Trial | Phase | Enrollment | Study Type | Start Date | Status |
A Open-label Study to Investigate the Potential Pharmacokinetic Interaction of Perampanel With Oral Contraceptives in Healthy Female Subjects [NCT01209858] | Phase 1 | 48 participants (Actual) | Interventional | 2010-03-31 | Completed |
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 1 | 36 participants (Actual) | Interventional | 2022-02-26 | Completed |
Phase II Study of Pembrolizumab and Mifepristone in Patients With Advanced HER2-negative Breast Cancer [NCT03225547] | Phase 2 | 74 participants (Anticipated) | Interventional | 2018-02-12 | Active, 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) | Interventional | 2009-06-30 | Completed |
Pharmacokinetics of Levonorgestrel and Ulipristal Acetate Emergency Contraception in Women With Normal and Obese Body Mass Index [NCT02689804] | Phase 4 | 34 participants (Actual) | Interventional | 2015-07-10 | Completed |
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 2 | 201 participants (Anticipated) | Interventional | 2023-10-18 | Recruiting |
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 4 | 144 participants (Anticipated) | Interventional | 2015-02-28 | Recruiting |
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 2 | 16 participants (Actual) | Interventional | 2015-01-31 | Completed |
Mifepristone and Misoprostol Versus Misoprostol Alone for Missed Abortion: A Randomized-controlled Trial [NCT02342002] | Phase 4 | 416 participants (Anticipated) | Interventional | 2015-01-31 | Terminated(stopped due to lack of funding) |
Alternative Provision of Medication Abortion Via Pharmacy Dispensing [NCT03320057] | Phase 4 | 326 participants (Actual) | Interventional | 2018-06-01 | Completed |
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 1 | 24 participants (Anticipated) | Interventional | 2023-12-07 | Not 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 4 | 23 participants (Actual) | Interventional | 2022-10-07 | Terminated(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 4 | 76 participants (Actual) | Interventional | 2012-03-31 | Completed |
Improving Access to Abortion in the Republic of Georgia [NCT04458558] | Phase 4 | 120 participants (Anticipated) | Interventional | 2020-06-30 | Recruiting |
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 1 | 130 participants (Actual) | Interventional | 2014-09-30 | Completed |
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) | Interventional | 2009-12-31 | Completed |
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 2 | 64 participants (Anticipated) | Interventional | 2017-03-28 | Active, not recruiting |
A Pilot Study on the Safety and Efficacy of Mifepristone for the Prevention of Relapses of Alcohol Drinking [NCT02243709] | Phase 1/Phase 2 | 32 participants (Actual) | Interventional | 2014-09-30 | Completed |
Outpatient Medical Abortion With Mifepristone and Misoprostol Through 77 Days of Gestation: A Non-inferiority Trial [NCT02314754] | Phase 4 | 719 participants (Actual) | Interventional | 2014-12-31 | Completed |
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 4 | 1,000 participants (Anticipated) | Interventional | 2023-03-31 | Recruiting |
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 1 | 16 participants (Actual) | Interventional | 2014-06-30 | Completed |
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 1 | 24 participants (Actual) | Interventional | 2019-01-17 | Completed |
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 1 | 18 participants (Actual) | Interventional | 2008-07-31 | Completed |
Randomized Controlled Trial of Mifepristone Versus Laminaria for Cervical Ripening In Midtrimester Induction [NCT00383032] | | 72 participants | Interventional | 2004-01-31 | Completed |
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 1 | 27 participants (Actual) | Interventional | 2021-12-13 | Completed |
A Multicenter Randomized Clinical Trial of Mifepristone Versus GnRHa for the Treatment of Adenomyosis [NCT05151016] | Early Phase 1 | 140 participants (Anticipated) | Interventional | 2021-12-01 | Not 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 2 | 45 participants (Actual) | Interventional | 2013-09-30 | Completed |
Cervical Prostaglandin EP3 Receptor mRNA Expression 48 Hours After Administration of Mifepristone [NCT01224509] | | 18 participants (Actual) | Interventional | 2004-09-30 | Terminated(stopped due to Longer than expected recruitment period.) |
A Biomarker Study of Mifepristone in Early Stage Breast Cancer [NCT01138553] | Early Phase 1 | 4 participants (Actual) | Interventional | 2010-06-30 | Terminated(stopped due to Inadequate subject accrual) |
Efficacy of Mifepristone in Males With Type 2 Diabetes Mellitus [NCT03052400] | Phase 2 | 8 participants (Actual) | Interventional | 2017-02-03 | Terminated(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 1 | 19 participants (Actual) | Interventional | 2022-11-24 | Completed |
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) | Interventional | 2018-02-11 | Completed |
A Pilot Study of the Effect of a Glucocorticoid Receptor Antagonist in Patients With Subclinical Cushings [NCT00721201] | Phase 1/Phase 2 | 6 participants (Anticipated) | Interventional | 2008-11-30 | Completed |
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 3 | 449 participants (Actual) | Interventional | 2008-12-31 | Completed |
"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 4 | 230 participants (Actual) | Interventional | 2017-12-01 | Completed |
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 4 | 220 participants (Anticipated) | Interventional | 2021-10-27 | Recruiting |
Compassionate Use Protocol for the Administration of CORLUX® (Mifepristone) in the Treatment of the Signs and Symptoms of Endogenous Cushing's Syndrome [NCT01371565] | Phase 3 | 4 participants (Actual) | Interventional | 2010-11-30 | Completed |
RESET-medication: Glucocorticoid Receptor (GR) Blockade as Diseasemodifying Treatment for Depression With Childhood Trauma [NCT05217758] | Phase 2 | 158 participants (Anticipated) | Interventional | 2021-12-09 | Recruiting |
A Randomised Placebo-controlled Trial of Mifepristone and Misoprostol Versus Misoprostol Alone in the Medical Management of Missed Miscarriage [NCT03065660] | Phase 3 | 711 participants (Actual) | Interventional | 2017-09-20 | Completed |
Mifepristone 5 mg Versus 10 mg for the Treatment of Uterine Leiomyomata. A Randomized, Double Blinded Clinical Trial. [NCT00712595] | Phase 2/Phase 3 | 200 participants (Actual) | Interventional | 2007-01-31 | Completed |
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 1 | 20 participants (Actual) | Interventional | 2008-09-30 | Completed |
Uptake and Acceptability of Home-use of Mifepristone for Medical Abortion [NCT00994734] | | 615 participants (Actual) | Interventional | 2009-05-31 | Completed |
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 3 | 100 participants (Actual) | Interventional | 2008-05-31 | Completed |
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 4 | 43 participants (Actual) | Interventional | 2003-06-30 | Completed |
Mifepristone Versus Osmotic Dilators in Conjunction With Misoprostol for Cervical Preparation Prior to D&E at 14-19 Weeks [NCT02679092] | | 0 participants (Actual) | Interventional | 2016-04-30 | Withdrawn(stopped due to Funding changes.) |
Comparing Two Regimens for Medical Abortion: Mifepristone+Misoprostol Versus Misoprostol Alone [NCT00680394] | | 440 participants (Actual) | Interventional | 2007-07-31 | Completed |
Novel Therapeutics in PTSD: A Randomized Clinical Trial of Mifepristone [NCT00833339] | Phase 2 | 80 participants (Anticipated) | Interventional | 2008-05-31 | Recruiting |
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 2 | 30 participants (Actual) | Interventional | 2009-06-30 | Completed |
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) | Interventional | 2021-11-01 | Completed |
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 1 | 31 participants (Actual) | Interventional | 2014-06-30 | Completed |
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 2 | 3 participants (Actual) | Interventional | 2015-12-31 | Terminated(stopped due to Lack of enrollment) |
Glucocorticoid Antagonists in Heavy Drinkers: Effects on fMRI Connectivity, Withdrawal and Drinking [NCT02989662] | | 150 participants (Anticipated) | Interventional | 2016-02-29 | Recruiting |
A Randomized, Double-blind Placebo-controlled Crossover Trial of Mifepristone in Gulf War Veterans With Chronic Multisymptom Illness [NCT00691067] | Phase 4 | 65 participants (Actual) | Interventional | 2008-05-31 | Completed |
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) | Interventional | 2008-08-31 | Completed |
Comparison Between Misopristol and Pitocin After Mifepristone Preparation for Second Trimeter Abortion [NCT00784797] | Phase 4 | 145 participants (Actual) | Interventional | 2009-01-31 | Completed |
Understanding Gulf War Illness: An Integrative Modeling Approach [NCT04255498] | Phase 1 | 20 participants (Anticipated) | Interventional | 2017-10-30 | Recruiting |
Pilot Study of an Ambulatory Medical Abortion Service at 13-18 Weeks of Gestation in Colombia [NCT04063904] | Phase 4 | 16 participants (Actual) | Interventional | 2019-10-16 | Terminated(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 3 | 200 participants (Anticipated) | Interventional | 2015-04-01 | Terminated(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 2 | 30 participants (Actual) | Interventional | 2009-04-30 | Completed |
Medical Termination of Pregnancy Due to Emergency Contraception Failure: A Randomized Trial Comparing Mifepristone Combined Misoprostol and Misoprostol Alone. [NCT00677755] | | 394 participants (Actual) | Interventional | 2004-10-31 | Completed |
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 4 | 320 participants (Anticipated) | Interventional | 2014-05-31 | Recruiting |
Mifepristone and Misoprostol Versus Misoprostol Alone for Mid-trimester Termination of Pregnancy (14-21 Weeks LMP): A Randomized-controlled Double-blinded Trial [NCT00957346] | Phase 3 | 20 participants (Anticipated) | Interventional | 2011-02-28 | Terminated |
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) | Interventional | 2009-06-30 | Completed |
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 3 | 217 participants (Actual) | Interventional | 2009-01-31 | Completed |
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 4 | 648 participants (Anticipated) | Interventional | 2016-09-30 | Not 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 4 | 50 participants (Actual) | Interventional | 2014-07-31 | Completed |
Pre-treatment With Mifepristone in Patients With Mirena for Optimizing Bleeding Pattern in Pre-menopausal Women [NCT01931657] | Phase 2 | 60 participants (Anticipated) | Interventional | 2013-08-31 | Completed |
Carboplatin, Gemcitabine, and Mifepristone for Advanced Breast Cancer and Recurrent or Persistent Epithelial Ovarian Cancer [NCT02046421] | Phase 1 | 31 participants (Actual) | Interventional | 2013-11-30 | Completed |
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 3 | 50 participants (Actual) | Interventional | 2007-12-31 | Completed |
A Phase II Evaluation of Mifepristone in the Treatment of Recurrent or Persistent Epithelial Ovarian or Primary Peritoneal Carcinoma [NCT00459290] | Phase 2 | 24 participants (Actual) | Interventional | 2007-05-31 | Completed |
Assessing Acceptability and Use of Medical Menstrual Regulation in the United States [NCT03972358] | Phase 2 | 284 participants (Anticipated) | Interventional | 2020-02-12 | Recruiting |
Treatment of Early Pregnancy Failure [NCT00468299] | | 16 participants (Actual) | Interventional | 2007-04-30 | Terminated(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) | Interventional | 2003-01-31 | Completed |
Cervical Preparation With Mifepristone Prior to Osmotic Dilators: A Randomized, Double-blind, Placebo-controlled Pilot Study [NCT03714880] | Phase 2 | 44 participants (Actual) | Interventional | 2019-04-26 | Terminated(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 1 | 23 participants (Actual) | Interventional | 2013-10-31 | Completed |
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 1 | 37 participants (Actual) | Interventional | 2014-01-31 | Completed |
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) | Observational | 2013-10-31 | Completed |
Acceptability and Feasibility of a Demedicalized Medical Abortion Regimen in the Caucasus [NCT02219100] | | 613 participants (Actual) | Interventional | 2010-11-30 | Completed |
Early Versus Delayed Insertion of Nexplanon® at Medical Abortion - a Randomized Controlled Equivalence Trial. [NCT01920022] | Phase 4 | 551 participants (Actual) | Interventional | 2013-10-31 | Completed |
A Pilot Study of Mifepristone Followed by Misoprostol in Women Undergoing Second Trimester Abortion [NCT00592215] | Phase 1 | 0 participants (Actual) | Interventional | 2008-03-31 | Withdrawn |
Hypothalamic-Pituitary-Adrenal (HPA)/Dopamine Axis in Psychotic Depression [NCT00867360] | Phase 3 | 10 participants (Actual) | Interventional | 2005-08-31 | Terminated(stopped due to Insufficient recruitment.) |
Non-surgical Alternatives to Treatment of Failed Medical Abortion: A Randomized Controlled Double-blind Trial [NCT02704481] | Phase 4 | 16 participants (Actual) | Interventional | 2016-06-01 | Terminated(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 1 | 13 participants (Actual) | Interventional | 2016-07-31 | Terminated(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 1 | 25 participants (Actual) | Interventional | 2016-07-31 | Completed |
Mifepristone and Misoprostol for the Treatment of Early Pregnancy Failure: a Pilot Clinical Trial [NCT00177372] | Phase 4 | 30 participants (Actual) | Interventional | 2005-01-31 | Completed |
Feasibility and Acceptability of Dispensing Mifepristone Via Mail Order Pharmacy [NCT03913104] | Phase 4 | 538 participants (Actual) | Interventional | 2020-01-05 | Active, not recruiting |
Comparison of the Effectiveness of Abortive Measures From the Administration of Mifegyne and Cytotec at One and Two Visits [NCT00920465] | Phase 3 | 200 participants (Anticipated) | Interventional | 2009-06-30 | Recruiting |
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 4 | 1,400 participants (Actual) | Interventional | 2009-07-31 | Completed |
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 1 | 24 participants (Anticipated) | Interventional | 2008-04-30 | Completed |
[NCT00206193] | | 0 participants | Observational | | Recruiting |
The Effect of Preoperative Treatment With Mifepristone on Uterine Fibroids and Breast Tissue [NCT00579475] | Phase 1 | 30 participants (Actual) | Interventional | 2004-11-30 | Completed |
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 4 | 50 participants (Actual) | Interventional | 2013-04-30 | Completed |
Mifepristone and Misoprostol for Undesired Pregnancy of Unknown Location: A Randomized Pilot Study of Misoprostol Dosing [NCT05839899] | Phase 3 | 50 participants (Anticipated) | Interventional | 2023-08-30 | Recruiting |
COMPARATIVE STUDY OF EFFECTS BETWEEN LETROZOLE PLUS MISOPROSTOL AND MIFEPRISTONE PLUS MISOPROSTOL IN TERMINATING NON-VIABLE FIRST TRIMESTER PREGNANCIES [NCT05304273] | Phase 3 | 120 participants (Anticipated) | Interventional | 2022-05-05 | Recruiting |
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) | Interventional | 2016-04-30 | Completed |
A Randomized Phase I Trial of Nanoparticle Albumin Bound Paclitaxel (Nab-paclitaxel, Abraxane) With or Without Mifepristone for Advanced Breast Cancer [NCT01493310] | Phase 1 | 9 participants (Actual) | Interventional | 2011-11-30 | Completed |
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 2 | 13 participants (Actual) | Interventional | 2001-09-30 | Completed |
Mifepristone Outpatient Labour Induction [NCT05177510] | Phase 3 | 400 participants (Anticipated) | Interventional | 2023-08-25 | Recruiting |
Mifepristone After Trauma to Enhance Resilience [NCT00554177] | Phase 1 | 5 participants (Actual) | Interventional | 2007-09-30 | Completed |
The Use of Letrozole or Mifepristone for Pretreatment of Medical Termination of Pregnancy: a Randomized, Non-inferiority Trial [NCT05341817] | Phase 4 | 144 participants (Anticipated) | Interventional | 2022-11-22 | Recruiting |
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 3 | 30 participants (Actual) | Interventional | 2009-07-31 | Completed |
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 1 | 71 participants (Actual) | Interventional | 2017-07-17 | Completed |
Mifepristone Tablets in the Treatment of Symptomatic Uterine Fibroids With Safety and Efficacy in Open, Multicenter Phase IV Clinical Studies [NCT03210324] | Phase 4 | 434 participants (Actual) | Interventional | 2017-06-01 | Terminated(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) | Interventional | 2011-10-31 | Recruiting |
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 3 | 62 participants (Actual) | Interventional | 2014-07-31 | Completed |
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 2 | 48 participants | Interventional | | Completed |
A Double-blind, Placebo-controlled Trial of the Safety and Efficacy of C-1073 (Mifepristone) as Adjunctive Therapy in Alzheimer's Disease [NCT00105105] | Phase 2 | 160 participants | Interventional | 2003-04-30 | Terminated |
Medication Enhanced Rapid Therapy [NCT02099825] | Phase 1 | 15 participants (Actual) | Interventional | 2014-01-13 | Terminated(stopped due to COVID and staffing issues) |
[NCT00482209] | | 1,220 participants (Anticipated) | Interventional | 2007-05-31 | Completed |
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 3 | 247 participants (Actual) | Interventional | 2005-05-31 | Completed |
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 3 | 257 participants (Actual) | Interventional | 2004-09-30 | Completed |
A Phase II Study of Mifepristone (RU-486) in Androgen Independent Prostate Cancer With Correlative Assessment of Androgen Receptor Co-Repressor Proteins [NCT00140478] | Phase 2 | 48 participants (Anticipated) | Interventional | 2005-02-28 | Completed |
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 3 | 292 participants (Actual) | Interventional | 2008-03-31 | Terminated(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 3 | 58 participants (Actual) | Interventional | 2010-05-31 | Completed |
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 1 | 18 participants (Actual) | Interventional | 2011-04-30 | Completed |
Antiglucocorticoid Therapy for Cognitive Impairment in Late-life Anxiety Disorders [NCT01333098] | Phase 1/Phase 2 | 15 participants (Actual) | Interventional | 2012-09-30 | Completed |
"Assessing Use Of Mifepristone After Progestin Priming For Use As Missed Period Pills" [NCT04676776] | Phase 2 | 139 participants (Anticipated) | Interventional | 2021-01-25 | Recruiting |
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 2 | 22 participants (Actual) | Interventional | 2010-09-30 | Terminated(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 2 | 57 participants (Actual) | Interventional | 2007-03-31 | Completed |
Randomized Control Trial Of Mifepristone for Fibroids [NCT00133705] | Phase 3 | 70 participants (Actual) | Interventional | 2003-07-31 | Completed |
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 3 | 443 participants (Actual) | Interventional | 2004-09-30 | Completed |
Antiglucocorticoid Therapy in Bipolar Depression With Mifepristone (RU486) [NCT00043654] | Phase 2 | 110 participants | Interventional | 2002-08-07 | Completed |
Increased Access to Emergency Contraceptive Pills [NCT00060463] | | 1,490 participants | Interventional | 2002-10-31 | Active, 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 3 | 104 participants (Actual) | Interventional | 2005-08-31 | Completed |
Mifepristone vs. Laminaria Insertion for Cervical Preparation Prior to Surgical Abortion at 14-16 Weeks [NCT00986921] | | 50 participants (Actual) | Interventional | 2009-10-31 | Completed |
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 3 | 87 participants (Actual) | Interventional | 2005-05-31 | Completed |
A Placebo Controlled Study on the Efficacy of 10 mg Oral Mifepristone for the Treatment of Symptomatic Uterine Leiomyomas [NCT00219778] | Phase 2 | 20 participants (Anticipated) | Interventional | 2004-12-31 | Terminated |
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 3 | 840 participants (Actual) | Interventional | 2004-02-29 | Completed |
Glucocorticoid and Mineralocorticoid Receptor Function in Post Traumatic Stress Disorder [NCT00046553] | | 97 participants | Observational | 2002-09-30 | Completed |
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 2 | 58 participants (Actual) | Interventional | 2005-03-31 | Completed |
Comparison Expectant With Immediate Medical Management for the Evacuation of the no Evolutionary Pregnancies Before 13 GW [NCT00190294] | Phase 4 | 200 participants (Actual) | Interventional | 2003-04-30 | Completed |
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 2 | 18 participants (Actual) | Interventional | 2007-05-15 | Terminated |
INST 0817: Compassionate Use of Mifepristone [NCT00832871] | | 4 participants (Actual) | Interventional | 2008-11-30 | Terminated(stopped due to Low accrual; 4 patients enrolled between 2008-2015) |
Psychophysiology of Delayed Extinction and Reconsolidation in Humans [NCT01631682] | Phase 4 | 186 participants (Actual) | Interventional | 2010-11-30 | Completed |
Cervical Rippening With Antiprogesterone in Midtrimester Abortions [NCT00410345] | Phase 4 | 145 participants (Actual) | Interventional | 2004-08-31 | Completed |
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 3 | 1,494 participants (Actual) | Interventional | 1997-01-31 | Completed |
A Multicenter, Randomized Comparison of Mifepristone and Misoprostol Administered Simultaneously Versus 24 Hours Apart for Abortion Through 63 Days [NCT00269568] | Phase 4 | 1,128 participants (Actual) | Interventional | 2004-06-30 | Completed |
Mifepristone 2.5, 5, 10 mg Versus Placebo in the Treatment of Endometriosis [NCT02271958] | Phase 2/Phase 3 | 360 participants (Actual) | Interventional | 2010-11-30 | Completed |
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) | Interventional | 2005-08-31 | Completed |
Oral Mifepristone and Buccal Misoprostol Administered Simultaneously for Abortion Through 63 Days Gestation [NCT00330993] | Phase 2 | 120 participants | Interventional | 2006-03-31 | Completed |
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 4 | 5 participants (Actual) | Interventional | 2013-01-31 | Terminated(stopped due to Unable to recruit sufficient participants) |
Medical Abortion With Mifepristone + Misoprostol (13 - 22 Weeks): A Double-blind Randomized-controlled Trial [NCT01768299] | Phase 4 | 504 participants (Actual) | Interventional | 2013-02-28 | Completed |
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 3 | 220 participants (Actual) | Interventional | 2010-03-31 | Terminated |
Exploring a Patient-centered Approach to Mifepristone Administration in Medical Abortion [NCT01811056] | | 401 participants (Actual) | Interventional | 2013-04-30 | Completed |
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 4 | 102 participants (Actual) | Interventional | 2016-11-23 | Completed |
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 1 | 18 participants (Actual) | Interventional | 2013-11-30 | Terminated |
Mifepristone Versus Misoprostol for Cervical Preparation Prior to Surgical Abortion Between 11 to 15 Weeks [NCT01636063] | | 42 participants (Actual) | Interventional | 2012-06-30 | Terminated(stopped due to Poor subject enrollment) |
Comparative Effectiveness of Pregnancy Failure Management Regimens [NCT02012491] | Phase 3 | 300 participants (Actual) | Interventional | 2014-01-31 | Completed |
Double Blind Randomized Trial of the Anti-Progestational Agent Mifepristone In The Treatment of Unresectable Meningioma [NCT03015701] | Phase 3 | 193 participants (Actual) | Interventional | 1992-08-31 | Completed |
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) | Interventional | 2012-05-31 | Completed |
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 2 | 44 participants (Actual) | Interventional | 2005-11-30 | Completed |
Mifepristone Versus Osmotic Dilator Insertion for Cervical Preparation Prior to Surgical Abortion at 15-18 Weeks [NCT01436279] | Phase 3 | 50 participants (Actual) | Interventional | 2011-07-31 | Completed |
Glucocorticoid Antagonist Treatment of Alcohol Use Disorder [NCT02179749] | Phase 2 | 103 participants (Actual) | Interventional | 2014-09-30 | Completed |
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 1 | 18 participants (Actual) | Interventional | 2012-07-31 | Completed |
Cervical Preparation of Abortions Under Paracervical Block in the First Trimester: A Randomized Clinical Trial [NCT03043014] | | 110 participants (Actual) | Interventional | 2017-06-01 | Completed |
Mifepristone Induction for Fetal Demise, a Randomized Control Trial [NCT02620904] | Phase 4 | 9 participants (Actual) | Interventional | 2016-07-14 | Terminated(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 1 | 14 participants (Actual) | Interventional | 2019-10-23 | Terminated(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 2 | 12 participants (Actual) | Interventional | 2019-02-11 | Terminated(stopped due to Safety) |
A Randomized, Placebo-Controlled, Double-Blinded Study of Mifepristone in Midtrimester Termination of Pregnancy [NCT00382538] | | 64 participants | Interventional | 2005-03-31 | Completed |
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) | Interventional | 2006-09-30 | Completed |
Glucocorticoid Receptor Blockade With Mifepristone in Patients With Mild Adrenal Hypercortisolism [NCT01990560] | Phase 4 | 8 participants (Actual) | Interventional | 2013-11-30 | Completed |
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) | Observational | 2022-02-22 | Recruiting |
The HYsteroscopic Miscarriage MaNagement (HYMMN) Trial [NCT04751500] | | 149 participants (Actual) | Interventional | 2021-01-31 | Completed |
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 1 | 17 participants (Actual) | Interventional | 2018-11-08 | Completed |
Efficacy of Mifepristone (RU-486) in the Treatment of Bipolar Depression. [NCT00359125] | Phase 2 | 0 participants (Actual) | Interventional | 2006-07-31 | Withdrawn |
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 1 | 2 participants (Actual) | Interventional | 2016-05-20 | Terminated(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 4 | 30 participants (Anticipated) | Interventional | 2022-07-01 | Recruiting |
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 2 | 19 participants (Actual) | Interventional | 2006-07-31 | Completed |
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 3 | 198 participants (Anticipated) | Interventional | 2013-05-31 | Recruiting |
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 3 | 130 participants (Actual) | Interventional | 2016-10-31 | Completed |
Mifepristone and Misoprostol for 2nd Trimester Termination of Pregnancy (13-22 Weeks LMP) in Burkina Faso [NCT03269279] | Phase 3 | 100 participants (Anticipated) | Interventional | 2017-05-20 | Recruiting |
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 1 | 16 participants (Actual) | Interventional | 2017-06-29 | Completed |
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 2 | 88 participants (Actual) | Interventional | 2013-12-13 | Completed |
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) | Interventional | 2023-06-01 | Not yet recruiting |
Mifepristone Dynamic Testing for Diagnosis for Central Adrenal Insufficiency [NCT04588688] | Phase 2 | 3 participants (Actual) | Interventional | 2021-05-05 | Terminated(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 4 | 120 participants (Actual) | Interventional | 2020-11-25 | Completed |
Introducing Mifepristone-Misoprostol for Menstrual Regulation in Public Sector Facilities in Bangladesh [NCT01798017] | Phase 4 | 1,738 participants (Actual) | Interventional | 2012-11-30 | Completed |
Effects of the Glucocorticoid Antagonist, Mifepristone, on Glucose Intolerance in Obese and Overweight Individuals [NCT01419535] | Phase 1/Phase 2 | 19 participants (Actual) | Interventional | 2011-11-29 | Completed |
Mifepristone in Refractory Depression [NCT00186056] | | 31 participants (Actual) | Interventional | 2003-01-31 | Completed |
A Randomized Comparison of Same-Day Oral Mifepristone-Misoprostol to Misoprostol Only for Cervical Preparation in Second Trimester Surgical Abortion [NCT02412618] | Phase 4 | 100 participants (Actual) | Interventional | 2012-09-30 | Completed |
Medication Development in Alcoholism: Investigating Glucocorticoid Antagonists [NCT01548417] | Phase 2 | 56 participants (Actual) | Interventional | 2012-03-31 | Completed |
An Open-label Study of the Safety, Pharmacokinetics and Pharmacodynamics of Mifepristone in Children With Refractory Cushing's Disease [NCT01925092] | Phase 3 | 0 participants (Actual) | Interventional | 2013-08-31 | Withdrawn(stopped due to Lack of enrollment) |
Alternative Provision of Medication Abortion Via Advance Provision [NCT03829696] | Phase 4 | 0 participants (Actual) | Interventional | 2020-01-31 | Withdrawn(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 3 | 30 participants (Actual) | Interventional | 2022-06-27 | Completed |
Developing Memory Reconsolidation Blockers as Novel PTSD Treatments [NCT01490697] | Phase 4 | 34 participants (Actual) | Interventional | 2009-03-31 | Completed |
Novel Therapeutics in PTSD: A Randomized Clinical Trial of Mifepristone [NCT01739335] | Phase 2 | 81 participants (Actual) | Interventional | 2012-11-19 | Completed |
Mifepristone and Misoprostol Compared With Misoprostol Alone for Second Trimester Abortion [NCT03044093] | Phase 4 | 200 participants (Anticipated) | Interventional | 2017-01-31 | Recruiting |
Why Antiprogestrone (Mifepristone) and Cyp 26 Inhibitor Must be Combined With Tamoxifen or ( Tamoxifen and Retinoic Acid) for Treating Early Breast Cancer [NCT05016349] | Phase 3 | 160 participants (Anticipated) | Interventional | 2021-08-31 | Not 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 1 | 20 participants (Actual) | Interventional | 2013-07-31 | Completed |
Evaluation of Cortisol Resistance in Young Sedentary and Endurance-trained Men and Elderly Sedentary Men [NCT01294319] | Phase 2 | 51 participants (Actual) | Interventional | 2011-01-24 | Completed |
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 1 | 22 participants (Actual) | Interventional | 2011-03-31 | Completed |
Treatment of Schizoaffective Disorder Using Mifepristone [NCT00725270] | Phase 2/Phase 3 | 12 participants (Actual) | Interventional | 1998-04-30 | Terminated(stopped due to Lack of funding.) |
Mifepristone Versus Placebo to Treat Adenomyosis: a Double-blind, Multicentre,Randomized Clinical Trial [NCT03520439] | Phase 2/Phase 3 | 134 participants (Actual) | Interventional | 2018-05-19 | Completed |
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) | Interventional | 2013-01-31 | Completed |
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 1 | 33 participants (Actual) | Interventional | 2017-08-09 | Completed |
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 1 | 48 participants (Actual) | Interventional | 2017-08-16 | Completed |
Targeting Progesterone Signaling for Breast Cancer Prevention in BRCA1 Carriers: a Pilot Study [NCT05062174] | | 0 participants (Actual) | Observational | 2021-11-01 | Withdrawn(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 1 | 76 participants (Actual) | Interventional | 2008-11-30 | Completed |
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) | Interventional | 2013-07-31 | Completed |
Tumor Necrosis Factor (TNF) and Glucocorticoid Antagonist for Gulf War Illness (GWI)-Associated Multi-symptom Disease Homeostasis Reset [NCT04254627] | Phase 1 | 20 participants (Anticipated) | Interventional | 2021-09-24 | Recruiting |
Glucocorticoid Antagonist Treatment for Tobacco Use Disorder [NCT03248713] | Early Phase 1 | 8 participants (Actual) | Interventional | 2017-11-29 | Terminated(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 4 | 342 participants (Actual) | Interventional | 2018-06-27 | Terminated(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) | Interventional | 2015-07-31 | Active, not recruiting |
[information is prepared from clinicaltrials.gov, extracted Sep-2024] |
Trial | Outcome |
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
Intervention | mL (Mean) |
---|
Treatment Group | 719 |
Placebo Group | 449 |
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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
Intervention | units on a scale (Mean) |
---|
Mifepristone | 18.75 |
Placebo | 19.68 |
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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
Intervention | copies/mL on log scale (Log Mean) |
---|
Placebo | 0.30 |
VGX-410 150mg Daily | 0.00 |
VGX-410 300mg Daily | 0.18 |
VGX-410 300mg Twice Daily | 0.04 |
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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
Intervention | units on a scale (Mean) |
---|
| Baseline | Visit 4; 4 weeks |
---|
Mifepristone | 28.5 | 20.5 |
,Placebo | 23.0 | 19.0 |
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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
Intervention | copies/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
Intervention | participants (Number) |
---|
Mifepristone | 2 |
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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
Intervention | participants (Number) |
---|
Prospective, Open-label, Study of Mifepristone | 2 |
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Overall Survival
(NCT00459290)
Timeframe: Five years
Intervention | months (Median) |
---|
Mifepristone | NA |
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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.
Intervention | months (Median) |
---|
Mifepristone | 1.8 |
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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.
Intervention | percentage of participants (Number) |
---|
Mifepristone | 13.6 |
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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.
Intervention | months (Median) |
---|
< 60 | 1.7 |
60 <70 | 4.0 |
>=70 | 1.7 |
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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.
Intervention | months (Median) |
---|
Not Platinum Sensitive | 1.7 |
Platinum Sensitive | 1.9 |
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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.
Intervention | percentage of participants (Number) |
---|
Mifepristone | 4.5 |
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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).
Intervention | Participants (Count of Participants) |
---|
| Anemia | Coagulation | Dermatologic | Gastrointestinal | Hemorrhage |
---|
Mifepristone | 1 | 2 | 1 | 1 | 1 |
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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
Intervention | participants (Number) |
---|
Misoprostol and Placebo | 6 |
Mifepristone and Misoprostol | 7 |
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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
Intervention | participants (Number) |
---|
Misoprostol and Placebo | 5 |
Mifepristone and Misoprostol | 5 |
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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
Intervention | participants (Number) |
---|
Mifepristone | 8 |
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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
Intervention | participants (Number) |
---|
Mifepristone | 15 |
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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
Intervention | participants (Number) |
---|
Active | 37 |
Placebo | 48 |
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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
Intervention | participants (Number) |
---|
Active | 51 |
Placebo | 48 |
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Percentage of Participants With <5% and <7% Increase From Baseline in Body Weight
(NCT00698022)
Timeframe: Baseline and 28 days
Intervention | Participants (Count of Participants) |
---|
| <5% increase in body weight | <7% increase in body weight |
---|
Mifepristone Plus Risperidone | 9 | 13 |
,Risperidone Plus Mifepristone-matched Placebo | 3 | 10 |
,Risperidone-matched Placebo Plus Mifepristone | 8 | 11 |
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Percentage of Participants With One or More Adverse Events
(NCT00698022)
Timeframe: Up to 28 days
Intervention | Participants (Count of Participants) |
---|
Mifepristone Plus Risperidone | 29 |
Risperidone Plus Mifepristone-matched Placebo | 27 |
Risperidone-matched Placebo Plus Mifepristone | 13 |
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Percentage of Participants Discontinued From the Study Due to an Adverse Event
(NCT00698022)
Timeframe: Up to 28 days
Intervention | Participants (Count of Participants) |
---|
Mifepristone Plus Risperidone | 5 |
Risperidone Plus Mifepristone-matched Placebo | 4 |
Risperidone-matched Placebo Plus Mifepristone | 1 |
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Change From Baseline in Body Weight
(NCT00698022)
Timeframe: Baseline and 28 days
Intervention | kilograms (Mean) |
---|
Mifepristone Plus Risperidone | 2.32 |
Risperidone Plus Mifepristone-matched Placebo | 4.23 |
Risperidone-matched Placebo Plus Mifepristone | 2.87 |
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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
Intervention | units on a scale (Mean) |
---|
| Baseline | Day 9 |
---|
Mifepristone | 24.86 | 13.57 |
,Placebo | 26.2 | 19.0 |
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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
Intervention | units on a scale (Mean) |
---|
| Baseline PSS Scores | Day 9 PSS scores |
---|
Mifepristone | 7.57 | 6.0 |
,Placebo | 12.0 | 11.0 |
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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)
Intervention | Scores on a scale (Mean) |
---|
EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID) | 3.1 |
EE/LNG (Microgynon) + Placebo | 3.7 |
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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)
Intervention | Scores on a scale (Mean) |
---|
EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID) | 74.8 |
EE/LNG (Microgynon) + Placebo | 74.1 |
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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
Intervention | Scores on a scale (Mean) |
---|
EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID) | 86.20 |
EE/LNG (Microgynon) + Placebo | 85.79 |
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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)
Intervention | Scores on a scale (Mean) |
---|
EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID) | 87.24 |
EE/LNG (Microgynon) + Placebo | 89.94 |
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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
Intervention | Scores on a scale (Mean) |
---|
EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID) | 79.12 |
EE/LNG (Microgynon) + Placebo | 81.00 |
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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)
Intervention | Scores on a scale (Mean) |
---|
EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID) | 80.22 |
EE/LNG (Microgynon) + Placebo | 81.17 |
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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
Intervention | Scores on a scale (Mean) |
---|
EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID) | 47.88 |
EE/LNG (Microgynon) + Placebo | 48.46 |
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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)
Intervention | Scores on a scale (Mean) |
---|
EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID) | 49.41 |
EE/LNG (Microgynon) + Placebo | 49.26 |
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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
Intervention | Scores on a scale (Mean) |
---|
EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID) | 66.40 |
EE/LNG (Microgynon) + Placebo | 66.66 |
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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)
Intervention | Scores on a scale (Mean) |
---|
EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID) | 66.95 |
EE/LNG (Microgynon) + Placebo | 67.18 |
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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
Intervention | Scores on a scale (Mean) |
---|
EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID) | 60.27 |
EE/LNG (Microgynon) + Placebo | 60.93 |
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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)
Intervention | Scores on a scale (Mean) |
---|
EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID) | 61.83 |
EE/LNG (Microgynon) + Placebo | 63.58 |
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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
Intervention | Scores on a scale (Mean) |
---|
EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID) | 67.75 |
EE/LNG (Microgynon) + Placebo | 67.98 |
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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)
Intervention | Scores on a scale (Mean) |
---|
EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID) | 69.20 |
EE/LNG (Microgynon) + Placebo | 69.86 |
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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
Intervention | Scores on a scale (Mean) |
---|
EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID) | 0.54 |
EE/LNG (Microgynon) + Placebo | 0.47 |
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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)
Intervention | Scores on a scale (Mean) |
---|
EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID) | 0.27 |
EE/LNG (Microgynon) + Placebo | 0.25 |
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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
Intervention | Scores on a scale (Mean) |
---|
EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID) | 0.33 |
EE/LNG (Microgynon) + Placebo | 0.38 |
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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)
Intervention | Scores on a scale (Mean) |
---|
EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID) | 0.34 |
EE/LNG (Microgynon) + Placebo | 0.31 |
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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)
Intervention | Scores 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)
Intervention | Percentage of participants (Number) |
---|
| spotting | light | normal | heavy |
---|
EE/LNG (Microgynon) + Placebo | 80.0 | 20.0 | 0.0 | 0.0 |
,EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID) | 75.0 | 6.3 | 12.5 | 6.3 |
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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)
Intervention | Percentage of participants (Number) |
---|
| spotting | light | normal | heavy |
---|
EE/LNG (Microgynon) + Placebo | 75.0 | 25.0 | 0.0 | 0.0 |
,EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID) | 64.7 | 23.5 | 11.8 | 0.0 |
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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)
Intervention | Percentage of participants (Number) |
---|
| spotting | light | normal | heavy |
---|
EE/LNG (Microgynon) + Placebo | 100.0 | 0.0 | 0.0 | 0.0 |
,EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID) | 66.7 | 8.3 | 16.7 | 8.3 |
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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)
Intervention | Percentage of participants (Number) |
---|
| spotting | light | normal | heavy |
---|
EE/LNG (Microgynon) + Placebo | 7.7 | 25.0 | 53.8 | 13.5 |
,EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID) | 22.4 | 44.7 | 30.3 | 2.6 |
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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)
Intervention | Percentage of participants (Number) |
---|
| spotting | light | normal | heavy |
---|
EE/LNG (Microgynon) + Placebo | 4.0 | 25.3 | 61.6 | 9.1 |
,EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID) | 26.5 | 33.7 | 37.3 | 2.4 |
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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)
Intervention | Percentage of participants (Number) |
---|
| spotting | light | normal | heavy |
---|
EE/LNG (Microgynon) + Placebo | 13.0 | 26.1 | 47.8 | 13.0 |
,EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID) | 38.9 | 27.8 | 27.8 | 5.6 |
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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)
Intervention | Percentage of participants (Number) |
---|
| without withdrawal bleeding | with withdrawal bleeding |
---|
EE/LNG (Microgynon) + Placebo | 2.8 | 97.2 |
,EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID) | 24.8 | 75.2 |
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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)
Intervention | Percentage of participants (Number) |
---|
| without withdrawal bleeding | with withdrawal bleeding |
---|
EE/LNG (Microgynon) + Placebo | 0.0 | 100.0 |
,EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID) | 13.5 | 86.5 |
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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)
Intervention | Percentage of participants (Number) |
---|
| without withdrawal bleeding | with withdrawal bleeding |
---|
EE/LNG (Microgynon) + Placebo | 8.0 | 92.0 |
,EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID) | 51.4 | 48.6 |
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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)
Intervention | Percentage of participants (Number) |
---|
| no | yes |
---|
EE/LNG (Microgynon) + Placebo | 87.9 | 12.1 |
,EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID) | 63.1 | 36.9 |
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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)
Intervention | Percentage of participants (Number) |
---|
| with absence of intracyclic bleeding | with presence of intracyclic bleeding |
---|
EE/LNG (Microgynon) + Placebo | 95.3 | 4.7 |
,EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID) | 84.2 | 15.8 |
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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)
Intervention | Percentage of participants (Number) |
---|
| with absence of intracyclic bleeding | with presence of intracyclic bleeding |
---|
EE/LNG (Microgynon) + Placebo | 96.0 | 4.0 |
,EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID) | 82.3 | 17.7 |
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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)
Intervention | Percentage of participants (Number) |
---|
| with absence of intracyclic bleeding | with presence of intracyclic bleeding |
---|
EE/LNG (Microgynon) + Placebo | 94.7 | 5.3 |
,EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID) | 83.8 | 16.2 |
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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)
Intervention | Proportion of participants (Number) |
---|
| Vaginal pH < 4.0 | Vaginal pH 4.0 - 4.4 | Vaginal pH 4.5 - 5.0 | Vaginal pH > 5.0 |
---|
EE/LNG (Microgynon) + Placebo | 0.039 | 0.294 | 0.637 | 0.029 |
,EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID) | 0.053 | 0.298 | 0.521 | 0.117 |
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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)
Intervention | scores on a scale (Mean) |
---|
EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID) | 6.45 |
EE/LNG (Microgynon) + Placebo | 5.98 |
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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)
Intervention | scores on a scale (Mean) |
---|
EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID) | 6.43 |
EE/LNG (Microgynon) + Placebo | 6.37 |
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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
Intervention | Days (Mean) |
---|
EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID) | 3.8 |
EE/LNG (Microgynon) + Placebo | 2.2 |
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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
Intervention | Days (Mean) |
---|
EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID) | 2.3 |
EE/LNG (Microgynon) + Placebo | 1.3 |
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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
Intervention | Days (Mean) |
---|
EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID) | 1.1 |
EE/LNG (Microgynon) + Placebo | 1.0 |
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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
Intervention | Days (Mean) |
---|
EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID) | 1.3 |
EE/LNG (Microgynon) + Placebo | 0.8 |
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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)
Intervention | Days (Mean) |
---|
EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID) | 4.3 |
EE/LNG (Microgynon) + Placebo | 4.6 |
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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)
Intervention | Days (Mean) |
---|
EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID) | 4.3 |
EE/LNG (Microgynon) + Placebo | 4.4 |
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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)
Intervention | Days (Mean) |
---|
EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID) | 3.4 |
EE/LNG (Microgynon) + Placebo | 4.0 |
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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
Intervention | episodes (Mean) |
---|
EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID) | 1.1 |
EE/LNG (Microgynon) + Placebo | 0.4 |
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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)
Intervention | Scores on a scale (Mean) |
---|
EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID) | 3.2 |
EE/LNG (Microgynon) + Placebo | 3.8 |
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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)
Intervention | Scores on a scale (Mean) |
---|
EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID) | 3.0 |
EE/LNG (Microgynon) + Placebo | 3.6 |
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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
Intervention | Days (Mean) |
---|
EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID) | 6.6 |
EE/LNG (Microgynon) + Placebo | 5.6 |
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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
Intervention | Days (Mean) |
---|
EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID) | 5.3 |
EE/LNG (Microgynon) + Placebo | 4.7 |
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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)
Intervention | Days (Mean) |
---|
EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID) | 3.5 |
EE/LNG (Microgynon) + Placebo | 2.4 |
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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)
Intervention | Days (Mean) |
---|
EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID) | 5.0 |
EE/LNG (Microgynon) + Placebo | 2.8 |
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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)
Intervention | Days (Mean) |
---|
EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID) | 3.5 |
EE/LNG (Microgynon) + Placebo | 5.0 |
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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
Intervention | Days (Mean) |
---|
EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID) | 3.9 |
EE/LNG (Microgynon) + Placebo | 3.3 |
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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
Intervention | Days (Mean) |
---|
EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID) | 3.9 |
EE/LNG (Microgynon) + Placebo | 3.7 |
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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)
Intervention | Scores 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)
Intervention | scores on a scale (Mean) |
---|
EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID) | 1.43 |
EE/LNG (Microgynon) + Placebo | 1.24 |
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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)
Intervention | scores on a scale (Mean) |
---|
EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID) | 1.02 |
EE/LNG (Microgynon) + Placebo | 1.11 |
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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)
Intervention | Scores on a scale (Mean) |
---|
EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID) | 1.36 |
EE/LNG (Microgynon) + Placebo | 1.04 |
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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)
Intervention | Scores on a scale (Mean) |
---|
EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID) | 1.26 |
EE/LNG (Microgynon) + Placebo | 1.06 |
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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)
Intervention | Scores on a scale (Mean) |
---|
EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID) | 0.69 |
EE/LNG (Microgynon) + Placebo | 0.22 |
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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)
Intervention | Scores on a scale (Mean) |
---|
EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID) | 1.03 |
EE/LNG (Microgynon) + Placebo | 1.03 |
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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)
Intervention | Scores on a scale (Mean) |
---|
EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID) | 6.7 |
EE/LNG (Microgynon) + Placebo | 5.7 |
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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)
Intervention | Scores on a scale (Mean) |
---|
EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID) | 4.9 |
EE/LNG (Microgynon) + Placebo | 2.6 |
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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)
Intervention | Scores on a scale (Mean) |
---|
EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID) | 1.75 |
EE/LNG (Microgynon) + Placebo | 4.25 |
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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)
Intervention | Scores 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)
Intervention | Scores on a scale (Mean) |
---|
EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID) | 0.91 |
EE/LNG (Microgynon) + Placebo | 0.98 |
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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)
Intervention | Scores on a scale (Mean) |
---|
EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID) | 0.02 |
EE/LNG (Microgynon) + Placebo | 0.71 |
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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)
Intervention | Scores on a scale (Mean) |
---|
EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID) | 1.42 |
EE/LNG (Microgynon) + Placebo | 2.65 |
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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)
Intervention | Scores on a scale (Mean) |
---|
EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID) | 1.93 |
EE/LNG (Microgynon) + Placebo | 1.90 |
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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)
Intervention | Scores on a scale (Mean) |
---|
EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID) | 2.60 |
EE/LNG (Microgynon) + Placebo | 4.12 |
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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
Intervention | Days (Mean) |
---|
EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID) | 4.47 |
EE/LNG (Microgynon) + Placebo | 4.42 |
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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
Intervention | Days (Mean) |
---|
EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID) | 4.13 |
EE/LNG (Microgynon) + Placebo | 4.03 |
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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
Intervention | Days (Mean) |
---|
EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID) | 3.38 |
EE/LNG (Microgynon) + Placebo | 2.79 |
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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
Intervention | Days (Mean) |
---|
EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID) | 3.18 |
EE/LNG (Microgynon) + Placebo | 3.23 |
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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
Intervention | Days (Mean) |
---|
EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID) | 16.3 |
EE/LNG (Microgynon) + Placebo | 15.3 |
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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
Intervention | Days (Mean) |
---|
EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID) | 12.2 |
EE/LNG (Microgynon) + Placebo | 12.6 |
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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
Intervention | episodes (Mean) |
---|
EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID) | 3.5 |
EE/LNG (Microgynon) + Placebo | 3.3 |
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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
Intervention | episodes (Mean) |
---|
EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID) | 3.0 |
EE/LNG (Microgynon) + Placebo | 3.1 |
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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)
Intervention | Days (Mean) |
---|
EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID) | 0.6 |
EE/LNG (Microgynon) + Placebo | 0.1 |
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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)
Intervention | Days (Mean) |
---|
EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID) | 0.9 |
EE/LNG (Microgynon) + Placebo | 0.1 |
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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)
Intervention | Days (Mean) |
---|
EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID) | 0.6 |
EE/LNG (Microgynon) + Placebo | 0.3 |
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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)
Intervention | episodes (Mean) |
---|
EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID) | 0.2 |
EE/LNG (Microgynon) + Placebo | 0.1 |
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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)
Intervention | episodes (Mean) |
---|
EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID) | 0.2 |
EE/LNG (Microgynon) + Placebo | 0.1 |
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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)
Intervention | episodes (Mean) |
---|
EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID) | 0.2 |
EE/LNG (Microgynon) + Placebo | 0.1 |
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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
Intervention | Days (Mean) |
---|
EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID) | 7.6 |
EE/LNG (Microgynon) + Placebo | 3.8 |
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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
Intervention | Days (Mean) |
---|
EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID) | 6.1 |
EE/LNG (Microgynon) + Placebo | 3.3 |
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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)
Intervention | Scores 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
Intervention | episodes (Mean) |
---|
EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID) | 1.1 |
EE/LNG (Microgynon) + Placebo | 0.4 |
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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
Intervention | Days (Mean) |
---|
EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID) | 3.5 |
EE/LNG (Microgynon) + Placebo | 3.4 |
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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
Intervention | Days (Mean) |
---|
EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID) | 4.2 |
EE/LNG (Microgynon) + Placebo | 3.6 |
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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
Intervention | Days (Mean) |
---|
EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID) | 1.1 |
EE/LNG (Microgynon) + Placebo | 3.3 |
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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)
Intervention | Percentage of participants (Number) |
---|
EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID) | 70.3 |
EE/LNG (Microgynon) + Placebo | 62.7 |
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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)
Intervention | Percentage of participants (Number) |
---|
EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID) | 68.1 |
EE/LNG (Microgynon) + Placebo | 70.5 |
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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
Intervention | Scores on a scale (Mean) |
---|
EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID) | 25.6 |
EE/LNG (Microgynon) + Placebo | 27.5 |
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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)
Intervention | Scores on a scale (Mean) |
---|
EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID) | 14.8 |
EE/LNG (Microgynon) + Placebo | 17.6 |
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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
Intervention | scores on a scale (Mean) |
---|
EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID) | 2.65 |
EE/LNG (Microgynon) + Placebo | 2.77 |
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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)
Intervention | scores on a scale (Mean) |
---|
EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID) | 4.03 |
EE/LNG (Microgynon) + Placebo | 4.05 |
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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
Intervention | scores on a scale (Mean) |
---|
EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID) | 2.51 |
EE/LNG (Microgynon) + Placebo | 2.39 |
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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)
Intervention | scores on a scale (Mean) |
---|
EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID) | 3.53 |
EE/LNG (Microgynon) + Placebo | 3.52 |
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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
Intervention | Scores on a scale (Mean) |
---|
EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID) | 3.56 |
EE/LNG (Microgynon) + Placebo | 3.73 |
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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)
Intervention | scores on a scale (Mean) |
---|
EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID) | 4.90 |
EE/LNG (Microgynon) + Placebo | 4.81 |
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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
Intervention | Scores on a scale (Mean) |
---|
EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID) | 2.97 |
EE/LNG (Microgynon) + Placebo | 2.93 |
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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)
Intervention | Scores on a scale (Mean) |
---|
EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID) | 4.22 |
EE/LNG (Microgynon) + Placebo | 4.05 |
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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
Intervention | Scores on a scale (Mean) |
---|
EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID) | 4.34 |
EE/LNG (Microgynon) + Placebo | 4.74 |
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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)
Intervention | Scores on a scale (Mean) |
---|
EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID) | 5.04 |
EE/LNG (Microgynon) + Placebo | 5.01 |
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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
Intervention | Scores on a scale (Mean) |
---|
EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID) | 3.16 |
EE/LNG (Microgynon) + Placebo | 3.20 |
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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)
Intervention | Scores on a scale (Mean) |
---|
EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID) | 4.19 |
EE/LNG (Microgynon) + Placebo | 4.26 |
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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
Intervention | scores on a scale (Mean) |
---|
EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID) | 19.2 |
EE/LNG (Microgynon) + Placebo | 19.8 |
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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)
Intervention | Scores on a scale (Mean) |
---|
EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID) | 25.8 |
EE/LNG (Microgynon) + Placebo | 25.7 |
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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
Intervention | Scores on a scale (Mean) |
---|
EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID) | 69.76 |
EE/LNG (Microgynon) + Placebo | 68.47 |
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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)
Intervention | Scores on a scale (Mean) |
---|
EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID) | 71.63 |
EE/LNG (Microgynon) + Placebo | 72.48 |
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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
Intervention | Scores on a scale (Mean) |
---|
EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID) | 70.3 |
EE/LNG (Microgynon) + Placebo | 71.5 |
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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)
Intervention | percentage of participants (Number) |
---|
| Nausea | Vomiting | Lethargy | Dizziness | Fatigue | Anorexia | Skin Rash |
---|
Mifepristone | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
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Overall Survival
The time from patient entry into the protocol to death by any cause. (NCT00832871)
Timeframe: 5 years
Intervention | Months (Median) |
---|
Mifepristone | 24.2 |
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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
Intervention | days (Median) |
---|
Mifepristone | 44 |
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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
Intervention | units on a scale (Mean) |
---|
Mifepristone | .000 |
Placebo | 1.00 |
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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
Intervention | ug/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
Intervention | percentage change (Mean) |
---|
Mifepristone | 14 |
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.
Intervention | participants (Number) |
---|
Open-label | 30 |
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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.
Intervention | units on a scale (Mean) |
---|
Open-label | 3.3 |
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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.
Intervention | Minutes (Mean) |
---|
Standard Osmotic Dilators | 8.0 |
Mifepristone | 9.87 |
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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
Intervention | percentage of participants (Number) |
---|
Standard Osmotic Dilators | 52 |
Mifepristone | 8 |
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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.
Intervention | percentage of participants (Number) |
---|
Standard Osmotic Dilators | 46 |
Mifepristone | 36 |
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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
Intervention | Participants (Count of Participants) |
---|
| Day 1072243148 | Day 1072243149 | Day 2872243148 | Day 2872243149 |
---|
| relapsed | abstinent |
---|
Mifepristone | 3 |
Mifepristone | 6 |
Mifepristone | 5 |
Placebo | 8 |
Mifepristone | 4 |
Placebo | 3 |
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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)
Intervention | Scores on a scale (Mean) |
---|
| SCl-90-R - Somatization | SCL-90-R - Obsessive-Complusive | SCL-90-R - Interpersonal Sensitivity | SCL-90-R - Depression | SCL-90-R - Anxiety | SCL-90-R - Hostility | SCL-90-R - Phobic Anxiety | SCL-90-R - Paranoid Ideation | SCL-90-R - Psychoticism | SCL-90-R - Global Severity Index | SCL-90-R - Positive Symptom Total | SCL-90-R - Positive Symptom Distress Index |
---|
Mifepristone | 49.78 | 51.33 | 48.89 | 49.00 | 48.44 | 50.11 | 46.00 | 50.33 | 45.44 | 49.00 | 49.56 | 51.67 |
,Placebo | 47.60 | 44.60 | 45.30 | 44.00 | 42.70 | 48.80 | 50.10 | 46.80 | 45.70 | 45.10 | 44.80 | 46.60 |
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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)
Intervention | Scores on a scale (Mean) |
---|
| BPDSI Subscale Score - Abandonment | BPDSI Subscale Score - Interpersonal Relationships | BPDSI Subscale Score - Identity | BPDSI Subscale Score - Impulsivity | BPDSI Subscale Score - Parasuicidal Behavior | BPDSI Subscale Score - Affective Instability | BPDSI Subscale Score - Emptiness | BPDSI Subscale Score - Outbursts of Anger | BPDSI Sub. Score-Dissociation & Paranoid Ideation |
---|
Mifepristone | 0.90 | 0.80 | 1.64 | 0.66 | 0.37 | 3.67 | 2.76 | 1.08 | 1.63 |
,Placebo | 1.27 | 0.58 | 1.34 | 0.11 | 0.19 | 2.89 | 1.51 | 0.79 | 0.77 |
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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)
Intervention | Scores on a scale (Mean) |
---|
| BPDSI Subscale Score - Abandonment | BPDSI Subscale Score - Interpersonal Relationships | BPDSI Subscale Score - Identity | BPDSI Subscale Score - Impulsivity | BPDSI Subscale Score - Parasuicidal Behavior | BPDSI Subscale Score - Affective Instability | BPDSI Subscale Score - Emptiness | BPDSI Subscale Score - Outbursts of Anger | BPDSI Sub. Score-Dissociation & Paranoid Ideation |
---|
Mifepristone | 1.46 | 1.34 | 2.76 | 0.78 | 0.48 | 4.40 | 3.96 | 1.45 | 1.45 |
,Placebo | 1.36 | 0.70 | 1.49 | 0.32 | 0.30 | 4.48 | 2.35 | 1.53 | 1.14 |
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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)
Intervention | Scores on a scale (Mean) |
---|
| SCl-90-R - Somatization | SCL-90-R - Obsessive-Complusive | SCL-90-R - Interpersonal Sensitivity | SCL-90-R - Depression | SCL-90-R - Anxiety | SCL-90-R - Hostility | SCL-90-R - Phobic Anxiety | SCL-90-R - Paranoid Ideation | SCL-90-R - Psychoticism | SCL-90-R - Global Severity Index | SCL-90-R - Positive Symptom Total | SCL-90-R - Positive Symptom Distress Index |
---|
Mifepristone | 55.80 | 56.20 | 56.50 | 54.40 | 52.60 | 53.70 | 50.00 | 56.40 | 52.20 | 55.20 | 55.90 | 54.50 |
,Placebo | 50.25 | 51.50 | 51.58 | 49.75 | 47.17 | 53.00 | 54.58 | 48.45 | 47.67 | 50.00 | 49.00 | 52.25 |
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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)
Intervention | Scores on a scale (Mean) |
---|
| BPDSI Subscale Score - Abandonment | BPDSI Subscale Score - Interpersonal Relationships | BPDSI Subscale Score - Identity | BPDSI Subscale Score - Impulsivity | BPDSI Subscale Score - Parasuicidal Behavior | BPDSI Subscale Score - Affective Instability | BPDSI Subscale Score - Emptiness | BPDSI Subscale Score - Outbursts of Anger | BPDSI Sub. Score-Dissociation & Paranoid Ideation |
---|
Mifepristone | 1.06 | 0.84 | 1.92 | 0.53 | 0.43 | 3.27 | 2.94 | 0.97 | 1.62 |
,Placebo | 0.63 | 0.64 | 0.63 | 0.11 | 0.25 | 2.96 | 1.79 | 0.62 | 0.56 |
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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)
Intervention | Scores on a scale (Mean) |
---|
| SCl-90-R - Somatization | SCL-90-R - Obsessive-Complusive | SCL-90-R - Interpersonal Sensitivity | SCL-90-R - Depression | SCL-90-R - Anxiety | SCL-90-R - Hostility | SCL-90-R - Phobic Anxiety | SCL-90-R - Paranoid Ideation | SCL-90-R - Psychoticism | SCL-90-R - Global Severity Index | SCL-90-R - Positive Symptom Total | SCL-90-R - Positive Symptom Distress Index |
---|
Mifepristone | 53.00 | 54.30 | 53.00 | 52.60 | 49.10 | 52.80 | 49.60 | 53.80 | 48.80 | 52.30 | 53.40 | 54.20 |
,Placebo | 46.27 | 47.91 | 48.45 | 47.82 | 43.09 | 52.00 | 49.55 | 47.91 | 47.27 | 45.82 | 46.91 | 51.91 |
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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)
Intervention | Scores on a scale (Mean) |
---|
| CGI-I - 7 days of study med | CGI-I - 21 days after disc of study med |
---|
Mifepristone | 3.30 | 3.44 |
,Placebo | 3.36 | 2.80 |
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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)
Intervention | Scores on a scale (Mean) |
---|
| CGI-S - Baseline | CGI-S - 7 days of study med | CGI-S - 21 days after disc of study med |
---|
Mifepristone | 4.30 | 4.20 | 3.89 |
,Placebo | 4.42 | 4.09 | 3.70 |
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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)
Intervention | Scores on a scale (Mean) |
---|
| BPRS - Baseline | BPRS - 7 days of study medication | BPRS - 7 days after disc of study med | BPRS - 21 days after disc study med |
---|
Mifepristone | 37.70 | 33.90 | 35.78 | 35.22 |
,Placebo | 37.50 | 33.36 | 33.50 | 30.50 |
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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
Intervention | Scores on a scale (Mean) |
---|
| BPDSI Total Score after 7 days of medication | BPDSI Total Score 21 days after discont. study med |
---|
Mifepristone | 13.50 | 13.58 |
,Placebo | 9.45 | 8.17 |
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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)
Intervention | mcg/dL (Mean) |
---|
| Cortisol Level - Baseline | Cortisol Level - 7 days of study med | Cortisol Level - 7 days after disc of study med | Cortisol Level - 21 days after disc study med |
---|
Mifepristone | 13.88 | 35.01 | 20.91 | 11.90 |
,Placebo | 14.38 | 16.33 | 14.30 | 15.73 |
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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
Intervention | Scores on a scale (Mean) |
---|
| BPDSI Total Score after 7 days of medication | BPDSI Total Score at Baseline |
---|
Mifepristone | 13.5 | 17.99 |
,Placebo | 9.45 | 13.66 |
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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)
Intervention | Scores on a scale (Mean) |
---|
| BPD Checklist - Baseline | BPD Checklist - 7 days of study med | BPD Checklist - 7 days after disc of study med | BPD Checklist - 21 days after disc study med |
---|
Mifepristone | 103.60 | 98.10 | 91.56 | 87.89 |
,Placebo | 96.92 | 88.36 | 82.80 | 78.80 |
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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
Intervention | Participants (Count of Participants) |
---|
Endurance-trained Young Athletes | 0 |
Sedentary Young Adults | 1 |
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Post-dexamethasone Cortisol Level
(NCT01294319)
Timeframe: Cortisol obtained at 8-9 AM after dexamethasone taken between 11 pm and midnight
Intervention | mcg/dL (Mean) |
---|
Endurance-trained Young Athletes | 11.98 |
Sedentary Young Adults | 9.98 |
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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
Intervention | participants (Number) |
---|
Microgynon | 0 |
Microgynon Plus Empa | 0 |
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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.
Intervention | hours(h) (Geometric Mean) |
---|
Microgynon | 36.7 |
Microgynon Plus Empa | 37.6 |
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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.
Intervention | 1/h (Geometric Mean) |
---|
Microgynon | 0.0189 |
Microgynon Plus Empa | 0.0184 |
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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.
Intervention | hours(h) (Median) |
---|
Microgynon | 1.00 |
Microgynon Plus Empa | 1.00 |
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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
Intervention | percentage of participants (Number) |
---|
| Good | Satisfactory | Not satisfactory | Bad | Not assessable |
---|
Microgynon | 94.4 | 5.6 | 0.0 | 0.0 | 0.0 |
,Microgynon Plus Empa | 94.4 | 5.6 | 0.0 | 0.0 | 0.0 |
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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.
Intervention | mL/min (Geometric Mean) |
---|
Microgynon | 552 |
Microgynon Plus Empa | 536 |
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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.
Intervention | L (Geometric Mean) |
---|
Microgynon | 729 |
Microgynon Plus Empa | 757 |
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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.
Intervention | pg/mL (Geometric Mean) |
---|
Microgynon | 97.6 |
Microgynon Plus Empa | 96.8 |
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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.
Intervention | hours(h) (Geometric Mean) |
---|
Microgynon | 18.6 |
Microgynon Plus Empa | 19.5 |
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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.
Intervention | hours(h) (Geometric Mean) |
---|
Microgynon | 15.3 |
Microgynon Plus Empa | 16.3 |
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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.
Intervention | 1/h (Geometric Mean) |
---|
Microgynon | 0.0454 |
Microgynon Plus Empa | 0.0425 |
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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.
Intervention | hours(h) (Median) |
---|
Microgynon | 1.26 |
Microgynon Plus Empa | 1.50 |
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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.
Intervention | mL/min (Geometric Mean) |
---|
Microgynon | 26.6 |
Microgynon Plus Empa | 26.1 |
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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.
Intervention | L (Geometric Mean) |
---|
Microgynon | 84.6 |
Microgynon Plus Empa | 85.0 |
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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.
Intervention | ng/mL (Geometric Mean) |
---|
Microgynon | 7.98 |
Microgynon Plus Empa | 8.44 |
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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.
Intervention | hours(h) (Geometric Mean) |
---|
Microgynon | 48.8 |
Microgynon Plus Empa | 49.6 |
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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
Intervention | z-score (Mean) |
---|
| Baseline | Week 4 | Week 12 |
---|
High Baseline Cortisol | 0.93 | 1.85 | 3.00 |
,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
Intervention | participants with reported side effects (Number) |
---|
| dizziness | fatigue | nausea |
---|
Mifepristone | 5 | 3 | 2 |
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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
Intervention | Participants (Count of Participants) |
---|
Mifepristone | 1 |
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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
Intervention | Scores on a scale (Mean) |
---|
| Baseline | Week 4 | Week 12 |
---|
High Baseline Cortisol | 30.80 | 22.40 | 23.0 |
,Without High Baseline Corisol | 27.88 | 27.00 | 25.29 |
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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
Intervention | participants (Number) |
---|
Mifepristone | 4 |
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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
Intervention | units on a scale (Mean) |
---|
Post-mifepristone | 3.58 |
Post-placebo | 5.78 |
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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
Intervention | min-1·μU·ml-1 (Mean) |
---|
Post-mifepristone | 1.49 |
Post-placebo | 1.41 |
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Change in Fasting Plasma Glucose
fasting plasma glucose after study agent compared to baseline (NCT01419535)
Timeframe: Nine days
Intervention | mg/dL (Mean) |
---|
Post-mifepristone | 100.4 |
Post-placebo | 107.8 |
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Change in Fasting Insulin Levels
Fasting insulin after study agent administration compared to baseline (NCT01419535)
Timeframe: 9 days
Intervention | pmol/L (Mean) |
---|
Post-mifepristone | 95.6 |
Post-placebo | 142.8 |
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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
Intervention | ln(mmol /uU/mL*min)*10^8 (Mean) |
---|
Post-mifepristone | 61.7 |
Post-placebo | 42.8 |
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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
Intervention | mmol/l·μU/l (Mean) |
---|
Post-mifepristone | 49.9 |
Post-placebo | 65.5 |
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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
Intervention | Participants (Count of Participants) |
---|
Mifepristone + Misoprostol | 26 |
Osmotic Dilators | 11 |
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Cervical Dilation Achieved
Cervical dilation at start of procedure (NCT01436279)
Timeframe: At time of abortion
Intervention | mm (Mean) |
---|
Mifepristone + Misoprostol | 42 |
Osmotic Dilators | 56 |
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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.
Intervention | minutes (Median) |
---|
Mifepristone + Misoprostol | 9 |
Osmotic Dilators | 8.5 |
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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
Intervention | Participants (Count of Participants) |
---|
Mifepristone + Misoprostol | 5 |
Osmotic Dilators | 3 |
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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.
Intervention | mcg (Mean) |
---|
Mifepristone + Misoprostol | 3.1 |
Osmotic Dilators | 2.9 |
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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.
Intervention | mg (Mean) |
---|
Mifepristone + Misoprostol | 104 |
Osmotic Dilators | 105 |
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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.
Intervention | participants (Number) |
---|
| None | Mild | Moderate | Severe |
---|
Mifepristone + Misoprostol | 18 | 7 | 5 | 0 |
,Osmotic Dilators | 7 | 6 | 3 | 4 |
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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.
Intervention | minutes (Mean) |
---|
Mifepristone + Misoprostol | 14 |
Osmotic Dilators | 13.5 |
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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
Intervention | score on a scale (Mean) |
---|
| Baseline | Change from Baseline at Day 14 |
---|
Mifepristone Plus d-Cycloserine (DCS) | 52.4 | -8.9 |
,Placebo Plus Placebo | 55.3 | -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)
Intervention | percent probability (Mean) |
---|
Placebo Plus Placebo | 44 |
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
Intervention | alcoholic drinks per week (Mean) |
---|
Korlym (Mifepristone) | 27.661 |
Sugar Pill | 38.175 |
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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
Intervention | units on a scale (Mean) |
---|
Korlym (Mifepristone) | 36.5 |
Sugar Pill | 42.9 |
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Total Procedure Time
(NCT01615731)
Timeframe: Measured at clinic visits and on OR day, over a 3 day period
Intervention | hours (Mean) |
---|
Two Sets of Dilators | 165 |
Mifepristone Plus One Set of Dilators | 86 |
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Adverse Events
uterine perforation, uterine injury, etc. (NCT01615731)
Timeframe: Intraoperatively and 2 weeks post operatively
Intervention | participants (Number) |
---|
| Pre-Procedure Delivery | Cervical Injury | RUpture of Membranes with Subsequent Fever |
---|
Mifepristone Plus One Set of Dilators | 1 | 1 | 0 |
,Two Sets of Dilators | 2 | 0 | 1 |
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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
Intervention | participants (Number) |
---|
| Pre-op Cervical Dilation 2 cm | Pre-op Cervical Dilation 3 cm | Pre-Op Cervical Dilation 4 cm | Pre-Op Cervical Dilation 5 cm |
---|
Mifepristone Plus One Set of Dilators | 3 | 14 | 5 | 1 |
,Two Sets of Dilators | 2 | 9 | 8 | 2 |
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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)
Intervention | units on a scale (Median) |
---|
| Subject Pain Pre-Op | Subject Pain Post-Op |
---|
Mifepristone Plus One Set of Dilators | 63 | 16 |
,Two Sets of Dilators | 13 | 3 |
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Procedure Time
Measured as time from speculum insertion to removal (NCT01615731)
Timeframe: Intraoperative Time
Intervention | minutes (Mean) |
---|
Two Sets of Dilators | 10.9 |
Mifepristone Plus One Set of Dilators | 11.8 |
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Adverse Events (EBL)
One adverse event: Estimated Blood Loss (NCT01615731)
Timeframe: Intraoperatively
Intervention | mL (Mean) |
---|
Two Sets of Dilators | 57 |
Mifepristone Plus One Set of Dilators | 63 |
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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
Intervention | units on a scale (Median) |
---|
Two Sets of Dilators | 29 |
Mifepristone Plus One Set of Dilators | 30 |
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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
Intervention | units on a scale (Median) |
---|
Two Sets of Dilators | 72 |
Mifepristone Plus One Set of Dilators | 79 |
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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
Intervention | microSiemens (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
Intervention | French units (Mean) |
---|
Mifepristone | 30.8 |
Misoprostol | 31.1 |
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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
Intervention | units on a scale (Least Squares Mean) |
---|
| Change Score from Baseline to 4-week | Change 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
Intervention | units on a scale (Least Squares Mean) |
---|
| Change Score from Baseline to 4-week | Change 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
Intervention | units on a scale (Least Squares Mean) |
---|
| Change Score from Baseline to 4-week | Change 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
Intervention | units on a scale (Least Squares Mean) |
---|
| Change Score from Baseline to 4-week | Change 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
Intervention | units on a scale (Least Squares Mean) |
---|
| Change Score from Baseline to 4-week | Change 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
Intervention | pg/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
Intervention | pg/ml (Median) |
---|
Mifepristone (600 mg/Day) | -0.8 |
Sugar Pill | 1.5 |
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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
Intervention | ug/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
Intervention | ug/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
Intervention | units on a scale (Least Squares Mean) |
---|
| Change Score from Baseline to 4-week | Change 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
Intervention | units on a scale (Least Squares Mean) |
---|
| Change Score from Baseline to 4-week | Change 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
Intervention | units on a scale (Least Squares Mean) |
---|
| Change Score from Baseline to 4-week | Change 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
Intervention | participants (Number) |
---|
Osmotic Dilators + Placebo (Vit c) + Placebo (Vit B12) | 10 |
Osmotic Dilators + Placebo (Vit c) + Misoprostol | 2 |
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
Intervention | participants (Number) |
---|
Osmotic Dilators + Placebo (Vit c) + Placebo (Vit B12) | 12 |
Osmotic Dilators + Placebo (Vit c) + Misoprostol | 39 |
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
Intervention | participants (Number) |
---|
Osmotic Dilators + Placebo (Vit c) + Placebo (Vit B12) | 98 |
Osmotic Dilators + Placebo (Vit c) + Misoprostol | 98 |
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
Intervention | centimeters (Mean) |
---|
Osmotic Dilators + Placebo (Vit c) + Placebo (Vit B12) | 2.2 |
Osmotic Dilators + Placebo (Vit c) + Misoprostol | 2.5 |
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
Intervention | participants (Number) |
---|
Osmotic Dilators + Placebo (Vit c) + Placebo (Vit B12) | 72 |
Osmotic Dilators + Placebo (Vit c) + Misoprostol | 80 |
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
Intervention | minutes (Mean) |
---|
Osmotic Dilators + Placebo (Vit c) + Placebo (Vit B12) | 6.27 |
Osmotic Dilators + Placebo (Vit c) + Misoprostol | 6.28 |
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
Intervention | participants (Number) |
---|
Osmotic Dilators + Placebo (Vit c) + Placebo (Vit B12) | 26 |
Osmotic Dilators + Placebo (Vit c) + Misoprostol | 9 |
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
Intervention | participants (Number) |
---|
Osmotic Dilators + Placebo (Vit c) + Placebo (Vit B12) | 6 |
Osmotic Dilators + Placebo (Vit c) + Misoprostol | 4 |
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
Intervention | participants (Number) |
---|
Osmotic Dilators + Placebo (Vit c) + Placebo (Vit B12) | 71 |
Osmotic Dilators + Placebo (Vit c) + Misoprostol | 78 |
Osmotic Dilators + Mifepristone + Placebo (Vit B12) | 85 |
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Adverse Events
Uterine perforation (NCT01862991)
Timeframe: Intraoperatively and 2 weeks post operatively
Intervention | Participants (Count of Participants) |
---|
Dilapan-Placebo | 0 |
Dilapan-Mifepristone | 1 |
Mifepristone | 2 |
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Procedure Time
Measured as time from speculum insertion to removal (NCT01862991)
Timeframe: Intraoperative Time, Collected immediately within procedure
Intervention | minutes (Median) |
---|
Dilapan-Placebo | 13 |
Dilapan-Mifepristone | 12 |
Mifepristone | 18.5 |
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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
Intervention | pg/mL (Geometric Mean) |
---|
Microgynon Alone | 3390 |
Baricitinib + Microgynon | 3340 |
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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
Intervention | pg*hr/mL (Geometric Mean) |
---|
Microgynon Alone | 48200 |
Baricitinib + Microgynon | 42400 |
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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
Intervention | picograms*hour/milliliter (pg*hr/mL) (Geometric Mean) |
---|
Microgynon Alone | 694 |
Baricitinib + Microgynon | 697 |
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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
Intervention | picograms/milliliter (pg/mL) (Geometric Mean) |
---|
Microgynon Alone | 63.8 |
Baricitinib + Microgynon | 59.7 |
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Waist Circumference
Change in metabolic syndrome as assessed by waist circumference (NCT01990560)
Timeframe: Baseline and 6 months
Intervention | cm (Mean) |
---|
| Baseline | 6 months |
---|
Mifepristone | 103.25 | 99.3125 |
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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
Intervention | units on a scale (Mean) |
---|
| Baseline | 6 months |
---|
Mifepristone | 25.4286 | 28.8571 |
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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
Intervention | units on a scale (Mean) |
---|
| Baseline | 6 months |
---|
Mifepristone | 16.1429 | 11.7143 |
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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
Intervention | units on a scale (Mean) |
---|
| Baseline | 6 months |
---|
Mifepristone | 16.2857 | 11.1667 |
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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
Intervention | HOMA-IR score (Mean) |
---|
| Baseline | 6 months |
---|
Mifepristone | 2.418 | 1.465 |
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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
Intervention | mg/dL (Mean) |
---|
| Total Cholesterol Baseline | Total Cholesterol 6 months | LDL baseline | LDL 6 months | HDL Baseline | HDL 6 months | Trigs Baseline | Trigs 6 months |
---|
Mifepristone | 178.63 | 171.43 | 97.88 | 104.37 | 59.13 | 46.86 | 107.88 | 100.29 |
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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
Intervention | units on a scale (Mean) |
---|
| Baseline | 6 months |
---|
Mifepristone | 37.2857 | 38.7857 |
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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
Intervention | units on a scale (Mean) |
---|
| Energy Level (EL) Baseline | EL 6 months | Pain (P) Baseline | P 6 months | Emotional Reaction (ER) Baseline | ER 6 months | Sleep (S) Baseline | S 6 months | Social Isolation (SI) Baseline | SI 6 months | Physical Abilities (PA) Baseline | PA 6 months |
---|
Mifepristone | 32.60 | 45.40 | 24.88 | 32.08 | 27.03 | 35.09 | 24.87 | 31.15 | 20.09 | 31.15 | 23.06 | 27.49 |
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Body Mass Index (BMI)
Change in metabolic syndrome as assessed by BMI (NCT01990560)
Timeframe: Baseline and 6 months
Intervention | kg/m2 (Mean) |
---|
| Baseline | 6 months |
---|
Mifepristone | 35.1538 | 34.5463 |
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Weight
Change in metabolic syndrome as assessed by weight (NCT01990560)
Timeframe: Baseline and 6 months
Intervention | kg (Mean) |
---|
| Baseline | 6 months |
---|
Mifepristone | 99.57 | 97.75 |
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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
Intervention | percentage of red blood cells (Mean) |
---|
| Baseline | 3 months | 6 months |
---|
Mifepristone | 6.2 | 6.1375 | 6.125 |
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Cortisol
Change in log(Cortisol) from week 12 to week 16 (NCT02012296)
Timeframe: 12 to 16 weeks
Intervention | log(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
Intervention | Months (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
Intervention | log(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
Intervention | ng/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
Intervention | Months (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)
Intervention | Participants (Count of Participants) |
---|
Treatment (Enzalutamide) | 17 |
Treatment (Enzalutamide, Mifepristone) | 8 |
Not Randomized | 5 |
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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)
Intervention | Participants (Count of Participants) |
---|
Treatment (Enzalutamide) | 16 |
Treatment (Enzalutamide, Mifepristone) | 8 |
Not Randomized | 5 |
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Uterine Asperation
Surgical removal of the miscarriage. (NCT02012491)
Timeframe: 30 Days
Intervention | Participants (Count of Participants) |
---|
Misoprostol | 35 |
Misoprostol Plus Mifepristone | 13 |
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Frequency of Serious Adverse Events Between Study Arms.
(NCT02012491)
Timeframe: 30 days
Intervention | Participants (Count of Participants) |
---|
Misoprostol | 3 |
Misoprostol Plus Mifepristone | 5 |
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Gestational Sac Expulsion by the 30-day Telephone Call
(NCT02012491)
Timeframe: 30 Days
Intervention | Participants (Count of Participants) |
---|
Misoprostol | 113 |
Misoprostol Plus Mifepristone | 135 |
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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)
Intervention | Participants (Count of Participants) |
---|
Misoprostol | 111 |
Misoprostol Plus Mifepristone | 132 |
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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
Intervention | Participants (Count of Participants) |
---|
Misoprostol | 100 |
Misoprostol Plus Mifepristone | 124 |
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Adverse Event Reported by Participants
(NCT02012491)
Timeframe: 30 Days
Intervention | adverse events (Mean) |
---|
Misoprostol | 5.6 |
Misoprostol Plus Mifepristone | 6.1 |
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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
Intervention | Standard drinks per day (Mean) |
---|
Placebo | 1.25 |
600 mg/d of Mifepristone | 1.38 |
1200 mg/d of Mifepristone | 1.10 |
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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
Intervention | score on a scale (Mean) |
---|
Experimental: Mifepristone 1200 mg Daily | 29.02 |
Placebo Daily, 1-week | 33.66 |
Experimental: Mifepristone 600 mg Day | 28.33 |
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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)
Intervention | Participants (Count of Participants) |
---|
Mifepristone | 0 |
Placebo | 3 |
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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
Intervention | score on a scale (Mean) |
---|
Mifepristone | 42.92 |
Placebo | 50.13 |
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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
Intervention | drinks (Mean) |
---|
Mifepristone | 0.8 |
Placebo | 0.5 |
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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
Intervention | mm (Mean) |
---|
Mifepristone | 11.7 |
Placebo | 10.9 |
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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
Intervention | units on a scale (Mean) |
---|
| Nausea | Severe Cramps |
---|
Mifepristone | 4 | 4 |
,Placebo | 4 | 4 |
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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
Intervention | hours (Mean) |
---|
Mifepristone | 14 |
Placebo Pill | 20 |
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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
Intervention | ng*h/mL (Mean) |
---|
Normal-BMI | 208.5 |
Obese-BMI | 100.8 |
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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
Intervention | ng*h/mL (Mean) |
---|
Normal-BMI | 293.5 |
Obese-BMI | 362.5 |
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Clearance of Serum LNG
(Cl) calculated in women with normal and obese BMI (NCT02689804)
Timeframe: Up to 24 hours
Intervention | L/h (Mean) |
---|
Normal-BMI | 4.8 |
Obese-MRI | 9.8 |
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Clearance of Serum UPA
(Cl) calculated in women with normal and obese BMI (NCT02689804)
Timeframe: Up to 24 hours
Intervention | L/h (Mean) |
---|
Normal-BMI | 4.1 |
Obese-MRI | 3.0 |
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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
Intervention | h (Mean) |
---|
Normal-BMI | 27.0 |
Obese-BMI | 50.4 |
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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
Intervention | h (Mean) |
---|
Normal-BMI | 34.9 |
Obese-MRI | 65.9 |
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Maximum Concentration of Serum LNG
(Cmax) calculated in women with normal and obese BMI (NCT02689804)
Timeframe: Up to 24 hours
Intervention | ng/mL (Mean) |
---|
Normal-BMI | 18.2 |
Obese-MRI | 10.8 |
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Maximum Concentration of Serum UPA
(Cmax) calculated in women with normal and obese BMI (NCT02689804)
Timeframe: Up to 24 hours
Intervention | ng/mL (Mean) |
---|
Normal-BMI | 89.3 |
Obese-MRI | 95.6 |
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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
Intervention | h (Mean) |
---|
Normal-BMI | 2.0 |
Obese-MRI | 3.0 |
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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
Intervention | h (Mean) |
---|
Normal-BMI | 1.6 |
Obese-MRI | 1.5 |
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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
Intervention | picogram/milliliter[pg/mL] (Geometric Mean) |
---|
| Ethinylestradiol | Levonorgestrel |
---|
Microgynon® | 32.6 | 2680 |
,Microgynon® With Nintedanib | 36.9 | 1630 |
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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
Intervention | picogram*hour/mililiter (Geometric Mean) |
---|
| Ethinylestradiol | Levonorgestrel |
---|
Microgynon® | 410 | 41500 |
,Microgynon® With Nintedanib | 348 | 43600 |
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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
Intervention | pg*h/mL (Geometric Mean) |
---|
| Ethinylestradiol | Levonorgestrel |
---|
Microgynon® | 503 | 54500 |
,Microgynon® With Nintedanib | 580 | 57600 |
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LDL-cholesterol
Low-density lipoprotein cholesterol (NCT03052400)
Timeframe: Baseline to 3 months
Intervention | mg/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
Intervention | ng/mL, change from baseline (Mean) |
---|
Mifepristone 600 mg Daily | -0.3 |
Placebo | 0.1 |
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Hemoglobin A1c
Glycemic lowering (NCT03052400)
Timeframe: Baseline to 3 months
Intervention | Percentage 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
Intervention | mm Hg, change from baseline (Mean) |
---|
Mifepristone 600 mg Daily | 3.0 |
Placebo | -3.7 |
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Uric Acid
Serum uric acid level (NCT03052400)
Timeframe: Baseline to 3 months
Intervention | mg/dL, change from baseline (Mean) |
---|
Mifepristone 600 mg Daily | -0.8 |
Placebo | 1.1 |
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Weight
Weight in kg (NCT03052400)
Timeframe: Baseline to 3 months
Intervention | kg, change from baseline (Mean) |
---|
Mifepristone 600 mg Daily | 1.4 |
Placebo | 0.5 |
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Hypoglycemic Events
Symptomatic mild and severe hypoglycemic events (NCT03052400)
Timeframe: Baseline to 3 months
Intervention | number of events (Number) |
---|
Mifepristone 600 mg Daily | 22 |
Placebo | 31 |
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Diastolic BP
Diastolic blood pressure (NCT03052400)
Timeframe: Baseline to 3 months
Intervention | mm 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
Intervention | mg/dL, change from baseline (Mean) |
---|
Mifepristone 600 mg Daily | 18.8 |
Placebo | -0.9 |
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Body Mass Index
Body mass index in kg/m^2 (NCT03052400)
Timeframe: Baseline to 3 months
Intervention | kg/m^2, change from baseline (Mean) |
---|
Mifepristone 600 mg Daily | 0.6 |
Placebo | 0.0 |
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Basal Insulin Dose
Total daily basal insulin dosage (NCT03052400)
Timeframe: Baseline to 3 months
Intervention | Units of insulin per day (Mean) |
---|
Mifepristone 600 mg Daily | -1.3 |
Placebo | 0.7 |
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Adverse Events
Non-hypoglycemia-related adverse events (NCT03052400)
Timeframe: Baseline to 3 months
Intervention | number of events (Number) |
---|
Mifepristone 600 mg Daily | 6 |
Placebo | 2 |
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ACTH
Serum adrenocorticotrophic hormone level (AM) (NCT03052400)
Timeframe: Baseline to 3 months
Intervention | pg/mL, change from baseline (Mean) |
---|
Mifepristone 600 mg Daily | 56.0 |
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
Intervention | Participants (Count of Participants) |
---|
Pharmacists | 36 |
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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
Intervention | Participants (Count of Participants) |
---|
Pharmacists | 4 |
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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
Intervention | Participants (Count of Participants) |
---|
Medication Abortion Patients | 4 |
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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
Intervention | Participants (Count of Participants) |
---|
Medication Abortion Patients | 243 |
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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
Intervention | Participants (Count of Participants) |
---|
Medication Abortion Patients | 230 |
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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.
Intervention | picograms * 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.
Intervention | picograms * 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.
Intervention | picograms * 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.
Intervention | picograms 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.
Intervention | picograms 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.
Intervention | picograms * 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
Intervention | Participants (Count of Participants) |
---|
Mifepristone | 2 |
Placebo | 4 |
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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)
Intervention | Participants (Count of Participants) |
---|
Mifepristone | 2 |
Placebo | 4 |
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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)
Intervention | cm (Median) |
---|
Mifepristone | 1.2 |
Placebo | 3.3 |
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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)
Intervention | Participants (Count of Participants) |
---|
Mifepristone | 17 |
Placebo | 21 |
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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)
Intervention | Participants (Count of Participants) |
---|
Mifepristone | 3 |
Placebo | 3 |
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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)
Intervention | cm (Median) |
---|
Mifepristone | 3.2 |
Placebo | 2.6 |
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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
Intervention | Participants (Count of Participants) |
---|
Mifepristone | 8 |
Placebo | 9 |
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Expulsion During Follow-up Evaluation
Pregnancy expulsion following mifepristone treatment (NCT03774745)
Timeframe: up to 16 days after mifepristone administration
Intervention | Participants (Count of Participants) |
---|
Progesterone | 1 |
Placebo Oral Capsule | 2 |
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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
Intervention | Participants (Count of Participants) |
---|
Progesterone | 4 |
Placebo Oral Capsule | 2 |
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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
Intervention | participants (Number) |
---|
| Progesterone increase from baseline at FU 1 | Progesterone decrease from baseline at FU 1 | hCG increase from baseline at FU 1 | hCG decrease from baseline at FU 1 |
---|
Placebo Oral Capsule | 2 | 2 | 3 | 3 |
,Progesterone | 5 | 0 | 4 | 1 |
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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
Intervention | participants (Number) |
---|
| Nausea | Vomiting | Mastalgia | Tiredness | Mood changes | Reflux | Dizziness | Bleeding | Spotting | Cramping |
---|
Placebo Oral Capsule | 1 | 0 | 0 | 1 | 0 | 0 | 0 | 3 | 0 | 0 |
,Progesterone | 2 | 2 | 0 | 0 | 1 | 0 | 0 | 1 | 0 | 0 |
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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
Intervention | participants (Number) |
---|
| Hemorrhage | Emergency Room Visit | Transfusion | Emergent D&C | Side effects - request D&C |
---|
Placebo Oral Capsule | 2 | 2 | 1 | 2 | 1 |
,Progesterone | 1 | 1 | 0 | 0 | 1 |
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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
Intervention | h*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)
Intervention | nanograms 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)
Intervention | percentage 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)
Intervention | percentage 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
Intervention | picograms 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)
Intervention | hours*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
Intervention | pg/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
Intervention | hours*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
Intervention | Participants (Count of Participants) |
---|
Mifepristone | 3 |
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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)
Intervention | micrograms per deciliter (Mean) |
---|
ITT Greater or Equal to 15 Max Cortisol | 13.9 |
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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)
Intervention | Picogram per milliliter (Mean) |
---|
Greater or Equal to 15 Max Cortisol | 18.5 |
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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
Intervention | Participants (Count of Participants) |
---|
Mifepristone | 3 |
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