionunits on a scale (Least Squares Mean)
Change Score from Baseline to 4-weekChange Score from Baseline to 12-week
Mifepristone (600 mg/Day)-3.50-2.25
Sugar Pill-4.52-5.07

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Change in Adrenocorticotropic Hormone (ACTH) From Baseline to 1-week

Mifepristone will induce acute increase in Cortisol and ACTH levels. Higher ACTH value indicates higher magnitude of mifepristone's effects on negative feedback inhibition. ACTH value in placebo group at follow-up visits will remain at the similar level as its baseline magnitude. A positive change value indicates an increased ACTH level at 1-week (i.e., higher magnitude on negative feedback inhibition) compared to its baseline value, while a negative change value indicates an opposite direction. (NCT01739335)
Timeframe: baseline to 1-week

Interventionpg/ml (Median)
Mifepristone (600 mg/Day)28.8
Sugar Pill-0.5

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Change in Adrenocorticotropic Hormone (ACTH) From Baseline to 4-week

Mifepristone will induce acute increase in Cortisol and ACTH levels. Higher ACTH value indicates higher magnitude of mifepristone's effects on negative feedback inhibition. ACTH value in placebo group at follow-up visits will remain at the similar level as its baseline magnitude. A positive change value indicates an increased ACTH level at 4-week (i.e., higher magnitude on negative feedback inhibition) compared to its baseline value, while a negative change value indicates an opposite direction. (NCT01739335)
Timeframe: Baseline to 4-week

Interventionpg/ml (Median)
Mifepristone (600 mg/Day)-0.8
Sugar Pill1.5

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Change in Plasma Cortisol From Baseline to 1-Week

Mifepristone will induce acute increase in Cortisol and ACTH levels. Higher Cortisol value indicates higher magnitude of mifepristone's effects on negative feedback inhibition. Cortisol value in placebo group at follow-up visits will remain at the similar level as its baseline magnitude. A positive change value indicates increased cortisol level at 1-week (i.e., higher magnitude on negative feedback inhibition) compared to its baseline value, while a negative change value indicates an opposite direction. (NCT01739335)
Timeframe: Baseline to 1-week

Interventionug/dl (Median)
Mifepristone (600 mg/Day)22.3
Sugar Pill-0.9

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Change in Plasma Cortisol From Baseline to 4-Week

Mifepristone will induce acute increase in Cortisol and ACTH levels. Higher Cortisol value indicates higher magnitude of mifepristone's effects on negative feedback inhibition. Cortisol value in placebo group at follow-up visits will remain at the similar level as its baseline magnitude. A positive change value indicates an increased cortisol level at 4-week (i.e., higher magnitude on negative feedback inhibition) compared to its baseline value, while a negative change value indicates an opposite direction. (NCT01739335)
Timeframe: Baseline to 4-week

Interventionug/dl (Median)
Mifepristone (600 mg/Day)-0.6
Sugar Pill-0.4

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Change in CAPS Avoidance Symptom Scores From Baseline to 4-Week and 12-Week

"The Clinical Administered PTSD Scale (CAPS) was used to assess the diagnosis of PTSD symptoms. Its avoidance symptom subscale (ranges 0 - 56) is the sum of 7 PTSD symptoms (each ranges 0 - 8) in the avoidance/emotional numbing symptom subcategory. A higher avoidance symptom score indicates worse PTSD symptoms. A positive change score indicates an increased avoidance symptom score (i.e., worse PTSD symptoms) at 4-week (or 12-week) compared to its baseline value, while a negative change score indicates an opposite direction.~The higher is the avoidance/emotional numbing PTSD subscale score, the worse is the PTSD symptom." (NCT01739335)
Timeframe: baseline to 4-Week and 12-Week

,
Interventionunits on a scale (Least Squares Mean)
Change Score from Baseline to 4-weekChange Score from Baseline to 12-week
Mifepristone 600 mg/Day-6.24-6.30
Sugar Pill-6.81-6.22

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Change in CAPS Hyperarousal Symptom Scores From Baseline to 4-Week and 12-Week

The Clinical Administered PTSD Scale (CAPS) was used to assess the diagnosis of PTSD symptoms. Its hyperarousal symptom subscale (ranges 0 - 40) is the sum of 5 PTSD symptoms (each ranges 0 - 8) in the hyperarousal symptom subcategory. A higher hyperarousal symptom score indicates worse PTSD symptoms. A positive change score indicates an increased hyperarousal symptom score (i.e., worse PTSD symptoms) at 4-week (or 12-week) compared to its baseline value, while a negative change score indicates an opposite direction. (NCT01739335)
Timeframe: baseline to 4-Week and 12-Week

,
Interventionunits on a scale (Least Squares Mean)
Change Score from Baseline to 4-weekChange Score from Baseline to 12-week
Mifepristone (600 mg/Day)-3.35-3.22
Sugar Pill-3.49-4.15

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Change in CAPS Intrusive Symptom Scores From Baseline to 4-Week and 12-Week

The Clinical Administered PTSD Scale (CAPS) was used to assess the diagnosis of PTSD symptoms. Its intrusive symptom subscale (ranges 0 - 40) is the sum of 5 PTSD symptoms (each ranges 0 - 8) in the intrusive/re-experiencing symptom subcategory. A higher intrusive symptom score indicates worse PTSD symptoms. A positive change score indicates an increased intrusive symptom score (i.e., worse PTSD symptoms) at 4-week (or 12-week) compared to its baseline value, while a negative change score indicates an opposite direction. (NCT01739335)
Timeframe: baseline to 4-Week and 12-Week

,
Interventionunits on a scale (Least Squares Mean)
Change Score from Baseline to 4-weekChange Score from Baseline to 12-week
Mifepristone (600 mg/Day)-4.27-4.77
Sugar Pill-5.49-7.78

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Complications From Procedure

Patient having any complication, including hospitalizations transfusions additional unplanned procedures (NCT01751087)
Timeframe: assessed immediately after completion of D&E and at 1 week and 1 month post-procedure

Interventionparticipants (Number)
Osmotic Dilators + Placebo (Vit c) + Placebo (Vit B12)10
Osmotic Dilators + Placebo (Vit c) + Misoprostol2
Osmotic Dilators + Mifepristone + Placebo (Vit B12)2

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Chills (Any) After Day 2 Medication Administration

chills (any) after Day 2 medication administration (NCT01751087)
Timeframe: assessed immediately after administration of day 2 medication

Interventionparticipants (Number)
Osmotic Dilators + Placebo (Vit c) + Placebo (Vit B12)12
Osmotic Dilators + Placebo (Vit c) + Misoprostol39
Osmotic Dilators + Mifepristone + Placebo (Vit B12)18

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Ability to Complete the D&E on the First Attempt

Assessed on day of procedure and following day. If the procedure was unable to be completed as planned and the subject had to leave the procedure room and return for another attempt either at a time later the same day or the next day. (NCT01751087)
Timeframe: participants were assessed for the duration of the procedure, an average of 6 minutes

Interventionparticipants (Number)
Osmotic Dilators + Placebo (Vit c) + Placebo (Vit B12)98
Osmotic Dilators + Placebo (Vit c) + Misoprostol98
Osmotic Dilators + Mifepristone + Placebo (Vit B12)98

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Initial Cervical Dilation

Measured at the time of procedure (immediately before the start of D&E) (NCT01751087)
Timeframe: participants were assessed during cervical dilation process, average time of 1 minute

Interventioncentimeters (Mean)
Osmotic Dilators + Placebo (Vit c) + Placebo (Vit B12)2.2
Osmotic Dilators + Placebo (Vit c) + Misoprostol2.5
Osmotic Dilators + Mifepristone + Placebo (Vit B12)2.4

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Patient Satisfaction With Cervical Prep

Patients who were very satisfied or satisfied with cervical preparation. Assessed on Day of procedure. Assessed after completion of D&E procedure and just prior to discharge home. (NCT01751087)
Timeframe: patients' satisfaction with cervical prep was evaluated over course of cervical prep and procedure, up to 3 days

Interventionparticipants (Number)
Osmotic Dilators + Placebo (Vit c) + Placebo (Vit B12)72
Osmotic Dilators + Placebo (Vit c) + Misoprostol80
Osmotic Dilators + Mifepristone + Placebo (Vit B12)80

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Operative Time

The duration of the D&E procedure was measured with a stopwatch, starting with the first instrument that passes into the uterus and ending when the last instrument is removed from the uterus upon completion of the D&E (NCT01751087)
Timeframe: participants were assessed for the duration of the procedure, an average of 6 minutes

Interventionminutes (Mean)
Osmotic Dilators + Placebo (Vit c) + Placebo (Vit B12)6.27
Osmotic Dilators + Placebo (Vit c) + Misoprostol6.28
Osmotic Dilators + Mifepristone + Placebo (Vit B12)5.53

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Need for Mechanical Dilation

Assessed on Day of procedure. Assessed immediately after completion of D&E (NCT01751087)
Timeframe: participants were assessed for the duration of the procedure, an average of 6 minutes

Interventionparticipants (Number)
Osmotic Dilators + Placebo (Vit c) + Placebo (Vit B12)26
Osmotic Dilators + Placebo (Vit c) + Misoprostol9
Osmotic Dilators + Mifepristone + Placebo (Vit B12)16

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Ease of Mechanical Dilation

Number of participants for whom, if additional mechanical dilation was required, it was difficult or very difficult. Assessed on day of procedure. Assessed after completion of D&E (NCT01751087)
Timeframe: participants were assessed for the duration of the procedure, an average of 6 minutes

Interventionparticipants (Number)
Osmotic Dilators + Placebo (Vit c) + Placebo (Vit B12)6
Osmotic Dilators + Placebo (Vit c) + Misoprostol4
Osmotic Dilators + Mifepristone + Placebo (Vit B12)1

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Physician Satisfaction With Cervical Preparation

Participants for whom the operating physician reported being satisfied or very satisfied with the cervical preparation. Assessed on Day of procedure. Assessed after completion of D&E procedure. (NCT01751087)
Timeframe: physicians' satisfaction with cervical prep was evaluated over course of procedure, an average of 6 minutes

Interventionparticipants (Number)
Osmotic Dilators + Placebo (Vit c) + Placebo (Vit B12)71
Osmotic Dilators + Placebo (Vit c) + Misoprostol78
Osmotic Dilators + Mifepristone + Placebo (Vit B12)85

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Adverse Events

Uterine perforation (NCT01862991)
Timeframe: Intraoperatively and 2 weeks post operatively

InterventionParticipants (Count of Participants)
Dilapan-Placebo0
Dilapan-Mifepristone1
Mifepristone2

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Procedure Time

Measured as time from speculum insertion to removal (NCT01862991)
Timeframe: Intraoperative Time, Collected immediately within procedure

Interventionminutes (Median)
Dilapan-Placebo13
Dilapan-Mifepristone12
Mifepristone18.5

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PK: Cmax of Levonorgestrel

(NCT01896726)
Timeframe: Days 1 and 29: predose and 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 14, 24 and 48 hours post dose

Interventionpg/mL (Geometric Mean)
Microgynon Alone3390
Baricitinib + Microgynon3340

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PK: AUC(0-∞) of Levonorgestrel

(NCT01896726)
Timeframe: Days 1 and 29: predose and 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 14, 24 and 48 hours post dose

Interventionpg*hr/mL (Geometric Mean)
Microgynon Alone48200
Baricitinib + Microgynon42400

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PK: Area Under the Concentration Versus Time Curve From Time Zero to Infinity [AUC(0-∞)] of Ethinyl Estradiol

(NCT01896726)
Timeframe: Days 1 and 29: predose and 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 14, 24 and 48 hours post dose

Interventionpicograms*hour/milliliter (pg*hr/mL) (Geometric Mean)
Microgynon Alone694
Baricitinib + Microgynon697

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Pharmacokinetics (PK): Maximum Concentration (Cmax) of Ethinyl Estradiol

(NCT01896726)
Timeframe: Days 1 and 29: predose and 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 14, 24 and 48 hours post dose

Interventionpicograms/milliliter (pg/mL) (Geometric Mean)
Microgynon Alone63.8
Baricitinib + Microgynon59.7

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Waist Circumference

Change in metabolic syndrome as assessed by waist circumference (NCT01990560)
Timeframe: Baseline and 6 months

Interventioncm (Mean)
Baseline6 months
Mifepristone103.2599.3125

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State Trait Anxiety Inventory (STAI)

Change in Quality of Life - as assessed by the State Trait Anxiety Inventory (STAI). The State-Trait Anxiety Inventory both state and trait anxiety separately. Each type of anxiety has its own scale of 20 different questions that are scored and averaged. Total scores range from 20 to 80, with higher scores correlating with greater anxiety. (NCT01990560)
Timeframe: Baseline and 6 months

Interventionunits on a scale (Mean)
Baseline6 months
Mifepristone25.428628.8571

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Quality of Life

Change in Quality of Life as assessed by the Beck Depression Inventory. a 21-question multiple choice, self-report inventory that is used for measuring the severity of anxiety. Scoring is from a 0 (not at all) to 3 (severe) with a total score range of 0-63. Higher total scores indicate more severe anxiety symptoms. (NCT01990560)
Timeframe: Baseline and 6 months

Interventionunits on a scale (Mean)
Baseline6 months
Mifepristone16.142911.7143

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Hospital Anxiety and Depression Scale (HADS)

Change in Quality of Life as assessed by the Hospital Anxiety and Depression Scale (HADS). Questionnaire with 7 items for anxiety and 7 items for depression, each item is scored on a 4 point response 0 - 3, with full range from 0 to 42, with higher score indicating more severe anxiety or depression (NCT01990560)
Timeframe: Baseline and 6 months

Interventionunits on a scale (Mean)
Baseline6 months
Mifepristone16.285711.1667

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HOMA-IR

Change in hyperglycemia assessed by Homeostatic Model Assessment of Insulin Resistance, HOMA-IR (a validated assessment of insulin resistance). HOMA-IR = fasting insulin (microU/L) x fasting glucose (nmol/L)/22.5. (NCT01990560)
Timeframe: Baseline and 6 months

InterventionHOMA-IR score (Mean)
Baseline6 months
Mifepristone2.4181.465

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Fasting Lipid Profile

Change in metabolic syndrome as assessed by fasting lipid profile which includes Low-density lipoproteins ( LDL), High-density lipoproteins (HDL), and Triglycerides (Trigs) levels, and total cholesterol which is the sum of HDL plus LDL and 20% of trigs. (NCT01990560)
Timeframe: Baseline and 6 months

Interventionmg/dL (Mean)
Total Cholesterol BaselineTotal Cholesterol 6 monthsLDL baselineLDL 6 monthsHDL BaselineHDL 6 monthsTrigs BaselineTrigs 6 months
Mifepristone178.63171.4397.88104.3759.1346.86107.88100.29

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CushingQoL

Change in Quality of Life - as assessed by the Cushing's Quality of Life questionnaire (CushingQoL). Patient completed questionnaire, 12 items, each scored on a 5 point score, resulting in a score of 12 (worst) to 60 (best) where higher scores indicate more favorable QOL. (NCT01990560)
Timeframe: Baseline and 6 months

Interventionunits on a scale (Mean)
Baseline6 months
Mifepristone37.285738.7857

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Nottingham Health Profile (NHP)

Change in Quality of Life as assessed by the Nottingham Health Profile (NHP) which is a patient reported questionnaire to measure a patient's view of their own health status. There are 6 sections (Energy level, Pain, Emotional Reaction, Sleep, Social Isolation, and Physical Abilities. All questions have only yes/no answer options and each section score is weighted so that the possible score range for any section is 0-100. The higher the score, the greater the number and severity of problems. (NCT01990560)
Timeframe: Baseline and 6 months

Interventionunits on a scale (Mean)
Energy Level (EL) BaselineEL 6 monthsPain (P) BaselineP 6 monthsEmotional Reaction (ER) BaselineER 6 monthsSleep (S) BaselineS 6 monthsSocial Isolation (SI) BaselineSI 6 monthsPhysical Abilities (PA) BaselinePA 6 months
Mifepristone32.6045.4024.8832.0827.0335.0924.8731.1520.0931.1523.0627.49

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Body Mass Index (BMI)

Change in metabolic syndrome as assessed by BMI (NCT01990560)
Timeframe: Baseline and 6 months

Interventionkg/m2 (Mean)
Baseline6 months
Mifepristone35.153834.5463

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Weight

Change in metabolic syndrome as assessed by weight (NCT01990560)
Timeframe: Baseline and 6 months

Interventionkg (Mean)
Baseline6 months
Mifepristone99.5797.75

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A1C Level

Change in hyperglycemia assessed by HbA1c, also known as glycated hemoglobin (NCT01990560)
Timeframe: Baseline, 3 months, and 6 months

Interventionpercentage of red blood cells (Mean)
Baseline3 months6 months
Mifepristone6.26.13756.125

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Cortisol

Change in log(Cortisol) from week 12 to week 16 (NCT02012296)
Timeframe: 12 to 16 weeks

Interventionlog(ug/dL) (Mean)
Treatment (Enzalutamide)0.072
Treatment (Enzalutamide, Mifepristone)0.733

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Radiographic PFS

Radiographic progression or death from any cause. (NCT02012296)
Timeframe: Up to 3 years, measured from randomization

InterventionMonths (Median)
Treatment (Enzalutamide)NA
Treatment (Enzalutamide, Mifepristone)16.5

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Thyroid Stimulating Hormone

Change in log(TSH) from week 12 to week 16 (NCT02012296)
Timeframe: 12 to 16 weeks

Interventionlog(mcU/mL) (Mean)
Treatment (Enzalutamide)-0.121
Treatment (Enzalutamide, Mifepristone)0.306

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Testosterone

Change from week 12 to week 16 (NCT02012296)
Timeframe: 12 to 16 weeks

Interventionng/dL (Mean)
Treatment (Enzalutamide)0.6
Treatment (Enzalutamide, Mifepristone)21.0

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PSA Progression-free Survival

PSA progression was defined as a PSA that is ≥1.25 times (25% increase) the PSA at randomization (week 12) and an absolute 5 ng/ml increase. PSA progression-free survival is PSA progression or death from any cause. (NCT02012296)
Timeframe: Up to 3 years, measured from randomization

InterventionMonths (Median)
Treatment (Enzalutamide)20.8
Treatment (Enzalutamide, Mifepristone)16.5

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Number of Participants With Positive GR Expression Within Circulating Tumor Cells (CTCs)

Positive/negative classification with positive defined as a cytokeratin cell for whom there was an glucocorticoid receptor > 0 (NCT02012296)
Timeframe: Week 12 (randomization)

InterventionParticipants (Count of Participants)
Treatment (Enzalutamide)17
Treatment (Enzalutamide, Mifepristone)8
Not Randomized5

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Number of Participants With Positive AR Expression Within Circulating Tumor Cells (CTCs)

Positive/negative classification with positive defined as a cytokeratin cell for whom there was an androgen receptor > 0 (NCT02012296)
Timeframe: Week 12 (randomization)

InterventionParticipants (Count of Participants)
Treatment (Enzalutamide)16
Treatment (Enzalutamide, Mifepristone)8
Not Randomized5

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Uterine Asperation

Surgical removal of the miscarriage. (NCT02012491)
Timeframe: 30 Days

InterventionParticipants (Count of Participants)
Misoprostol35
Misoprostol Plus Mifepristone13

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Frequency of Serious Adverse Events Between Study Arms.

(NCT02012491)
Timeframe: 30 days

InterventionParticipants (Count of Participants)
Misoprostol3
Misoprostol Plus Mifepristone5

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Gestational Sac Expulsion by the 30-day Telephone Call

(NCT02012491)
Timeframe: 30 Days

InterventionParticipants (Count of Participants)
Misoprostol113
Misoprostol Plus Mifepristone135

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Gestational Sac Expulsion by the Second Follow-up Visit at Day 8

(NCT02012491)
Timeframe: Day 8 (visit 3) and up to 30 day to ensure additional measures were not done (surgical)

InterventionParticipants (Count of Participants)
Misoprostol111
Misoprostol Plus Mifepristone132

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Gestational Sac Expulsion With One Treatment Dose on Day 3 (Visit 2) and no Need for Additional Medical or Surgical Intervention Within 30 Days of Treatment.

(NCT02012491)
Timeframe: Day 3 (visit 2) and up to 30 days following visit (to ensure surgical measures were not done

InterventionParticipants (Count of Participants)
Misoprostol100
Misoprostol Plus Mifepristone124

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Adverse Event Reported by Participants

(NCT02012491)
Timeframe: 30 Days

Interventionadverse events (Mean)
Misoprostol5.6
Misoprostol Plus Mifepristone6.1

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Drinking Quantity Per Day

"Drinking quantity in standard drinks per day is measured by the Timeline Followback interview.~A standard drink contains 14 grams of alcohol, e.g., 1.5 ounces of distilled spirits, 5 ounces of wine, or 12 ounces of beer." (NCT02179749)
Timeframe: Participants will be followed for up to 12 weeks post-assignment

InterventionStandard drinks per day (Mean)
Placebo1.25
600 mg/d of Mifepristone1.38
1200 mg/d of Mifepristone1.10

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Craving

Alcohol Craving Questionnaire; minimum value equals 12, maximum value equals 84; higher scores mean greater craving for alcohol. (NCT02179749)
Timeframe: Participants will be followed for up to 12 weeks

Interventionscore on a scale (Mean)
Experimental: Mifepristone 1200 mg Daily29.02
Placebo Daily, 1-week33.66
Experimental: Mifepristone 600 mg Day28.33

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Number of Participants Experiencing Adverse Events in the Mifepristone Versus Placebo Group as a Measure of Safety and Tolerability

Safety and tolerability was assessed by the number of participants who experienced adverse events (AEs) while taking the medication, in the mifepristone group verses the placebo group during Visit 2 through and until Visit 5. AEs were assessed at each visit and special attention was paid to any AEs experienced after administration of the oral administration of mifepristone or placebo- Visit 2 to Visit 3 (7 days total) and Visit 4 through Visit 5 (7 days total), and when it was administered with alcohol during the laboratory paradigms at visits 3 and 4. (NCT02243709)
Timeframe: 5 weeks (one week of drug administration, 3 weeks of washout, followed by one week of drug administration)

InterventionParticipants (Count of Participants)
Mifepristone0
Placebo3

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Alcohol Craving Score on the Alcohol Craving Questionnaire in the Mifepristone Versus Placebo Group

Alcohol craving will be assessed by the Alcohol Craving Questionnaire Short Form - Revised (ACQ-SF-R). The ACQ-SF-R is a 12-item self-report scale that contains items from the 47-item Alcohol Craving Questionnaire (ACQ-Now). ACQ-SF-R also produces scores for compulsivity, expectancy, purposefulness, and emotionality. To assess this outcome, at the alcohol cue reactivity procedures/visits 3 and 5 during alcohol trial 1, the 12-item total ACQ will be summed for each participant and then the total score will be averaged for a mean score. The average ACQ score in the presence of alcohol cues will be compared when participants are taking mifepristone compared to placebo. The ACQ has a total score range between 0-84. A lower score indicates less subjective alcohol craving. (NCT02243709)
Timeframe: 1 day

Interventionscore on a scale (Mean)
Mifepristone42.92
Placebo50.13

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Drinking Consumption in the Mifepristone Verses Placebo Group

Number of standard drinks desired to be consumed by participants during mifepristone administration compared to placebo administration during the open bar (free choice procedure) in the alcohol cue reactivity at visits 3 and 5. (NCT02243709)
Timeframe: 1 day

Interventiondrinks (Mean)
Mifepristone0.8
Placebo0.5

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Initial Cervical Dilation

Initial cervical dilation as measured by Hegar Dilator accepted with least resistance (NCT02412618)
Timeframe: Assessed 4-6 hour following medications at time of D&E procedure

Interventionmm (Mean)
Mifepristone11.7
Placebo10.9

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Patient Acceptability and Assessment of Pain and Side Effects (5-point Likert Scale)

"5-point Likert scale given to patients following procedure once recovered from anesthesia assessing pain, side effects including nausea, vomiting, diarrhea, cramping, and if they would choose the method again or recommend to friends.~Likert scale: Strongly agree (5), Agree (4), Neutral (3), Disagree (2), Strongly Disagree (1)" (NCT02412618)
Timeframe: intraoperative

,
Interventionunits on a scale (Mean)
NauseaSevere Cramps
Mifepristone44
Placebo44

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Time to Delivery of Fetus

From the initiation of medical therapy for induction to delivery of fetus, assessed up to 36 hours (NCT02620904)
Timeframe: From the initiation of medical therapy for induction to delivery of fetus, assessed up to 36 hours

Interventionhours (Mean)
Mifepristone14
Placebo Pill20

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Area Under the Curve From Time 0 to 24 Hours of Serum LNG Concentration

LNG-EC PK parameter (AUC 0-24 h) in women with normal and obese BMI women. (NCT02689804)
Timeframe: Up to 24 hours

Interventionng*h/mL (Mean)
Normal-BMI208.5
Obese-BMI100.8

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Area Under the Curve From Time 0 to 24 Hours of Serum UPA Concentration

UPA-EC PK parameter (AUC 0-24 h) in women with normal and obese BMI women. (NCT02689804)
Timeframe: Up to 24 hours

Interventionng*h/mL (Mean)
Normal-BMI293.5
Obese-BMI362.5

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Clearance of Serum LNG

(Cl) calculated in women with normal and obese BMI (NCT02689804)
Timeframe: Up to 24 hours

InterventionL/h (Mean)
Normal-BMI4.8
Obese-MRI9.8

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Clearance of Serum UPA

(Cl) calculated in women with normal and obese BMI (NCT02689804)
Timeframe: Up to 24 hours

InterventionL/h (Mean)
Normal-BMI4.1
Obese-MRI3.0

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Elimination Half-life of Serum LNG

(t1/2) calculated in women with normal and obese BMI (NCT02689804)
Timeframe: Up to 24 hours

Interventionh (Mean)
Normal-BMI27.0
Obese-BMI50.4

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Elimination Half-life of Serum UPA

(t1/2) calculated in women with normal and obese BMI (NCT02689804)
Timeframe: Up to 24 hours

Interventionh (Mean)
Normal-BMI34.9
Obese-MRI65.9

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Maximum Concentration of Serum LNG

(Cmax) calculated in women with normal and obese BMI (NCT02689804)
Timeframe: Up to 24 hours

Interventionng/mL (Mean)
Normal-BMI18.2
Obese-MRI10.8

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Maximum Concentration of Serum UPA

(Cmax) calculated in women with normal and obese BMI (NCT02689804)
Timeframe: Up to 24 hours

Interventionng/mL (Mean)
Normal-BMI89.3
Obese-MRI95.6

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Time to Maximum Concentration of Serum LNG

(Tmax) calculated in women with normal and obese BMI (NCT02689804)
Timeframe: Up to 24 hours

Interventionh (Mean)
Normal-BMI2.0
Obese-MRI3.0

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Time to Maximum Concentration of Serum UPA

(Tmax) calculated in women with normal and obese BMI (NCT02689804)
Timeframe: Up to 24 hours

Interventionh (Mean)
Normal-BMI1.6
Obese-MRI1.5

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Maximum Measured Concentration (Cmax) of Ethinylestradiol and Levonorgestrel

"Maximum blood concentrations (Cmax) for ethinylestradiol and levonorgestrel after a single dose of the combination of ethinylestradiol and levonorgestrel. In Period 1, blood samples were collected at pre-dose at 0.35 hour (h) and at 0.5h, 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 12h, 24h, 48h and 72h after drug administration of Microgynon®. Nintedanib in Period 2 was started at least 7 days before Microgynon® administration.~In Period 2, blood samples were collected at pre-dose at 0.35 hour (h) and at 0.5h, 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 11.55h, 23.55h, 47.55h and 71.55h after drug administration of Microgynon®." (NCT02751385)
Timeframe: Please refer to description section for the details about the actual sampling time points

,
Interventionpicogram/milliliter[pg/mL] (Geometric Mean)
EthinylestradiolLevonorgestrel
Microgynon®32.62680
Microgynon® With Nintedanib36.91630

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Area Under the Concentration-time Curve of the the Ethinylestradiol and Levonorgestrel in Plasma Over the Time Interval From 0 to the Last Quantifiable Data Point (AUC0-tz)

"Area under the concentration-time curve in plasma over the time interval from 0 to the time of the last quantifiable data point (AUC 0-tz) for ethinylestradiol and levonorgestrel after a single dose of the combination of ethinylestradiol and levonorgestrel. In Period 1, blood samples were collected at pre-dose at 0.35 hour (h) and at 0.5h, 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 12h, 24h, 48h and 72h after drug administration of Microgynon®. Nintedanib in Period 2 was started at least 7 days before Microgynon® administration.~In Period 2, blood samples were collected at pre-dose at 0.35 hour (h) and at 0.5h, 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 11.55h, 23.55h, 47.55h and 71.55h after drug administration of Microgynon®." (NCT02751385)
Timeframe: Please refer to description section for the details about the actual sampling time points

,
Interventionpicogram*hour/mililiter (Geometric Mean)
EthinylestradiolLevonorgestrel
Microgynon®41041500
Microgynon® With Nintedanib34843600

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Area Under the Concentration-time Curve of the Ethinylestradiol and Levonorgestrel in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC0-infinity).

"Area under curve from zero to infinity (AUC0-∞) for ethinylestradiol and for levonorgestrel after intake of a single dose of the combination of ethinylestradiol and levonorgestrel. In Period 1, blood samples were collected at pre-dose at 0.35 hour (h) and at 0.5h, 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 12h, 24h, 48h and 72h after drug administration of Microgynon®. Nintedanib in Period 2 was started at least 7 days before Microgynon® administration.~In Period 2, blood samples were collected at pre-dose at 0.35 hour (h) and at 0.5h, 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 11.55h, 23.55h, 47.55h and 71.55h after drug administration of Microgynon®." (NCT02751385)
Timeframe: Please refer to description section for the details about the actual sampling time points

,
Interventionpg*h/mL (Geometric Mean)
EthinylestradiolLevonorgestrel
Microgynon®50354500
Microgynon® With Nintedanib58057600

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LDL-cholesterol

Low-density lipoprotein cholesterol (NCT03052400)
Timeframe: Baseline to 3 months

Interventionmg/dL, change from baseline (Mean)
Mifepristone 600 mg Daily-1.3
Placebo-9.7

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PSA

Prostate-specific antigen level (NCT03052400)
Timeframe: Baseline to 3 months

Interventionng/mL, change from baseline (Mean)
Mifepristone 600 mg Daily-0.3
Placebo0.1

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Hemoglobin A1c

Glycemic lowering (NCT03052400)
Timeframe: Baseline to 3 months

InterventionPercentage of hemoglobin (Mean)
Mifepristone 600 mg Daily-2.4
Placebo-1.5

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Systolic BP

Systolic blood pressure (NCT03052400)
Timeframe: Baseline to 3 months

Interventionmm Hg, change from baseline (Mean)
Mifepristone 600 mg Daily3.0
Placebo-3.7

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Uric Acid

Serum uric acid level (NCT03052400)
Timeframe: Baseline to 3 months

Interventionmg/dL, change from baseline (Mean)
Mifepristone 600 mg Daily-0.8
Placebo1.1

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Weight

Weight in kg (NCT03052400)
Timeframe: Baseline to 3 months

Interventionkg, change from baseline (Mean)
Mifepristone 600 mg Daily1.4
Placebo0.5

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Hypoglycemic Events

Symptomatic mild and severe hypoglycemic events (NCT03052400)
Timeframe: Baseline to 3 months

Interventionnumber of events (Number)
Mifepristone 600 mg Daily22
Placebo31

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Diastolic BP

Diastolic blood pressure (NCT03052400)
Timeframe: Baseline to 3 months

Interventionmm Hg, change from baseline (Mean)
Mifepristone 600 mg Daily-4.3
Placebo-3.7

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Cortisol

Serum cortisol level (AM) (NCT03052400)
Timeframe: Baseline to 3 months

Interventionmg/dL, change from baseline (Mean)
Mifepristone 600 mg Daily18.8
Placebo-0.9

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Body Mass Index

Body mass index in kg/m^2 (NCT03052400)
Timeframe: Baseline to 3 months

Interventionkg/m^2, change from baseline (Mean)
Mifepristone 600 mg Daily0.6
Placebo0.0

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Basal Insulin Dose

Total daily basal insulin dosage (NCT03052400)
Timeframe: Baseline to 3 months

InterventionUnits of insulin per day (Mean)
Mifepristone 600 mg Daily-1.3
Placebo0.7

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Adverse Events

Non-hypoglycemia-related adverse events (NCT03052400)
Timeframe: Baseline to 3 months

Interventionnumber of events (Number)
Mifepristone 600 mg Daily6
Placebo2

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ACTH

Serum adrenocorticotrophic hormone level (AM) (NCT03052400)
Timeframe: Baseline to 3 months

Interventionpg/mL, change from baseline (Mean)
Mifepristone 600 mg Daily56.0
Placebo-8.3

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Number of Pharmacists Who Report Being Satisfied With Pharmacy Dispensing of Mifeprex

"Number of pharmacists who report being somewhat satisfied or very satisfied when asked Overall, how satisfied are you with mifepristone dispensing at your pharmacy? in endline survey" (NCT03320057)
Timeframe: End of the study, month 24

InterventionParticipants (Count of Participants)
Pharmacists36

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Number of Pharmacists Who Objected to Participate in Dispensing Mifeprex

Number of pharmacists who objected to participate in dispensing Mifeprex at least once during the study period. This includes pharmacists who declined participation in the study training on medication abortion due to discomfort as well as pharmacists who participated in the training but declined to dispense Mifeprex. (NCT03320057)
Timeframe: End of the study, month 24

InterventionParticipants (Count of Participants)
Pharmacists4

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Number of Participants With an Adverse Event

Number of participants who had a medical problem that required them to go to the hospital, emergency department or a doctor's office (other than regularly scheduled follow-up visit) since receiving the abortion pill (NCT03320057)
Timeframe: Up to 6 weeks after initial visit

InterventionParticipants (Count of Participants)
Medication Abortion Patients4

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Number of Participants With a Complete Abortion With Medication Alone and Who do Not Require a Surgical Procedure to Complete the Abortion

"Number of participants who report that their abortion is now complete and they are no longer pregnant and who did not end up having a suction procedure (or vacuum aspiration or dilation and curettage procedure) to complete the abortion" (NCT03320057)
Timeframe: Up to 6 weeks after initial visit

InterventionParticipants (Count of Participants)
Medication Abortion Patients243

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Number of Participants Who Report Being Satisfied With Obtaining Mifeprex in the Pharmacy

"Number of participants who report being somewhat satisfied or very satisfied when asked Overall, how satisfied were you with your experience at the pharmacy when you got the abortion pill?" (NCT03320057)
Timeframe: Day 2 following initial medication abortion visit

InterventionParticipants (Count of Participants)
Medication Abortion Patients230

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Area Under the Concentration-time Curve of Ethinylestradiol in Plasma Over the Time Interval From 0 to the Last Quantifiable Data Point (AUC0-tz)

"Area under the concentration-time curve of ethinylestradiol in plasma over the time interval from 0 to the last quantifiable data point (AUC0-tz).~For Microgynon (ethinylestradiol + levonorgestrel) alone (Reference treatment, R) and Microgynon (ethinylestradiol + levonorgestrel) + nintedanib (Test treatment, T) plasma concentrations of ethinylestradiol were measured 35 minutes (min) before and at 30 min, 1 hour (h), 1h 30 min, 2h, 3h, 4h, 6h, 8h, 11h 55 min, 23h 55 min, 47h 55 min after Microgynon administration alone or in combination with nintedanib." (NCT03675581)
Timeframe: 35 minutes (min) before and at 30 min, 1 hour (h), 1h 30 min, 2h, 3h, 4h, 6h, 8h, 11h 55 min, 23h 55 min, 47h 55 min after microgynon administration alone or in combination with nintedanib.

Interventionpicograms * hours per milliliters (Geometric Mean)
Microgynon Alone (Reference Treatment, R)610.00
Microgynon + Nintedanib (Test Treatment, T)618.28

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Area Under the Concentration-time Curve of Levonorgestrel in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC0-∞)

"Area under the concentration-time curve of levonorgestrel in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞).~For Microgynon (ethinylestradiol + levonorgestrel) alone (Reference treatment, R) and Microgynon (ethinylestradiol + levonorgestrel) + nintedanib (Test treatment, T) plasma concentrations of levonorgestrel were measured 35 minutes (min) before and at 30 min, 1 hour (h), 1h 30 min, 2h, 3h, 4h, 6h, 8h, 11h 55 min, 23h 55 min, 47h 55 min after Microgynon administration alone or in combination with nintedanib." (NCT03675581)
Timeframe: 35 minutes (min) before and at 30 min, 1 hour (h), 1h 30 min, 2h, 3h, 4h, 6h, 8h, 11h 55 min, 23h 55 min, 47h 55 min after microgynon administration alone or in combination with nintedanib.

Interventionpicograms * hours per milliliters (Geometric Mean)
Microgynon Alone (Reference Treatment, R)56311.68
Microgynon + Nintedanib (Test Treatment, T)49605.41

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Area Under the Concentration-time Curve of Levonorgestrel in Plasma Over the Time Interval From 0 to the Last Quantifiable Data Point (AUC0-tz)

"Area under the concentration-time curve of levonorgestrel in plasma over the time interval from 0 to the last quantifiable data point (AUC0-tz).~For Microgynon (ethinylestradiol + levonorgestrel) alone (Reference treatment, R) and Microgynon (ethinylestradiol + levonorgestrel) + nintedanib (Test treatment, T) plasma concentrations of levonorgestrel were measured 35 minutes (min) before and at 30 min, 1 hour (h), 1h 30 min, 2h, 3h, 4h, 6h, 8h, 11h 55 min, 23h 55 min, 47h 55 min after Microgynon administration alone or in combination with nintedanib." (NCT03675581)
Timeframe: 35 minutes (min) before and at 30 min, 1 hour (h), 1h 30 min, 2h, 3h, 4h, 6h, 8h, 11h 55 min, 23h 55 min, 47h 55 min after microgynon administration alone or in combination with nintedanib.

Interventionpicograms * hours per milliliters (Geometric Mean)
Microgynon Alone (Reference Treatment, R)33062.73
Microgynon + Nintedanib (Test Treatment, T)31872.47

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Maximum Measured Concentration of Levonorgestrel in Plasma (Cmax)

Maximum measured concentration of levonorgestrel in plasma (Cmax). For Microgynon (ethinylestradiol + levonorgestrel) alone (Reference treatment, R) and Microgynon (ethinylestradiol + levonorgestrel) + nintedanib (Test treatment, T) plasma concentrations of levonorgestrel were measured 35 minutes (min) before and at 30 min, 1 hour (h), 1h 30 min, 2h, 3h, 4h, 6h, 8h, 11h 55 min, 23h 55 min, 47h 55 min after Microgynon administration alone or in combination with nintedanib. (NCT03675581)
Timeframe: 35 minutes (min) before and at 30 min, 1 hour (h), 1h 30 min, 2h, 3h, 4h, 6h, 8h, 11h 55 min, 23h 55 min, 47h 55 min after microgynon administration alone or in combination with nintedanib.

Interventionpicograms per milliliters (Geometric Mean)
Microgynon Alone (Reference Treatment, R)3124.48
Microgynon + Nintedanib (Test Treatment, T)3152.35

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Maximum Measured Concentration of Ethinylestradiol in Plasma (Cmax)

Maximum measured concentration of ethinylestradiol in plasma (Cmax). For Microgynon (ethinylestradiol + levonorgestrel) alone (Reference treatment, R) and Microgynon (ethinylestradiol + levonorgestrel) + nintedanib (Test treatment, T) plasma concentrations of ethinylestradiol were measured 35 minutes (min) before and at 30 min, 1 hour (h), 1h 30 min, 2h, 3h, 4h, 6h, 8h, 11h 55 min, 23h 55 min, 47h 55 min after Microgynon administration alone or in combination with nintedanib. (NCT03675581)
Timeframe: 35 minutes (min) before and at 30 min, 1 hour (h), 1h 30 min, 2h, 3h, 4h, 6h, 8h, 11h 55 min, 23h 55 min, 47h 55 min after microgynon administration alone or in combination with nintedanib.

Interventionpicograms per milliliters (Geometric Mean)
Microgynon Alone (Reference Treatment, R)54.75
Microgynon + Nintedanib (Test Treatment, T)63.89

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Area Under the Concentration-time Curve of Ethinylestradiol in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC0-∞)

"Area under the concentration-time curve of ethinylestradiol in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞).~For Microgynon (ethinylestradiol + levonorgestrel) alone (Reference treatment, R) and Microgynon (ethinylestradiol + levonorgestrel) + nintedanib (Test treatment, T) plasma concentrations of ethinylestradiol were measured 35 minutes (min) before and at 30 min, 1 hour (h), 1h 30 min, 2h, 3h, 4h, 6h, 8h, 11h 55 min, 23h 55 min, 47h 55 min after Microgynon administration alone or in combination with nintedanib." (NCT03675581)
Timeframe: 35 minutes (min) before and at 30 min, 1 hour (h), 1h 30 min, 2h, 3h, 4h, 6h, 8h, 11h 55 min, 23h 55 min, 47h 55 min after microgynon administration alone or in combination with nintedanib.

Interventionpicograms * hours per milliliters (Geometric Mean)
Microgynon Alone (Reference Treatment, R)749.65
Microgynon + Nintedanib (Test Treatment, T)758.95

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Number of Participants That Required Mechanical Dilation

Number of participants that required mechanical dilation at time of procedure (NCT03714880)
Timeframe: At time of ~1 hour scheduled procedure time

InterventionParticipants (Count of Participants)
Mifepristone2
Placebo4

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Number of Participants That Required Mechanical Dilation

A count of the number of participants that required of mechanical dilation at time of procedure (NCT03714880)
Timeframe: At time of ~1 hour scheduled procedure time (10 minute)

InterventionParticipants (Count of Participants)
Mifepristone2
Placebo4

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Pain Dilator Placement Using Visual Analog Scale

"Title: Pain at time of dilator placement. Participants mark their associated pain score on a 10-cm visual analog scale at time of dilator placement with anchors of no pain at 0 cm and worst pain in your life at 10 cm.~Higher scores indicate worse outcome." (NCT03714880)
Timeframe: At time of 1 hour clinic visit (10 minutes)

Interventioncm (Median)
Mifepristone1.2
Placebo3.3

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Number of Participants That Had Placement of Expected Dilators or More

"The number of expected dilators (Dilapan-S) is calculated based on the gestational age. Four dilators are expected to be placed at 18 weeks 0 days to 19 weeks 6 days gestation. Five dilators are expected to be placed at 20 weeks 0 days to 20 weeks 6 days gestation. Six dilators are expected to be placed at 21 weeks 0 days to 21 weeks 6 days gestation. Seven dilators are expected to be placed at 22 weeks 0 days to 23 weeks 5 days gestation. Therefore, at any given gestational age, if the expected number of dilators (or additional dilators) were placed, the participant was counted as Yes, participant had placement of expected dilators or more." (NCT03714880)
Timeframe: At time of 1 hour clinic visit (10 minutes)

InterventionParticipants (Count of Participants)
Mifepristone17
Placebo21

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Number of Participants That Experienced Complications

Composite of complications including cervical lacerations requiring repair, perforations, blood transfusions, ED visits, hospitalizations, infections, additional surgical procedures, or extramural deliveries (NCT03714880)
Timeframe: At time of ~1 hour scheduled procedure time (0-30 minute)

InterventionParticipants (Count of Participants)
Mifepristone3
Placebo3

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Cervical Dilation

Measurement of cervical dilation at time of procedure (NCT03714880)
Timeframe: At time of ~1 hour scheduled procedure time (1 minute)

Interventioncm (Median)
Mifepristone3.2
Placebo2.6

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"Provider Assessment of Procedure as Very Easy or Easy"

"Survey providers blinded to study grouping regarding overall ease of procedure based on cervical dilation Identified procedures that were categorized as Very Easy or Easy (Survey response based on Likert scale: Very Easy, Easy, Moderate, Difficult, Very Difficult)" (NCT03714880)
Timeframe: At time of ~1 hour scheduled procedure time

InterventionParticipants (Count of Participants)
Mifepristone8
Placebo9

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Expulsion During Follow-up Evaluation

Pregnancy expulsion following mifepristone treatment (NCT03774745)
Timeframe: up to 16 days after mifepristone administration

InterventionParticipants (Count of Participants)
Progesterone1
Placebo Oral Capsule2

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Continuing Pregnancy Based on Ultrasound Examination

Pregnancy still in uterus with normal growth and gestational cardiac activity present based on ultrasound examination (NCT03774745)
Timeframe: at 14-16 days after mifepristone administration

InterventionParticipants (Count of Participants)
Progesterone4
Placebo Oral Capsule2

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Number of Participants With Change in Serum Progesterone and hCG During Follow-up

Change in serum progesterone and hCG during follow-up evaluation (NCT03774745)
Timeframe: up to 16 days after mifepristone administration

,
Interventionparticipants (Number)
Progesterone increase from baseline at FU 1Progesterone decrease from baseline at FU 1hCG increase from baseline at FU 1hCG decrease from baseline at FU 1
Placebo Oral Capsule2233
Progesterone5041

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Number of Participants With Adverse Events During Follow-up Evaluation

Side effects from progesterone/placebo treatment and ability to continued treatment as prescribed (NCT03774745)
Timeframe: up to 16 days after mifepristone administration

,
Interventionparticipants (Number)
NauseaVomitingMastalgiaTirednessMood changesRefluxDizzinessBleedingSpottingCramping
Placebo Oral Capsule1001000300
Progesterone2200100100

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Medical Safety During Treatment and Follow-up

Adverse events related to morbidity, e.g. hemorrhage, emergency department visits, emergent dilation and curettage procedures (NCT03774745)
Timeframe: up to 16 days after mifepristone administration

,
Interventionparticipants (Number)
HemorrhageEmergency Room VisitTransfusionEmergent D&CSide effects - request D&C
Placebo Oral Capsule22121
Progesterone11001

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Area Under the Concentration-time Curve From Time 0 to Infinity (AUC[0-inf]) of Levonorgestrel in Part 1

AUC0-inf is the area under the concentration time curve from time 0 extrapolated to infinity for levonorgestrel was reported. This outcome measure was planned to be analyzed for 'Oral Contraceptive Alone' and 'PSL + Oral Contraceptive' arms. (NCT04131517)
Timeframe: Day 13, 14, 15, 34, 35, 36 during Treatment Sequence A and on Day 1, 2, 3, 30, 31 and 32 during Treatment Sequence B

Interventionh*pg/mL (Geometric Mean)
Part 1 Oral Contraceptive Alone (PKS)NA
Part 1 PSL + Oral Contraceptive (PKS)NA

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Steady State Plasma Concentration (Cmax,ss) of Padsevonil in Part 1

Maximum observed plasma concentration of padsevonil at steady-state was reported. This outcome measure was planned to be analyzed for 'PSL + Oral contraceptive' and 'PSL Alone' arms. (NCT04131517)
Timeframe: Day 12 and 13 (Sequence A) and Day 29 and 30 (Sequence B)

Interventionnanograms per milliliter (ng/mL) (Geometric Mean)
Part 1 PSL + Oral Contraceptive (PKS)2008
Part 1 PSL Alone (PKS)2083

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Percentage of Participants With Treatment-emergent Adverse Events (TEAEs) in Part 1

An adverse event (AE) was any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. An AE could therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product. TEAEs were defined as AEs with a start date/time on or after the first dose of study medication (OC or PSL) or any unresolved event already present before administration of study medication that worsened in intensity following exposure to the treatment. (NCT04131517)
Timeframe: From Baseline up to Safety Follow-Up during Treatment Sequences A and B (up to Day 46)

Interventionpercentage of participants (Number)
Part 1 PSL + Oral Contraceptive (SS)85.7
Part 1 Oral Contraceptive Alone (SS)50.0
Part 1 PSL Alone (SS)100.0

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Percentage of Participants With Serious TEAEs in Part 1

Serious AEs were defined as any untoward medical occurrence that resulted in death, is life threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent disability, is a congenital anomaly, or is an important medical event which based on medical or scientific judgement may jeopardize the participants, or may require medical or surgical intervention to prevent any of the above. (NCT04131517)
Timeframe: From Baseline up to Safety Follow-Up during Treatment Sequences A and B (up to Day 46)

Interventionpercentage of participants (Number)
Part 1 PSL + Oral Contraceptive (SS)0
Part 1 Oral Contraceptive Alone (SS)0
Part 1 PSL Alone (SS)0

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Maximum Observed Plasma Concentration (Cmax) of Ethinylestradiol in Part 1

Cmax is maximum observed plasma concentration of ethinylestradiol (EE). Values were determined from the observed concentration and time data. This outcome measure was planned to be analyzed for 'Oral Contraceptive Alone' and 'PSL + Oral Contraceptive' arms. (NCT04131517)
Timeframe: Day 13, 14, 15, 34, 35, 36 during Treatment Sequence A and on Day 1, 2, 3, 30, 31 and 32 during Treatment Sequence B

Interventionpicograms per milliliter (pg/mL) (Geometric Mean)
Part 1 Oral Contraceptive Alone (PKS)41.17
Part 1 PSL + Oral Contraceptive (PKS)42.83

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Area Under the Concentration-time Curve From Time 0 to Time Tau (AUC[0-tau]) of Padsevonil in Part 1

Area under the concentration-time curve over a dosing interval from time 0 to tau for padsevonil was reported. This outcome measure was planned to be analyzed for 'PSL + Oral contraceptive' and 'PSL Alone' arms. (NCT04131517)
Timeframe: Day 12 and 13 (Sequence A) and Day 29 and 30 (Sequence B)

Interventionhours*nanograms per milliliter (h*ng/mL) (Geometric Mean)
Part 1 PSL + Oral Contraceptive (PKS)9612
Part 1 PSL Alone (PKS)9925

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Maximum Observed Plasma Concentration (Cmax) of Levonorgestrel in Part 1

Cmax is maximum observed plasma concentration of levonorgestrel. Values were determined from the observed concentration and time data. This outcome measure was planned to be analyzed for 'Oral Contraceptive Alone' and 'PSL + Oral Contraceptive' arms. (NCT04131517)
Timeframe: Day 13, 14, 15, 34, 35, 36 during Treatment Sequence A and on Day 1, 2, 3, 30, 31 and 32 during Treatment Sequence B

Interventionpg/mL (Geometric Mean)
Part 1 Oral Contraceptive Alone (PKS)2868
Part 1 PSL + Oral Contraceptive (PKS)2560

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Area Under the Concentration-time Curve From Time 0 to Infinity (AUC[0-inf]) of Ethinylestradiol in Part 1

Area under the concentration time curve from time 0 extrapolated to infinity for ethinylestradiol was reported. This outcome measure was planned to be analyzed for 'Oral Contraceptive Alone' and 'PSL + Oral Contraceptive' arms. (NCT04131517)
Timeframe: Day 13, 14, 15, 34, 35, 36 during Treatment Sequence A and on Day 1, 2, 3, 30, 31 and 32 during Treatment Sequence B

Interventionhours*picograms per milliliter (h*pg/mL) (Geometric Mean)
Part 1 Oral Contraceptive Alone (PKS)614.6
Part 1 PSL + Oral Contraceptive (PKS)629.5

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Number of Study Participants With Complete Study Data Captured

Because this was a feasibility trial, the goal was to see how many participants could be successfully recruited. The original intent was for the recruitment period to be for 36 months, with a target enrollment of 26 participants. Because of low enrollment, the decision to terminate was made after the trial had been open for recruitment for approximately 30 months (February 17, 2020 - September 7, 2022). (NCT04588688)
Timeframe: 30 days

InterventionParticipants (Count of Participants)
Mifepristone3

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Peak Cortisol Measured After Mifepristone

Serum cortisol was collected the day after mifepristone administration and insulin tolerance test insulin tolerance test (ITT). (NCT04588688)
Timeframe: Day 2 (day after mifepristone administration)

Interventionmicrograms per deciliter (Mean)
ITT Greater or Equal to 15 Max Cortisol13.9

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Absolute ACTH After Mifepristone

ACTH level 8:00 am (Day 2) following administration of mifepristone the night before at 10:00 pm. (NCT04588688)
Timeframe: Day 2 (day after mifepristone administration)

InterventionPicogram per milliliter (Mean)
Greater or Equal to 15 Max Cortisol18.5

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Number of Study Participants Recruited

Because this was a feasibility trial, the goal was to see how many participants could be successfully recruited. The original intent was for the recruitment period to be for 36 months, with a target enrollment of 26 participants. The trial opened for recruitment on February 17, 2020. Because of low enrollment, the decision to terminate was made on September 7, 2022, approximately 30 months later. (NCT04588688)
Timeframe: Up to 88 days

InterventionParticipants (Count of Participants)
Mifepristone3

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