Page last updated: 2024-12-06

dienogest

Description Research Excerpts Clinical Trials Roles Classes Pathways Study Profile Bioassays Related Drugs Related Conditions Protein Interactions Research Growth Market Indicators

Cross-References

ID SourceID
PubMed CID68861
CHEMBL ID1201864
CHEBI ID70708
SCHEMBL ID37293
MeSH IDM0081095

Synonyms (80)

Synonym
AC-2166
zk-37659
zk 37659
chebi:70708 ,
m 18575
CHEMBL1201864
AKOS015840152
endometrion
sh-t00660aa
visanne
sts-557
m-18575
mjr-35
dienogest ,
dinagest
dienogest (jan/usan/inn)
65928-58-7
endometrion (tn)
D03799
sts 557
17-alpha-cyanomethyl-17-beta-hydroxy-estra-4,9(10)-dien-3-one
17-hydroxy-3-oxo-19-nor-17alpha-pregna-4,9-diene-21-nitrile
17-alpha-cyanomethyl-17-beta-hydroxyestra-4,9(10)-diene-3-one
17alpha-17-hydroxy-3-oxo-19-norpregna-4,9-diene-21-nitrile
dienogest [inn]
19-norpregna-4,9-diene-21-nitrile, 17-hydroxy-3-oxo-, (17-alpha)-
19-norpregna-4,9-diene-21-nitrile, 17-hydroxy-3-oxo-, (17alpha)-
dienogestum [latin]
2-[(8s,13s,14s,17r)-17-hydroxy-13-methyl-3-oxo-1,2,6,7,8,11,12,14,15,16-decahydrocyclopenta[a]phenanthren-17-yl]acetonitrile
dienogestril
46m3ev8hhe ,
dienogestum
unii-46m3ev8hhe
bay86-5258
dienogest [usan:inn:ban]
bay 86-5258
dienogestrel
natazia
dienogest [ep monograph]
dienogest [who-dd]
19-norpregna-4,9-diene-21-nitrile, 17-hydroxy-3-oxo-, (17.alpha.)-
dienogest [mart.]
dienogest [jan]
dienogest [orange book]
dienogest [mi]
dienogest [usan]
dienogest [vandf]
(17-hydroxy-3-oxoestra-4,9-dien-17beta-yl)acetonitrile
[(17beta)-17-hydroxy-3-oxoestra-4,9-dien-17-yl]acetonitrile
17alpha-cyanomethyl-17beta-hydroxyestra-4,9(10)-dien-3-one
S1251
AKOS015896680
HY-B0084
CS-1782
gtpl7654
SCHEMBL37293
AZFLJNIPTRTECV-FUMNGEBKSA-N
[(17?)-17-hydroxy-3-oxoestra-4,9-dien-17-yl]acetonitrile
2-((8s,13s,14s,17r)-17-hydroxy-13-methyl-3-oxo-2,3,6,7,8,11,12,13,14,15,16,17-dodecahydro-1h-cyclopenta[a]phenanthren-17-yl)acetonitrile
AB01566807_01
DB09123
SR-01000942230-1
sr-01000942230
dienogest, >=98% (hplc)
dienogest for system suitability, europepharmacopoeia (ep) reference standard
dienogest, europepharmacopoeia (ep) reference standard
dienogest; dienogestril; dinagest; sts 557; (17alpha)-17-hydroxy-3-oxo-19-norpregna-4,9-diene-21-nitrile; 17alpha-cyanomethyl-17beta-hydroxyestra-4,9-dien-3-one
BCP22681
DTXSID80891478
mfcd00868356
D5230
Q139160
BRD-K50853363-001-02-3
sts557
CCG-267594
NCGC00346502-04
2-[(1r,3as,3bs,11as)-1-hydroxy-11a-methyl-7-oxo-1h,2h,3h,3ah,3bh,4h,5h,7h,8h,9h,10h,11h,11ah-cyclopenta[a]phenanthren-1-yl]acetonitrile
EN300-6477654
dienogest for system suitability
Z2235801839

Research Excerpts

Overview

Dienogest (DNG) is an oral progestin effective for the treatment of symptomatic endometriosis, such as reduction of endometrial lesion and control of pain intensity. A subset of cases show resistance to DNG treatment.

ExcerptReferenceRelevance
"Dienogest is a type of progestin used for the treatment of endometriosis (EM). "( Dienogest-induced major depressive disorder with suicidal ideation: A case report.
Lee, SM; Park, JK, 2021
)
3.51
"Dienogest is a conservative treatment choice for preventing the recurrence of pyosalpinx for patients with CE."( Dienogest Use for Recurrent Pyosalpinx as a Long-Term Complication of Cloacal Exstrophy: A Case Report.
Bitoh, Y; Iwabuchi, S; Okata, Y; Samejima, Y; Tomioka, Y; Uemura, K; Watanabe, A; Yoshimura, S, 2023
)
3.8
"Dienogest (DNG) is an oral progestin effective for the treatment of symptomatic endometriosis, such as reduction of endometrial lesion and control of pain intensity. "( New treatment strategy for endometriosis using progestin-primed ovarian stimulation with dienogest: A prospective cohort study, comparison of dienogest versus dydrogesterone.
Iwami, N; Kamiya, H; Kawamata, M; Mizuuchi, M; Moriwaka, O; Ozawa, N; Watanabe, E; Yamamoto, T, 2021
)
2.29
"Dienogest (DNG), is an effective and widely used progestin used in the treatment of endometriosis, yet clinically, a subset of cases show resistance to DNG treatment. "( Identification of biomarkers for drug-resistant endometriosis using clinical proteomics.
Fukutomi, T; Kobayashi, Y; Mita, S; Suzuki, A; Watanabe, M, 2021
)
2.06
"Dienogest is a progestin with demonstrated efficacy in the treatment of endometriosis in European women. "( Dienogest for Treatment of Endometriosis in Chinese Women: A Placebo-Controlled, Randomized, Double-Blind Phase 3 Study.
Dong, L; Gude, K; Lang, J; Li, H; Ren, X; von Ludwig, C; Yu, Q; Zhang, S, 2018
)
3.37
"Dienogest (DNG) is a progestin with highly selective progesterone activity and minimal androgenic activity and is helpful in reducing endometriosis-related pain. "( Efficacy and Safety of Long-Term Use of Dienogest in Women With Ovarian Endometrioma.
Cho, S; Kim, SH; Lee, DY; Lee, SR; Seo, SK; Song, JY; Yi, KW, 2018
)
2.19
"Dienogest is a fourth-generation progestin that is used for the treatment of endometriosis. "( Treatment of premenstrual mood changes in a patient with schizophrenia using dienogest: A case report.
Kamada, Y; Kotani, S; Masuyama, H; Sakamoto, A, 2018
)
2.15
"Dienogest is a novel progestin that is highly selective for progesterone receptors and inhibits endometriosis. "( Dienogest reduces proliferation, aromatase expression and angiogenesis, and increases apoptosis in human endometriosis.
Fujii, T; Harada, M; Hirata, T; Hirota, Y; Izumi, G; Koga, K; Miyashita, M; Nagai, M; Osuga, Y; Takamura, M, 2014
)
3.29
"Dienogest (DNG) is an oral progestin, derivative of 19-nortestosterone, that has recently been introduced for the treatment of endometriosis."( Dienogest in the treatment of endometriosis.
Bizzarri, N; Candiani, M; Ferrero, S; Ghirardi, V; Leone Roberti Maggiore, U; Remorgida, V; Salvatore, S; Scala, C; Tafi, E; Venturini, PL, 2014
)
3.29
"Dienogest (DNG) is a selective progesterone receptor (PR) agonist and oral administration of DNG is used for the treatment of endometriosis. "( Dienogest, a synthetic progestin, down-regulates expression of CYP19A1 and inflammatory and neuroangiogenesis factors through progesterone receptor isoforms A and B in endometriotic cells.
Bono, Y; Ichioka, M; Imada, K; Kiyono, T; Kyo, S; Mita, S; Shimizu, Y, 2015
)
3.3
"Dienogest is a novel progestin with potent oral progestational activity that inhibits the clinical symptoms of endometriosis. "( Immunohistochemical Analysis of the Effect of Dienogest on Ovarian Endometriotic Cysts.
Hachisuga, T; Hisaoka, M; Kagami, S; Kawagoe, T; Kurita, T; Nguyen, TT; Ueda, T; Urabe, R,
)
1.83
"Dienogest is an effective medication to control symptoms of pain related to DIE, even without reducing the volume of DIE nodules."( Dienogest and deep infiltrating endometriosis: The remission of symptoms is not related to endometriosis nodule remission.
Benetti-Pinto, CL; Cursino, K; Leonardo-Pinto, JP; Yela, DA, 2017
)
3.34
"Dienogest is a selective progestin that has been shown to arrest ovarian follicular development in women, without affecting gonadotropin secretion. "( Dienogest, a selective progestin, reduces plasma estradiol level through induction of apoptosis of granulosa cells in the ovarian dominant follicle without follicle-stimulating hormone suppression in monkeys.
Imada, K; Mizuguchi, K; Nagaoka, T; Sasagawa, S; Shimizu, Y; Tokado, H, 2008
)
3.23
"Dienogest is a specific progesterone receptor agonist with potent oral endometrial activity and is used in the treatment of endometriosis. "( Dienogest, a synthetic progestin, inhibits the proliferation of immortalized human endometrial epithelial cells with suppression of cyclin D1 gene expression.
Inoue, M; Kiyono, T; Kyo, S; Mita, S; Mizuguchi, K; Shimizu, Y; Takeuchi, T, 2009
)
3.24
"Dienogest is a selective progestin that has been investigated in a clinical trial programme for the treatment of endometriosis. "( Dienogest is as effective as leuprolide acetate in treating the painful symptoms of endometriosis: a 24-week, randomized, multicentre, open-label trial.
Faustmann, T; Gerlinger, C; Marr, J; Seitz, C; Strowitzki, T, 2010
)
3.25
"Dienogest is a novel 19-nortestosterone-derived progestin with a unique pharmacokinetic and pharmacological profile, including antiandrogenic properties."( Ethinylestradiol/dienogest in oral contraception.
Pérez-Campos, EF, 2010
)
1.42
"Dienogest (DNG) is an orally active progestin used for the treatment of endometriosis."( Effect of dienogest administration on angiogenesis and hemodynamics in a rat endometrial autograft model.
Hiratsuka, M; Ito, M; Katayama, H; Katayama, T; Kiyomura, M; Shimizu, Y; Sugita, A; Uematsu, K, 2010
)
1.48
"Dienogest (Visanne®) is a synthetic oral progestogen with unique pharmacological properties that is indicated at a dosage of 2 mg/day for the treatment of endometriosis. "( Dienogest: a review of its use in the treatment of endometriosis.
McCormack, PL, 2010
)
3.25
"Dienogest (DNG) is a 19-nortestosterone derivative (a C-19 progestogen) with a cyanomethyl instead of an ethinyl group at the C-17 position, which may make the compound elicit fewer hepatic effects than other C-19 nortestosterone derivatives. "( The pharmacology of dienogest.
Mueck, AO; Ruan, X; Seeger, H, 2012
)
2.15
"Dienogest is a synthetic progestational steroid that is used for contraception. "( Dienogest, a novel synthetic steroid, overcomes hormone-dependent cancer in a different manner than progestins.
Aoki, D; Katsuki, Y; Nozawa, S; Shibutani, Y, 1997
)
3.18
"Dienogest is an orally active synthetic steroid that is used for contraception and is currently being studied for the possible treatment of endometriosis. "( Animal studies on the endocrinological profile of dienogest, a novel synthetic steroid.
Aoki, D; Katsuki, Y; Nozawa, S; Sasagawa, S; Shibutani, Y; Takano, Y; Udagawa, Y, 1997
)
1.99
"Dienogest appears to be a potent agent with mechanisms of action different from those of danazol and GnRH agonists currently available for the treatment of endometriosis."( Effects of dienogest, a synthetic steroid, on experimental endometriosis in rats.
Aoki, D; Futamura, Y; Katsuki, Y; Nozawa, S; Shibutani, Y; Takano, Y; Udagawa, Y, 1998
)
2.13
"Dienogest is a synthetic steroid that has been used as a progestogen in contraceptive pills and is currently being studied for its possible clinical use in the treatment of endometriosis. "( The inhibitory effect of dienogest, a synthetic steroid, on the growth of human endometrial stromal cells in vitro.
Kanzaki, H; Nakajima, T; Okada, H; Yasuda, K; Yoshimura, T, 2001
)
2.06
"Dienogest is a new gestagen, used for temporary contraception."( [Effect of a new gestagen--dienogest--and its combination with ethinyl estradiol on the activity of biotransformation reactions].
Balogh, A; Hoffmann, A; Klinger, G; Liewald, S; Liewald, T; Schröder, S; Splinter, FC, 1990
)
1.3

Effects

Dienogest (DNG) has the essential properties of an effective progestogen for use in a new contraceptive pill using estradiol valerate as estrogenic component. It inhibits ovulation and protects against endometrial proliferation. At a dosage of 2 mg/day only moderately suppressesEstradiol levels. DienogEST plus TU has the potential for development as a monthly injectable showing reversible hormonal male contraception with good efficacy.

ExcerptReferenceRelevance
"Dienogest has a 17 alpha-cyanomethyl group instead of the 17 alpha-ethinyl group typical of the common 19-nortestosterone derivatives."( The role of antiandrogens in hormone replacement therapy.
Schneider, HP, 2000
)
1.03
"Dienogest (DNG) has anti-inflammatory and anti-angiogenic activity and so may theoretically improve IVF outcomes in women with endometriosis."( Pretreatment with dienogest in women with endometriosis undergoing IVF after a previous failed cycle.
Barra, F; Ferrero, S; Garzon, S; Ghezzi, F; Laganà, AS; Scala, C, 2020
)
1.61
"Dienogest has proven to be as effective as GnRH agonists in preventing recurrence of DIE and associated pelvic pain after surgery. "( Dienogest vs GnRH agonists as postoperative therapy after laparoscopic eradication of deep infiltrating endometriosis with bowel and parametrial surgery: a randomized controlled trial.
Ceccarello, M; Ceccaroni, M; Clarizia, R; Donati, A; Ferrero, S; Liverani, S; Manzone, M; Roviglione, G, 2021
)
3.51
"Dienogest has recently been marketed as a medical treatment for endometriosis. "( Efficacy of dienogest in improving pain in women with endometriosis: a 12-month single-center experience.
Alio, L; Alio, W; Giambanco, L; Incandela, D; Maiorana, A; Mercurio, A; Parazzini, F, 2017
)
2.28
"Dienogest has long been used to suppress endometrium development and reduce adenomyosis-related dysmenorrhea."( Combination of microwave endometrial ablation and postoperative dienogest administration is effective for treating symptomatic adenomyosis.
Mizunuma, H; Ota, K; Shiraishi, S; Takahashi, T, 2018
)
1.44
"Dienogest has been shown to substantially improve endometriosis-associated symptoms such as debilitating chronic pelvic pain, and in turn, health-related quality of life (HRQoL). "( Effectiveness of dienogest in improving quality of life in Asian women with endometriosis (ENVISIOeN): interim results from a prospective cohort study under real-life clinical practice.
Ahlers, C; Banal-Silao, MJ; Hestiantoro, A; Kim, MR; Lee, BS; Ruey, S; Seong, SJ; Shin, SY; Techatraisak, K; Thaufik, S, 2019
)
2.3
"Dienogest has been developed as a fourth-generation progestin for treating endometriosis."( Development of a mouse model for testing therapeutic agents: the anticancer effect of dienogest on endometrial neoplasms.
Honda, R; Katabuchi, H; Ohba, T; Saito, F; Suzuki, A; Tashiro, H; Yamaguchi, M, 2016
)
1.38
"Dienogest plus TU has the potential for development as a monthly injectable showing reversible hormonal male contraception with good efficacy."( Trials for development of once-a-month injectable, hormonal male contraceptive using dienogest plus testosterone undecanoate: dose standardization, efficacy and reversibility studies in rats.
Chaki, SP; Kaushik, MC; Misro, MM; Nandan, D, 2009
)
2.02
"Dienogest (DNG) has the essential properties of an effective progestogen for use in a new contraceptive pill using estradiol valerate as estrogenic component -- it inhibits ovulation and protects against endometrial proliferation. "( Why use of dienogest for the first contraceptive pill with estradiol?
Bühling, KJ; Mueck, AO; Seeger, H, 2010
)
2.19
"Dienogest has moderate affinity for progesterone receptors (10% that of progesterone) and at a dosage of 2 mg/day only moderately suppresses estradiol levels."( Dienogest: a review of its use in the treatment of endometriosis.
McCormack, PL, 2010
)
2.52
"Dienogest has been used in other oral contraceptive pills for over 10 years."( Estradiol valerate and dienogest: a novel four-phasic oral contraceptive pill effective for pregnancy prevention and treatment of heavy menstrual bleeding.
Jensen, JT; Micks, E, 2011
)
1.4
"Dienogest has been developed as a fourth-generation progestin for hormone therapy for endometriosis that can be used with high safety for long periods of time."( Progestin therapy for endometrial cancer: the potential of fourth-generation progestin (review).
Aoki, D; Banno, K; Kisu, I; Kobayashi, Y; Masuda, K; Nomura, H; Susumu, N; Tsuji, K; Ueki, A; Yamagami, W; Yanokura, M, 2012
)
1.1
"Dienogest has the essential properties of an effective progestogen, so that it protects against endometrial proliferation and remarkably does not counteract the effects of estrogens."( Pharmacology of estradiol valerate/dienogest.
Teichmann, A, 2003
)
1.32
"Dienogest alone has no significant effects on the serum SHBG and androgen concentrations."( [Effect of ethinyl estradiol-dienogest combination on serum androgen concentrations].
Carol, W; Gräser, T; Klinger, G; Mellinger, U; Moore, C; Oettel, M; Schindler, AE; Winkler, UH, 1997
)
1.31
"Dienogest has a 17 alpha-cyanomethyl group instead of the 17 alpha-ethinyl group typical of the common 19-nortestosterone derivatives."( The role of antiandrogens in hormone replacement therapy.
Schneider, HP, 2000
)
1.03

Actions

ExcerptReferenceRelevance
"Dienogest activate PR (EC50=3.4 or 10.5 nmol/l) with antagonistic activity on AR (EC50=420.6 or 775.0 nmol/l) but not agonistic nor antagonistic action on GR, MR (3000 nmol/l)."( Dienogest is a selective progesterone receptor agonist in transactivation analysis with potent oral endometrial activity due to its efficient pharmacokinetic profile.
Imada, K; Kami, H; Kato, S; Mita, S; Mizuguchi, K; Sasagawa, S; Shimizu, Y; Takeuchi, T, 2008
)
2.51

Treatment

Treatment with dienogest or COCP was associated with improved self-reported pain after 6 months of treatment. The study found significantly lower scores for pelvic pain and dyspareunia compared with placebo.

ExcerptReferenceRelevance
"Dienogest treatment compared with GnRHa was associated with a lower rate of hot flashes and a trend to lower incidence of vaginal dryness."( The Efficacy of Dienogest in Reducing Disease and Pain Recurrence After Endometriosis Surgery: a Systematic Review and Meta-Analysis.
Bogani, G; Carbone, F; Di Donato, V; Di Tucci, C; Galati, G; Kontopantelis, E; Muzii, L; Palaia, I; Perniola, G; Tomao, F, 2023
)
1.98
"Treatment with dienogest or COCP was associated with improved self-reported pain after 6 months of treatment, as evidenced by significantly lower scores for pelvic pain and dyspareunia compared with placebo (P < 0.05). "( A randomized, double-blind, placebo-controlled pilot study of the comparative effects of dienogest and the combined oral contraceptive pill in women with endometriosis.
Alkatout, I; Allahqoli, L; Ebrahimpour, M; Gitas, G; Hassanlouei, B; Mehdizadeh Kashi, A; Niakan, G, 2022
)
1.3

Toxicity

Both dienogest doses were generally well tolerated, with low rates of treatment discontinuation due to adverse events. We assessed the pelvic pain score and quality-of-life (QOL) score before and after taking dienOGest.

ExcerptReferenceRelevance
"STS 557 was tested for adverse effects in mice by prenatal and postnatal investigations."( Prenatal toxic effects of STS 557. I. Investigations in mice.
Klaus, S, 1983
)
0.27
" Neither clinical, functional nor morphological investigations revealed toxic side effects of the drugs on the liver, the kidneys, the bone marrow, or on blood clotting function."( Toxicity of the progestagen STS 557 compared to levonorgestrel in beagles after oral administration for 6 months.
Güttner, J; Hillesheim, HG; Hoffmann, H; Oettel, M, 1982
)
0.26
"Continuous combined estrogen-progestin therapy with Climodien is effective, safe and well tolerated in postmenopausal women, with a profile and incidence of adverse events consistent with those of existing HRT preparations."( Climodien (estradiol valerate 2 mg plus dienogest 2 mg) is safe and effective in the treatment of postmenopausal complaints.
Gräser, T; Janaud, A; Römer, T; Wiedey, KD, 2001
)
0.58
" The incidences of adverse events were similar in all groups."( Comparison of the efficacy and endometrial safety of two estradiol valerate/dienogest combinations and Kliogest for continuous combined hormone replacement therapy in postmenopausal women.
Gräser, T; Koytchev, R; Müller, A; Oettel, M, 2000
)
0.54
" Overall, the profiles of adverse events recorded in clinical use were similar in the two preparations, whilst the safety profile of E2V/DNG in the large-scale study was similar to that of other HRT preparations and gave no cause for clinical concern."( Clinical efficacy and safety of combined estradiol valerate and dienogest: a new no-bleed treatment.
von Schoultz, B, 2003
)
0.56
" Both dienogest doses were generally well tolerated, with low rates of treatment discontinuation due to adverse events."( A dose-ranging study to determine the efficacy and safety of 1, 2, and 4mg of dienogest daily for endometriosis.
Faustmann, TA; Gerlinger, C; Köhler, G; Mueck, AO; Seitz, C, 2010
)
1.07
" Treatment-related adverse events (considered at least possibly treatment-related) occurred in 19."( Efficacy and safety of a novel oral contraceptive based on oestradiol (oestradiol valerate/dienogest): a Phase III trial.
Bitzer, J; Machlitt, A; Palacios, S; Parke, S; Römer, T; Wildt, L, 2010
)
0.58
" Data were documented on volunteer diaries, and adverse events (AEs) were reported during five visits."( Effect of extended-cycle regimen with an oral contraceptive containing 30 mcg ethinylestradiol and 2 mg dienogest on bleeding patterns, safety, acceptance and contraceptive efficacy.
Kuhl, H; Lange, E; Manthey, T; Mellinger, U; Mittmann, K; Palombo-Kinne, E; Sänger, N; Stahlberg, S; Wiegratz, I, 2011
)
0.58
" During continuation of DNG, the recurrence rate of ovarian endometrioma on ultrasound, adverse events, changes in menstrual pattern, and pain score (visual analogue scale) were analyzed."( Efficacy and Safety of Long-Term Use of Dienogest in Women With Ovarian Endometrioma.
Cho, S; Kim, SH; Lee, DY; Lee, SR; Seo, SK; Song, JY; Yi, KW, 2018
)
0.75
" We assessed the pelvic pain score and quality-of-life (QOL) score before and after taking dienogest as well as the prevalence of short-term (≤12 weeks) and long-term adverse effects (>52 weeks)."( Symptom-alleviating effect and adverse effect of dienogest in Korean women with endometriosis.
Jee, BC; Jeong, SH; Kim, SK; Lee, D, 2018
)
0.96
" Adverse events including bleeding disturbances and depressive symptoms were recorded."( Long-term treatment of endometriosis with dienogest: retrospective analysis of efficacy and safety in clinical practice.
Römer, T, 2018
)
0.75
" Dienogest was well tolerated and adverse effects were clinically managed."( Long-term treatment of endometriosis with dienogest: retrospective analysis of efficacy and safety in clinical practice.
Römer, T, 2018
)
1.66
"This review aims to summarize the clinical outcomes (efficacy and adverse events) of DNG treatment for symptomatic adenomyosis compared with other hormonal treatments, discuss the mechanism underlying adverse events, and identify future challenges."( Efficacy, Adverse Events, and Challenges of Dienogest in the Management of Symptomatic Adenomyosis: A Comparison with Different Hormonal Treatments.
Kobayashi, H, 2023
)
1.17
" Five prospective and three retrospective studies showed that DNG and other hormonal agents had similar efficacy for pain relief; however, the most common adverse event of DNG was abnormal uterine bleeding."( Efficacy, Adverse Events, and Challenges of Dienogest in the Management of Symptomatic Adenomyosis: A Comparison with Different Hormonal Treatments.
Kobayashi, H, 2023
)
1.17
"DNG represents an important therapeutic option to be included in the treatment algorithm for adenomyosis owing to sufficient pain relief, despite high rates of bleeding-related adverse events."( Efficacy, Adverse Events, and Challenges of Dienogest in the Management of Symptomatic Adenomyosis: A Comparison with Different Hormonal Treatments.
Kobayashi, H, 2023
)
1.17

Pharmacokinetics

The stronger oral activity of dienogest could be explained simply by its in vitro potency on PR and its oral pharmacokinetic profile. This pharmacodynamic study investigated the ovulation-inhibiting effects of diensogest monotherapy in healthy women. This study aims to investigate and compare the pharmacokinetics profiles and safety of test formulations to reference formulations of dients.

ExcerptReferenceRelevance
" From these data basic pharmacokinetic parameters were calculated."( Pharmacokinetics of the progestin dienogest (STS 557) in rabbits.
Hillesheim, HG; Hobe, G; Ritter, P; Valentin, U, 1989
)
0.56
" Thus, the stronger oral activity of dienogest could be explained simply by its in vitro potency on PR and its oral pharmacokinetic profile."( Dienogest is a selective progesterone receptor agonist in transactivation analysis with potent oral endometrial activity due to its efficient pharmacokinetic profile.
Imada, K; Kami, H; Kato, S; Mita, S; Mizuguchi, K; Sasagawa, S; Shimizu, Y; Takeuchi, T, 2008
)
2.06
" This pharmacodynamic study investigated the ovulation-inhibiting effects of dienogest monotherapy in healthy women."( Ovulation-inhibiting effects of dienogest in a randomized, dose-controlled pharmacodynamic trial of healthy women.
Duijkers, I; Faustmann, T; Klein, S; Klipping, C; Remmers, A; Schuett, B; Zurth, C, 2012
)
0.89
"14, and the terminal half-life remained unchanged when single dosing and multiple dosing were compared."( Pharmacokinetic study of single and multiple oral administrations of 2 mg dienogest in healthy Korean women.
Jang, IJ; Lee, S; Lim, KS; Park, JS; Shin, D; Shin, SG; Yu, KS, 2013
)
0.62
"The present study described the single- and multiple-dose pharmacokinetic profiles of dienogest in Korean women and showed linear pharmacokinetics of dienogest at steady state."( Pharmacokinetic study of single and multiple oral administrations of 2 mg dienogest in healthy Korean women.
Jang, IJ; Lee, S; Lim, KS; Park, JS; Shin, D; Shin, SG; Yu, KS, 2013
)
0.84
" This study aims to investigate and compare the pharmacokinetic profiles and safety of test formulations to reference formulations of dienogest in healthy Chinese female volunteers under fasting or fed conditions."( Pharmacokinetics, Bioequivalence, and Safety Evaluation of Dienogest in Healthy Subjects Under Fasting and Fed Conditions.
Chang, D; Hao, X; Ni, J; Wang, Y; Yang, Z; Zhang, W; Zhao, D; Zhao, X; Zhou, Y, 2023
)
1.36

Compound-Compound Interactions

ExcerptReferenceRelevance
" We investigated the effect of this new sexual hormone alone and in combination with ethynylestradiol on the elimination of both testdrugs."( [Effect of a new gestagen--dienogest--and its combination with ethinyl estradiol on the activity of biotransformation reactions].
Balogh, A; Hoffmann, A; Klinger, G; Liewald, S; Liewald, T; Schröder, S; Splinter, FC, 1990
)
0.58

Bioavailability

Dienogest (DNG), a progestin of 19-nortestosterone derivative, has good oral bioavailability and is highly selective for progesterone receptors.

ExcerptReferenceRelevance
" Following oral administration the high bioavailability of Dienogest which was already found in other animal species and in man could also be confirmed with rabbits."( Pharmacokinetics of the progestin dienogest (STS 557) in rabbits.
Hillesheim, HG; Hobe, G; Ritter, P; Valentin, U, 1989
)
0.8
" Bioavailability of orally administered STS 557 was found to be 80--90% in man and beagle dog, 70--80% in baboon and rat."( Studies on pharmacokinetics of STS 557 in animal species and man.
Carol, W; Chemnitius, KH; Claussen, C; Erdmann, A; Goncharov, NP; Hillesheim, HG; Hobe, G; Klinger, G; Komor, A; Ritter, P; Schumann, W; Wagner, H; Wehrberger, K; Wesemann, R, 1983
)
0.27
"Dienogest (DNG), a progestin of 19-nortestosterone derivative, has good oral bioavailability and is highly selective for progesterone receptors."( Dienogest: a new therapeutic agent for the treatment of endometriosis.
Harada, T; Taniguchi, F, 2010
)
3.25
" It has high oral bioavailability and a half-life suitable for once-daily administration."( Dienogest: a review of its use in the treatment of endometriosis.
McCormack, PL, 2010
)
1.8

Dosage Studied

The objective of this multicentre, randomised, double-blind study was to compare a combined oral contraceptive (COC) containing oestradiol valerate/dienogest (E2V/DNG) administered in a dynamic dosing regimen with a monophasic COC containing ethinyloestradio/levonorgestrel (EE/LNG)

ExcerptRelevanceReference
" This finding demonstrates that postcoital STS 557 in the chosen dosage does not suppress ovulation."( STS 557 as an interceptive in baboons.
Goncharov, NP; Komor, A; Oettel, M; Schubert, K, 1983
)
0.27
" Furthermore, the histological changes observed in the seminiferous tubules in testes of STS 557--treated mice were not different in different dosage groups."( Effect of 17 alpha-cyanomethyl-17 beta-hydroxy-estra-4, 9-dien-3-one on reproductive organs of the male laboratory mouse.
Chakravarty, S; Singh, SK, 1998
)
0.3
" In an additional experiment, ovaries were excised 24 h after dosing for histological examinations."( Dienogest, a selective progestin, reduces plasma estradiol level through induction of apoptosis of granulosa cells in the ovarian dominant follicle without follicle-stimulating hormone suppression in monkeys.
Imada, K; Mizuguchi, K; Nagaoka, T; Sasagawa, S; Shimizu, Y; Tokado, H, 2008
)
1.79
"To evaluate the pharmacokinetics of a combined oral contraceptive (OC) containing oestradiol valerate/dienogest (E2V/DNG) administered according to a four-phasic dosing regimen with an oestrogen step-down and a progestin step-up over 26 days of active treatment."( Pharmacokinetics of an oral contraceptive containing oestradiol valerate and dienogest.
Blode, H; Lu, M; Morrison, D; Uddin, A; Zeiler, B; Zeun, S, 2009
)
0.8
" However, it has a complex dosage regimen, and has its own missed-pill guidance which differs substantially from that for other pills."( What role for Qlaira in contraception?
, 2010
)
0.36
"Dienogest (Visanne®) is a synthetic oral progestogen with unique pharmacological properties that is indicated at a dosage of 2 mg/day for the treatment of endometriosis."( Dienogest: a review of its use in the treatment of endometriosis.
McCormack, PL, 2010
)
3.25
" Furthermore, the dynamic dosing regimen requires relatively complex instructions for users who miss pills."( Estradiol valerate and dienogest: a novel four-phasic oral contraceptive pill effective for pregnancy prevention and treatment of heavy menstrual bleeding.
Jensen, JT; Micks, E, 2011
)
0.68
" Klaira® (E2V/DNG) combines the use of natural estradiol in a dynamic dosing regimen with a progestin very similar to natural progesterone but with very potent antiproliferative action at the endometrial level."( [Association of E2v/DNG as contraceptive choice for a better quality of life of women].
Nappi, RE, 2012
)
0.38
"14, and the terminal half-life remained unchanged when single dosing and multiple dosing were compared."( Pharmacokinetic study of single and multiple oral administrations of 2 mg dienogest in healthy Korean women.
Jang, IJ; Lee, S; Lim, KS; Park, JS; Shin, D; Shin, SG; Yu, KS, 2013
)
0.62
" Recently, the oral combination contraceptive (COC) containing estradiol valerate (E2V) in combination with dienogest (DNG) was developed in a new estrogen step-down, progesterone step-up dosing strategy (Qlaira, Bayer Healthcare Pharmaceuticals)."( Effect of a new oral contraceptive with estradiol valerate/dienogest on carbohydrate metabolism.
De Leo, V; Di Sabatino, A; Fruzzetti, F; Morgante, G; Musacchio, MC; Scolaro, V, 2013
)
0.85
"The objective of this multicentre, randomised, double-blind study was to compare a combined oral contraceptive (COC) containing oestradiol valerate/dienogest (E2V/DNG) administered in a dynamic dosing regimen with a monophasic COC containing ethinyloestradiol/levonorgestrel (EE/LNG), with regard to their ability to reduce the frequency and intensity of headache and pelvic pain in women with hormone withdrawal-associated symptoms (HWAS)."( Effects of a combined oral contraceptive containing oestradiol valerate/dienogest on hormone withdrawal-associated symptoms: results from the multicentre, randomised, double-blind, active-controlled HARMONY II study.
Macìas, G; Mellinger, U; Merki-Feld, GS; Parke, S; Serrani, M, 2013
)
0.82
" A marketed dosing regimen of estradiol valerate with dienogest (E2V/DNG) served as reference since it contains (like E4) a natural oestrogen."( Bleeding pattern and cycle control with estetrol-containing combined oral contraceptives: results from a phase II, randomised, dose-finding study (FIESTA).
Apter, D; Beekman, L; Coelingh Bennink, HJ; Foidart, JM; Maillard, C; Mawet, M; Zimmerman, Y, 2016
)
0.68
[information is derived through text-mining from research data collected from National Library of Medicine (NLM), extracted Dec-2023]

Roles (3)

RoleDescription
synthetic oral contraceptiveAn oral contraceptive which owes its effectiveness to synthetic preparation.
progesterone receptor agonistA hormone agonist that binds to and activates progesterone receptors.
progestinA synthetic progestogen.
[role information is derived from Chemical Entities of Biological Interest (ChEBI), Hastings J, Owen G, Dekker A, Ennis M, Kale N, Muthukrishnan V, Turner S, Swainston N, Mendes P, Steinbeck C. (2016). ChEBI in 2016: Improved services and an expanding collection of metabolites. Nucleic Acids Res]

Drug Classes (4)

ClassDescription
17beta-hydroxy steroidA 17-hydroxy steroid in which the hydroxy group at position 17 has a beta-configuration.
3-oxo-Delta(4) steroidA 3-oxo steroid conjugated to a C=C double bond at the alpha,beta position.
steroid hormoneAny steroid that acts as hormone.
aliphatic nitrileAny nitrile derived from an aliphatic compound.
[compound class information is derived from Chemical Entities of Biological Interest (ChEBI), Hastings J, Owen G, Dekker A, Ennis M, Kale N, Muthukrishnan V, Turner S, Swainston N, Mendes P, Steinbeck C. (2016). ChEBI in 2016: Improved services and an expanding collection of metabolites. Nucleic Acids Res]

Bioassays (4)

Assay IDTitleYearJournalArticle
AID1347411qHTS to identify inhibitors of the type 1 interferon - major histocompatibility complex class I in skeletal muscle: primary screen against the NCATS Mechanism Interrogation Plate v5.0 (MIPE) Libary2020ACS chemical biology, 07-17, Volume: 15, Issue:7
High-Throughput Screening to Identify Inhibitors of the Type I Interferon-Major Histocompatibility Complex Class I Pathway in Skeletal Muscle.
AID588213Literature-mined compound from Fourches et al multi-species drug-induced liver injury (DILI) dataset, effect in non-rodents2010Chemical research in toxicology, Jan, Volume: 23, Issue:1
Cheminformatics analysis of assertions mined from literature that describe drug-induced liver injury in different species.
AID588211Literature-mined compound from Fourches et al multi-species drug-induced liver injury (DILI) dataset, effect in humans2010Chemical research in toxicology, Jan, Volume: 23, Issue:1
Cheminformatics analysis of assertions mined from literature that describe drug-induced liver injury in different species.
AID588212Literature-mined compound from Fourches et al multi-species drug-induced liver injury (DILI) dataset, effect in rodents2010Chemical research in toxicology, Jan, Volume: 23, Issue:1
Cheminformatics analysis of assertions mined from literature that describe drug-induced liver injury in different species.
[information is prepared from bioassay data collected from National Library of Medicine (NLM), extracted Dec-2023]

Research

Studies (385)

TimeframeStudies, This Drug (%)All Drugs %
pre-199051 (13.25)18.7374
1990's25 (6.49)18.2507
2000's71 (18.44)29.6817
2010's168 (43.64)24.3611
2020's70 (18.18)2.80
[information is prepared from research data collected from National Library of Medicine (NLM), extracted Dec-2023]

Market Indicators

Research Demand Index: 89.44

According to the monthly volume, diversity, and competition of internet searches for this compound, as well the volume and growth of publications, there is estimated to be very strong demand-to-supply ratio for research on this compound.

MetricThis Compound (vs All)
Research Demand Index89.44 (24.57)
Research Supply Index6.22 (2.92)
Research Growth Index4.95 (4.65)
Search Engine Demand Index160.39 (26.88)
Search Engine Supply Index2.00 (0.95)

This Compound (89.44)

All Compounds (24.57)

Study Types

Publication TypeThis drug (%)All Drugs (%)
Trials98 (24.38%)5.53%
Reviews53 (13.18%)6.00%
Case Studies24 (5.97%)4.05%
Observational11 (2.74%)0.25%
Other216 (53.73%)84.16%
[information is prepared from research data collected from National Library of Medicine (NLM), extracted Dec-2023]

Clinical Trials (55)

Trial Overview

TrialPhaseEnrollmentStudy TypeStart DateStatus
A Double-blind, Randomized, Dose-controlled Study to Evaluate Pharmacodynamic Properties of Four Oral Doses of Dienogest (DNG) in 100 Healthy Young Female Volunteers Over a Period of Two Cycles up to a Maximum of 72 Days [NCT00754871]Phase 1102 participants (Actual)Interventional2008-09-30Completed
Dienogest Versus a Low-dose Combined Oral Contraceptive for Treatment of Adenomyotic Uteri [NCT03890042]100 participants (Actual)Interventional2019-03-01Completed
A Multi-center, Open Label, Single-arm Study to Investigate the Safety and Efficacy of Daily Oral Administration of 2 mg Dienogest Tablets for the Treatment of Endometriosis in Adolescents Over a Treatment Period of 52 Weeks [NCT01283724]Phase 2111 participants (Actual)Interventional2011-03-31Completed
A Randomised Open-label Multi-centre Comparative Study to Evaluate Cycle Control of 2 Dosages of Estetrol Combined With Either P1 or P2, Compared to a Combined Oral Contraceptive Containing E2V and DNG [NCT01221831]Phase 2396 participants (Actual)Interventional2010-09-30Completed
[NCT02440750]Phase 450 participants (Anticipated)Interventional2016-06-30Not yet recruiting
EffectiveNess of VISanne® in Improving Quality of Life in asIan wOmen With eNdometriosis [NCT02425462]895 participants (Actual)Observational2015-04-28Completed
Dienogest Versus Luteal Phase Fluoxetine in the Management of Premenstrual Syndrome: A Randomized Double Blind Placebo Controlled Trial [NCT02427334]Phase 3210 participants (Anticipated)Interventional2015-04-30Recruiting
A Prospective, Randomized Controlled Trial Comparing the Use of Dienogest and Combined Oral Contraceptive Pills (Microgynon) to Reduce the Risk of Recurrence of Endometriotic Cyst After Conservative Surgery [NCT02385448]Phase 4144 participants (Anticipated)Interventional2015-02-28Recruiting
Role of Dienogest in the Treatment of Patient With Symptomatic Adenomyosis [NCT03654144]Phase 4100 participants (Anticipated)Interventional2018-11-30Not yet recruiting
Effects of Dienogest and Dienogest Plus Estradiol Valerate on Ovarian Reserve and Endometrioma Size [NCT03789123]Phase 4710 participants (Anticipated)Interventional2019-01-01Recruiting
Comparison of the Operation and Medical Treatment of Endometriosis and Adenomyosis [NCT03778359]5,000 participants (Actual)Observational2005-01-01Completed
A Prospective Multicenter Non-interventional Study to Evaluate User Satisfaction With Estradiol Valerate/ Dienogest in Real Clinical Practice to be Conducted in Russia [NCT04901377]255 participants (Actual)Observational2021-06-24Completed
A Multi-center, Double-blind, Double-dummy, Randomized, Controlled, Parallel-group Study to Assess Efficacy and Safety of SH T00658ID Compared to SH D593B in the Treatment of Primary Dysmenorrhea [NCT00909857]Phase 3507 participants (Actual)Interventional2009-04-30Completed
Bioavailability of a Formulation of Dienogest 2.0 mg Coated Tablets With Regards to the Marketed Reference Product [NCT04230083]Phase 130 participants (Actual)Interventional2019-12-07Completed
The Effect of Dienogest vs. Norethindrone Acetate Treatment in Endometriosis [NCT05476172]70 participants (Actual)Interventional2021-04-01Completed
Far Eastern Memorial Hospital [NCT05697471]Phase 3120 participants (Anticipated)Interventional2023-02-25Recruiting
Pretreatment With Dienogest in Women With Endometriosis Undergoing in Vitro-fertilization After a Previous Failed Cycle [NCT04306276]140 participants (Actual)Observational2020-01-01Completed
Bioavailability of a Formulation of Estradiol Valerate and Dienogest 2 mg/2 mg Coated Tablets With Regards to the Marketed Reference Product [NCT05332106]Phase 110 participants (Actual)Interventional2022-03-12Completed
VISANNE OS/Treatment of Endometriosis With Dienogest in the Real World Clinical Practice [NCT04495855]968 participants (Actual)Observational2020-10-28Completed
Goserline Acetate Versus Dienogest in Treatment of Pain Associated With Endometriosis [NCT05013242]Phase 440 participants (Anticipated)Interventional2020-12-25Recruiting
A Multicenter, Non-Comparative Trial on the Contraceptive Efficacy, Safety, and Tolerability of LPRI-424 (Dienogest 2 mg / Ethinyl Estradiol 0.02 mg) During 13 Cycles [NCT03945513]Phase 31,034 participants (Actual)Interventional2019-12-03Completed
Prospective, Randomized, Double-blind, Placebo-controlled Clinical Trial on the Effects of an Estrogen-progestin Combination as add-on to Inpatient Psychotherapy in Adult Female Patients Suffering From Anorexia Nervosa [NCT03172533]Phase 211 participants (Actual)Interventional2016-03-15Terminated(stopped due to Difficulties in recruitment)
[NCT02400801]166 participants (Anticipated)Interventional2013-06-30Active, not recruiting
A Multicenter, Randomized, Double-blind, Active-controlled, Parallel Group, 2-arm Study to Show Superiority of the Oral Contraceptive SH T00658ID Over Ortho Tri-Cyclen Lo on Hormone Withdrawal-associated Symptoms After 6 Cycles of Treatment. [NCT00754065]Phase 3409 participants (Actual)Interventional2008-09-30Completed
Open-label, Randomized, Cross-over Study to Investigate the Bioequivalence of Estradiol Valerate (EV), Dienogest (DNG) and Levomefolate Calcium After Single Oral Administration of a Tablet Formulation Containing 2 mg Estradiol Valerate and 3 mg Dienogest [NCT00941057]Phase 143 participants (Actual)Interventional2009-09-30Completed
Impact vs. Dienogest: A Combined Oral Contraceptive in the Size of Endometriomas in Women With Diameters Smaller Than 4 Centimeters Thereof, at University Hospital Fundación Santa Fe de Bogota, Between the Years 2015-2017 [NCT02599077]Phase 2/Phase 350 participants (Anticipated)Interventional2015-11-30Suspended
Comparing the Safety and Efficacy in the Use of Dienogest, Leuprolide Acetate, DMPA and Combined Oral Contraceptive Pills (Microgynon) on Endometriosis Patients After Conservative Surgery [NCT06145438]Phase 3100 participants (Anticipated)Interventional2023-09-04Recruiting
A Multicenter, Double-Blind, Randomized, Parallel-Group, Placebo-Controlled, 7 Cycle Duration (196 Days), Phase 3 Study of Oral Estradiol Valerate/Dienogest Tablets for the Treatment of Dysfunctional Uterine Bleeding. [NCT00307801]Phase 3231 participants (Actual)Interventional2006-02-28Completed
Randomized Phase 2 Trial Comparing Preoperative Dienogest Therapy Followed by Surgery vs. Upfront Surgery to Save Ovarian Reserve in Young Women With Ovarian Endometrioma [NCT02728245]Phase 20 participants (Actual)Interventional2017-10-31Withdrawn(stopped due to Placebo cannot be prepared)
A Multicenter, Double-Blind, Randomized, Parallel-Group, Placebo- Controlled, 7 Cycle Duration (196 Days), Phase 3 Study of Oral Estradiol Valerate/Dienogest Tablets for the Treatment of Dysfunctional Uterine Bleeding. [NCT00293059]Phase 3190 participants (Actual)Interventional2005-12-31Completed
Clinical Experience of Dienogest in Perimenopausal Females With Symptomatic Adenomyosis [NCT05751876]87 participants (Actual)Observational2018-09-01Completed
Impact of the Type of Treatment of the Endometrioma on Ovarian Reserve [NCT05637073]100 participants (Anticipated)Observational [Patient Registry]2023-03-14Recruiting
Characterisation of Relative Bioavailability and Assessment of Bioequivalence of a Newly Developed Ethinylestradiol/Dienogest IR Formulation in Comparison With a Marketed Reference Product (Valette®) [NCT01600274]20 participants (Actual)Interventional2010-01-31Completed
Induction of Ovulation by Clomiphene Citrate Following Laparoscopic Surgery for Endometriosis Stage 1 and Stage 11 With and Without Suppression by Dienogest [NCT02575248]Phase 4310 participants (Anticipated)Interventional2014-10-31Recruiting
The Effect of Dionegest Use on the Frequency of Fibromyalgia in Endometriosis: A Cross-sectional Observational Study. [NCT05272930]61 participants (Actual)Observational2021-06-30Completed
Efficacy of Dienogest Versus Oral Contraceptive Pills on Pain Associated With Endometriosis [NCT04256200]Phase 2/Phase 3100 participants (Anticipated)Interventional2017-02-07Recruiting
Dienogest Versus Gonadotropin Releasing Hormone Agonist Pre-treatment in Women With Endometriosis Undergoing in Vitro Fertilization [NCT03142035]189 participants (Anticipated)Interventional2017-10-22Recruiting
Phase IV Study to Assess the Safety and Effectiveness of Dienogest (Visanne®) Amongst Indian Women With Endometriosis, in Real-world Clinical Practice: the VISAGE Study [NCT04808843]160 participants (Anticipated)Observational2022-05-13Active, not recruiting
Monocenter, Open-label, Randomized Study to Determine the Ovulation Inhibitory Effect of the Combined Oral Contraceptive SH T04769G and SH D00659AF (0.03 mg Ethinylestradiol and 2.0 mg Dienogest), Applied for Two Treatment Cycles to 60 Healthy Female Volu [NCT00471991]Phase 260 participants (Actual)Interventional2007-04-30Completed
Evaluation of Using Dienogest and N-Acetyl Cysteine on the Volume of Uterine Leiomyoma [NCT06115408]Phase 2/Phase 340 participants (Anticipated)Interventional2023-07-01Recruiting
Effects of Tetragonula Aff. Biroi Propolis Extract on Lesion Growth, Apoptotic and Inflammatory Activity of the Rat Endometriosis Tissue [NCT04374006]Early Phase 1120 participants (Actual)Interventional2019-11-01Completed
Assisted Reproductive Technology (ART) and Pregnancy Outcomes in Women With Adenomyosis (Internal Endometriosis) According to Stimulation Protocol in Relation to Immunological and Endometrial Features: a Prospective, Randomized Study [NCT05937490]Phase 4500 participants (Anticipated)Interventional2023-03-27Recruiting
Bioavailability of a Formulation of Dienogest and Ethinyl Estradiol 2.0 mg/0.03 mg Coated Tablets With Regards to the Marketed Reference Product [NCT04193852]Phase 110 participants (Actual)Interventional2019-11-09Completed
Synthetic vs Natural Estrogen in Combined Oral Contraception- Effect on Insulin Sensitivity, Coagulation, Inflammation and Endometrium - a Comparison With a Progestin-only Preparation. [NCT02352090]Phase 459 participants (Actual)Interventional2015-04-01Completed
Comparative, Prospective, Multi-Center, Open, Randomized Study to Investigate Bleeding Patterns, Metabolic Effects, Contraceptive Efficacy, Acceptance, and Safety of an Oral Contraceptive Containing 0.03 mg Ethinylestradiol and 2 mg Dienogest, in Two Diff [NCT00302666]Phase 31,315 participants (Actual)Interventional2003-06-30Completed
A Multi-center, Randomized, Double-blinded, Placebo-controlled, and Open-label, Active-controlled, Parallel-group Comparative Study to Assess Efficacy and Safety of an Extended Flexible Regimen of BAY 86-5300 [0.02 mg Ethinylestradiol (β-CDC) and 3 mg Dro [NCT01697111]Phase 3312 participants (Actual)Interventional2012-10-31Completed
Abnormal Uterine Bleeding in Women With Uterine Leiomyomas: Open Randomized Clinical Trial Of Non Inferiority Between Oral Dienogest, Oral Desogestrel and Subcutaneous Goserelin [NCT01738724]Phase 414 participants (Actual)Interventional2012-01-31Terminated(stopped due to PI went for a post-doc course and when he came back he moved for another job)
Visanne® (Dienogest 2mg) Regulatory Post Marketing Surveillance Study in Korea [NCT01788722]3,223 participants (Actual)Observational2013-07-19Completed
A Multicenter Study to Investigate the Efficacy and Safety of Daily Oral Administration of 2 mg Dienogest Tablets (Visanne/SH T00660AA) for the Treatment of Endometriosis in Chinese Patients: a Double-blind, Randomized, Placebo-controlled, Parallel Group [NCT01822080]Phase 3250 participants (Actual)Interventional2013-03-31Completed
Study to Characterize Patients Treated With Visanne for Their Endometriosis Under Real-life Practice Conditions and Evaluate Their Quality of Life at Baseline and After 6 Months of Treatment With Visanne. [NCT01595724]3,006 participants (Actual)Observational2012-05-31Completed
An Observational, Prospective, Multicentre Study to Assess the Sensitivity to Change of the SAMANTA Questionnaire in Women With Heavy Menstrual Bleeding (HMB) [NCT03751800]422 participants (Actual)Observational2018-12-12Completed
Which do You Think is the Best Treatment Choice in Primary Dysmenorrhea? [NCT03124524]Phase 499 participants (Actual)Interventional2015-01-15Completed
Ambispective Comparative Cohort Study to Assess the Effect of Pretreatment With a Levonorgestrel-Releasing Intrauterine System Versus Oral Progestin on ICSI and Vitrified-Warmed Embryo Transfer Outcomes in Women With Adenomyosis [NCT05152667]354 participants (Anticipated)Observational2021-11-27Recruiting
Open-label, Randomized, Fixed Sequence Cross-over Study With Five Parallel Treatment Arms and Three Treatment Periods to Quantify the Drug-drug Interactions of Two Rifampicin Dose Strengths on Four Progestins and a Fixed Progestin-ethinylestradiol Combina [NCT03353857]Phase 168 participants (Actual)Interventional2017-11-29Completed
Role of Suppression of Endometriosis With Progestins Before IVF-ET: a Non-inferiority Randomized Controlled Trial [NCT04500743]134 participants (Actual)Interventional2018-08-01Completed
[information is prepared from clinicaltrials.gov, extracted Sep-2024]

Trial Outcomes

TrialOutcome
NCT00293059 (54) [back to overview]Change From Baseline in EuroQoL (Quality of Life) 5 Dimensional Health Questionnaire (EQ-5D) Scores at Treatment Day 196
NCT00293059 (54) [back to overview]Change From Baseline in Serum Ferritin Concentration at Treatment Day 196
NCT00293059 (54) [back to overview]Change From Baseline in Psychological General Well-Being Index (PGWBI) Scores at Treatment Day 84
NCT00293059 (54) [back to overview]Change From Baseline in Psychological General Well-Being Index (PGWBI) Scores at Treatment Day 196
NCT00293059 (54) [back to overview]Change From Baseline in Number of Sanitary Protection Used at 90 Days of Treatment
NCT00293059 (54) [back to overview]Change From Baseline in Number of Bleeding Episodes to the Reference Period of 90 Days Under Treatment
NCT00293059 (54) [back to overview]Change From Baseline in Number of Bleeding Days to the Reference Period of 90 Days Under Treatment
NCT00293059 (54) [back to overview]Change From Baseline in McCoy Female Sexuality Questionnaire (MFSQ) Scores at Treatment Day 84
NCT00293059 (54) [back to overview]Change From Baseline in McCoy Female Sexuality Questionnaire (MFSQ) Scores at Treatment Day 196
NCT00293059 (54) [back to overview]Change From Baseline in Hemoglobin Concentration at Treatment Day 84
NCT00293059 (54) [back to overview]Change From Baseline in Hemoglobin Concentration at Treatment Day 196
NCT00293059 (54) [back to overview]Change From Baseline in Hematocrit (Hct) Concentrations at Treatment Day 196
NCT00293059 (54) [back to overview]Change From Baseline in EuroQoL (Quality of Life) 5 Dimensional Health Questionnaire (EQ-5D) Scores at Treatment Day 84
NCT00293059 (54) [back to overview]Resource Use Assessment by Use of a Self Administered Questionnaire (Days Missed From Work) at Treatment Day 84
NCT00293059 (54) [back to overview]Change From Baseline in Blood Loss Volume for Participants With Excessive Bleeding to the Reference Period of 90 Days Under Treatment
NCT00293059 (54) [back to overview]Change From Baseline in Blood Loss Volume for All Participants to the Reference Period of 90 Days Under Treatment
NCT00293059 (54) [back to overview]Proportion of Participants Cured From Prolonged Bleeding
NCT00293059 (54) [back to overview]Change From Baseline in Serum Ferritin Concentration at Treatment Day 84
NCT00293059 (54) [back to overview]Change From Baseline in Visual Analogue Scale (VAS) of the EQ-5D Score at Treatment Day 196
NCT00293059 (54) [back to overview]Change From Baseline in Visual Analogue Scale (VAS) of the EQ-5D Score at Treatment Day 84
NCT00293059 (54) [back to overview]Change in Absolute Value From Baseline MBL to end-of Study MBL
NCT00293059 (54) [back to overview]Menstrual Blood Loss Volume for All Participants at Cycle 1
NCT00293059 (54) [back to overview]Menstrual Blood Loss Volume for All Participants at Cycle 3
NCT00293059 (54) [back to overview]Menstrual Blood Loss Volume for All Participants at Cycle 7
NCT00293059 (54) [back to overview]Menstrual Blood Loss Volume for Participants With Excessive Bleeding at Cycle 1
NCT00293059 (54) [back to overview]Menstrual Blood Loss Volume for Participants With Excessive Bleeding at Cycle 3
NCT00293059 (54) [back to overview]Menstrual Blood Loss Volume for Participants With Excessive Bleeding at Cycle 7
NCT00293059 (54) [back to overview]Proportion of Participants Cured From Excessive Bleeding
NCT00293059 (54) [back to overview]Proportion of Participants Cured From Frequent Bleeding
NCT00293059 (54) [back to overview]Proportion of Participants With Improvement in the Investigator's Global Assessment Scale at Treatment Day 196
NCT00293059 (54) [back to overview]Proportion of Participants With Improvement in the Investigator's Global Assessment Scale at Treatment Day 84
NCT00293059 (54) [back to overview]Proportion of Participants With Improvement in the Participant's Overall Assessment Scale at Treatment Day 196
NCT00293059 (54) [back to overview]Proportion of Participants With Improvement in the Participant's Overall Assessment Scale at Treatment Day 84
NCT00293059 (54) [back to overview]Proportion of Participants With no Dysfunctional Uterine Bleeding (DUB) Symptoms
NCT00293059 (54) [back to overview]Resource Use Assessment by Use of a Self Administered Questionnaire (Additional Unscheduled Procedures) at Treatment Day 196
NCT00293059 (54) [back to overview]Resource Use Assessment by Use of a Self Administered Questionnaire (Additional Unscheduled Procedures) at Treatment Day 84
NCT00293059 (54) [back to overview]Resource Use Assessment by Use of a Self Administered Questionnaire (Any Medical Treatment) at Treatment Day 196
NCT00293059 (54) [back to overview]Resource Use Assessment by Use of a Self Administered Questionnaire (Any Medical Treatment) at Treatment Day 84
NCT00293059 (54) [back to overview]Resource Use Assessment by Use of a Self Administered Questionnaire (Change in the Employment Status) at Treatment Day 196
NCT00293059 (54) [back to overview]Resource Use Assessment by Use of a Self Administered Questionnaire (Change in the Employment Status) at Treatment Day 84
NCT00293059 (54) [back to overview]Resource Use Assessment by Use of a Self Administered Questionnaire (Days Missed From Work) at Treatment Day 196
NCT00293059 (54) [back to overview]Resource Use Assessment by Use of a Self Administered Questionnaire (Out-of-pocket Expenses) at Treatment Day 196
NCT00293059 (54) [back to overview]Resource Use Assessment by Use of a Self Administered Questionnaire (Out-of-pocket Expenses) at Treatment Day 84
NCT00293059 (54) [back to overview]Resource Use Assessment by Use of a Self Administered Questionnaire (Productivity While Working) at Treatment Day 196
NCT00293059 (54) [back to overview]Resource Use Assessment by Use of a Self Administered Questionnaire (Productivity While Working) at Treatment Day 84
NCT00293059 (54) [back to overview]Resource Use Assessment by Use of a Self Administered Questionnaire (Received Ambulatory Services) at Treatment Day 196
NCT00293059 (54) [back to overview]Resource Use Assessment by Use of a Self Administered Questionnaire (Received Ambulatory Services) at Treatment Day 84
NCT00293059 (54) [back to overview]Resource Use Assessment by Use of a Self Administered Questionnaire (Regular Daily Activities) at Treatment Day 196
NCT00293059 (54) [back to overview]Resource Use Assessment by Use of a Self Administered Questionnaire (Regular Daily Activities) at Treatment Day 84
NCT00293059 (54) [back to overview]Resource Use Assessment by Use of a Self Administered Questionnaire (Unscheduled Outpatient Visit at Hospital) at Treatment Day 196
NCT00293059 (54) [back to overview]Resource Use Assessment by Use of a Self Administered Questionnaire (Unscheduled Outpatient Visit at Hospital) at Treatment Day 84
NCT00293059 (54) [back to overview]Resource Use Assessment by Use of a Self Administered Questionnaire (Unscheduled Visit to Physician) at Treatment Day 196
NCT00293059 (54) [back to overview]Resource Use Assessment by Use of a Self Administered Questionnaire (Unscheduled Visit to Physician) at Treatment Day 84
NCT00293059 (54) [back to overview]Proportion of Participants With Successful Treatment
NCT00307801 (53) [back to overview]Change From Baseline in Psychological General Well-Being Index (PGWBI) Score at Treatment Day 84.
NCT00307801 (53) [back to overview]Change From Baseline in Psychological General Well-Being Index (PGWBI) Score at Treatment Day 196.
NCT00307801 (53) [back to overview]Change From Baseline in Number of Sanitary Protection Used at 90 Days of Treatment
NCT00307801 (53) [back to overview]Change From Baseline in Number of Bleeding Episodes to the Reference Period of 90 Days Under Treatment
NCT00307801 (53) [back to overview]Change From Baseline in Number of Bleeding Days to the Reference Period of 90 Days Under Treatment
NCT00307801 (53) [back to overview]Change From Baseline in McCoy Female Sexuality Questionnaire (MFSQ) Score at Treatment Day 84
NCT00307801 (53) [back to overview]Change From Baseline in McCoy Female Sexuality Questionnaire (MFSQ) Score at Treatment Day 196
NCT00307801 (53) [back to overview]Change From Baseline in Hemoglobin Concentration at Treatment Day 84
NCT00307801 (53) [back to overview]Change From Baseline in Hemoglobin Concentration at Treatment Day 196
NCT00307801 (53) [back to overview]Change From Baseline in Hematocrit at Treatment Day 196.
NCT00307801 (53) [back to overview]Change From Baseline in Ferritin Concentration at Treatment Day 84
NCT00307801 (53) [back to overview]Change From Baseline in Ferritin Concentration at Treatment Day 196
NCT00307801 (53) [back to overview]Change From Baseline in EuroQol 5 Dimensional (EQ-5D) Score at Treatment Day 196
NCT00307801 (53) [back to overview]Change From Baseline in Blood Loss Volume for Participants With Excessive Bleeding to the Reference Period of 90 Days Under Treatment.
NCT00307801 (53) [back to overview]Change From Baseline in Blood Loss Volume for All Participants to the Reference Period of 90 Days Under Treatment
NCT00307801 (53) [back to overview]Proportion of Participants With Successful Treatment
NCT00307801 (53) [back to overview]Resource Use Assessment by Use of a Self Administered Questionnaire (Unscheduled Outpatient Visit to Physician) at Treatment Day 84
NCT00307801 (53) [back to overview]Resource Use Assessment by Use of a Self Administered Questionnaire (Unscheduled Outpatient Visit to Physician) at Treatment Day 196
NCT00307801 (53) [back to overview]Resource Use Assessment by Use of a Self Administered Questionnaire (Unscheduled Outpatient Visit at Hospital) at Treatment Day 84
NCT00307801 (53) [back to overview]Resource Use Assessment by Use of a Self Administered Questionnaire (Unscheduled Outpatient Visit at Hospital) at Treatment Day 196
NCT00307801 (53) [back to overview]Resource Use Assessment by Use of a Self Administered Questionnaire (Regular Daily Activities) at Treatment Day 84
NCT00307801 (53) [back to overview]Resource Use Assessment by Use of a Self Administered Questionnaire (Regular Daily Activities) at Treatment Day 196.
NCT00307801 (53) [back to overview]Resource Use Assessment by Use of a Self Administered Questionnaire (Received Ambulatory Services) at Treatment Day 84
NCT00307801 (53) [back to overview]Resource Use Assessment by Use of a Self Administered Questionnaire (Received Ambulatory Services) at Treatment Day 196
NCT00307801 (53) [back to overview]Resource Use Assessment by Use of a Self Administered Questionnaire (Productivity While Working) at Treatment Day 196.
NCT00307801 (53) [back to overview]Resource Use Assessment by Use of a Self Administered Questionnaire (Not Have Any Medical Treatment) at Treatment Day 84
NCT00307801 (53) [back to overview]Resource Use Assessment by Use of a Self Administered Questionnaire (Not Have Any Medical Treatment) at Treatment Day 196
NCT00307801 (53) [back to overview]Resource Use Assessment by Use of a Self Administered Questionnaire (no Out-of-pocket Expenses) at Treatment Day 84
NCT00307801 (53) [back to overview]Resource Use Assessment by Use of a Self Administered Questionnaire (no Out-of-pocket Expenses) at Treatment Day 196
NCT00307801 (53) [back to overview]Resource Use Assessment by Use of a Self Administered Questionnaire (Days Missed From Work) at Treatment Day 84
NCT00307801 (53) [back to overview]Resource Use Assessment by Use of a Self Administered Questionnaire (Days Missed From Work) at Treatment Day 196
NCT00307801 (53) [back to overview]Resource Use Assessment by Use of a Self Administered Questionnaire (Change in the Employment Status) at Treatment Day 84.
NCT00307801 (53) [back to overview]Resource Use Assessment by Use of a Self Administered Questionnaire (Change in the Employment Status) at Treatment Day 196.
NCT00307801 (53) [back to overview]Resource Use Assessment by Use of a Self Administered Questionnaire (Additional Unscheduled Procedures) at Treatment Day 84
NCT00307801 (53) [back to overview]Resource Use Assessment by Use of a Self Administered Questionnaire (Additional Unscheduled Procedures) at Treatment Day 196
NCT00307801 (53) [back to overview]Resource Use Assessment by Use of a Self Administered Questionnaire (Productivity While Working) at Treatment Day 84.
NCT00307801 (53) [back to overview]Proportion of Participants With no Dysfunctional Uterine Bleeding (DUB) Symptoms
NCT00307801 (53) [back to overview]Proportion of Participants With Improvement in the Patient's Overall Assessment Scale at Treatment Day 84
NCT00307801 (53) [back to overview]Proportion of Participants With Improvement in the Patient's Overall Assessment Scale at Treatment Day 196
NCT00307801 (53) [back to overview]Change From Baseline in Visual Analogue Scale (VAS) of the EQ-5D Score at Treatment Day 196.
NCT00307801 (53) [back to overview]Proportion of Participants With Improvement in the Investigator's Global Assessment Scale at Treatment Day 84
NCT00307801 (53) [back to overview]Proportion of Participants With Improvement in the Investigator's Global Assessment Scale at Treatment Day 196
NCT00307801 (53) [back to overview]Proportion of Participants Cured From Prolonged Bleeding
NCT00307801 (53) [back to overview]Proportion of Participants Cured From Excessive Bleeding
NCT00307801 (53) [back to overview]Menstrual Blood Loss Volume for Participants With Excessive Bleeding at Cycle 7.
NCT00307801 (53) [back to overview]Menstrual Blood Loss Volume for Participants With Excessive Bleeding at Cycle 3.
NCT00307801 (53) [back to overview]Menstrual Blood Loss Volume for Participants With Excessive Bleeding at Cycle 1.
NCT00307801 (53) [back to overview]Menstrual Blood Loss Volume for All Participants at Cycle 7
NCT00307801 (53) [back to overview]Menstrual Blood Loss Volume for All Participants at Cycle 3
NCT00307801 (53) [back to overview]Menstrual Blood Loss Volume for All Participants at Cycle 1
NCT00307801 (53) [back to overview]Change in Absolute Value From Baseline Menstrual Blood Loss (MBL) to end-of Study MBL
NCT00307801 (53) [back to overview]Change From Baseline in Visual Analogue Scale (VAS) of the EQ-5D Score at Treatment Day 84.
NCT00307801 (53) [back to overview]Change From Baseline in EuroQol 5 Dimensional (EQ-5D) Score at Treatment Day 84
NCT00754065 (117) [back to overview]Mean Change From Baseline to Cycle 13 in Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) - Social Relationship
NCT00754065 (117) [back to overview]Mean Change From Baseline to Cycle 13 in Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) - Work
NCT00754065 (117) [back to overview]Mean Change From Baseline to Cycle 6 in Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) - General Activities
NCT00754065 (117) [back to overview]Mean Change From Baseline to Cycle 6 in Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) - Household Duties
NCT00754065 (117) [back to overview]Mean Change From Baseline to Cycle 6 in Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) - Item Satisfaction
NCT00754065 (117) [back to overview]Mean Change From Baseline to Cycle 6 in Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) - Leisure Time Activities
NCT00754065 (117) [back to overview]Mean Change From Baseline to Cycle 6 in Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) - Overall Life Satisfaction and Contentment
NCT00754065 (117) [back to overview]Mean Change From Baseline to Cycle 6 in Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) - Participant Feeling
NCT00754065 (117) [back to overview]Mean Change From Baseline to Cycle 6 in Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) - School/Course Work
NCT00754065 (117) [back to overview]Mean Change From Baseline to Cycle 6 in Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) - Social Relationship
NCT00754065 (117) [back to overview]Mean Change From Baseline to Cycle 6 in Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) - Work
NCT00754065 (117) [back to overview]Mean Length of Bleeding / Spotting Episodes in Reference Period 1
NCT00754065 (117) [back to overview]Mean Length of Bleeding / Spotting Episodes in Reference Period 2
NCT00754065 (117) [back to overview]Mean Length of Bleeding / Spotting Episodes in Reference Period 3
NCT00754065 (117) [back to overview]Mean Length of Bleeding / Spotting Episodes in Reference Period 4
NCT00754065 (117) [back to overview]Mean Length of Spotting-only Episodes in Reference Period 1
NCT00754065 (117) [back to overview]Mean Length of Spotting-only Episodes in Reference Period 2
NCT00754065 (117) [back to overview]Mean Length of Spotting-only Episodes in Reference Period 3
NCT00754065 (117) [back to overview]Mean Length of Spotting-only Episodes in Reference Period 4
NCT00754065 (117) [back to overview]Number of Bleeding / Spotting Episodes in Reference Period 1
NCT00754065 (117) [back to overview]Number of Bleeding / Spotting Episodes in Reference Period 2
NCT00754065 (117) [back to overview]Number of Bleeding / Spotting Episodes in Reference Period 3
NCT00754065 (117) [back to overview]Number of Bleeding / Spotting Episodes in Reference Period 4
NCT00754065 (117) [back to overview]Number of Days With Bleeding or Spotting in Reference Period 1
NCT00754065 (117) [back to overview]Number of Days With Bleeding or Spotting in Reference Period 2
NCT00754065 (117) [back to overview]Number of Days With Bleeding or Spotting in Reference Period 3
NCT00754065 (117) [back to overview]Number of Days With Bleeding or Spotting in Reference Period 4
NCT00754065 (117) [back to overview]Number of Days With Spotting-only in Reference Period 1
NCT00754065 (117) [back to overview]Number of Days With Spotting-only in Reference Period 2
NCT00754065 (117) [back to overview]Number of Days With Spotting-only in Reference Period 3
NCT00754065 (117) [back to overview]Number of Days With Spotting-only in Reference Period 4
NCT00754065 (117) [back to overview]Number of Intracyclic Bleeding Days at Cycle 1
NCT00754065 (117) [back to overview]Number of Intracyclic Bleeding Days at Cycle 13
NCT00754065 (117) [back to overview]Number of Intracyclic Bleeding Days at Cycle 3
NCT00754065 (117) [back to overview]Number of Intracyclic Bleeding Days at Cycle 6
NCT00754065 (117) [back to overview]Number of Intracyclic Bleeding Episodes at Cycle 1
NCT00754065 (117) [back to overview]Number of Intracyclic Bleeding Episodes at Cycle 13
NCT00754065 (117) [back to overview]Number of Intracyclic Bleeding Episodes at Cycle 3
NCT00754065 (117) [back to overview]Number of Intracyclic Bleeding Episodes at Cycle 6
NCT00754065 (117) [back to overview]Number of Spotting-only Episodes in Reference Period 1
NCT00754065 (117) [back to overview]Number of Spotting-only Episodes in Reference Period 2
NCT00754065 (117) [back to overview]Number of Spotting-only Episodes in Reference Period 3
NCT00754065 (117) [back to overview]Number of Spotting-only Episodes in Reference Period 4
NCT00754065 (117) [back to overview]Onset of Withdrawal Bleeding Episodes at Cycle 1
NCT00754065 (117) [back to overview]Mean Change From Baseline to Cycle 6 in Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) - Physical Health
NCT00754065 (117) [back to overview]Onset of Withdrawal Bleeding Episodes at Cycle 3
NCT00754065 (117) [back to overview]Onset of Withdrawal Bleeding Episodes at Cycle 6
NCT00754065 (117) [back to overview]The Change in Average of the 3 Highest Visual Analog Scale (VAS) Values of the Hormone Withdrawal-associated Symptoms Pelvic Pain or Headache During Cycle Days 22 to 28 From Baseline to Cycle 6
NCT00754065 (117) [back to overview]The Change of Pelvic Pain or Headache as Determined by the Highest Visual Analog Scale (VAS) Values During Cycle Days 22 to 28 From Baseline to Cycle 6
NCT00754065 (117) [back to overview]Change From Baseline to Cycle 13 in the Number of Days With at Least Moderate Pain/Intensity of Individual Hormone-related Symptoms During Cycle Days 1-21
NCT00754065 (117) [back to overview]Change From Baseline to Cycle 13 in the Number of Days With at Least Moderate Pain/Intensity of Individual Hormone-related Symptoms During the Hormone-free Interval Cycle Days 27 to 28 for EV/DNG and Cycle Days 22 to 28 for EE/NGM
NCT00754065 (117) [back to overview]Change From Baseline to Cycle 13 in the Number of Days With at Least Moderate Pain/Intensity of Other Hormone-related Symptoms During Cycle Days 22-28
NCT00754065 (117) [back to overview]Change From Baseline to Cycle 6 in the Number of Days With at Least Moderate Pain/Intensity of Individual Hormone-related Symptoms During Cycle Days 1-21
NCT00754065 (117) [back to overview]Change From Baseline to Cycle 6 in the Number of Days With at Least Moderate Pain/Intensity of Individual Hormone-related Symptoms During the Hormone-free Interval Cycle Days 27 to 28 for EV/DNG and Cycle Days 22 to 28 for EE/NGM
NCT00754065 (117) [back to overview]Change From Baseline to Cycle 6 in the Number of Days With at Least Moderate Pain/Intensity of Other Hormone-related Symptoms During Cycle Days 22-28
NCT00754065 (117) [back to overview]Mean Change From Baseline to Cycle 13 in Psychological General Well-Being Index (PGWBI)
NCT00754065 (117) [back to overview]Mean Change From Baseline to Cycle 6 in Psychological General Well-Being Index (PGWBI)
NCT00754065 (117) [back to overview]Percentage of Participants by Maximum Intensity of Intracyclic Bleeding Episodes at Cycle 1
NCT00754065 (117) [back to overview]Percentage of Participants by Maximum Intensity of Intracyclic Bleeding Episodes at Cycle 13
NCT00754065 (117) [back to overview]Percentage of Participants by Maximum Intensity of Intracyclic Bleeding Episodes at Cycle 3
NCT00754065 (117) [back to overview]Percentage of Participants by Maximum Intensity of Intracyclic Bleeding Episodes at Cycle 6
NCT00754065 (117) [back to overview]Percentage of Participants With / Without Withdrawal Bleeding at Cycle 1
NCT00754065 (117) [back to overview]Percentage of Participants With / Without Withdrawal Bleeding at Cycle 13
NCT00754065 (117) [back to overview]Percentage of Participants With / Without Withdrawal Bleeding at Cycle 3
NCT00754065 (117) [back to overview]Percentage of Participants With / Without Withdrawal Bleeding at Cycle 6
NCT00754065 (117) [back to overview]Percentage of Participants With at Least 1 Intracyclic Bleeding Episode at Cycles 2 to 13
NCT00754065 (117) [back to overview]Percentage of Participants With at Least 1 Intracyclic Bleeding Episode at Cycles 2 to 6
NCT00754065 (117) [back to overview]Percentage of Participants With Improvement in the Investigator's Assessment in Clinical Global Impression (CGI) at Cycle 13
NCT00754065 (117) [back to overview]Percentage of Participants With Improvement in the Investigator's Assessment in Clinical Global Impression (CGI) at Cycle 6
NCT00754065 (117) [back to overview]Percentage of Participants With Improvement in the Participant's Assessment in Clinical Global Impression (CGI) at Cycle 13
NCT00754065 (117) [back to overview]Percentage of Participants With Improvement in the Participant's Assessment in Clinical Global Impression (CGI) at Cycle 6
NCT00754065 (117) [back to overview]Percentage of Participants With no Increase in Rescue Medication and VAS Decrease During Cycle Days 22 to 28 From Baseline to Cycle 6
NCT00754065 (117) [back to overview]Percentage of Participants With Presence or Absence of Intracyclic Bleeding at Cycle 1
NCT00754065 (117) [back to overview]Percentage of Participants With Presence or Absence of Intracyclic Bleeding at Cycle 13
NCT00754065 (117) [back to overview]Percentage of Participants With Presence or Absence of Intracyclic Bleeding at Cycle 3
NCT00754065 (117) [back to overview]Percentage of Participants With Presence or Absence of Intracyclic Bleeding at Cycle 6
NCT00754065 (117) [back to overview]The Change From Baseline to Cycle 13 in the Number of Ibuprofen Tablets Used as Rescue Medication
NCT00754065 (117) [back to overview]The Change From Baseline to Cycle 6 in the Number of Ibuprofen Tablets Used as Rescue Medication
NCT00754065 (117) [back to overview]Onset of Withdrawal Bleeding Episodes at Cycle 13
NCT00754065 (117) [back to overview]Difference in Duration Between Longest and Shortest Spotting-only Episodes in Reference Period 1
NCT00754065 (117) [back to overview]Change From Baseline to Cycle 13 in the Average of the Three Highest VAS Values of the Hormone Withdrawal-associated Symptoms Pelvic Pain or Headache During Cycle Days 22 to 28
NCT00754065 (117) [back to overview]Change From Baseline to Cycle 3 in the Average of the Three Highest VAS Values of the Hormone Withdrawal-associated Symptoms Pelvic Pain or Headache During Cycle Days 22 to 28
NCT00754065 (117) [back to overview]Difference in Duration Between Longest and Shortest Bleeding / Spotting Episodes in Reference Period 1
NCT00754065 (117) [back to overview]Difference in Duration Between Longest and Shortest Bleeding / Spotting Episodes in Reference Period 2
NCT00754065 (117) [back to overview]Difference in Duration Between Longest and Shortest Bleeding / Spotting Episodes in Reference Period 3
NCT00754065 (117) [back to overview]Difference in Duration Between Longest and Shortest Bleeding / Spotting Episodes in Reference Period 4
NCT00754065 (117) [back to overview]Difference in Duration Between Longest and Shortest Spotting-only Episodes in Reference Period 2
NCT00754065 (117) [back to overview]Difference in Duration Between Longest and Shortest Spotting-only Episodes in Reference Period 3
NCT00754065 (117) [back to overview]Difference in Duration Between Longest and Shortest Spotting-only Episodes in Reference Period 4
NCT00754065 (117) [back to overview]Length of Withdrawal Bleeding Episodes at Cycle 1
NCT00754065 (117) [back to overview]Length of Withdrawal Bleeding Episodes at Cycle 13
NCT00754065 (117) [back to overview]Length of Withdrawal Bleeding Episodes at Cycle 3
NCT00754065 (117) [back to overview]Length of Withdrawal Bleeding Episodes at Cycle 6
NCT00754065 (117) [back to overview]Maximum Intensity of Withdrawal Bleeding Episodes at Cycle 1
NCT00754065 (117) [back to overview]Maximum Intensity of Withdrawal Bleeding Episodes at Cycle 13
NCT00754065 (117) [back to overview]Maximum Intensity of Withdrawal Bleeding Episodes at Cycle 3
NCT00754065 (117) [back to overview]Maximum Intensity of Withdrawal Bleeding Episodes at Cycle 6
NCT00754065 (117) [back to overview]Maximum Length of Bleeding / Spotting Episodes in Reference Period 1
NCT00754065 (117) [back to overview]Maximum Length of Bleeding / Spotting Episodes in Reference Period 2
NCT00754065 (117) [back to overview]Maximum Length of Bleeding / Spotting Episodes in Reference Period 3
NCT00754065 (117) [back to overview]Maximum Length of Bleeding / Spotting Episodes in Reference Period 4
NCT00754065 (117) [back to overview]Maximum Length of Intracyclic Bleeding Episodes at Cycle 1
NCT00754065 (117) [back to overview]Maximum Length of Intracyclic Bleeding Episodes at Cycle 13
NCT00754065 (117) [back to overview]Maximum Length of Intracyclic Bleeding Episodes at Cycle 3
NCT00754065 (117) [back to overview]Maximum Length of Intracyclic Bleeding Episodes at Cycle 6
NCT00754065 (117) [back to overview]Maximum Length of Spotting-only Episodes in Reference Period 1
NCT00754065 (117) [back to overview]Maximum Length of Spotting-only Episodes in Reference Period 2
NCT00754065 (117) [back to overview]Maximum Length of Spotting-only Episodes in Reference Period 3
NCT00754065 (117) [back to overview]Maximum Length of Spotting-only Episodes in Reference Period 4
NCT00754065 (117) [back to overview]Mean Change From Baseline to Cycle 13 in Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) - General Activities
NCT00754065 (117) [back to overview]Mean Change From Baseline to Cycle 13 in Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) - Household Duties
NCT00754065 (117) [back to overview]Mean Change From Baseline to Cycle 13 in Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) - Item Satisfaction
NCT00754065 (117) [back to overview]Mean Change From Baseline to Cycle 13 in Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) - Leisure Time Activities
NCT00754065 (117) [back to overview]Mean Change From Baseline to Cycle 13 in Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) - Overall Life Satisfaction and Contentment
NCT00754065 (117) [back to overview]Mean Change From Baseline to Cycle 13 in Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) - Participant Feeling
NCT00754065 (117) [back to overview]Mean Change From Baseline to Cycle 13 in Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) - Physical Health
NCT00754065 (117) [back to overview]Mean Change From Baseline to Cycle 13 in Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) - School/Course Work
NCT00909857 (68) [back to overview]Number of Intracyclic Bleeding Days at Cycle 3
NCT00909857 (68) [back to overview]Number of Intracyclic Bleeding Days at Cycle 1
NCT00909857 (68) [back to overview]Number of Episodes With Spotting-only
NCT00909857 (68) [back to overview]Number of Episodes With Bleeding or Spotting
NCT00909857 (68) [back to overview]Number of Days With Spotting-only
NCT00909857 (68) [back to overview]Number of Days With Bleeding or Spotting
NCT00909857 (68) [back to overview]Mental Health as Measured by General Health and Well-being Questionnaire SF-36 at Final Examination
NCT00909857 (68) [back to overview]Mental Health as Measured by General Health and Well-being Questionnaire SF-36 at Baseline Cycle
NCT00909857 (68) [back to overview]Mean Length of Spotting Only Episodes
NCT00909857 (68) [back to overview]Mean Length of Bleeding or Spotting Episodes
NCT00909857 (68) [back to overview]Maximum Length of Spotting Only Episodes
NCT00909857 (68) [back to overview]Maximum Length of Intracyclic Bleeding Episodes at Cycle 3
NCT00909857 (68) [back to overview]Maximum Length of Intracyclic Bleeding Episodes at Cycle 1
NCT00909857 (68) [back to overview]Maximum Length of Bleeding or Spotting Episodes
NCT00909857 (68) [back to overview]Maximum Intensity of Withdrawal Bleeding Episodes at Cycle 3
NCT00909857 (68) [back to overview]Maximum Intensity of Withdrawal Bleeding Episodes at Cycle 1
NCT00909857 (68) [back to overview]Length of Withdrawal Bleeding Episodes at Cycle 3
NCT00909857 (68) [back to overview]Length of Withdrawal Bleeding Episodes at Cycle 1
NCT00909857 (68) [back to overview]General Health as Measured by General Health and Well-being Questionnaire SF-36 at Final Examination
NCT00909857 (68) [back to overview]General Health as Measured by General Health and Well-being Questionnaire SF-36 at Baseline Cycle
NCT00909857 (68) [back to overview]Difference in Duration Between Longest and Shortest Spotting Only Episode
NCT00909857 (68) [back to overview]Difference in Duration Between Longest and Shortest Bleeding or Spotting Episode
NCT00909857 (68) [back to overview]Change Between Baseline Evaluation Period and Treatment Evaluation Period in the Sum of Score Points of Dysmenorrheic Pain
NCT00909857 (68) [back to overview]Change Between Baseline Evaluation Period and Treatment Evaluation Period in the Number of Days With Dysmenorrheic Pain
NCT00909857 (68) [back to overview]Change Between Baseline Evaluation Period and Treatment Evaluation Period in Rescue Medication Use (Only Bleeding Episodes Used Including the Two Days Before the Episode)
NCT00909857 (68) [back to overview]Change Between Baseline Evaluation Period and Treatment Evaluation Period in Rescue Medication Use (Entire Evaluation Period Used)
NCT00909857 (68) [back to overview]Change Between Baseline Evaluation Period and Treatment Evaluation Period in Number of Days With Pelvic Pain Independent of Occurrence of Vaginal Bleeding
NCT00909857 (68) [back to overview]Change Between Baseline Evaluation Period and Treatment Evaluation Period in Number of Days With Pelvic Pain During Unscheduled Bleeding
NCT00909857 (68) [back to overview]Bodily Pain as Measured by General Health and Well-being Questionnaire SF-36 at Final Examination
NCT00909857 (68) [back to overview]Percentage of Participants With Maximum Intensity of Intracyclic Bleeding Episodes at Cycle 3
NCT00909857 (68) [back to overview]Percentage of Participants With Maximum Intensity of Intracyclic Bleeding Episodes at Cycle 1
NCT00909857 (68) [back to overview]Own Costs of Herbs/Teas Per Treatment Converted to U.S. Dollars as Measured by Resource Use Questionnaire
NCT00909857 (68) [back to overview]Percentage of Participants With Interference of Dysmenorrheic Pain With Work/School and Social or Other Activity (Only Bleeding Episodes Used Including the Two Days Before)
NCT00909857 (68) [back to overview]Percentage of Participants With Interference of Dysmenorrheic Pain With Work/School and Social or Other Activity (Entire Evaluation Period Used)
NCT00909857 (68) [back to overview]Percentage of Participants Satisfied With Study Treatment
NCT00909857 (68) [back to overview]Percentage of Participants Missing Time From Work Due to Dysmenorrheic Pain at Screening
NCT00909857 (68) [back to overview]Percentage of Participants Missing Time From Work Due to Dysmenorrheic Pain at Final Examination
NCT00909857 (68) [back to overview]Percentage of Participants Missing Time From Work Due to Dysmenorrheic Pain at Cycle 2
NCT00909857 (68) [back to overview]Percentage of Participants Missing Time From Work Due to Dysmenorrheic Pain at Baseline Cycle
NCT00909857 (68) [back to overview]Participants With Improvement in the Investigators' Assessment in the Clinical Global Impression
NCT00909857 (68) [back to overview]Participants With Improvement in Participants' Assessment in the Clinical Global Impression
NCT00909857 (68) [back to overview]Bodily Pain as Measured by General Health and Well-being Questionnaire SF-36 at Baseline Cycle
NCT00909857 (68) [back to overview]Vitality as Measured by General Health and Well-being Questionnaire SF-36 at Final Examination
NCT00909857 (68) [back to overview]Vitality as Measured by General Health and Well-being Questionnaire SF-36 at Baseline Cycle
NCT00909857 (68) [back to overview]Social Functioning as Measured by General Health and Well-being Questionnaire SF-36 at Final Examination
NCT00909857 (68) [back to overview]Social Functioning as Measured by General Health and Well-being Questionnaire SF-36 at Baseline Cycle
NCT00909857 (68) [back to overview]Role Physical as Measured by General Health and Well-being Questionnaire SF-36 at Final Examination
NCT00909857 (68) [back to overview]Role Physical as Measured by General Health and Well-being Questionnaire SF-36 at Baseline Cycle
NCT00909857 (68) [back to overview]Role Emotional as Measured by General Health and Well-being Questionnaire SF-36 at Final Examination
NCT00909857 (68) [back to overview]Role Emotional as Measured by General Health and Well-being Questionnaire SF-36 at Baseline Cycle
NCT00909857 (68) [back to overview]Physical Functioning as Measured by General Health and Well-being Questionnaire SF-36 at Final Examination
NCT00909857 (68) [back to overview]Physical Functioning as Measured by General Health and Well-being Questionnaire SF-36 at Baseline Cycle
NCT00909857 (68) [back to overview]Percentage of Participants With Withdrawal Bleeding at Cycle 3
NCT00909857 (68) [back to overview]Percentage of Participants With Withdrawal Bleeding at Cycle 1
NCT00909857 (68) [back to overview]Percentage of Participants With Intracyclic Bleeding at Cycle 3
NCT00909857 (68) [back to overview]Percentage of Participants With Intracyclic Bleeding at Cycle 1
NCT00909857 (68) [back to overview]Own Costs of Vitamins Per Treatment Converted to U.S. Dollars as Measured by Resource Use Questionnaire
NCT00909857 (68) [back to overview]Own Costs of Physiotherapy Per Treatment Converted to U.S. Dollars as Measured by Resource Use Questionnaire
NCT00909857 (68) [back to overview]Own Costs of Pain Medication Per Treatment Converted to U.S. Dollars as Measured by Resource Use Questionnaire
NCT00909857 (68) [back to overview]Own Costs of Medical Counseling Per Treatment Converted to U.S. Dollars as Measured by Resource Use Questionnaire
NCT00909857 (68) [back to overview]Own Costs of Massages Per Treatment Converted to U.S. Dollars as Measured by Resource Use Questionnaire
NCT00909857 (68) [back to overview]Own Costs of Alternative Medicine Per Treatment Converted to U.S. Dollars as Measured by Resource Use Questionnaire
NCT00909857 (68) [back to overview]Own Costs of Acupuncture Per Treatment Converted to U.S. Dollars as Measured by Resource Use Questionnaire
NCT00909857 (68) [back to overview]Other Own Costs Per Treatment Converted to U.S. Dollars as Measured by Resource Use Questionnaire
NCT00909857 (68) [back to overview]Onset of Withdrawal Bleeding Episodes at Cycle 3
NCT00909857 (68) [back to overview]Onset of Withdrawal Bleeding Episodes at Cycle 1
NCT00909857 (68) [back to overview]Number of Intracyclic Bleeding Episodes at Cycle 3
NCT00909857 (68) [back to overview]Number of Intracyclic Bleeding Episodes at Cycle 1
NCT02352090 (11) [back to overview]Anti Mullerian Hormone (AMH)
NCT02352090 (11) [back to overview]D-dimer
NCT02352090 (11) [back to overview]F1+2
NCT02352090 (11) [back to overview]Fasting Insulin
NCT02352090 (11) [back to overview]High-Density Lipoprotein (HDL)
NCT02352090 (11) [back to overview]High-sensitivity C Reactive Protein
NCT02352090 (11) [back to overview]Low-Density Lipoprotein (LDL)
NCT02352090 (11) [back to overview]Matsuda Index- Whole Body Insulin Sensitivity Index
NCT02352090 (11) [back to overview]Thrombin Generation, ETP Endogenous Thrombin Potential
NCT02352090 (11) [back to overview]Total Cholesterol
NCT02352090 (11) [back to overview]Triglyceride

Change From Baseline in EuroQoL (Quality of Life) 5 Dimensional Health Questionnaire (EQ-5D) Scores at Treatment Day 196

The Health State Classification of the EQ-5D comprised 5 questions addressing mobility, self-care, usual activity, pain/discomfort, and anxiety/depression. Participants were asked to indicate their current health state by ticking the most appropriate of 3 statements about each of the questions (ie, no problems, some problems, extreme problems). The best possible answers were (1,1,1,1,1), which equals a valuation score of 1.0. The worst possible answers were (3,3,3,3,3), which equals a valuation score of .594. The change from the baseline score at day 196 is presented. (NCT00293059)
Timeframe: baseline and treatment day 196

InterventionScores on a scale (Mean)
Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027)0.0052
Placebo0.0154

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Change From Baseline in Serum Ferritin Concentration at Treatment Day 196

Serum ferritin was measured before treatment and after 196 days under treatment. A positive value indicates an increase in serum ferritin from baseline at treatment day 196. (NCT00293059)
Timeframe: baseline and treatment day 196

Interventionng/mL (Mean)
Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027)5.3
Placebo2.0

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Change From Baseline in Psychological General Well-Being Index (PGWBI) Scores at Treatment Day 84

The PGWBI questionnaire consisted of 22 questions that were answered using a 6-grade Likert scale. The minimum overall score was 22 and the maximum was 132. The higher the score, the better the well being of the participant. The observation phase was the last 4 weeks. The following 6 dimensions were derived from the questionnaire: anxiety, depressed mood, positive well-being, self-control, health, and vitality and the highest possible scores were 30, 18, 24, 18, 18, and 24, respectively. (NCT00293059)
Timeframe: baseline and treatment day 84

InterventionScores on a scale (Mean)
Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027)-1.0
Placebo-0.7

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Change From Baseline in Psychological General Well-Being Index (PGWBI) Scores at Treatment Day 196

The PGWBI questionnaire consisted of 22 questions that were answered using a 6-grade Likert scale. The minimum overall score was 22 and the maximum was 132. The higher the score, the better the well being of the participant. The observation phase was the last 4 weeks. The following 6 dimensions were derived from the questionnaire: anxiety, depressed mood, positive well-being, self-control, health, and vitality and the highest possible scores were 30, 18, 24, 18, 18, and 24, respectively. (NCT00293059)
Timeframe: baseline and treatment day 196

InterventionScores on a scale (Mean)
Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027)0.7
Placebo1.0

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Change From Baseline in Number of Sanitary Protection Used at 90 Days of Treatment

The number of total sanitary protection items used during the 90-day run-in phase before treatment (baseline) and the number of total sanitary protection items used during the 90 days while under treatment was determined. A negative value indicates a reduction in the number of sanitary protection items used while under treatment compared to the number used before treatment. (NCT00293059)
Timeframe: baseline and reference period of 90 days under treatment

InterventionSanitary protection products (Mean)
Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027)-43.6
Placebo-21.2

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Change From Baseline in Number of Bleeding Episodes to the Reference Period of 90 Days Under Treatment

A bleeding episode was one that lasted for at least 2 days, and where the bleeding days were separated by no more than 1 bleeding-free day. An episode stopped with 2 consecutive bleeding-free days. The number of episodes was determined for the 90 days before treatment and for the 90 days under treatment. A negative values indicates a reduction from baseline in the number of episodes while under treatment. (NCT00293059)
Timeframe: baseline and reference period of 90 days under treatment

Interventionbleeding episodes (Mean)
Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027)-0.5
Placebo-0.3

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Change From Baseline in Number of Bleeding Days to the Reference Period of 90 Days Under Treatment

The number of bleeding days was determine for the 90 days before treatment (baseline) and for 90 days while under treatment. A negative value indicates a reduction in the number of bleeding days while under treatment compared to baseline. (NCT00293059)
Timeframe: baseline and reference period of 90 days under treatment

Interventionbleeding days (Mean)
Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027)-5.2
Placebo-2.0

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Change From Baseline in McCoy Female Sexuality Questionnaire (MFSQ) Scores at Treatment Day 84

The MFSQ was designed to measure aspects of female sexuality and asked about the participants' sexual experience during the last 4 weeks. Higher scores represent higher, more complete, or better integrated levels of female sexual function. Minimum and maximum possible values are 19 and 133. (NCT00293059)
Timeframe: baseline and treatment day 84

InterventionScores on a scale (Mean)
Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027)-3.5
Placebo0.8

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Change From Baseline in McCoy Female Sexuality Questionnaire (MFSQ) Scores at Treatment Day 196

The MFSQ was designed to measure aspects of female sexuality and asked about the participants' sexual experience during the last 4 weeks. Higher scores represent higher, more complete, or better integrated levels of female sexual function. Minimum and maximum possible values are 19 and 133. (NCT00293059)
Timeframe: baseline and treatment day 196

InterventionScores on a scale (Mean)
Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027)-2.0
Placebo-0.8

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Change From Baseline in Hemoglobin Concentration at Treatment Day 84

Hemoglobin was measured before treatment and after 84 days under treatment. A positive value indicates an increase in hemoglobin from baseline at treatment day 84. (NCT00293059)
Timeframe: baseline and treatment day 84

Interventiong/dL (Mean)
Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027)0.22
Placebo0.17

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Change From Baseline in Hemoglobin Concentration at Treatment Day 196

Hemoglobin was measured before treatment and after 196 days under treatment. A positive value indicates an increase in hemoglobin from baseline at treatment day 196. (NCT00293059)
Timeframe: baseline and treatment day 196

Interventiong/dL (Mean)
Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027)0.57
Placebo0.20

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Change From Baseline in Hematocrit (Hct) Concentrations at Treatment Day 196

Hematocrit was measured before treatment and after 196 days under treatment. A positive value indicates an increase in hematocrit from baseline at treatment day 196. (NCT00293059)
Timeframe: baseline and treatment day 196

InterventionPercentage of blood volume (Mean)
Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027)1.30
Placebo0.09

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Change From Baseline in EuroQoL (Quality of Life) 5 Dimensional Health Questionnaire (EQ-5D) Scores at Treatment Day 84

The Health State Classification of the EQ-5D comprised 5 questions addressing mobility, self-care, usual activity, pain/discomfort, and anxiety/depression. Participants were asked to indicate their current health state by ticking the most appropriate of 3 statements about each of the questions (ie, no problems, some problems, extreme problems). The best possible answers were (1,1,1,1,1), which equals a valuation score of 1.0. The worst possible answers were (3,3,3,3,3), which equals a valuation score of .594. The change from the baseline score at day 84 is presented. (NCT00293059)
Timeframe: baseline and treatment day 84

Interventionscores on a scale (Mean)
Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027)-0.0035
Placebo-0.0024

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Resource Use Assessment by Use of a Self Administered Questionnaire (Days Missed From Work) at Treatment Day 84

Participants were asked how many days and hours they missed from work during the past 12 weeks because of problems associated with DUB, not including the time missed to participate in this study. (NCT00293059)
Timeframe: treatment day 84

Interventionday (Mean)
Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027)0.4
Placebo0.7

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Change From Baseline in Blood Loss Volume for Participants With Excessive Bleeding to the Reference Period of 90 Days Under Treatment

The blood loss volume for participants with excessive bleeding (2 or more bleeding episodes each with blood loss volume of 80 mL or more during the run-in phase) was determined for the 90 days before treatment (ie, run-in phase) and for the 90 days under treatment. A negative value indicates a reduction in blood loss while under treatment compared to before treatment. (NCT00293059)
Timeframe: baseline and reference period of 90 days under treatment

InterventionmL (Mean)
Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027)-411.9
Placebo-152.3

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Change From Baseline in Blood Loss Volume for All Participants to the Reference Period of 90 Days Under Treatment

Menstrual blood loss was determined using the alkaline hematin method for the 90 days before treatment (baseline) and for 90 days under treatment. A negative value indicates a reduction in blood loss after treatment. (NCT00293059)
Timeframe: Baseline and reference period of 90 days under treatment

InterventionmL (Mean)
Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027)-353.1
Placebo-130.4

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Proportion of Participants Cured From Prolonged Bleeding

Prolonged bleeding was defined as 2 or more bleeding episodes, each lasting 8 or more days in a 90-day period. Participants were considered cured if they had no bleeding episodes lasting more than 7 days and the decrease between the maximum duration during the run-in phase and the maximum duration during the efficacy phase was at least 2 days. (NCT00293059)
Timeframe: during a time period of 90 days under treatment

InterventionProportion of participants (Number)
Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027)0.154
Placebo0.083

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Change From Baseline in Serum Ferritin Concentration at Treatment Day 84

Serum ferritin was measured before treatment and after 84 days under treatment. A positive value indicates an increase in serum ferritin from baseline at treatment day 84. (NCT00293059)
Timeframe: baseline and treatment day 84

Interventionng/mL (Mean)
Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027)0.2
Placebo-1.5

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Change From Baseline in Visual Analogue Scale (VAS) of the EQ-5D Score at Treatment Day 196

"The visual analogue scale (ie, thermometer) had endpoints of 100 (best imaginable health state) at the top, and 0 (worst imaginable health state) at the bottom. Participants rated their current health state by drawing a line from the box marked 'your own health state today' to the appropriate point on the thermometer scale. The change from baseline at day 196 is presented." (NCT00293059)
Timeframe: baseline and treatment day 196

InterventionScores on a scale (Mean)
Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027)-0.07
Placebo-0.51

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Change From Baseline in Visual Analogue Scale (VAS) of the EQ-5D Score at Treatment Day 84

"The visual analogue scale (ie, thermometer) had endpoints of 100 (best imaginable health state) at the top, and 0 (worst imaginable health state) at the bottom. Participants rated their current health state by drawing a line from the box marked 'your own health state today' to the appropriate point on the thermometer scale. The change from baseline at day 84 is presented." (NCT00293059)
Timeframe: baseline and treatment day 84

InterventionScores on a scale (Mean)
Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027)-2.07
Placebo-0.26

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Change in Absolute Value From Baseline MBL to end-of Study MBL

The MBL for each cycle includes intermenstrual bleeding in addition to withdrawal bleeding. Baseline MBL was the mean MBL of measured MBL during three cycles in the run-in Phase. One cycle was defined as 28 days. For this analysis, the run-in Phase was defined by the days 1 to 84 (= 3 cycles each of 28 days). End of Study MBL was measured during Cycle 7 of the Treatment Phase (data imputation and Last Observation Carried Forward was applied). (NCT00293059)
Timeframe: during a time period of 28 days under treatment

InterventionmL (Mean)
Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027)-114.60
Placebo-49.944

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Menstrual Blood Loss Volume for All Participants at Cycle 1

Menstrual blood loss volume was determined using the alkaline hematin method after participants were on treatment for one cycle (NCT00293059)
Timeframe: 28 days

InterventionmL (Mean)
Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027)136.5
Placebo146.9

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Menstrual Blood Loss Volume for All Participants at Cycle 3

Menstrual blood loss volume was determined using the alkaline hematin method after participants were on treatment for 3 cycles (NCT00293059)
Timeframe: 28 days

InterventionmL (Mean)
Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027)59.9
Placebo139.6

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Menstrual Blood Loss Volume for All Participants at Cycle 7

Menstrual blood loss volume was determined using the alkaline hematin methods after participants were on treatment for 7 cycles (NCT00293059)
Timeframe: 28 days

InterventionmL (Mean)
Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027)41.3
Placebo113.3

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Menstrual Blood Loss Volume for Participants With Excessive Bleeding at Cycle 1

The blood loss volume for participants with excessive bleeding (2 or more bleeding episodes each with blood loss volume of 80 mL or more during the run-in phase) was determined using the alkaline hematin method after participants were on treatment for one cycle. (NCT00293059)
Timeframe: 28 days

InterventionmL (Mean)
Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027)206.1
Placebo194.7

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Menstrual Blood Loss Volume for Participants With Excessive Bleeding at Cycle 3

The blood loss volume for participants with excessive bleeding (2 or more bleeding episodes each with blood loss volume of 80 mL or more during the run-in phase) was determined using the alkaline hematin method after participants were on treatment for 3 cycles. (NCT00293059)
Timeframe: 28 days

InterventionmL (Mean)
Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027)67.1
Placebo147.4

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Menstrual Blood Loss Volume for Participants With Excessive Bleeding at Cycle 7

The blood loss volume for participants with excessive bleeding (2 or more bleeding episodes each with blood loss volume of 80 mL or more during the run-in phase) was determined using the alkaline hematin method after participants were on treatment for 7 cycles. (NCT00293059)
Timeframe: 28 days

InterventionmL (Mean)
Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027)47.5
Placebo116.9

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Proportion of Participants Cured From Excessive Bleeding

Excessive bleeding was defined as 2 or more bleeding episodes each with blood loss volume of 80 mL or more in a 90-day period. Participants were considered cured if (1) the blood loss volume associated with each episode was less than 80 mL and (2) the blood loss volume associated with each bleeding episode represented a decrease of at least 50% from the average of the qualifying bleeding episodes, where the qualifying bleeding episodes were those with a blood loss volume ≥ 80 mL (per episode) that occurred during the run-in phase. (NCT00293059)
Timeframe: during a time period of 90 days under treatment

InterventionProportion of participants (Number)
Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027)0.385
Placebo0.05

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Proportion of Participants Cured From Frequent Bleeding

Frequent bleeding was defined as greater than 5 bleeding episodes, with a minimum of 20 bleeding days overall in a 90-day period. Participants were considered cured if they had no more than 4 bleeding episodes and the total number of bleeding days did not exceed 24 days and there was no increase in the total number of bleeding days in the efficacy phase as compared to the run-in phase. (NCT00293059)
Timeframe: during a time period of 90 days under treatment

InterventionProportion of participants (Number)
Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027)0.250
Placebo0.0

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Proportion of Participants With Improvement in the Investigator's Global Assessment Scale at Treatment Day 196

The investigators assessed the participants' change in DUB symptoms at day 196 (visit 11) compared with admission to the study according to a scale of 1 (very much improved) to 7 (very much worse), using the following information: central laboratory data, physical examination, e-diary data, and participant interview. Improvement was defined as being classified as a score of 3 or less. (NCT00293059)
Timeframe: from baseline up to treatment day 196

InterventionProportion of participants (Number)
Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027)0.807
Placebo0.419

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Proportion of Participants With Improvement in the Investigator's Global Assessment Scale at Treatment Day 84

The investigators assessed the participants' change in DUB symptoms at day 84 (visit 7) compared with admission to the study according to a scale of 1 (very much improved) to 7 (very much worse), using the following information: central laboratory data, physical examination, e-diary data, and participant interview. Improvement was defined as being classified as a score of 3 or less. (NCT00293059)
Timeframe: from baseline up to treatment day 84

InterventionProportion of participants (Number)
Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027)0.880
Placebo0.509

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Proportion of Participants With Improvement in the Participant's Overall Assessment Scale at Treatment Day 196

Participants assessed their overall improvement at day 196 (visit 11) compared with their condition at admission to the study on a scale of 1 (very much improved) to 7 (very much worse). Improvement was defined as being classified as a score of 3 or less. (NCT00293059)
Timeframe: from baseline up to treatment day 196

InterventionProportion of participants (Number)
Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027)0.812
Placebo0.383

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Proportion of Participants With Improvement in the Participant's Overall Assessment Scale at Treatment Day 84

Participants assessed their overall improvement at day 84 (visit 7) compared with their condition at admission to the study on a scale of 1 (very much improved) to 7 (very much worse). Improvement was defined as being classified as a score of 3 or less. (NCT00293059)
Timeframe: from baseline up to treatment day 84

InterventionProportion of participants (Number)
Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027)0.835
Placebo0.426

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Proportion of Participants With no Dysfunctional Uterine Bleeding (DUB) Symptoms

Up to 8 criteria had to be met for complete response during 90-day period. No bleeding episodes (BE) >7 days, no >4 BE, no BE with MBL >=80 mL, no >1 BE increase from baseline, no increase from baseline in an individual participant's total number of bleeding days and total number of bleeding days not >24 days. Additionally, for participants included with prolonged bleeding: decrease between maximum duration during run-in and efficacy >=2 days excessive bleeding: MBL associated with each episode decreased by >=50% from average of qualifying episodes during run-in. (NCT00293059)
Timeframe: during a time period of 90 days under treatment

InterventionProportion of participants (Number)
Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027)0.292
Placebo0.029

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Resource Use Assessment by Use of a Self Administered Questionnaire (Additional Unscheduled Procedures) at Treatment Day 196

Participants were asked if they had any unscheduled procedures (eg, laparoscopy, laboratory tests, ultrasound) because of DUB during the past 12 weeks. The proportion of participants with such procedures is displayed. (NCT00293059)
Timeframe: treatment day 196

InterventionProportion of participants (Number)
Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027)0.024
Placebo0.0

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Resource Use Assessment by Use of a Self Administered Questionnaire (Additional Unscheduled Procedures) at Treatment Day 84

Participants were asked if they had any unscheduled procedures (eg, laparoscopy, laboratory tests, ultrasound) because of DUB during the past 12 weeks. The proportion of participants with such procedures is displayed. (NCT00293059)
Timeframe: treatment day 84

InterventionProportion of participants (Number)
Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027)0.012
Placebo0.0

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Resource Use Assessment by Use of a Self Administered Questionnaire (Any Medical Treatment) at Treatment Day 196

Participants were asked if they had any medical treatment (eg, prescribed medication, other treatment) because of DUB during the past 12 weeks. The proportion of participants with such treatment is displayed. (NCT00293059)
Timeframe: treatment day 196

InterventionProportion of participants (Number)
Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027)0.047
Placebo0.043

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Resource Use Assessment by Use of a Self Administered Questionnaire (Any Medical Treatment) at Treatment Day 84

Participants were asked if they had any medical treatment (eg, prescribed medication, other treatment) because of DUB during the past 12 weeks. The proportion of participants with such treatment is displayed. (NCT00293059)
Timeframe: treatment day 84

InterventionProportion of participants (Number)
Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027)0.047
Placebo0.062

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Resource Use Assessment by Use of a Self Administered Questionnaire (Change in the Employment Status) at Treatment Day 196

Participants were asked if there was any change in employment status in the last 12 weeks. The proportion of participants with a change is displayed. (NCT00293059)
Timeframe: treatment day 196

InterventionProportion of participants (Number)
Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027)0.129
Placebo0.213

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Resource Use Assessment by Use of a Self Administered Questionnaire (Change in the Employment Status) at Treatment Day 84

Participants were asked if there was any change in her employment status in the last 12 weeks. The proportion of participants with a change is displayed. (NCT00293059)
Timeframe: treatment day 84

InterventionProportion of participants (Number)
Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027)0.221
Placebo0.106

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Resource Use Assessment by Use of a Self Administered Questionnaire (Days Missed From Work) at Treatment Day 196

Participants were asked how many days and hours were missed from work during the past 12 weeks because of problems associated with DUB, not including the time missed to participate in this study. (NCT00293059)
Timeframe: treatment day 196

Interventiondays (Mean)
Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027)0.2
Placebo0.4

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Resource Use Assessment by Use of a Self Administered Questionnaire (Out-of-pocket Expenses) at Treatment Day 196

Participants were asked to specify out-of-pocket expenses because of DUB during the past 12 weeks, including over-the-counter medication, co-payments due to prescribed medication, and costs to travel to and from medical appointments. The proportion of participants with such expenses is displayed. (NCT00293059)
Timeframe: treatment day 196

InterventionProportion of participants (Number)
Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027)0.241
Placebo0.314

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Resource Use Assessment by Use of a Self Administered Questionnaire (Out-of-pocket Expenses) at Treatment Day 84

Participants were asked to specify if they had out-of-pocket expenses because of DUB during the past 12 weeks, including over-the-counter medication (the name of the medication, the number of packages, and the cost per package), co-payments due to prescribed medication, and costs to travel to and from medical appointments. The proportion of participants with such expenses is displayed. (NCT00293059)
Timeframe: treatment day 84

InterventionProportion of participants (Number)
Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027)0.323
Placebo0.407

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Resource Use Assessment by Use of a Self Administered Questionnaire (Productivity While Working) at Treatment Day 196

Participants were asked to rate on a scale of 0 to 10, how much DUB affected their productivity while working during the past 12 weeks, where 0 represented that DUB had no effect on work and 10 represented that DUB completely prevented her from working. (NCT00293059)
Timeframe: treatment day 196

InterventionScores on a scale (Mean)
Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027)2.40
Placebo4.03

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Resource Use Assessment by Use of a Self Administered Questionnaire (Productivity While Working) at Treatment Day 84

Participants were asked to rate on a scale of 0 to 10, how much their DUB affected productivity while working during the past 12 weeks, where 0 represented that DUB had no effect on work and 10 represented that DUB completely prevented her from working. (NCT00293059)
Timeframe: treatment day 84

InterventionScores on a scale (Mean)
Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027)2.38
Placebo3.07

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Resource Use Assessment by Use of a Self Administered Questionnaire (Received Ambulatory Services) at Treatment Day 196

Participants were asked if they had received ambulatory services (eg, home help, child care) because of DUB during the past 12 weeks. The proportion of participants who had received such services is displayed. (NCT00293059)
Timeframe: treatment day 196

InterventionProportion of participants (Number)
Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027)0.012
Placebo0.0

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Resource Use Assessment by Use of a Self Administered Questionnaire (Received Ambulatory Services) at Treatment Day 84

Participants were asked if they had received ambulatory services (eg, home help, child care) because of DUB during the past 12 weeks. The proportion of participants who received such services is displayed. (NCT00293059)
Timeframe: treatment day 84

InterventionProportion of participants (Number)
Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027)0.0
Placebo0.0

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Resource Use Assessment by Use of a Self Administered Questionnaire (Regular Daily Activities) at Treatment Day 196

Participants were asked to rate on a scale of 0 to 10 how much DUB affected their ability to do regular daily activities, other than work at a job, during the past 12 weeks where 0 represented that DUB had no effect on daily activities and 10 represented that DUB completely prevented her from doing her daily activities. (NCT00293059)
Timeframe: treatment day 196

InterventionScores on a scale (Mean)
Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027)2.48
Placebo4.10

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Resource Use Assessment by Use of a Self Administered Questionnaire (Regular Daily Activities) at Treatment Day 84

Participants were asked to rate on a scale of 0 to 10 how much DUB affected their ability to do their regular daily activities, other than work at a job, during the past 12 weeks where 0 represented that DUB had no effect on daily activities and 10 represented that DUB completely prevented her from doing daily activities. (NCT00293059)
Timeframe: treatment day 84

InterventionScores on a scale (Mean)
Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027)2.81
Placebo3.91

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Resource Use Assessment by Use of a Self Administered Questionnaire (Unscheduled Outpatient Visit at Hospital) at Treatment Day 196

Participants were asked if they had any unscheduled outpatient visits to a hospital because of DUB during the past 12 weeks, not including visits that were due to participation in this study. The proportion of participants with such visits is displayed. (NCT00293059)
Timeframe: treatment day 196

InterventionProportion of participants (Number)
Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027)0.012
Placebo0.0

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Resource Use Assessment by Use of a Self Administered Questionnaire (Unscheduled Outpatient Visit at Hospital) at Treatment Day 84

Participants were asked if they had any unscheduled outpatient visits to a hospital because of DUB during the past 12 weeks, not including visits that were due to participation in this study. The proportion of participants with such visits is displayed. (NCT00293059)
Timeframe: treatment day 84

InterventionProportion of participants (Number)
Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027)0.012
Placebo0.0

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Resource Use Assessment by Use of a Self Administered Questionnaire (Unscheduled Visit to Physician) at Treatment Day 196

Participants were asked if they had any unscheduled visits to a physician (non-hospital medical care) because of DUB during the past 12 weeks, not including visits that were due to participation in this study. The proportion of participants with such visits is displayed. (NCT00293059)
Timeframe: treatment day 196

InterventionProportion of participants (Number)
Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027)0.024
Placebo0.0

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Resource Use Assessment by Use of a Self Administered Questionnaire (Unscheduled Visit to Physician) at Treatment Day 84

Participants were asked if they had any unscheduled visits to a physician (non-hospital medical care) because of DUB during the past 12 weeks, not including visits that were due to participation in this study. The proportion of participants with such visits is displayed. (NCT00293059)
Timeframe: treatment day 84

InterventionProportion of participants (Number)
Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027)0.012
Placebo0.0

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Proportion of Participants With Successful Treatment

End of Study menstrual blood loss (MBL) ≤ 80 mL and a decrease to a value of ≤ 50% of the Baseline MBL was considered as treatment success. (NCT00293059)
Timeframe: during a time period of 28 days under treatment

,
InterventionProportion of participants (Number)
End of study MBL <=80 mLDecrease MBL >=50% of baseline MBLSuccessful treatment
Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027)0.5680.5680.511
Placebo0.1830.2170.133

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Change From Baseline in Psychological General Well-Being Index (PGWBI) Score at Treatment Day 84.

The PGWBI questionnaire consisted of 22 questions that were answered using a 6-grade Likert scale. The minimum overall score was 22 and the maximum 132. The higher the score, the better the well-being of the patient. The observation phase was the last 4 weeks. The following 6 dimensions were derived from the questionnaire: anxiety, depressed mood, positive well-being, self-control, health, and vitality and the highest possible scores were 30, 18, 24, 18, 18, and 24, respectively. (NCT00307801)
Timeframe: Baseline (visit 5, day 1) and treatment day 84

InterventionScores on a scale (Mean)
Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027)-1.2
Placebo2.2

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Change From Baseline in Psychological General Well-Being Index (PGWBI) Score at Treatment Day 196.

The PGWBI questionnaire consisted of 22 questions that were answered using a 6-grade Likert scale. The minimum overall score was 22 and the maximum 132. The higher the score, the better the well-being of the patient. The observation phase was the last 4 weeks. The following 6 dimensions were derived from the questionnaire: anxiety, depressed mood, positive well-being, self-control, health, and vitality and the highest possible scores were 30, 18, 24, 18, 18, and 24, respectively. (NCT00307801)
Timeframe: Baseline (visit 5, day 1) and treatment day 196

InterventionScores on a scale (Mean)
Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027)-2.3
Placebo4.6

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Change From Baseline in Number of Sanitary Protection Used at 90 Days of Treatment

The number of total sanitary protection items used during the 90 days before treatment (baseline) and those used during the 90 days while under treatment was determined. A negative value indicates a reduction in the number of sanitary protection items used while under treatment compared to baseline. (NCT00307801)
Timeframe: Baseline and reference period of 90 days under treatment. For patients who completed up to day 6 of treatment cycle 7, the efficacy phase started on the first day of treatment cycle 4, and continued through day 6 of treatment cycle 7

InterventionSanitary protection products (Mean)
Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027)-38.4
Placebo-16.5

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Change From Baseline in Number of Bleeding Episodes to the Reference Period of 90 Days Under Treatment

A bleeding episode is characterized by the following: • Bleeding for at least 2 days • Bleeding days can be separated by no more than 1 bleeding-free day • An episode stops with 2 consecutive bleeding-free days. The number of episodes was determined for the 90 days before treatment and for the 90 days under treatment. negative value indicates a reduction from baseline in the number of episodes while under treatment. (NCT00307801)
Timeframe: Baseline and reference period of 90 days under treatment. For patients who completed up to day 6 of treatment cycle 7, the efficacy phase started on the first day of treatment cycle 4, and continued through day 6 of treatment cycle 7

InterventionBleeding episodes (Mean)
Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027)-0.35
Placebo-0.38

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Change From Baseline in Number of Bleeding Days to the Reference Period of 90 Days Under Treatment

A bleeding day is a day on which sanitary protection is required. The number of bleeding days was determined for the 90 days before treatment (baseline) and for 90 days while under treatment. A negative value indicates a reduction in the number of bleeding days while under treatment compared to baseline. (NCT00307801)
Timeframe: Baseline and reference period of 90 days under treatment. For patients who completed up to day 6 of treatment cycle 7, the efficacy phase started on the first day of treatment cycle 4, and continued through day 6 of treatment cycle 7

InterventionBleeding days (Mean)
Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027)-5.13
Placebo-3.08

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Change From Baseline in McCoy Female Sexuality Questionnaire (MFSQ) Score at Treatment Day 84

The MFSQ was designed to measure aspects of female sexuality and asked about the patients´sexual experience during the last 4 weeks. Higher scores represent higher, more complete, or better integrated levels of female sexual function. Minimum and maximum values are 19 and 133. (NCT00307801)
Timeframe: Baseline (visit 5, day 1) and treatment day 84

InterventionScores on a scale (Mean)
Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027)-1.2
Placebo0.4

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Change From Baseline in McCoy Female Sexuality Questionnaire (MFSQ) Score at Treatment Day 196

The MFSQ was designed to measure aspects of female sexuality and asked about the patients´sexual experience during the last 4 weeks. Higher scores represent higher, more complete, or better integrated levels of female sexual function. Minimum and maximum values are 19 and 133. (NCT00307801)
Timeframe: Baseline (visit 5, day 1) and treatment day 196

InterventionScores on a scale (Mean)
Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027)-4.9
Placebo-2.4

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Change From Baseline in Hemoglobin Concentration at Treatment Day 84

Hemoglobin was measured before treatment and after 84 days under treatment. A positive value indicates an increase in hemoglobin from baseline at treatment day 84. (NCT00307801)
Timeframe: Baseline (visit 5) and treatment day 84

Interventiong/dL (Mean)
Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027)0.36
Placebo0.12

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Change From Baseline in Hemoglobin Concentration at Treatment Day 196

Hemoglobin was measured before treatment and after 196 days under treatment. A positive value indicates an increase in hemoglobin from baseline at treatment day 196. (NCT00307801)
Timeframe: Baseline (visit 5) and treatment day 196

Interventiong/dL (Mean)
Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027)0.70
Placebo0.06

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Change From Baseline in Hematocrit at Treatment Day 196.

Hematocrit was measured before treatment and after 196 days under treatment. A positive value indicates an increase in hematocrit from baseline at treatment day 196. (NCT00307801)
Timeframe: Baseline (visit 5) and treatment day 196

Interventionng/mL (Mean)
Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027)1.63
Placebo0.08

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Change From Baseline in Ferritin Concentration at Treatment Day 84

Ferritin was measured before treatment and after 84 days under treatment. A positive value indicates an increase in ferritin from baseline at treatment day 84. (NCT00307801)
Timeframe: Baseline (visit 5, day 1) and treatment day 84

Interventionng/mL (Mean)
Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027)2.8
Placebo0.0

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Change From Baseline in Ferritin Concentration at Treatment Day 196

Ferritin was measured before treatment and after 196 days under treatment. A positive value indicates an increase in ferritin from baseline at treatment day 196. (NCT00307801)
Timeframe: Baseline (visit 5, day 1) and treatment day 196

Interventionng/mL (Mean)
Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027)8.6
Placebo0.5

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Change From Baseline in EuroQol 5 Dimensional (EQ-5D) Score at Treatment Day 196

The health state classification of the EQ-5D comprises 5 questions addressing mobility, self-care, usual activity, pain/discomfort, and anxiety/depression. Patients were asked to indicate their current health state by ticking the most appropriate of 3 statements about each of the questions (ie, no problems, some problems, extreme problems). The best possible answers were (1,1,1,1,1), which equals a valuation score of 1.0. The worst possible answers were (3,3,3,3,3), which equals a score of .594. (NCT00307801)
Timeframe: Baseline (visit 5, day 1) and treatment day 196

InterventionScores on a scale (Mean)
Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027)-0.0191
Placebo0.0116

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Change From Baseline in Blood Loss Volume for Participants With Excessive Bleeding to the Reference Period of 90 Days Under Treatment.

Blood loss volume as assessed by the alkaline hematin method for participants with excessive bleeding (2 or more bleeding episodes each with blood loss volume of 80 ml or more during the run-in phase) for the 90 days before treatment (ie, run-in phase) and for the 90 days under treatment. A negative value indicates a reduction in blood loss while under treatment compared to before treatment. (NCT00307801)
Timeframe: Baseline and reference period of 90 days under treatment. For patients who completed up to day 6 of treatment cycle 7, the efficacy phase started on the first day of treatment cycle 4, and continued through day 6 of treatment cycle 7

Interventionml (Mean)
Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027)-480.6
Placebo-94.2

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Change From Baseline in Blood Loss Volume for All Participants to the Reference Period of 90 Days Under Treatment

Menstrual blood loss volume as assessed by the alkaline hematin method for the 90 days before treatment (baseline) and for 90 days under treatment. This spectrophotometrical method measures hemoglobin (Hb) in fixed amount of alkaline solution, taken from pool of solution in which materials (used sanitary protection) to be tested have been macerated for Hb extraction. A negative value indicates a reduction in blood loss after treatment. (NCT00307801)
Timeframe: Baseline and reference period of 90 days under treatment. For patients who completed up to day 6 of treatment cycle 7, the efficacy phase started on the first day of treatment cycle 4, and continued through day 6 of treatment cycle 7

Interventionml (Mean)
Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027)-458.4
Placebo-93.2

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Proportion of Participants With Successful Treatment

End of Study menstrual blood loss (MBL) ≤ 80 mL and a decrease to a value of ≤ 50% of the Baseline MBL was considered as treatment success. (NCT00307801)
Timeframe: during a time period of 28 days under treatment

,
InterventionProportion of participants (Number)
End of study MBL <=80 mLDecrease MBL >=50% of baseline MBLSuccessful treatment
Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027)0.7580.7880.720
Placebo0.1330.1330.107

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Resource Use Assessment by Use of a Self Administered Questionnaire (Unscheduled Outpatient Visit to Physician) at Treatment Day 84

The patient was asked if she had any unscheduled outpatient visits to a physician (non-hospital medical care) because of her DUB during the past 12 weeks, not including visits that were due to her participation in this study. She was also asked to indicate the number of visits. The proportion of participants with such visits are displayed. (NCT00307801)
Timeframe: Treatment day 84

InterventionProportion of participants (Number)
Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027)0.058
Placebo0.031

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Resource Use Assessment by Use of a Self Administered Questionnaire (Unscheduled Outpatient Visit to Physician) at Treatment Day 196

The patient was asked if she had any unscheduled outpatient visits to a physician (non-hospital medical care) because of her DUB during the past 12 weeks, not including visits that were due to her participation in this study. She was also asked to indicate the number of visits. The proportion of participants with such visits are displayed. (NCT00307801)
Timeframe: Treatment day 196

InterventionProportion of participants (Number)
Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027)0.031
Placebo0.015

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Resource Use Assessment by Use of a Self Administered Questionnaire (Unscheduled Outpatient Visit at Hospital) at Treatment Day 84

The patient was asked if she had any unscheduled outpatient visits to a hospital because of her DUB during the past 12 weeks, not including visits that were due to her participation in this study. She was also asked to indicate the number of visits. The proportion of participants with any unscheduled outpatient visits are displayed. (NCT00307801)
Timeframe: Treatment day 84

InterventionProportion of participants (Number)
Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027)0.008
Placebo0.0

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Resource Use Assessment by Use of a Self Administered Questionnaire (Unscheduled Outpatient Visit at Hospital) at Treatment Day 196

The patient was asked if she had any unscheduled outpatient visits to a hospital because of her DUB during the past 12 weeks, not including visits that were due to her participation in this study. She was also asked to indicate the number of visits. The proportion of participants with any unscheduled outpatient visits are displayed. (NCT00307801)
Timeframe: Treatment day 196

InterventionProportion of participants (Number)
Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027)0.008
Placebo0.0

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Resource Use Assessment by Use of a Self Administered Questionnaire (Regular Daily Activities) at Treatment Day 84

The patient was asked to rate on a scale of 0 to 10, how much her DUB affected her ability to do her regular daily activities, other than work at a job, during the past 12 weeks, where 0 represented that her DUB had no effect on her daily activities and 10 represented that her DUB completely prevented her from doing her daily activities. (NCT00307801)
Timeframe: Treatment day 84

InterventionScores on a scale (Mean)
Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027)2.1
Placebo3.2

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Resource Use Assessment by Use of a Self Administered Questionnaire (Regular Daily Activities) at Treatment Day 196.

The patient was asked to rate on a scale of 0 to 10, how much her DUB affected her ability to do her regular daily activities, other than work at a job, during the past 12 weeks, where 0 represented that her DUB had no effect on her daily activities and 10 represented that her DUB completely prevented her from doing her daily activities. (NCT00307801)
Timeframe: Treatment day 196

InterventionScores on a scale (Mean)
Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027)2.0
Placebo3.2

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Resource Use Assessment by Use of a Self Administered Questionnaire (Received Ambulatory Services) at Treatment Day 84

The patient was asked if she received ambulatory services (eg, home help, child care) because of her DUB during the past 12 weeks, and if yes, how many hours per week. The proportion of participants with such services are displayed. (NCT00307801)
Timeframe: Treatment day 84

InterventionProportion of participants (Number)
Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027)0.0
Placebo0.0

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Resource Use Assessment by Use of a Self Administered Questionnaire (Received Ambulatory Services) at Treatment Day 196

The patient was asked if she received ambulatory services (eg, home help, child care) because of her DUB during the past 12 weeks, and if yes, how many hours per week. The proportion of participants with such services are displayed. (NCT00307801)
Timeframe: Treatment day 196

InterventionProportion of participants (Number)
Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027)0.0
Placebo0.0

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Resource Use Assessment by Use of a Self Administered Questionnaire (Productivity While Working) at Treatment Day 196.

The patient was asked to rate on a scale of 0 to 10, how much her DUB affected her productivity while she was working during the past 12 weeks, where 0 represented that her DUB had no effect on her work and 10 represented that her DUB completely prevented her from working. (NCT00307801)
Timeframe: Treatment day 196

InterventionScores on a scale (Mean)
Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027)1.8
Placebo3.1

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Resource Use Assessment by Use of a Self Administered Questionnaire (Not Have Any Medical Treatment) at Treatment Day 84

The patient was asked if she had any medical treatment (eg, prescribed medication, other treatment) because of her DUB during the past 12 weeks, and to specify the cost. The proportion of participants with such treatment are displayed. (NCT00307801)
Timeframe: Treatment day 84

InterventionProportion of participants (Number)
Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027)0.966
Placebo0.954

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Resource Use Assessment by Use of a Self Administered Questionnaire (Not Have Any Medical Treatment) at Treatment Day 196

The patient was asked if she had any medical treatment (eg, prescribed medication, other treatment) because of her DUB during the past 12 weeks, and to specify the cost. The proportion of participants with such treatment are displayed. (NCT00307801)
Timeframe: Treatment day 196

InterventionProportion of participants (Number)
Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027)0.977
Placebo0.985

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Resource Use Assessment by Use of a Self Administered Questionnaire (no Out-of-pocket Expenses) at Treatment Day 84

The patient was asked to specify her out-of pocket expenses because of her DUB during the past 12 weeks, including over-the-counter medication (the name of the medication, the number of packages, and the cost per package), co-payments due to prescribed medication, and costs to travel to and from medical appointments. The proportion of participants with no out-of pocket expenses are displayed. (NCT00307801)
Timeframe: Treatment day 84

InterventionProportion of participants (Number)
Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027)0.855
Placebo0.881

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Resource Use Assessment by Use of a Self Administered Questionnaire (no Out-of-pocket Expenses) at Treatment Day 196

The patient was asked to specify her out-of pocket expenses because of her DUB during the past 12 weeks, including over-the-counter medication (the name of the medication, the number of packages, and the cost per package), co-payments due to prescribed medication, and costs to travel to and from medical appointments. The proportion of participants with no out-of pocket expenses are displayed. (NCT00307801)
Timeframe: Treatment day 196

InterventionProportion of participants (Number)
Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027)0.920
Placebo0.879

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Resource Use Assessment by Use of a Self Administered Questionnaire (Days Missed From Work) at Treatment Day 84

The patient was asked how many days and hours she missed from work during the past 12 weeks because of her problems associated with her DUB, not including the time missed to participate in this study. (NCT00307801)
Timeframe: Treatment day 84

Interventiondays (Mean)
Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027)0.14
Placebo0.27

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Resource Use Assessment by Use of a Self Administered Questionnaire (Days Missed From Work) at Treatment Day 196

The patient was asked how many days and hours she missed from work during the past 12 weeks because of her problems associated with her DUB, not including the time missed to participate in this study. (NCT00307801)
Timeframe: Treatment day 196

Interventiondays (Mean)
Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027)0.13
Placebo0.52

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Resource Use Assessment by Use of a Self Administered Questionnaire (Change in the Employment Status) at Treatment Day 84.

The patient was asked if there was any change in her employment status in the last 12 weeks and was asked to specify the number of hours per week. The proportion of participants with such changes are displayed. (NCT00307801)
Timeframe: Treatment day 84

InterventionProportion of participants (Number)
Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027)0.095
Placebo0.152

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Resource Use Assessment by Use of a Self Administered Questionnaire (Change in the Employment Status) at Treatment Day 196.

The patient was asked if there was any change in her employment status in the last 12 weeks and was asked to specify the number of hours per week. The proportion of participants with such changes are displayed. (NCT00307801)
Timeframe: Treatment day 196

InterventionProportion of participants (Number)
Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027)0.098
Placebo0.087

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Resource Use Assessment by Use of a Self Administered Questionnaire (Additional Unscheduled Procedures) at Treatment Day 84

The patient was asked if she had any unscheduled procedures (eg, laparoscopy, laboratory tests, ultrasound) because of her DUB during the past 12 weeks. The proportion of participants with such procedures are displayed. (NCT00307801)
Timeframe: Treatment day 84

InterventionProportion of participants (Number)
Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027)0.0
Placebo0.0

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Resource Use Assessment by Use of a Self Administered Questionnaire (Additional Unscheduled Procedures) at Treatment Day 196

The patient was asked if she had any unscheduled procedures (eg, laparoscopy, laboratory tests, ultrasound) because of her DUB during the past 12 weeks. The proportion of participants with such procedures are displayed. (NCT00307801)
Timeframe: Treatment day 196

InterventionProportion of participants (Number)
Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027)0.0
Placebo0.0

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Resource Use Assessment by Use of a Self Administered Questionnaire (Productivity While Working) at Treatment Day 84.

The patient was asked to rate on a scale of 0 to 10, how much her DUB affected her productivity while she was working during the past 12 weeks, where 0 represented that her DUB had no effect on her work and 10 represented that her DUB completely prevented her from working. (NCT00307801)
Timeframe: Treatment day 84

InterventionScores on a scale (Mean)
Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027)2.0
Placebo3.1

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Proportion of Participants With no Dysfunctional Uterine Bleeding (DUB) Symptoms

At least 6, up to 8 criteria to be met in complete response during 90-day period: no bleeding episodes(BE) >7 days, no >4 BE, no BE with blood loss (menstrual blood loss, MBL) ≥80 mL, no >1 BE increase from baseline, no increase from baseline in individual patient's total number of bleeding days and total number of bleeding days not >24 days. Additionally, for subjects included with prolonged bleeding: decrease between maximum duration during run-in and efficacy ≥2 days excessive bleeding: MBL associated with each episode decreased by ≥50% from average of qualifying episodes during run-in. (NCT00307801)
Timeframe: Efficacy phase was defined as a 90-day period under treatment. For patients who completed up to day 6 of treatment cycle 7, the efficacy phase started on the first day of treatment cycle 4, and continued through day 6 of treatment cycle 7

InterventionProportion of participants (Number)
Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027)0.295
Placebo0.012

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Proportion of Participants With Improvement in the Patient's Overall Assessment Scale at Treatment Day 84

"According to the patient's global assessment scale improved was defined as being classified as 'very much improved', 'much improved', or 'improved' and not improved was defined as being classified as 'no change', 'worse', 'much worse', 'very much worse', or 'not assessed'. Patients assessed the overall improvement at day 84 compared with admission to the study condition." (NCT00307801)
Timeframe: From baseline (visit 5, day 1) up to treatment day 84

InterventionProportion of participants (Number)
Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027)0.724
Placebo0.529

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Proportion of Participants With Improvement in the Patient's Overall Assessment Scale at Treatment Day 196

"According to the patient´s global assessment scale improved was defined as being classified as 'very much improved', 'much improved', or 'improved' and not improved was defined as being classified as 'no change', 'worse', 'much worse', 'very much worse', or 'not assessed'. Patients assessed the overall improvement at day 196 compared with admission to the study condition." (NCT00307801)
Timeframe: From baseline (visit 5, day 1) up to treatment day 196

InterventionProportion of participants (Number)
Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027)0.779
Placebo0.451

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Change From Baseline in Visual Analogue Scale (VAS) of the EQ-5D Score at Treatment Day 196.

"The visual analogue scale (ie, thermometer) had endpoints of 100 (best imaginable health state) at the top, and 0 (worst imaginable health state) at the bottom. Patients rated their current health state by drawing a line from the box marked your own health state today to the appropriate point on the thermometer scale." (NCT00307801)
Timeframe: Baseline (visit 5, day 1) and treatment day 196

InterventionScores on a scale (Mean)
Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027)-3.00
Placebo2.69

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Proportion of Participants With Improvement in the Investigator's Global Assessment Scale at Treatment Day 84

"According to the investigator's global assessment scale improved was defined as being classified as 'very much improved', 'much improved', or 'improved' and not improved was defined as being classified as 'no change', 'worse', 'much worse', 'very much worse', or 'not assessed'. Central laboratory data, physical examination, e-diary data, and patient interview were used as sources for the assessment at day 84 compared with admission to study data." (NCT00307801)
Timeframe: From baseline (visit 5, day 1) up to treatment day 84

InterventionProportion of participants (Number)
Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027)0.838
Placebo0.394

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Proportion of Participants With Improvement in the Investigator's Global Assessment Scale at Treatment Day 196

"According to the investigator's global assessment scale improved was defined as being classified as 'very much improved', 'much improved', or 'improved' and not improved was defined as being classified as 'no change', 'worse', 'much worse', 'very much worse', or 'not assessed'. Central laboratory data, physical examination, e-diary data, and patient interview were used as sources for the assessment at day 196 compared with admission to study data." (NCT00307801)
Timeframe: From baseline (visit 5, day 1) up to treatment day 196

InterventionProportion of participants (Number)
Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027)0.847
Placebo0.395

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Proportion of Participants Cured From Prolonged Bleeding

Prolonged bleeding: 2 or more bleeding episodes, each lasting 8 or more days. Cure from prolonged bleeding: no bleeding episodes lasting more than 7 days and the decrease between maximum duration during run-in and maximum duration during the efficacy phase was at least 2 days. (NCT00307801)
Timeframe: Efficacy phase was defined as a 90-day period under treatment. For patients who completed up to day 6 of treatment cycle 7, the efficacy phase started on the first day of treatment cycle 4, and continued through day 6 of treatment cycle 7

InterventionProportion of participants (Number)
Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027)0.350
Placebo0.100

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Proportion of Participants Cured From Excessive Bleeding

Excessive bleeding:>=2 bleeding episodes each with blood loss volume (MBL) of >=80 mL in 90-day period, assessed by alkaline hematin method. This spectrophotometrical method measures hemoglobin (Hb) in fixed amount of alkaline solution, taken from pool of solution in which materials (used sanitary protection) to be tested have been macerated for Hb extraction. Cure from excessive bleeding: MBL in each episode <80 mL + blood loss volume associated with each bleeding episode is decrease of ≥50% from average of qualifying bleeding episodes (with blood loss volume ≥80 mL per episode during run-in) (NCT00307801)
Timeframe: Efficacy phase was defined as a 90-day period under treatment. For patients who completed up to day 6 of treatment cycle 7, the efficacy phase started on the first day of treatment cycle 4, and continued through day 6 of treatment cycle 7

InterventionProportion of participants (Number)
Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027)0.441
Placebo0.013

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Menstrual Blood Loss Volume for Participants With Excessive Bleeding at Cycle 7.

Blood loss volume as assessed by the alkaline hematin method for participants with excessive bleeding (2 or more bleeding episodes each with blood loss volume of 80 ml or more during the run-in phase) after participants were on treatment for 7 cycles. This spectrophotometrical method measures hemoglobin (Hb) in fixed amount of alkaline solution, taken from pool of solution in which materials (used sanitary protection) to be tested have been macerated for Hb extraction. (NCT00307801)
Timeframe: Cycle 7 = 28 days (one cycle)

Interventionml (Mean)
Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027)46.7
Placebo168.6

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Menstrual Blood Loss Volume for Participants With Excessive Bleeding at Cycle 3.

Blood loss volume as assessed by the alkaline hematin method for participants with excessive bleeding (2 or more bleeding episodes each with blood loss volume of 80 ml or more during the run-in phase) after participants were on treatment for 3 cycles. This spectrophotometrical method measures hemoglobin (Hb) in fixed amount of alkaline solution, taken from pool of solution in which materials (used sanitary protection) to be tested have been macerated for Hb extraction. (NCT00307801)
Timeframe: Cycle 3 = 28 days (one cycle)

Interventionml (Mean)
Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027)72.1
Placebo188.4

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Menstrual Blood Loss Volume for Participants With Excessive Bleeding at Cycle 1.

Blood loss volume as assessed by the alkaline hematin method for participants with excessive bleeding (2 or more bleeding episodes each with blood loss volume of 80 ml or more during the run-in phase) after participants were on treatment for one cycle. This spectrophotometrical method measures hemoglobin (Hb) in fixed amount of alkaline solution, taken from pool of solution in which materials (used sanitary protection) to be tested have been macerated for Hb extraction. (NCT00307801)
Timeframe: Cycle 1 = 28 days (one cycle)

Interventionml (Mean)
Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027)207.8
Placebo238.9

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Menstrual Blood Loss Volume for All Participants at Cycle 7

Menstrual blood loss volume as assessed by the alkaline hematin method after patients were on treatment for 7 cycles. This spectrophotometrical method measures hemoglobin (Hb) in fixed amount of alkaline solution, taken from pool of solution in which materials (used sanitary protection) to be tested have been macerated for Hb extraction. (NCT00307801)
Timeframe: Cycle 7 = 28 days (one cycle)

Interventionml (Mean)
Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027)44.6
Placebo167.2

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Menstrual Blood Loss Volume for All Participants at Cycle 3

Menstrual blood loss volume as assessed by the alkaline hematin method after patients were on treatment for 3 cycles. This spectrophotometrical method measures hemoglobin (Hb) in fixed amount of alkaline solution, taken from pool of solution in which materials (used sanitary protection) to be tested have been macerated for Hb extraction. (NCT00307801)
Timeframe: Cycle 3 = 28 days (one cycle)

Interventionml (Mean)
Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027)68.3
Placebo195.1

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Menstrual Blood Loss Volume for All Participants at Cycle 1

Menstrual blood loss volume as assessed by the alkaline hematin method after patients were on treatment for one cycle. This spectrophotometrical method measures hemoglobin (Hb) in fixed amount of alkaline solution, taken from pool of solution in which materials (used sanitary protection) to be tested have been macerated for Hb extraction. (NCT00307801)
Timeframe: Cycle 1 = 28 days (one cycle)

Interventionml (Mean)
Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027)175.6
Placebo194.3

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Change in Absolute Value From Baseline Menstrual Blood Loss (MBL) to end-of Study MBL

The MBL for each cycle includes intermenstrual bleeding in addition to withdrawal bleeding. Baseline MBL was the mean MBL of measured MBL during three cycles in the run-in Phase. One cycle was defined as 28 days. For this analysis, the run-in Phase was defined by the days 1 to 84 (= 3 cycles each of 28 days). End of Study MBL was measured during Cycle 7 of the Treatment Phase (data imputation and Last Observation Carried Forward was applied). (NCT00307801)
Timeframe: during a time period of 28 days under treatment

InterventionmL (Mean)
Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027)-169.94
Placebo4.628

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Change From Baseline in Visual Analogue Scale (VAS) of the EQ-5D Score at Treatment Day 84.

"The visual analogue scale (ie, thermometer) had endpoints of 100 (best imaginable health state) at the top, and 0 (worst imaginable health state) at the bottom. Patients rated their current health state by drawing a line from the box marked your own health state today to the appropriate point on the thermometer scale." (NCT00307801)
Timeframe: Baseline (visit 5, day 1) and treatment day 84

InterventionScores on a scale (Mean)
Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027)-1.63
Placebo0.62

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Change From Baseline in EuroQol 5 Dimensional (EQ-5D) Score at Treatment Day 84

The health state classification of the EQ-5D comprises 5 questions addressing mobility, self-care, usual activity, pain/discomfort, and anxiety/depression. Patients were asked to indicate their current health state by ticking the most appropriate of 3 statements about each of the questions (ie, no problems, some problems, extreme problems). The best possible answers were (1,1,1,1,1), which equals a valuation score of 1.0. The worst possible answers were (3,3,3,3,3), which equals a score of .594. (NCT00307801)
Timeframe: Baseline (visit 5, day 1) and treatment day 84

InterventionScores on a scale (Mean)
Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027)-0.0041
Placebo0.0082

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Mean Change From Baseline to Cycle 13 in Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) - Social Relationship

Change from Baseline to Cycle 13 in the overall enjoyment and satisfaction experienced during the past week as scored on the Q-LES-Q (social relationship - 11 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). (NCT00754065)
Timeframe: Baseline up to Cycle 13 (28 days per Cycle)

InterventionScores on a scale (Mean)
Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)1.01
Ortho Tri-Cyclen Lo1.75

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Mean Change From Baseline to Cycle 13 in Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) - Work

Change from Baseline to Cycle 13 in the overall enjoyment and satisfaction experienced during the past week as scored on the Q-LES-Q (work - yes or no; if yes, then 4 choices, and 13 items with a scale of 1-5 [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). (NCT00754065)
Timeframe: Baseline up to Cycle 13 (28 days per Cycle)

InterventionScores on a scale (Mean)
Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)-1.38
Ortho Tri-Cyclen Lo-1.71

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Mean Change From Baseline to Cycle 6 in Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) - General Activities

Change from Baseline to Cycle 6 in the overall enjoyment and satisfaction experienced during the past week as scored on the Q-LES-Q (general activities - 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). (NCT00754065)
Timeframe: Baseline up to Cycle 6 (28 days per Cycle)

InterventionScores on a scale (Mean)
Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)0.56
Ortho Tri-Cyclen Lo1.27

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Mean Change From Baseline to Cycle 6 in Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) - Household Duties

Change from Baseline to Cycle 6 in the overall enjoyment and satisfaction experienced during the past week as scored on the Q-LES-Q (household duties - yes or no; if yes, then 4 choices, and 10 items with a scale of 1-5 [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). (NCT00754065)
Timeframe: Baseline up to Cycle 6 (28 days per Cycle)

InterventionScores on a scale (Mean)
Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)1.50
Ortho Tri-Cyclen Lo3.08

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

Change from Baseline to Cycle 6 in the overall enjoyment and satisfaction experienced during the past week as scored on the Q-LES-Q (item satisfaction). 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). (NCT00754065)
Timeframe: Baseline up to Cycle 6 (28 days per Cycle)

InterventionScores on a scale (Mean)
Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)-0.1
Ortho Tri-Cyclen Lo0.1

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Mean Change From Baseline to Cycle 6 in Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) - Leisure Time Activities

Change from Baseline to Cycle 6 in the overall enjoyment and satisfaction experienced during the past week as scored on the Q-LES-Q (leisure time activities - 6 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). (NCT00754065)
Timeframe: Baseline up to Cycle 6 (28 days per Cycle)

InterventionScores on a scale (Mean)
Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)1.22
Ortho Tri-Cyclen Lo2.77

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Mean Change From Baseline to Cycle 6 in Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) - Overall Life Satisfaction and Contentment

Change from Baseline to Cycle 6 in the overall enjoyment and satisfaction experienced during the past week as scored on the Q-LES-Q (overall life satisfaction and contentment). 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). (NCT00754065)
Timeframe: Baseline up to Cycle 6 (28 days per Cycle)

InterventionScores on a scale (Mean)
Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)-0.1
Ortho Tri-Cyclen Lo0.0

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Mean Change From Baseline to Cycle 6 in Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) - Participant Feeling

Change from Baseline to Cycle 6 in the overall enjoyment and satisfaction experienced during the past week as scored on the Q-LES-Q (participant feeling - 14 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). (NCT00754065)
Timeframe: Baseline up to Cycle 6 (28 days per Cycle)

InterventionScores on a scale (Mean)
Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)0.12
Ortho Tri-Cyclen Lo2.19

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Mean Change From Baseline to Cycle 6 in Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) - School/Course Work

Change from Baseline to Cycle 6 in the overall enjoyment and satisfaction experienced during the past week as scored on the Q-LES-Q (school / course work - yes or no; if yes, then 4 choices, and 10 items with a scale of 1-5 (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). (NCT00754065)
Timeframe: Baseline up to Cycle 6 (28 days per Cycle)

InterventionScores on a scale (Mean)
Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)-0.18
Ortho Tri-Cyclen Lo5.13

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Mean Change From Baseline to Cycle 6 in Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) - Social Relationship

Change from Baseline to Cycle 6 in the overall enjoyment and satisfaction experienced during the past week as scored on the Q-LES-Q (social relationship - 11 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). (NCT00754065)
Timeframe: Baseline up to Cycle 6 (28 days per Cycle)

InterventionScores on a scale (Mean)
Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)-0.30
Ortho Tri-Cyclen Lo0.41

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

Change from Baseline to Cycle 6 in the overall enjoyment and satisfaction experienced during the past week as scored on the Q-LES-Q (work - yes or no; if yes, then 4 choices, and 13 items with a scale of 1-5 [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). (NCT00754065)
Timeframe: Baseline up to Cycle 6 (28 days per Cycle)

InterventionScores on a scale (Mean)
Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)0.54
Ortho Tri-Cyclen Lo0.08

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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. (NCT00754065)
Timeframe: From Day 1 to Day 90

InterventionDays (Mean)
Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)4.82
Ortho Tri-Cyclen Lo6.20

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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. (NCT00754065)
Timeframe: From Day 91 to Day 180

InterventionDays (Mean)
Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)4.46
Ortho Tri-Cyclen Lo5.71

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Mean Length of Bleeding / Spotting Episodes in Reference Period 3

Reference Period 3 is defined as Day 181 to Day 270 during study treatment. (NCT00754065)
Timeframe: From Day 181 to Day 270

InterventionDays (Mean)
Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)4.70
Ortho Tri-Cyclen Lo5.85

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Mean Length of Bleeding / Spotting Episodes in Reference Period 4

Reference Period 4 is defined as Day 271 to Day 360 during study treatment. (NCT00754065)
Timeframe: From Day 271 to Day 360

InterventionDays (Mean)
Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)4.25
Ortho Tri-Cyclen Lo5.65

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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. (NCT00754065)
Timeframe: From Day 1 to Day 90

InterventionDays (Mean)
Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)2.64
Ortho Tri-Cyclen Lo2.53

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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. (NCT00754065)
Timeframe: From Day 91 to Day 180

InterventionDays (Mean)
Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)2.74
Ortho Tri-Cyclen Lo2.77

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Mean Length of Spotting-only Episodes in Reference Period 3

Reference Period 3 is defined as Day 181 to Day 270 during study treatment. (NCT00754065)
Timeframe: From Day 181 to Day 270

InterventionDays (Mean)
Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)2.75
Ortho Tri-Cyclen Lo2.44

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Mean Length of Spotting-only Episodes in Reference Period 4

Reference Period 4 is defined as Day 271 to Day 360 during study treatment. (NCT00754065)
Timeframe: From Day 271 to Day 360

InterventionDays (Mean)
Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)2.77
Ortho Tri-Cyclen Lo2.10

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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 first treatment cycle includes 2 bleeding episodes. (Episode is a set of days with bleeding/spotting) (NCT00754065)
Timeframe: From Day 1 to Day 90

InterventionEpisodes (Mean)
Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)3.6
Ortho Tri-Cyclen Lo3.7

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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. (Episode is a set of days with bleeding/spotting) (NCT00754065)
Timeframe: From Day 91 to Day 180

InterventionEpisodes (Mean)
Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)3.3
Ortho Tri-Cyclen Lo3.4

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Number of Bleeding / Spotting Episodes in Reference Period 3

Reference Period 3 is defined as Day 181 to Day 270 during study treatment. (Episode is a set of days with bleeding/spotting) (NCT00754065)
Timeframe: From Day 181 to Day 270

InterventionEpisodes (Mean)
Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)3.0
Ortho Tri-Cyclen Lo3.3

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Number of Bleeding / Spotting Episodes in Reference Period 4

Reference Period 4 is defined as Day 271 to Day 360 during study treatment. (Episode is a set of days with bleeding/spotting) (NCT00754065)
Timeframe: From Day 271 to Day 360

InterventionEpisodes (Mean)
Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)3.0
Ortho Tri-Cyclen Lo3.7

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Number of Days With Bleeding or Spotting 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. (NCT00754065)
Timeframe: From Day 1 to Day 90

InterventionDays (Mean)
Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)19.0
Ortho Tri-Cyclen Lo23.7

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Number of Days With Bleeding or Spotting in Reference Period 2

Reference Period 2 is defined as Day 91 to Day 180 during study treatment. (NCT00754065)
Timeframe: From Day 91 to Day 180

InterventionDays (Mean)
Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)1.3
Ortho Tri-Cyclen Lo18.8

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Number of Days With Bleeding or Spotting in Reference Period 3

Reference Period 3 is defined as Day 181 to Day 270 during study treatment. (NCT00754065)
Timeframe: From Day 181 to Day 270

InterventionDays (Mean)
Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)14.1
Ortho Tri-Cyclen Lo19.1

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Number of Days With Bleeding or Spotting in Reference Period 4

Reference Period 4 is defined as Day 271 to Day 360 during study treatment. (NCT00754065)
Timeframe: From Day 271 to Day 360

InterventionDays (Mean)
Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)12.8
Ortho Tri-Cyclen Lo19.4

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Number of Days With Spotting-only in Reference Period 1

Reference Period 1 is defined as Day 1 to Day 90 during study treatment. (NCT00754065)
Timeframe: From Day 1 to Day 90

InterventionDays (Mean)
Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)9.3
Ortho Tri-Cyclen Lo8.6

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Number of Days With Spotting-only in Reference Period 2

Reference Period 2 is defined as Day 91 to Day 180 during study treatment. (NCT00754065)
Timeframe: From Day 91 to Day 180

InterventionDays (Mean)
Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)6.8
Ortho Tri-Cyclen Lo6.4

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Number of Days With Spotting-only in Reference Period 3

Reference Period 3 is defined as Day 181 to Day 270 during study treatment. (NCT00754065)
Timeframe: From Day 181 to Day 270

InterventionDays (Mean)
Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)6.6
Ortho Tri-Cyclen Lo6.3

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Number of Days With Spotting-only in Reference Period 4

Reference Period 4 is defined as Day 271 to Day 360 during study treatment. (NCT00754065)
Timeframe: From Day 271 to Day 360

InterventionDays (Mean)
Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)5.6
Ortho Tri-Cyclen Lo5.6

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Number of Intracyclic Bleeding Days at Cycle 1

Intracyclic bleeding is any unexpected bleeding episode occurring in cyclical treatment regimens. (NCT00754065)
Timeframe: At Cycle 1 (28 days per Cycle)

InterventionDays (Mean)
Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)1.5
Ortho Tri-Cyclen Lo0.5

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Number of Intracyclic Bleeding Days at Cycle 13

Intracyclic bleeding is any unexpected bleeding episode occurring in cyclical treatment regimens. (NCT00754065)
Timeframe: At Cycle 13 (28 days per Cycle)

InterventionDays (Mean)
Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)0.5
Ortho Tri-Cyclen Lo0.4

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Number of Intracyclic Bleeding Days at Cycle 3

Intracyclic bleeding is any unexpected bleeding episode occurring in cyclical treatment regimens. (NCT00754065)
Timeframe: At Cycle 3 (28 days per Cycle)

InterventionDays (Mean)
Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)1.4
Ortho Tri-Cyclen Lo0.7

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Number of Intracyclic Bleeding Days at Cycle 6

Intracyclic bleeding is any unexpected bleeding episode occurring in cyclical treatment regimens. (NCT00754065)
Timeframe: At Cycle 6 (28 days per Cycle)

InterventionDays (Mean)
Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)0.9
Ortho Tri-Cyclen Lo1.1

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Number of Intracyclic Bleeding Episodes at Cycle 1

Intracyclic bleeding is any unexpected bleeding episode occurring in cyclical treatment regimens. (Episode is a set of days with intracyclic bleeding) (NCT00754065)
Timeframe: At Cycle 1 (28 days per Cycle)

InterventionEpisodes (Mean)
Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)0.3
Ortho Tri-Cyclen Lo0.1

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Number of Intracyclic Bleeding Episodes at Cycle 13

Intracyclic bleeding is any unexpected bleeding episode occurring in cyclical treatment regimens. (Episode is a set of days with intracyclic bleeding) (NCT00754065)
Timeframe: At Cycle 13 (28 days per Cycle)

InterventionEpisodes (Mean)
Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)0.2
Ortho Tri-Cyclen Lo0.1

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Number of Intracyclic Bleeding Episodes at Cycle 3

Intracyclic bleeding is any unexpected bleeding episode occurring in cyclical treatment regimens. (Episode is a set of days with intracyclic bleeding) (NCT00754065)
Timeframe: At Cycle 3 (28 days per Cycle)

InterventionEpisodes (Mean)
Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)0.2
Ortho Tri-Cyclen Lo0.2

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Number of Intracyclic Bleeding Episodes at Cycle 6

Intracyclic bleeding is any unexpected bleeding episode occurring in cyclical treatment regimens. (Episode is a set of days with intracyclic bleeding) (NCT00754065)
Timeframe: At Cycle 6 (28 days per Cycle)

InterventionEpisodes (Mean)
Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)0.2
Ortho Tri-Cyclen Lo0.2

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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. (NCT00754065)
Timeframe: From Day 1 to Day 90

InterventionEpisodes (Mean)
Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)1.2
Ortho Tri-Cyclen Lo0.5

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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. (NCT00754065)
Timeframe: From Day 91 to Day 180

InterventionEpisodes (Mean)
Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)1.0
Ortho Tri-Cyclen Lo0.5

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Number of Spotting-only Episodes in Reference Period 3

Reference Period 3 is defined as Day 181 to Day 270 during study treatment. (NCT00754065)
Timeframe: From Day 181 to Day 270

InterventionEpisodes (Mean)
Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)0.7
Ortho Tri-Cyclen Lo0.3

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Number of Spotting-only Episodes in Reference Period 4

Reference Period 4 is defined as Day 271 to Day 360 during study treatment. (NCT00754065)
Timeframe: From Day 271 to Day 360

InterventionEpisodes (Mean)
Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)0.6
Ortho Tri-Cyclen Lo0.2

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Onset of Withdrawal Bleeding Episodes at Cycle 1

Onset was defined as the number of days between progestogen withdrawal and the first day of the withdrawal bleeding episode (ie, starting on or after Day 25 for EV/DNG and on or after Day 22 for EE/NGM). (NCT00754065)
Timeframe: At Cycle 1 (28 days per Cycle)

InterventionDays (Mean)
Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)4.7
Ortho Tri-Cyclen Lo4.0

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Mean Change From Baseline to Cycle 6 in Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) - Physical Health

Change from Baseline to Cycle 6 in the overall enjoyment and satisfaction experienced during the past week as scored on the Q-LES-Q (physical health - 13 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). (NCT00754065)
Timeframe: Baseline up to Cycle 6 (28 days per Cycle)

InterventionScores on a scale (Mean)
Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)1.13
Ortho Tri-Cyclen Lo3.44

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Onset of Withdrawal Bleeding Episodes at Cycle 3

Onset was defined as the number of days between progestogen withdrawal and the first day of the withdrawal bleeding episode (ie, starting on or after Day 25 for EV/DNG and on or after Day 22 for EE/NGM). (NCT00754065)
Timeframe: At Cycle 3 (28 days per Cycle)

InterventionDays (Mean)
Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)4.3
Ortho Tri-Cyclen Lo3.3

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Onset of Withdrawal Bleeding Episodes at Cycle 6

Onset was defined as the number of days between progestogen withdrawal and the first day of the withdrawal bleeding episode (ie, starting on or after Day 25 for EV/DNG and on or after Day 22 for EE/NGM). (NCT00754065)
Timeframe: At Cycle 6 (28 days per Cycle)

InterventionDays (Mean)
Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)5.3
Ortho Tri-Cyclen Lo3.1

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The Change in Average of the 3 Highest Visual Analog Scale (VAS) Values of the Hormone Withdrawal-associated Symptoms Pelvic Pain or Headache During Cycle Days 22 to 28 From Baseline to Cycle 6

Subject self-assessed pelvic pain or headache per visual analog scale (VAS) values during the menstrual/withdrawal bleeding episode and Baseline. The VAS consists of a 100 mm long straight line, with verbal anchors at either end, representing a continuum of pain intensity. Accordingly, the scale ranges from 0 mm (absence of pain) to 100 mm (unbearable pain), and the change ranges from -100 mm (best) to 100 mm (worst). (NCT00754065)
Timeframe: Day 22-28 from Baseline to Day 22-28 from Cycle 6 (28 days per Cycle)

Interventionmm (Mean)
Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)43.05
Ortho Tri-Cyclen Lo34.97

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The Change of Pelvic Pain or Headache as Determined by the Highest Visual Analog Scale (VAS) Values During Cycle Days 22 to 28 From Baseline to Cycle 6

Subject self-assessed pelvic pain or headache per visual analog scale (VAS) values during the menstrual/withdrawal bleeding episode and Baseline. The VAS consists of a 100 mm long straight line, with verbal anchors at either end, representing a continuum of pain intensity. Accordingly, the scale ranges from 0 mm (absence of pain) to 100 mm (unbearable pain), and the change ranges from -100 mm (best) to 100 mm (worst). (NCT00754065)
Timeframe: Days 22-28 from Baseline to Days 22-28 from Cycle 6 (28 days per Cycle)

Interventionmm (Mean)
Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)43.60
Ortho Tri-Cyclen Lo34.55

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Mean Change From Baseline to Cycle 13 in Psychological General Well-Being Index (PGWBI)

Change from Baseline to Cycle 13 in PGWBI Questionnaire's assessment of participant's overall sense of well-being or distress. The PGWBI includes 22 items that, apart from combining into a global overall score, are divided into 6 dimensions: anxiety, depressed mood, positive well-being, self-control, health, and vitality. The response format used a 6-grade Likert scale and the change in the normalized PGWBI global score as well as all the sub-domains score ranges from -100 (worst) to 100 (best). (NCT00754065)
Timeframe: Baseline up to Cycle 13 (28 days per Cycle)

,
InterventionScores on a scale (Mean)
Global scoreAnxietyDepressed moodPositive well-beingSelf-controlGeneral healthVitality
Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)-0.14-1.2-0.650.60-0.490.860.28
Ortho Tri-Cyclen Lo-0.18-0.8-0.980.38-0.161.35-0.51

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

Change from Baseline to Cycle 6 in PGWBI Questionnaire's assessment of participant's overall sense of well-being or distress. The PGWBI includes 22 items that, apart from combining into a global overall score, are divided into 6 dimensions: anxiety, depressed mood, positive well-being, self-control, health, and vitality. The response format used a 6-grade Likert scale and the change in the normalized PGWBI global score as well as all the sub-domains score ranges from -100 (worst) to 100 (best). (NCT00754065)
Timeframe: Baseline up to Cycle 6 (28 days per Cycle)

,
InterventionScores on a scale (Mean)
Global scoreAnxietyDepressed moodPositive well-beingSelf-controlGeneral healthVitality
Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)0.410.30.1849.660.6981.81-0.17
Ortho Tri-Cyclen Lo1.102.8-1.0450.290.1281.120.19

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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 was scored as 1=none, 2=spotting, 3=light, 4=normal, or 5=heavy. (NCT00754065)
Timeframe: At Cycle 1 (28 days per Cycle)

,
InterventionPercentage of participants (Number)
SpottingLightNormalHeavy
Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)46.223.115.415.4
Ortho Tri-Cyclen Lo50.018.818.812.5

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Percentage of Participants by Maximum Intensity of Intracyclic Bleeding Episodes at Cycle 13

Intracyclic bleeding is any unexpected bleeding episode occurring in cyclical treatment regimens. Intensity was scored as 1=none, 2=spotting, 3=light, 4=normal, or 5=heavy. (NCT00754065)
Timeframe: At Cycle 13 (28 days per Cycle)

,
InterventionPercentage of participants (Number)
SpottingLightNormalHeavy
Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)31.652.610.55.3
Ortho Tri-Cyclen Lo57.10.028.614.3

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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 was scored as 1=none, 2=spotting, 3=light, 4=normal, or 5=heavy. (NCT00754065)
Timeframe: At Cycle 3 (28 days per Cycle)

,
InterventionPercentage of participants (Number)
SpottingLightNormalHeavy
Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)47.123.520.68.8
Ortho Tri-Cyclen Lo57.715.423.13.8

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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 was scored as 1=none, 2=spotting, 3=light, 4=normal, or 5=heavy. (NCT00754065)
Timeframe: At Cycle 6 (28 days per Cycle)

,
InterventionPercentage of participants (Number)
SpottingLightNormalHeavy
Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)44.425.918.511.1
Ortho Tri-Cyclen Lo61.33.219.416.1

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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. (NCT00754065)
Timeframe: At Cycle 1 (28 days per Cycle)

,
InterventionPercentage of participants (Number)
without withdrawal bleedingwith withdrawal bleeding
Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)25.075.0
Ortho Tri-Cyclen Lo12.887.2

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Percentage of Participants With / Without Withdrawal Bleeding at Cycle 13

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. (NCT00754065)
Timeframe: At Cycle 13 (28 days per Cycle)

,
InterventionPercentage of participants (Number)
without withdrawal bleedingwith withdrawal bleeding
Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)58.241.8
Ortho Tri-Cyclen Lo19.180.9

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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. (NCT00754065)
Timeframe: At Cycle 3 (28 days per Cycle)

,
InterventionPercentage of participants (Number)
without withdrawal bleedingwith withdrawal bleeding
Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)21.079.0
Ortho Tri-Cyclen Lo7.792.3

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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. (NCT00754065)
Timeframe: At Cycle 6 (28 days per Cycle)

,
InterventionPercentage of participants (Number)
without withdrawal bleedingwith withdrawal bleeding
Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)17.782.3
Ortho Tri-Cyclen Lo8.391.7

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Percentage of Participants With at Least 1 Intracyclic Bleeding Episode at Cycles 2 to 13

Intracyclic bleeding is any unexpected bleeding episode occurring in cyclical treatment regimens. (NCT00754065)
Timeframe: Cycles 2 to 13 (28 days per Cycle)

,
InterventionPercentage of participants (Number)
YesNo
Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)62.038.0
Ortho Tri-Cyclen Lo49.750.3

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Percentage of Participants With at Least 1 Intracyclic Bleeding Episode at Cycles 2 to 6

Intracyclic bleeding is any unexpected bleeding episode occurring in cyclical treatment regimens. (NCT00754065)
Timeframe: Cycles 2 to 6 (28 days per Cycle)

,
InterventionPercentage of participants (Number)
YesNo
Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)53.846.2
Ortho Tri-Cyclen Lo40.559.5

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Percentage of Participants With Improvement in the Investigator's Assessment in Clinical Global Impression (CGI) at Cycle 13

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. (NCT00754065)
Timeframe: At Cycle 13 (28 days per Cycle)

,
InterventionPercentage of participants (Number)
Very much improvedMuch improvedMinimally improved
Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)37.932.315.3
Ortho Tri-Cyclen Lo20.326.627.3

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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. (NCT00754065)
Timeframe: At Cycle 6 (28 days per Cycle)

,
InterventionPercentage of participants (Number)
Very much improvedMuch improvedMinimally improved
Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)21.141.527.2
Ortho Tri-Cyclen Lo20.025.233.5

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Percentage of Participants With Improvement in the Participant's Assessment in Clinical Global Impression (CGI) at Cycle 13

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. (NCT00754065)
Timeframe: At Cycle 13 (28 days per Cycle)

,
InterventionPercentage of participants (Number)
Very much improvedMuch improvedMinimally improved
Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)33.935.516.9
Ortho Tri-Cyclen Lo17.225.028.1

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Percentage of Participants With Improvement in the 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. (NCT00754065)
Timeframe: At Cycle 6 (28 days per Cycle)

,
InterventionPercentage of participants (Number)
Very much improvedMuch improvedMinimally improved
Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)25.232.729.3
Ortho Tri-Cyclen Lo11.630.332.2

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Percentage of Participants With no Increase in Rescue Medication and VAS Decrease During Cycle Days 22 to 28 From Baseline to Cycle 6

Rescue medication was standardized intake of 200 mg Ibuprofen tablets. Baseline: 7 days (Day 22) before first menstrual bleeding to Day 28. Treatment: 7 days (Day 22) before withdrawal bleeding of 6th cycle to Day 28 before the same cycle. The visual analog scale (VAS) is a subject-assessed measure of pelvic pain or headache consisting of a 100 mm long straight line, with verbal anchors at either end, representing a continuum of pain intensity. Accordingly, the scale ranges from 0 mm (absence of pain) to 100 mm (unbearable pain), and the change ranges from -100 mm (best) to 100 mm (worst). (NCT00754065)
Timeframe: Day 22-28 from Baseline to Day 22-28 from Cycle 6 (28 days per Cycle)

,
InterventionPercentage of participants (Number)
15 mm VAS decrease30 mm VAS decrease45 mm VAS decrease25% VAS decrease50% VAS decrease75% VAS decreaseHalf-SD decrease
Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)68.158.138.267.056.038.270.2
Ortho Tri-Cyclen Lo54.442.626.054.442.225.559.8

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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. (NCT00754065)
Timeframe: At Cycle 1 (28 days per Cycle)

,
InterventionPercentage of participants (Number)
with absence of intracyclic bleedingwithout absence of intracyclic bleeding
Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)78.321.7
Ortho Tri-Cyclen Lo91.58.5

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Percentage of Participants With Presence or Absence of Intracyclic Bleeding at Cycle 13

Intracyclic bleeding is any unexpected bleeding episode occurring in cyclical treatment regimens. (NCT00754065)
Timeframe: At Cycle 13 (28 days per Cycle)

,
InterventionPercentage of participants (Number)
with absence of intracyclic bleedingwithout absence of intracyclic bleeding
Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)82.717.3
Ortho Tri-Cyclen Lo93.66.4

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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. (NCT00754065)
Timeframe: At Cycle 3 (28 days per Cycle)

,
InterventionPercentage of participants (Number)
with absence of intracyclic bleedingwithout absence of intracyclic bleeding
Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)79.620.4
Ortho Tri-Cyclen Lo85.714.3

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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. (NCT00754065)
Timeframe: At Cycle 6 (28 days per Cycle)

,
InterventionPercentage of participants (Number)
with absence of intracyclic bleedingwithout absence of intracyclic bleeding
Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)81.618.4
Ortho Tri-Cyclen Lo80.319.7

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The Change From Baseline to Cycle 13 in the Number of Ibuprofen Tablets Used as Rescue Medication

Rescue medication use was standardized intake of 200 mg Ibuprofen tablets. Baseline period: 7 days (Day 22) before the first menstrual bleeding until Day 28 (normalized to a standard 28-day cycle). Treatment period: 7 days (Day 22) before the withdrawal bleeding (WB) of the 13th treatment cycle until Day 28 before the same cycle (normalized to a standard 28-day cycle). Number of tablets taken by each subject, and then the Mean and standard deviation ((SD) derived. (NCT00754065)
Timeframe: From Baseline to Cycle 13 (28 days per Cycle)

,
InterventionTablets (Mean)
Days 1-21Days 22-28
Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)-2.3-5.3
Ortho Tri-Cyclen Lo-3.5-5.2

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The Change From Baseline to Cycle 6 in the Number of Ibuprofen Tablets Used as Rescue Medication

Rescue medication use was standardized intake of 200 mg Ibuprofen tablets. Baseline period: 7 days (Day 22) before the first menstrual bleeding until Day 28 (normalized to a standard 28-day cycle). Treatment period: 7 days (Day 22) before the withdrawal bleeding (WB) of the 6th treatment cycle until Day 28 of the same cycle (normalized to a standard 28-day cycle). Number of tablets taken by each subject, and then the Mean and standard deviation (SD) derived. (NCT00754065)
Timeframe: From Baseline to Cycle 6 (28 days per Cycle)

,
InterventionTablets (Mean)
Days 1-21Days 22-28
Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)-1.6-5.8
Ortho Tri-Cyclen Lo-3.0-4.6

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Onset of Withdrawal Bleeding Episodes at Cycle 13

Onset was defined as the number of days between progestogen withdrawal and the first day of the withdrawal bleeding episode (ie, starting on or after Day 25 for EV/DNG and on or after Day 22 for EE/NGM). (NCT00754065)
Timeframe: At Cycle 13 (28 days per Cycle)

InterventionDays (Mean)
Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)1.1
Ortho Tri-Cyclen Lo2.1

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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. (NCT00754065)
Timeframe: From Day 1 to Day 90

InterventionDays (Mean)
Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)1.2
Ortho Tri-Cyclen Lo0.5

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Change From Baseline to Cycle 13 in the Average of the Three Highest VAS Values of the Hormone Withdrawal-associated Symptoms Pelvic Pain or Headache During Cycle Days 22 to 28

Subject self-assessed pelvic pain or headache per visual analog scale (VAS) values during the menstrual/withdrawal bleeding episode and Baseline. The VAS consists of a 100 mm long straight line, with verbal anchors at either end, representing a continuum of pain intensity. Accordingly, the scale ranges from 0 mm (absence of pain) to 100 mm (unbearable pain), and the change ranges from -100 mm (best) to 100 mm (worst). (NCT00754065)
Timeframe: Days 22-28 from Baseline to Days 22-28 from Cycle 13 (28 days per Cycle)

Interventionmm (Mean)
Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)45.89
Ortho Tri-Cyclen Lo39.19

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Change From Baseline to Cycle 3 in the Average of the Three Highest VAS Values of the Hormone Withdrawal-associated Symptoms Pelvic Pain or Headache During Cycle Days 22 to 28

Subject self-assessed pelvic pain or headache per visual analog scale (VAS) values during the menstrual/withdrawal bleeding episode and Baseline. The VAS consists of a 100 mm long straight line, with verbal anchors at either end, representing a continuum of pain intensity. Accordingly, the scale ranges from 0 mm (absence of pain) to 100 mm (unbearable pain), and the change ranges from -100 mm (best) to 100 mm (worst). (NCT00754065)
Timeframe: Days 22-28 from Baseline to Days 22-28 from Cycle 3 (28 days per Cycle)

Interventionmm (Mean)
Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)36.92
Ortho Tri-Cyclen Lo32.28

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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. (NCT00754065)
Timeframe: From Day 1 to Day 90

InterventionDays (Mean)
Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)5.1
Ortho Tri-Cyclen Lo5.1

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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. (NCT00754065)
Timeframe: From Day 91 to Day 180

InterventionDays (Mean)
Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)3.3
Ortho Tri-Cyclen Lo3.5

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Difference in Duration Between Longest and Shortest Bleeding / Spotting Episodes in Reference Period 3

Reference Period 3 is defined as Day 181 to Day 270 during study treatment. (NCT00754065)
Timeframe: From Day 181 to Day 270

InterventionDays (Mean)
Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)3.0
Ortho Tri-Cyclen Lo3.1

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Difference in Duration Between Longest and Shortest Bleeding / Spotting Episodes in Reference Period 4

Reference Period 4 is defined as Day 271 to Day 360 during study treatment. (NCT00754065)
Timeframe: From Day 271 to Day 360

InterventionDays (Mean)
Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)2.7
Ortho Tri-Cyclen Lo2.8

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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. (NCT00754065)
Timeframe: From Day 91 to Day 180

InterventionDays (Mean)
Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)1.0
Ortho Tri-Cyclen Lo0.7

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Difference in Duration Between Longest and Shortest Spotting-only Episodes in Reference Period 3

Reference Period 3 is defined as Day 181 to Day 270 during study treatment. (NCT00754065)
Timeframe: From Day 181 to Day 270

InterventionDays (Mean)
Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)1.4
Ortho Tri-Cyclen Lo0.6

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Difference in Duration Between Longest and Shortest Spotting-only Episodes in Reference Period 4

Reference Period 4 is defined as Day 271 to Day 360 during study treatment. (NCT00754065)
Timeframe: From Day 271 to Day 360

InterventionDays (Mean)
Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)0.9
Ortho Tri-Cyclen Lo0.2

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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. (NCT00754065)
Timeframe: At Cycle 1 (28 days per Cycle)

InterventionDays (Mean)
Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)4.2
Ortho Tri-Cyclen Lo6.0

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Length of Withdrawal Bleeding Episodes at Cycle 13

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. (NCT00754065)
Timeframe: At Cycle 13 (28 days per Cycle)

InterventionDays (Mean)
Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)4.8
Ortho Tri-Cyclen Lo5.5

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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. (NCT00754065)
Timeframe: At Cycle 3 (28 days per Cycle)

InterventionDays (Mean)
Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)4.3
Ortho Tri-Cyclen Lo5.8

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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. (NCT00754065)
Timeframe: At Cycle 6 (28 days per Cycle)

InterventionDays (Mean)
Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)4.6
Ortho Tri-Cyclen Lo5.7

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Maximum Intensity of Withdrawal Bleeding Episodes at Cycle 1

Intensity was scored as 1=none, 2=spotting, 3=light, 4=normal, or 5=heavy. (NCT00754065)
Timeframe: At Cycle 1 (28 days per Cycle)

InterventionScores on a scale (Mean)
Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)3.2
Ortho Tri-Cyclen Lo4.0

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Maximum Intensity of Withdrawal Bleeding Episodes at Cycle 13

Intensity was scored as 1=none, 2=spotting, 3=light, 4=normal, or 5=heavy. (NCT00754065)
Timeframe: At Cycle 13 (28 days per Cycle)

InterventionScores on a scale (Mean)
Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)3.5
Ortho Tri-Cyclen Lo4.1

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Maximum Intensity of Withdrawal Bleeding Episodes at Cycle 3

Intensity was scored as 1=none, 2=spotting, 3=light, 4=normal, or 5=heavy. (NCT00754065)
Timeframe: At Cycle 3 (28 days per Cycle)

InterventionScores on a scale (Mean)
Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)3.2
Ortho Tri-Cyclen Lo4.2

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Maximum Intensity of Withdrawal Bleeding Episodes at Cycle 6

Intensity was scored as 1=none, 2=spotting, 3=light, 4=normal, or 5=heavy. (NCT00754065)
Timeframe: At Cycle 6 (28 days per Cycle)

InterventionScores on a scale (Mean)
Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)3.4
Ortho Tri-Cyclen Lo4.0

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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. (NCT00754065)
Timeframe: From Day 1 to Day 90

InterventionDays (Mean)
Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)7.8
Ortho Tri-Cyclen Lo9.0

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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. (NCT00754065)
Timeframe: From Day 91 to Day 180

InterventionDays (Mean)
Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)6.2
Ortho Tri-Cyclen Lo7.5

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Maximum Length of Bleeding / Spotting Episodes in Reference Period 3

Reference Period 3 is defined as Day 181 to Day 270 during study treatment. (NCT00754065)
Timeframe: From Day 181 to Day 270

InterventionDays (Mean)
Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)6.2
Ortho Tri-Cyclen Lo7.4

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Maximum Length of Bleeding / Spotting Episodes in Reference Period 4

Reference Period 4 is defined as Day 271 to Day 360 during study treatment. (NCT00754065)
Timeframe: From Day 271 to Day 360

InterventionDays (Mean)
Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)5.7
Ortho Tri-Cyclen Lo7.1

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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. (NCT00754065)
Timeframe: At Cycle 1 (28 days per Cycle)

InterventionDays (Mean)
Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)6.7
Ortho Tri-Cyclen Lo6.2

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Maximum Length of Intracyclic Bleeding Episodes at Cycle 13

Intracyclic bleeding is any unexpected bleeding episode occurring in cyclical treatment regimens. (NCT00754065)
Timeframe: At Cycle 13 (28 days per Cycle)

InterventionDays (Mean)
Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)3.0
Ortho Tri-Cyclen Lo6.0

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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. (NCT00754065)
Timeframe: At Cycle 3 (28 days per Cycle)

InterventionDays (Mean)
Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)6.6
Ortho Tri-Cyclen Lo4.2

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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. (NCT00754065)
Timeframe: At Cycle 6 (28 days per Cycle)

InterventionDays (Mean)
Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)5.0
Ortho Tri-Cyclen Lo5.2

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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. (NCT00754065)
Timeframe: From Day 1 to Day 90

InterventionDays (Mean)
Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)3.3
Ortho Tri-Cyclen Lo2.8

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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. (NCT00754065)
Timeframe: From Day 91 to Day 180

InterventionDays (Mean)
Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)3.2
Ortho Tri-Cyclen Lo3.1

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Maximum Length of Spotting-only Episodes in Reference Period 3

Reference Period 3 is defined as Day 181 to Day 270 during study treatment. (NCT00754065)
Timeframe: From Day 181 to Day 270

InterventionDays (Mean)
Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)3.5
Ortho Tri-Cyclen Lo2.8

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Maximum Length of Spotting-only Episodes in Reference Period 4

Reference Period 4 is defined as Day 271 to Day 360 during study treatment. (NCT00754065)
Timeframe: From Day 271 to Day 360

InterventionDays (Mean)
Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)3.2
Ortho Tri-Cyclen Lo2.2

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Mean Change From Baseline to Cycle 13 in Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) - General Activities

Change from Baseline to Cycle 13 in the overall enjoyment and satisfaction experienced during the past week as scored on the Q-LES-Q (general activities - 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). (NCT00754065)
Timeframe: Baseline up to Cycle 13 (28 days per Cycle)

InterventionScores on a scale (Mean)
Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)0.73
Ortho Tri-Cyclen Lo1.34

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Mean Change From Baseline to Cycle 13 in Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) - Household Duties

Change from Baseline to Cycle 13 in the overall enjoyment and satisfaction experienced during the past week as scored on the Q-LES-Q (household duties - yes or no; if yes, then 4 choices, and 10 items with a scale of 1-5 [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). (NCT00754065)
Timeframe: Baseline up to Cycle 13 (28 days per Cycle)

InterventionScores on a scale (Mean)
Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)-0.66
Ortho Tri-Cyclen Lo2.83

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Mean Change From Baseline to Cycle 13 in Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) - Item Satisfaction

Change from Baseline to Cycle 13 in the overall enjoyment and satisfaction experienced during the past week as scored on the Q-LES-Q (item satisfaction). 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). (NCT00754065)
Timeframe: Baseline up to Cycle 13 (28 days per Cycle)

InterventionScores on a scale (Mean)
Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)0.0
Ortho Tri-Cyclen Lo0.1

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Mean Change From Baseline to Cycle 13 in Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) - Leisure Time Activities

Change from Baseline to Cycle 13 in the overall enjoyment and satisfaction experienced during the past week as scored on the Q-LES-Q (leisure time activities - 6 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). (NCT00754065)
Timeframe: Baseline up to Cycle 13 (28 days per Cycle)

InterventionScores on a scale (Mean)
Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)2.72
Ortho Tri-Cyclen Lo2.37

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Mean Change From Baseline to Cycle 13 in Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) - Overall Life Satisfaction and Contentment

Change from Baseline to Cycle 13 in the overall enjoyment and satisfaction experienced during the past week as scored on the Q-LES-Q (overall life satisfaction and contentment). 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). (NCT00754065)
Timeframe: Baseline up to Cycle 13 (28 days per Cycle)

InterventionScores on a scale (Mean)
Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)-0.1
Ortho Tri-Cyclen Lo0.0

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Mean Change From Baseline to Cycle 13 in Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) - Participant Feeling

Change from Baseline to Cycle 13 in the overall enjoyment and satisfaction experienced during the past week as scored on the Q-LES-Q (participant feeling - 14 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). (NCT00754065)
Timeframe: Baseline up to Cycle 13 (28 days per Cycle)

InterventionScores on a scale (Mean)
Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)-0.44
Ortho Tri-Cyclen Lo0.39

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Mean Change From Baseline to Cycle 13 in Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) - Physical Health

Change from Baseline to Cycle 13 in the overall enjoyment and satisfaction experienced during the past week as scored on the Q-LES-Q (physical health - 13 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). (NCT00754065)
Timeframe: Baseline up to Cycle 13 (28 days per Cycle)

InterventionScores on a scale (Mean)
Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)1.93
Ortho Tri-Cyclen Lo2.13

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Mean Change From Baseline to Cycle 13 in Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) - School/Course Work

Change from Baseline to Cycle 13 in the overall enjoyment and satisfaction experienced during the past week as scored on the Q-LES-Q (school / course work - yes or no; if yes, then 4 choices, and 10 items with a scale of 1-5 (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). (NCT00754065)
Timeframe: Baseline up to Cycle 13 (28 days per Cycle)

InterventionScores on a scale (Mean)
Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)-1.97
Ortho Tri-Cyclen Lo4.39

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Number of Intracyclic Bleeding Days at Cycle 3

Intracyclic bleeding episodes were any bleeding episodes not qualifying as withdrawal bleeding. The latter was defined as the first bleeding episode after complete or partial progestogen withdrawal (i.e. the first episode starting after the last day of progestogen intake). If a bleeding episode was ongoing on the last day of progestogen intake and the following day, this episode was regarded as the withdrawal bleeding episode, as long as it had started not more than 4 days before the progestogen withdrawal. The total number of days during intracyclic bleeding episodes was counted. (NCT00909857)
Timeframe: At cycle 3 (28 days per cycle)

InterventionDays (Mean)
Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)0.6
Ethinyl Estradiol, Levonorgestrel (Miranova)0.6

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Number of Intracyclic Bleeding Days at Cycle 1

Intracyclic bleeding episodes were any bleeding episodes not qualifying as withdrawal bleeding. The latter was defined as the first bleeding episode after complete or partial progestogen withdrawal (i.e. the first episode starting after the last day of progestogen intake). If a bleeding episode was ongoing on the last day of progestogen intake and the following day, this episode was regarded as the withdrawal bleeding episode, as long as it had started not more than 4 days before the progestogen withdrawal. The total number of days during intracyclic bleeding episodes was counted. (NCT00909857)
Timeframe: At cycle 1 (28 days per cycle)

InterventionDays (Mean)
Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)1.2
Ethinyl Estradiol, Levonorgestrel (Miranova)1.0

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Number of Episodes With Spotting-only

Bleeding/spotting episodes (day[s] with bleeding/spotting preceded and followed by at least 2 bleeding/spotting-free days) were described using the reference period (RP) method (length of RP: 90 days) recommended by the World Health Organization. 1st RP started on the 1st day of study medication. The total number of days during bleeding or spotting episodes was counted. Spotting = less than associated with normal menstruation relative to the subject's experience with no need for sanitary protection (except for panty liners). Bleeding = any bleeding of greater intensity than spotting. (NCT00909857)
Timeframe: From day 1 to day 90

InterventionEpisodes (Mean)
Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)0.5
Ethinyl Estradiol, Levonorgestrel (Miranova)0.4

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Number of Episodes With Bleeding or Spotting

Bleeding/spotting episodes (day[s] with bleeding/spotting preceded and followed by at least 2 bleeding/spotting-free days) were described using the reference period (RP) method (length of RP: 90 days) recommended by the World Health Organization. 1st RP started on the 1st day of study medication. The total number of days during bleeding or spotting episodes was counted. Spotting = less than associated with normal menstruation relative to the subject's experience with no need for sanitary protection (except for panty liners). Bleeding = any bleeding of greater intensity than spotting. (NCT00909857)
Timeframe: From day 1 to day 90

InterventionEpisodes (Mean)
Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)3.9
Ethinyl Estradiol, Levonorgestrel (Miranova)4.1

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Number of Days With Spotting-only

Bleeding/spotting episodes (day[s] with bleeding/spotting preceded and followed by at least 2 bleeding/spotting-free days) were described using the reference period (RP) method (length of RP: 90 days) recommended by the World Health Organization. 1st RP started on the 1st day of study medication. The total number of days during bleeding or spotting episodes was counted. Spotting = less than associated with normal menstruation relative to the subject's experience with no need for sanitary protection (except for panty liners). Bleeding = any bleeding of greater intensity than spotting. (NCT00909857)
Timeframe: From day 1 to day 90

InterventionDays (Mean)
Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)7.3
Ethinyl Estradiol, Levonorgestrel (Miranova)7.6

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Number of Days With Bleeding or Spotting

Bleeding/spotting episodes (day[s] with bleeding/spotting preceded and followed by at least 2 bleeding/spotting-free days) were described using the reference period (RP) method (length of RP: 90 days) recommended by the World Health Organization. 1st RP started on the 1st day of study medication. The total number of days during bleeding or spotting episodes was counted. Spotting = less than associated with normal menstruation relative to the subject's experience with no need for sanitary protection (except for panty liners). Bleeding = any bleeding of greater intensity than spotting. (NCT00909857)
Timeframe: From day 1 to day 90

InterventionDays (Mean)
Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)20.0
Ethinyl Estradiol, Levonorgestrel (Miranova)23.6

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Mental Health as Measured by General Health and Well-being Questionnaire SF-36 at Final Examination

The standard questionnaire SF-36v1, a general health status measure used to evaluate patient populations and to compare health status across different populations, was completed by participants as a self-administered native language version. Percentages of absolute scores were calculated such that 0 represents the lowest possible score (worst outcome) and 100 the highest possible score (best outcome) (NCT00909857)
Timeframe: At final examination (28 days)

InterventionScores on a scale (Mean)
Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)77.3
Ethinyl Estradiol, Levonorgestrel (Miranova)76.4

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Mental Health as Measured by General Health and Well-being Questionnaire SF-36 at Baseline Cycle

The standard questionnaire SF-36v1, a general health status measure used to evaluate patient populations and to compare health status across different populations, was completed by participants as a self-administered native language version. Percentages of absolute scores were calculated such that 0 represents the lowest possible score (worst outcome) and 100 the highest possible score (best outcome) (NCT00909857)
Timeframe: At baseline cycle (28 days per cycle)

InterventionScores on a scale (Mean)
Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)73.6
Ethinyl Estradiol, Levonorgestrel (Miranova)72.6

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Mean Length of Spotting Only Episodes

Bleeding/spotting episodes (day[s] with bleeding/spotting preceded and followed by at least 2 bleeding/spotting-free days) were described using the reference period (RP) method (length of RP: 90 days) recommended by the World Health Organization. 1st RP started on the 1st day of study medication. The total number of days during bleeding or spotting episodes was counted. Spotting = less than associated with normal menstruation relative to the subject's experience with no need for sanitary protection (except for panty liners). Bleeding = any bleeding of greater intensity than spotting. (NCT00909857)
Timeframe: From day 1 to day 90

InterventionDays (Mean)
Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)3.29
Ethinyl Estradiol, Levonorgestrel (Miranova)3.26

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Mean Length of Bleeding or Spotting Episodes

Bleeding/spotting episodes (day[s] with bleeding/spotting preceded and followed by at least 2 bleeding/spotting-free days) were described using the reference period (RP) method (length of RP: 90 days) recommended by the World Health Organization. 1st RP started on the 1st day of study medication. The total number of days during bleeding or spotting episodes was counted. Spotting = less than associated with normal menstruation relative to the subject's experience with no need for sanitary protection (except for panty liners). Bleeding = any bleeding of greater intensity than spotting. (NCT00909857)
Timeframe: From day 1 to day 90

InterventionDays (Mean)
Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)5.17
Ethinyl Estradiol, Levonorgestrel (Miranova)5.83

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Maximum Length of Spotting Only Episodes

Bleeding/spotting episodes (day[s] with bleeding/spotting preceded and followed by at least 2 bleeding/spotting-free days) were described using the reference period (RP) method (length of RP: 90 days) recommended by the World Health Organization. 1st RP started on the 1st day of study medication. The total number of days during bleeding or spotting episodes was counted. Spotting = less than associated with normal menstruation relative to the subject's experience with no need for sanitary protection (except for panty liners). Bleeding = any bleeding of greater intensity than spotting. (NCT00909857)
Timeframe: From day 1 to day 90

InterventionDays (Mean)
Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)3.9
Ethinyl Estradiol, Levonorgestrel (Miranova)3.6

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Maximum Length of Intracyclic Bleeding Episodes at Cycle 3

Intracyclic bleeding episodes were any bleeding episodes not qualifying as withdrawal bleeding. The latter was defined as the first bleeding episode after complete or partial progestogen withdrawal (i.e. the first episode starting after the last day of progestogen intake). If a bleeding episode was ongoing on the last day of progestogen intake and the following day, this episode was regarded as the withdrawal bleeding episode, as long as it had started not more than 4 days before the progestogen withdrawal. (NCT00909857)
Timeframe: At cycle 3 (28 days per cycle)

InterventionDays (Mean)
Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)5.5
Ethinyl Estradiol, Levonorgestrel (Miranova)4.9

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Maximum Length of Intracyclic Bleeding Episodes at Cycle 1

Intracyclic bleeding episodes were any bleeding episodes not qualifying as withdrawal bleeding. The latter was defined as the first bleeding episode after complete or partial progestogen withdrawal (i.e. the first episode starting after the last day of progestogen intake). If a bleeding episode was ongoing on the last day of progestogen intake and the following day, this episode was regarded as the withdrawal bleeding episode, as long as it had started not more than 4 days before the progestogen withdrawal. (NCT00909857)
Timeframe: At cycle 1 (28 days per cycle)

InterventionDays (Mean)
Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)6.0
Ethinyl Estradiol, Levonorgestrel (Miranova)6.2

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Maximum Length of Bleeding or Spotting Episodes

Bleeding/spotting episodes (day[s] with bleeding/spotting preceded and followed by at least 2 bleeding/spotting-free days) were described using the reference period (RP) method (length of RP: 90 days) recommended by the World Health Organization. 1st RP started on the 1st day of study medication. The total number of days during bleeding or spotting episodes was counted. Spotting = less than associated with normal menstruation relative to the subject's experience with no need for sanitary protection (except for panty liners). Bleeding = any bleeding of greater intensity than spotting. (NCT00909857)
Timeframe: From day 1 to day 90

InterventionDays (Mean)
Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)7.1
Ethinyl Estradiol, Levonorgestrel (Miranova)8.4

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Maximum Intensity of Withdrawal Bleeding Episodes at Cycle 3

Withdrawal bleeding was defined as the first bleeding episode after complete or partial progestogen withdrawal (i.e. the first episode starting after the last day of progestogen intake). If a bleeding episode was ongoing on the last day of progestogen intake and the following day, this episode was regarded as the withdrawal bleeding episode, as long as it had started not more than 4 days before the progestogen withdrawal. Intensity was defined as: 1 = none, 2 = spotting, 3 = light, 4 = normal, 5 = heavy. (NCT00909857)
Timeframe: At cycle 3 (28 days per cycle)

InterventionScores on a scale (Mean)
Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)3.7
Ethinyl Estradiol, Levonorgestrel (Miranova)4.1

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Maximum Intensity of Withdrawal Bleeding Episodes at Cycle 1

Withdrawal bleeding was defined as the first bleeding episode after complete or partial progestogen withdrawal (i.e. the first episode starting after the last day of progestogen intake). If a bleeding episode was ongoing on the last day of progestogen intake and the following day, this episode was regarded as the withdrawal bleeding episode, as long as it had started not more than 4 days before the progestogen withdrawal. Intensity was defined as: 1 = none, 2 = spotting, 3 = light, 4 = normal, 5 = heavy. (NCT00909857)
Timeframe: At cycle 1 (28 days per cycle)

InterventionScores on a scale (Mean)
Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)3.7
Ethinyl Estradiol, Levonorgestrel (Miranova)4.0

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Length of Withdrawal Bleeding Episodes at Cycle 3

Withdrawal bleeding was defined as the first bleeding episode after complete or partial progestogen withdrawal (i.e. the first episode starting after the last day of progestogen intake). If a bleeding episode was ongoing on the last day of progestogen intake and the following day, this episode was regarded as the withdrawal bleeding episode, as long as it had started not more than 4 days before the progestogen withdrawal. (NCT00909857)
Timeframe: At cycle 3 (28 days per cycle)

InterventionDays (Mean)
Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)4.5
Ethinyl Estradiol, Levonorgestrel (Miranova)5.2

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Length of Withdrawal Bleeding Episodes at Cycle 1

Withdrawal bleeding was defined as the first bleeding episode after complete or partial progestogen withdrawal (i.e. the first episode starting after the last day of progestogen intake). If a bleeding episode was ongoing on the last day of progestogen intake and the following day, this episode was regarded as the withdrawal bleeding episode, as long as it had started not more than 4 days before the progestogen withdrawal. (NCT00909857)
Timeframe: At cycle 1 (28 days per cycle)

InterventionDays (Mean)
Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)5.2
Ethinyl Estradiol, Levonorgestrel (Miranova)5.4

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General Health as Measured by General Health and Well-being Questionnaire SF-36 at Final Examination

The standard questionnaire SF-36v1, a general health status measure used to evaluate patient populations and to compare health status across different populations, was completed by participants as a self-administered native language version. Percentages of absolute scores were calculated such that 0 represents the lowest possible score (worst outcome) and 100 the highest possible score (best outcome) (NCT00909857)
Timeframe: At final examination (28 days)

InterventionScores on a scale (Mean)
Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)77.2
Ethinyl Estradiol, Levonorgestrel (Miranova)76.5

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General Health as Measured by General Health and Well-being Questionnaire SF-36 at Baseline Cycle

The standard questionnaire SF-36v1, a general health status measure used to evaluate patient populations and to compare health status across different populations, was completed by participants as a self-administered native language version. Percentages of absolute scores were calculated such that 0 represents the lowest possible score (worst outcome) and 100 the highest possible score (best outcome) (NCT00909857)
Timeframe: At baseline cycle (28 days per cycle)

InterventionScores on a scale (Mean)
Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)75.8
Ethinyl Estradiol, Levonorgestrel (Miranova)72.7

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Difference in Duration Between Longest and Shortest Spotting Only Episode

Bleeding/spotting episodes (day[s] with bleeding/spotting preceded and followed by at least 2 bleeding/spotting-free days) were described using the reference period (RP) method (length of RP: 90 days) recommended by the World Health Organization. 1st RP started on the 1st day of study medication. The total number of days during bleeding or spotting episodes was counted. Spotting = less than associated with normal menstruation relative to the subject's experience with no need for sanitary protection (except for panty liners). Bleeding = any bleeding of greater intensity than spotting. (NCT00909857)
Timeframe: From day 1 to day 90

InterventionDays (Mean)
Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)1.2
Ethinyl Estradiol, Levonorgestrel (Miranova)0.7

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Difference in Duration Between Longest and Shortest Bleeding or Spotting Episode

Bleeding/spotting episodes (day[s] with bleeding/spotting preceded and followed by at least 2 bleeding/spotting-free days) were described using the reference period (RP) method (length of RP: 90 days) recommended by the World Health Organization. 1st RP started on the 1st day of study medication. The total number of days during bleeding or spotting episodes was counted. Spotting = less than associated with normal menstruation relative to the subject's experience with no need for sanitary protection (except for panty liners). Bleeding = any bleeding of greater intensity than spotting. (NCT00909857)
Timeframe: From day 1 to day 90

InterventionDays (Mean)
Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)3.6
Ethinyl Estradiol, Levonorgestrel (Miranova)4.6

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Change Between Baseline Evaluation Period and Treatment Evaluation Period in the Sum of Score Points of Dysmenorrheic Pain

Dysmenorrheic pain: pelvic pain during menstrual/withdrawal bleeding (WB) episode and 2 days before. Scores per day: 0 No pain; 1 Mild pain with no need for painkiller; 2 Moderate pain with need for painkiller; 3 Severe pain with need for painkiller. Baseline period: 2 days before 1st menstrual bleeding until 3rd day before 3rd menstrual bleeding (normalized to standard 56-day period). Treatment period: 2 days before WB of 1st treatment cycle until 3rd day before WB of the cycle after 2nd treatment cycle (normalized to standard 56-day period). Score difference min -168 (best), max 168 (worst) (NCT00909857)
Timeframe: baseline period (2 baseline cycles, usually 56 days) vs. treatment period (on-treatment cycles 2 and 3, usually 56 days)

InterventionScores on a scale (Mean)
Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)-10.6
Ethinyl Estradiol, Levonorgestrel (Miranova)-10.0

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Change Between Baseline Evaluation Period and Treatment Evaluation Period in the Number of Days With Dysmenorrheic Pain

Dysmenorrheic pain was defined as pelvic pain during the menstrual/withdrawal bleeding episode and the 2 days before this episode. Baseline period: 2 days before the first menstrual bleeding until 3rd day before the 3rd menstrual bleeding (normalized to a standard 56-day period). Treatment period: 2 days before the withdrawal bleeding (WB) of the 1st evaluable treatment cycle until 3rd day before the WB of the cycle after the 2nd evaluable treatment cycle (normalized to a standard 56-day period). (NCT00909857)
Timeframe: baseline period (2 baseline cycles, usually 56 days) vs. treatment period (on-treatment cycles 2 and 3, usually 56 days)

InterventionDays (Mean)
Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)-4.6
Ethinyl Estradiol, Levonorgestrel (Miranova)-4.2

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Change Between Baseline Evaluation Period and Treatment Evaluation Period in Rescue Medication Use (Only Bleeding Episodes Used Including the Two Days Before the Episode)

Rescue medication use was standardized intake of 200 mg Ibuprofen tablets. Baseline period: 2 days before the first menstrual bleeding until 3rd day before the 3rd menstrual bleeding (normalized to a standard 56-day period). Treatment period: 2 days before the withdrawal bleeding (WB) of the 1st evaluable treatment cycle until 3rd day before the WB of the cycle after the 2nd evaluable treatment cycle (normalized to a standard 56-day period). (NCT00909857)
Timeframe: baseline period (2 baseline cycles, usually 56 days) vs. treatment period (on-treatment cycles 2 and 3, usually 56 days)

InterventionTablets (Mean)
Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)-6.2
Ethinyl Estradiol, Levonorgestrel (Miranova)-6.6

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Change Between Baseline Evaluation Period and Treatment Evaluation Period in Rescue Medication Use (Entire Evaluation Period Used)

Rescue medication use was standardized intake of 200 mg Ibuprofen tablets. Baseline period: 2 days before the first menstrual bleeding until 3rd day before the 3rd menstrual bleeding (normalized to a standard 56-day period). Treatment period: 2 days before the withdrawal bleeding (WB) of the 1st evaluable treatment cycle until 3rd day before the WB of the cycle after the 2nd evaluable treatment cycle (normalized to a standard 56-day period). (NCT00909857)
Timeframe: baseline period (2 baseline cycles, usually 56 days) vs. treatment period (on-treatment cycles 2 and 3, usually 56 days)

InterventionTablets (Mean)
Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)-4.5
Ethinyl Estradiol, Levonorgestrel (Miranova)-5.6

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Change Between Baseline Evaluation Period and Treatment Evaluation Period in Number of Days With Pelvic Pain Independent of Occurrence of Vaginal Bleeding

Baseline period: 2 days before the first menstrual bleeding until 3rd day before the 3rd menstrual bleeding (normalized to a standard 56-day period). Treatment period: 2 days before the withdrawal bleeding (WB) of the 1st evaluable treatment cycle until 3rd day before the WB of the cycle after the 2nd evaluable treatment cycle (normalized to a standard 56-day period). (NCT00909857)
Timeframe: baseline period (2 baseline cycles, usually 56 days) vs. treatment period (on-treatment cycles 2 and 3, usually 56 days)

InterventionDays (Mean)
Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)-4.0
Ethinyl Estradiol, Levonorgestrel (Miranova)-3.7

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Change Between Baseline Evaluation Period and Treatment Evaluation Period in Number of Days With Pelvic Pain During Unscheduled Bleeding

Evaluated was the number of days with bleeding-associated pelvic pain, excluding days during withdrawal bleeding (WB) and the 2 days preceding such WB, and during administration deviation bleeding and the 2 days preceding such bleeding (normalized to a standard 56-day period). Baseline period: 2 days before first menstrual bleeding until 3rd day before 3rd menstrual bleeding (normalized to standard 56-day period). Treatment period: 2 days before WB of the 1st treatment cycle until 3rd day before the WB of the cycle after the 2nd treatment cycle (normalized to standard 56-day period). (NCT00909857)
Timeframe: baseline period (2 baseline cycles, usually 56 days) vs. treatment period (on-treatment cycles 2 and 3, usually 56 days)

InterventionDays (Mean)
Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)0.3
Ethinyl Estradiol, Levonorgestrel (Miranova)0.1

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Bodily Pain as Measured by General Health and Well-being Questionnaire SF-36 at Final Examination

The standard questionnaire SF-36v1, a general health status measure used to evaluate patient populations and to compare health status across different populations, was completed by participants as a self-administered native language version. Percentages of absolute scores were calculated such that 0 represents the lowest possible score (worst outcome) and 100 the highest possible score (best outcome) (NCT00909857)
Timeframe: At final examination (28 days)

InterventionScores on a scale (Mean)
Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)77.0
Ethinyl Estradiol, Levonorgestrel (Miranova)74.0

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

Intracyclic bleeding episodes were any bleeding episodes not qualifying as withdrawal bleeding. The latter was defined as the first bleeding episode after complete or partial progestogen withdrawal (i.e. the first episode starting after the last day of progestogen intake). If a bleeding episode was ongoing on the last day of progestogen intake and the following day, this episode was regarded as the withdrawal bleeding episode, as long as it had started not more than 4 days before the progestogen withdrawal. Intensity could be described as spotting, light, normal or heavy. (NCT00909857)
Timeframe: At cycle 3 (28 days per cycle)

,
InterventionPercentage of participants (Number)
SpottingLightNormalHeavy
Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)45.527.313.613.6
Ethinyl Estradiol, Levonorgestrel (Miranova)30.421.730.417.4

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

Intracyclic bleeding episodes were any bleeding episodes not qualifying as withdrawal bleeding. The latter was defined as the first bleeding episode after complete or partial progestogen withdrawal (i.e. the first episode starting after the last day of progestogen intake). If a bleeding episode was ongoing on the last day of progestogen intake and the following day, this episode was regarded as the withdrawal bleeding episode, as long as it had started not more than 4 days before the progestogen withdrawal. Intensity could be described as spotting, light, normal or heavy. (NCT00909857)
Timeframe: At cycle 1 (28 days per cycle)

,
InterventionPercentage of participants (Number)
SpottingLightNormalHeavy
Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)53.530.29.37.0
Ethinyl Estradiol, Levonorgestrel (Miranova)62.210.813.513.5

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Own Costs of Herbs/Teas Per Treatment Converted to U.S. Dollars as Measured by Resource Use Questionnaire

The participants were asked to complete a resource use questionnaire indicating their own costs of herbs/teas per treatment of dysmenorrheic pain. Costs were converted to U.S. dollars. (NCT00909857)
Timeframe: At screening (average over 3 months before screening)

InterventionDollars (Median)
Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)0.00
Ethinyl Estradiol, Levonorgestrel (Miranova)0.00

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Percentage of Participants With Interference of Dysmenorrheic Pain With Work/School and Social or Other Activity (Only Bleeding Episodes Used Including the Two Days Before)

Interference of dysmenorrheic pain with work/school and social or other activity was assessed (yes/no). Baseline period: 2 days before the first menstrual bleeding until 3rd day before the 3rd menstrual bleeding (normalized to a standard 56-day period). Treatment period: 2 days before the withdrawal bleeding (WB) of the 1st evaluable treatment cycle until 3rd day before the WB of the cycle after the 2nd evaluable treatment cycle (normalized to a standard 56-day period). (NCT00909857)
Timeframe: baseline period (2 baseline cycles, usually 56 days) vs. treatment period (on-treatment cycles 2 and 3, usually 56 days)

,
InterventionPercentage of participants (Number)
Baseline period-daily activities impairedBaseline period- leisure activities impairedTreatment period-daily activities impairedTreatment period- leisure activities impaired
Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)92.390.651.747.9
Ethinyl Estradiol, Levonorgestrel (Miranova)91.389.656.556.5

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Percentage of Participants With Interference of Dysmenorrheic Pain With Work/School and Social or Other Activity (Entire Evaluation Period Used)

Interference of dysmenorrheic pain with work/school and social or other activity was assessed (yes/no). Baseline period: 2 days before the first menstrual bleeding until 3rd day before the 3rd menstrual bleeding (normalized to a standard 56-day period). Treatment period: 2 days before the withdrawal bleeding (WB) of the 1st evaluable treatment cycle until 3rd day before the WB of the cycle after the 2nd evaluable treatment cycle (normalized to a standard 56-day period). (NCT00909857)
Timeframe: baseline period (2 baseline cycles, usually 56 days) vs. treatment period (on-treatment cycles 2 and 3, usually 56 days)

,
InterventionPercentage of Participants (Number)
Baseline period-daily activities impairedBaseline period- leisure activities impairedTreatment period-daily activities impairedTreatment period- leisure activities impaired
Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)93.292.354.752.6
Ethinyl Estradiol, Levonorgestrel (Miranova)92.290.060.061.3

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Percentage of Participants Satisfied With Study Treatment

Participants were asked to express the degree of their satisfaction with study treatment. (NCT00909857)
Timeframe: From cycle 1 to cycle 3 (28 days per cycle)

,
InterventionPercentage of participants (Number)
MissingVery satisfiedSaatisfiedNeither satisfied nor dissatisfiedDissatisfiedVery dissatisfied
Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)0.953.432.17.32.10.4
Ethinyl Estradiol, Levonorgestrel (Miranova)1.350.430.08.33.50.4

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Percentage of Participants Missing Time From Work Due to Dysmenorrheic Pain at Screening

The investigator was asked to interview the participant and record the number of missed hours/days from work due to dysmenorrheic pain in the previous menstrual cycle. (NCT00909857)
Timeframe: At screening (28 days)

,
InterventionPercentage of Participants (Number)
MissingNever4 working hours1 working day>= 2 working days
Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)0.438.016.226.518.8
Ethinyl Estradiol, Levonorgestrel (Miranova)0.040.416.129.613.9

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Percentage of Participants Missing Time From Work Due to Dysmenorrheic Pain at Final Examination

The investigator was asked to interview the participant and record the number of missed hours/days from work due to dysmenorrheic pain in the previous menstrual cycle. (NCT00909857)
Timeframe: At final examination (28 days)

,
InterventionPercentage of Participants (Number)
MissingNever4 working hours1 working day>= 2 working days
Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)0.485.95.63.01.7
Ethinyl Estradiol, Levonorgestrel (Miranova)0.085.22.64.81.7

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Percentage of Participants Missing Time From Work Due to Dysmenorrheic Pain at Cycle 2

The investigator was asked to interview the participant and record the number of missed hours/days from work due to dysmenorrheic pain in the previous menstrual cycle. (NCT00909857)
Timeframe: At cycle 2 (28 days per cycle)

,
InterventionPercentage of Participants (Number)
MissingNever4 working hours1 working day>= 2 working days
Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)0.078.68.56.42.1
Ethinyl Estradiol, Levonorgestrel (Miranova)0.072.66.58.74.3

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Percentage of Participants Missing Time From Work Due to Dysmenorrheic Pain at Baseline Cycle

The investigator was asked to interview the participant and record the number of missed hours/days from work due to dysmenorrheic pain in the previous menstrual cycle. (NCT00909857)
Timeframe: At Baseline (28 days per cycle)

,
InterventionPercentage of Participants (Number)
MissingNever4 working hours1 working day>= 2 working days
Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)0.047.913.220.917.9
Ethinyl Estradiol, Levonorgestrel (Miranova)0.051.711.723.912.2

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Participants With Improvement in the Investigators' Assessment in the Clinical Global Impression

The Clinical Global Impression Scale (CGI) is a widely used rating scale/assessment instrument in psychopharmacology research in general, and in studies on women's health in particular. Investigators were asked to rate the participants' improvement during the course of the study. (NCT00909857)
Timeframe: At cycle 2 (28 days per cycle)

,
InterventionParticipants (Number)
MissingNot assessedVery much improvedMuch improvedMinimally improvedNo changeMinimally worseMuch worse
Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)016387491760
Ethinyl Estradiol, Levonorgestrel (Miranova)014284542336

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Participants With Improvement in Participants' Assessment in the Clinical Global Impression

The Clinical Global Impression Scale (CGI) is a widely used rating scale/assessment instrument in psychopharmacology research in general, and in studies on women's health in particular. Participants were asked to rate their improvement during the course of the study. (NCT00909857)
Timeframe: At cycle 2 (28 days per cycle)

,
InterventionParticipants (Number)
MissingNot assessedVery much improvedMuch improvedMinimally improvedNo changeMinimally worseMuch worse
Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)116091471850
Ethinyl Estradiol, Levonorgestrel (Miranova)014675572443

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Bodily Pain as Measured by General Health and Well-being Questionnaire SF-36 at Baseline Cycle

The standard questionnaire SF-36v1, a general health status measure used to evaluate patient populations and to compare health status across different populations, was completed by participants as a self-administered native language version. Percentages of absolute scores were calculated such that 0 represents the lowest possible score (worst outcome) and 100 the highest possible score (best outcome) (NCT00909857)
Timeframe: At baseline cycle (28 days per cycle)

InterventionScores on a scale (Mean)
Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)50.7
Ethinyl Estradiol, Levonorgestrel (Miranova)51.8

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Vitality as Measured by General Health and Well-being Questionnaire SF-36 at Final Examination

The standard questionnaire SF-36v1, a general health status measure used to evaluate patient populations and to compare health status across different populations, was completed by participants as a self-administered native language version. Percentages of absolute scores were calculated such that 0 represents the lowest possible score (worst outcome) and 100 the highest possible score (best outcome) (NCT00909857)
Timeframe: At final examination (28 days)

InterventionScores on a scale (Mean)
Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)68.2
Ethinyl Estradiol, Levonorgestrel (Miranova)67.2

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Vitality as Measured by General Health and Well-being Questionnaire SF-36 at Baseline Cycle

The standard questionnaire SF-36v1, a general health status measure used to evaluate patient populations and to compare health status across different populations, was completed by participants as a self-administered native language version. Percentages of absolute scores were calculated such that 0 represents the lowest possible score (worst outcome) and 100 the highest possible score (best outcome) (NCT00909857)
Timeframe: At baseline cycle (28 days per cycle)

InterventionScores on a scale (Mean)
Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)62.6
Ethinyl Estradiol, Levonorgestrel (Miranova)62.2

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Social Functioning as Measured by General Health and Well-being Questionnaire SF-36 at Final Examination

The standard questionnaire SF-36v1, a general health status measure used to evaluate patient populations and to compare health status across different populations, was completed by participants as a self-administered native language version. Percentages of absolute scores were calculated such that 0 represents the lowest possible score (worst outcome) and 100 the highest possible score (best outcome) (NCT00909857)
Timeframe: At final examination (28 days)

InterventionScores on a scale (Mean)
Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)85.95
Ethinyl Estradiol, Levonorgestrel (Miranova)84.79

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Social Functioning as Measured by General Health and Well-being Questionnaire SF-36 at Baseline Cycle

The standard questionnaire SF-36v1, a general health status measure used to evaluate patient populations and to compare health status across different populations, was completed by participants as a self-administered native language version. Percentages of absolute scores were calculated such that 0 represents the lowest possible score (worst outcome) and 100 the highest possible score (best outcome) (NCT00909857)
Timeframe: At baseline cycle (28 days per cycle)

InterventionScores on a scale (Mean)
Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)78.85
Ethinyl Estradiol, Levonorgestrel (Miranova)77.35

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Role Physical as Measured by General Health and Well-being Questionnaire SF-36 at Final Examination

The standard questionnaire SF-36v1, a general health status measure used to evaluate patient populations and to compare health status across different populations, was completed by participants as a self-administered native language version. Percentages of absolute scores were calculated such that 0 represents the lowest possible score (worst outcome) and 100 the highest possible score (best outcome) (NCT00909857)
Timeframe: At final examination (28 days)

InterventionScores on a scale (Mean)
Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)89.6
Ethinyl Estradiol, Levonorgestrel (Miranova)87.9

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Role Physical as Measured by General Health and Well-being Questionnaire SF-36 at Baseline Cycle

The standard questionnaire SF-36v1, a general health status measure used to evaluate patient populations and to compare health status across different populations, was completed by participants as a self-administered native language version. Percentages of absolute scores were calculated such that 0 represents the lowest possible score (worst outcome) and 100 the highest possible score (best outcome) (NCT00909857)
Timeframe: At baseline cycle (28 days per cycle)

InterventionScores on a scale (Mean)
Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)77.8
Ethinyl Estradiol, Levonorgestrel (Miranova)79.4

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Role Emotional as Measured by General Health and Well-being Questionnaire SF-36 at Final Examination

The standard questionnaire SF-36v1, a general health status measure used to evaluate patient populations and to compare health status across different populations, was completed by participants as a self-administered native language version. Percentages of absolute scores were calculated such that 0 represents the lowest possible score (worst outcome) and 100 the highest possible score (best outcome) (NCT00909857)
Timeframe: At final examination (28 days)

InterventionScores on a scale (Mean)
Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)88.64
Ethinyl Estradiol, Levonorgestrel (Miranova)83.87

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Role Emotional as Measured by General Health and Well-being Questionnaire SF-36 at Baseline Cycle

The standard questionnaire SF-36v1, a general health status measure used to evaluate patient populations and to compare health status across different populations, was completed by participants as a self-administered native language version. Percentages of absolute scores were calculated such that 0 represents the lowest possible score (worst outcome) and 100 the highest possible score (best outcome) (NCT00909857)
Timeframe: At baseline cycle (28 days per cycle)

InterventionScores on a scale (Mean)
Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)81.91
Ethinyl Estradiol, Levonorgestrel (Miranova)79.18

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Physical Functioning as Measured by General Health and Well-being Questionnaire SF-36 at Final Examination

The standard questionnaire SF-36v1, a general health status measure used to evaluate patient populations and to compare health status across different populations, was completed by participants as a self-administered native language version. Percentages of absolute scores were calculated such that 0 represents the lowest possible score (worst outcome) and 100 the highest possible score (best outcome) (NCT00909857)
Timeframe: at final examination (28 days)

InterventionScores on a scale (Mean)
Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)93.7
Ethinyl Estradiol, Levonorgestrel (Miranova)92.5

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Physical Functioning as Measured by General Health and Well-being Questionnaire SF-36 at Baseline Cycle

The standard questionnaire SF-36v1, a general health status measure used to evaluate patient populations and to compare health status across different populations, was completed by participants as a self-administered native language version. Percentages of absolute scores were calculated such that 0 represents the lowest possible score (worst outcome) and 100 the highest possible score (best outcome) (NCT00909857)
Timeframe: At baseline cycle (28 days per cycle)

InterventionScores on a scale (Mean)
Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)90.2
Ethinyl Estradiol, Levonorgestrel (Miranova)89.6

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Percentage of Participants With Withdrawal Bleeding at Cycle 3

Withdrawal bleeding was defined as the first bleeding episode after complete or partial progestogen withdrawal (i.e. the first episode starting after the last day of progestogen intake). If a bleeding episode was ongoing on the last day of progestogen intake and the following day, this episode was regarded as the withdrawal bleeding episode, as long as it had started not more than 4 days before the progestogen withdrawal. (NCT00909857)
Timeframe: At cycle 3 (28 days per cycle)

InterventionPercentage of Participants (Number)
Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)68.1
Ethinyl Estradiol, Levonorgestrel (Miranova)79.3

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Percentage of Participants With Withdrawal Bleeding at Cycle 1

Withdrawal bleeding was defined as the first bleeding episode after complete or partial progestogen withdrawal (i.e. the first episode starting after the last day of progestogen intake). If a bleeding episode was ongoing on the last day of progestogen intake and the following day, this episode was regarded as the withdrawal bleeding episode, as long as it had started not more than 4 days before the progestogen withdrawal. (NCT00909857)
Timeframe: At cycle 1 (28 days per cycle)

InterventionPercentage of Participants (Number)
Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)91.2
Ethinyl Estradiol, Levonorgestrel (Miranova)93.2

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Percentage of Participants With Intracyclic Bleeding at Cycle 3

Intracyclic bleeding episodes were any bleeding episodes not qualifying as withdrawal bleeding. The latter was defined as the first bleeding episode after complete or partial progestogen withdrawal (i.e. the first episode starting after the last day of progestogen intake). If a bleeding episode was ongoing on the last day of progestogen intake and the following day, this episode was regarded as the withdrawal bleeding episode, as long as it had started not more than 4 days before the progestogen withdrawal. (NCT00909857)
Timeframe: At cycle 3 (28 days per cycle)

InterventionPercentage of Participants (Number)
Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)10.8
Ethinyl Estradiol, Levonorgestrel (Miranova)11.6

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Percentage of Participants With Intracyclic Bleeding at Cycle 1

Intracyclic bleeding episodes were any bleeding episodes not qualifying as withdrawal bleeding. The latter was defined as the first bleeding episode after complete or partial progestogen withdrawal (i.e. the first episode starting after the last day of progestogen intake). If a bleeding episode was ongoing on the last day of progestogen intake and the following day, this episode was regarded as the withdrawal bleeding episode, as long as it had started not more than 4 days before the progestogen withdrawal. (NCT00909857)
Timeframe: At cycle 1 (28 days per cycle)

InterventionPercentage of Participants (Number)
Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)19.0
Ethinyl Estradiol, Levonorgestrel (Miranova)16.7

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Own Costs of Vitamins Per Treatment Converted to U.S. Dollars as Measured by Resource Use Questionnaire

The participants were asked to complete a resource use questionnaire indicating their own costs of vitamins per treatment of dysmenorrheic pain. Costs were converted to U.S. dollars. (NCT00909857)
Timeframe: At screening (average over 3 months before screening)

InterventionDollars (Median)
Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)0.00
Ethinyl Estradiol, Levonorgestrel (Miranova)0.00

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Own Costs of Physiotherapy Per Treatment Converted to U.S. Dollars as Measured by Resource Use Questionnaire

The participants were asked to complete a resource use questionnaire indicating their own costs of physiotherapy per treatment of dysmenorrheic pain. Costs were converted to U.S. dollars. (NCT00909857)
Timeframe: At screening (average over 3 months before screening)

InterventionDollars (Median)
Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)0.00
Ethinyl Estradiol, Levonorgestrel (Miranova)0.00

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Own Costs of Pain Medication Per Treatment Converted to U.S. Dollars as Measured by Resource Use Questionnaire

The participants were asked to complete a resource use questionnaire indicating their own costs of pain medication per treatment of dysmenorrheic pain. Costs were converted to U.S. dollars. (NCT00909857)
Timeframe: At screening (average over 3 months before screening)

InterventionDollars (Median)
Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)5.46
Ethinyl Estradiol, Levonorgestrel (Miranova)5.04

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Own Costs of Medical Counseling Per Treatment Converted to U.S. Dollars as Measured by Resource Use Questionnaire

The participants were asked to complete a resource use questionnaire indicating their own costs of medical counseling per treatment of dysmenorrheic pain. Costs were converted to U.S. dollars. (NCT00909857)
Timeframe: At screening (average over 3 months before screening)

InterventionDollars (Median)
Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)0.00
Ethinyl Estradiol, Levonorgestrel (Miranova)0.00

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Own Costs of Massages Per Treatment Converted to U.S. Dollars as Measured by Resource Use Questionnaire

The participants were asked to complete a resource use questionnaire indicating their own costs of massages per treatment of dysmenorrheic pain. Costs were converted to U.S. dollars. (NCT00909857)
Timeframe: At screening (average over 3 months before screening)

InterventionDollars (Median)
Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)0.00
Ethinyl Estradiol, Levonorgestrel (Miranova)0.00

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Own Costs of Alternative Medicine Per Treatment Converted to U.S. Dollars as Measured by Resource Use Questionnaire

The participants were asked to complete a resource use questionnaire indicating their own costs of alternative medicine per treatment of dysmenorrheic pain. Costs were converted to U.S. dollars. (NCT00909857)
Timeframe: At screening (average over 3 months before screening)

InterventionDollars (Median)
Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)0.00
Ethinyl Estradiol, Levonorgestrel (Miranova)0.00

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Own Costs of Acupuncture Per Treatment Converted to U.S. Dollars as Measured by Resource Use Questionnaire

The participants were asked to complete a resource use questionnaire indicating their own costs of acupuncture per treatment of dysmenorrheic pain. Costs were converted to U.S. dollars. (NCT00909857)
Timeframe: At screening (average over 3 months before screening)

InterventionDollars (Median)
Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)0.00
Ethinyl Estradiol, Levonorgestrel (Miranova)0.00

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Other Own Costs Per Treatment Converted to U.S. Dollars as Measured by Resource Use Questionnaire

The participants were asked to complete a resource use questionnaire indicating their other own costs per treatment of dysmenorrheic pain. Costs were converted to U.S. dollars. (NCT00909857)
Timeframe: At screening (average over 3 months before screening)

InterventionDollars (Median)
Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)0.00
Ethinyl Estradiol, Levonorgestrel (Miranova)0.00

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Onset of Withdrawal Bleeding Episodes at Cycle 3

Withdrawal bleeding was defined as the first bleeding episode after complete or partial progestogen withdrawal (i.e. the first episode starting after the last day of progestogen intake). If a bleeding episode was ongoing on the last day of progestogen intake and the following day, this episode was regarded as the withdrawal bleeding episode, as long as it had started not more than 4 days before the progestogen withdrawal. (NCT00909857)
Timeframe: At cycle 3 (28 days per cycle)

InterventionDays (Mean)
Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)3.1
Ethinyl Estradiol, Levonorgestrel (Miranova)4.3

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Onset of Withdrawal Bleeding Episodes at Cycle 1

Withdrawal bleeding was defined as the first bleeding episode after complete or partial progestogen withdrawal (i.e. the first episode starting after the last day of progestogen intake). If a bleeding episode was ongoing on the last day of progestogen intake and the following day, this episode was regarded as the withdrawal bleeding episode, as long as it had started not more than 4 days before the progestogen withdrawal. (NCT00909857)
Timeframe: At cycle 1 (28 days per cycle)

InterventionDays (Mean)
Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)4.8
Ethinyl Estradiol, Levonorgestrel (Miranova)4.9

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Number of Intracyclic Bleeding Episodes at Cycle 3

Intracyclic bleeding episodes were any bleeding episodes not qualifying as withdrawal bleeding. The latter was defined as the first bleeding episode after complete or partial progestogen withdrawal (i.e. the first episode starting after the last day of progestogen intake). If a bleeding episode was ongoing on the last day of progestogen intake and the following day, this episode was regarded as the withdrawal bleeding episode, as long as it had started not more than 4 days before the progestogen withdrawal. (NCT00909857)
Timeframe: At cycle 3 (28 days per cycle)

InterventionEpisodes (Mean)
Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)0.1
Ethinyl Estradiol, Levonorgestrel (Miranova)0.1

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Number of Intracyclic Bleeding Episodes at Cycle 1

Intracyclic bleeding episodes were any bleeding episodes not qualifying as withdrawal bleeding. The latter was defined as the first bleeding episode after complete or partial progestogen withdrawal (i.e. the first episode starting after the last day of progestogen intake). If a bleeding episode was ongoing on the last day of progestogen intake and the following day, this episode was regarded as the withdrawal bleeding episode, as long as it had started not more than 4 days before the progestogen withdrawal. (NCT00909857)
Timeframe: At cycle 1 (28 days per cycle)

InterventionEpisodes (Mean)
Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)0.2
Ethinyl Estradiol, Levonorgestrel (Miranova)0.2

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Anti Mullerian Hormone (AMH)

Change in Serum concentrations of anti-mullerian hormone reflecting ovarian reserve from baseline to nine weeks (NCT02352090)
Timeframe: baseline and 9 weeks

Interventionng/mL (Mean)
Synthetic Estrogen + Progestin-0.8
Natural Estrogen + Progestin-0.4
Progestin-Only0.07

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D-dimer

Markers of coagulation activation (NCT02352090)
Timeframe: baseline and 9 weeks

Interventionpercentage change from baseline (Mean)
Synthetic Estrogen + Progestin12.6
Natural Estrogen + Progestin2.4
Progestin-Only-1.6

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F1+2

Change in plasma concentrations of F1+2 a marker of coagulation activation (NCT02352090)
Timeframe: baseline and 9 weeks

Interventionpercentage change from baseline (Mean)
Synthetic Estrogen + Progestin24.1
Natural Estrogen + Progestin-5.5
Progestin-Only-8.5

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Fasting Insulin

Mean change in fasting serum insulin from baseline to nine weeks (NCT02352090)
Timeframe: baseline and 9 weeks

InterventionmU/l (Mean)
Synthetic Estrogen + Progestin1.4
Natural Estrogen + Progestin1.02
Progestin-Only1.99

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High-Density Lipoprotein (HDL)

Change in concentration of High-Density Lipoprotein HDL from baseline to nine weeks (NCT02352090)
Timeframe: baseline and 9 weeks

Interventionmmol/L (Mean)
Synthetic Estrogen + Progestin0.20
Natural Estrogen + Progestin-0.02
Progestin-Only-0.02

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High-sensitivity C Reactive Protein

Change in plasma concentrations of acute phase protein 'C reactive protein' (CRP), a marker of chronic inflammation. (NCT02352090)
Timeframe: baseline and 9 weeks

Interventionmg/L (Mean)
Synthetic Estrogen + Progestin1.10
Natural Estrogen + Progestin-0.06
Progestin-Only0.13

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Low-Density Lipoprotein (LDL)

Change in concentration of Low-Density Lipoprotein LDL from baseline to nine weeks (NCT02352090)
Timeframe: baseline and 9 weeks

Interventionmmol/L (Mean)
Synthetic Estrogen + Progestin-0.16
Natural Estrogen + Progestin-0.14
Progestin-Only0.01

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Matsuda Index- Whole Body Insulin Sensitivity Index

"Matsuda index is calculated from the standard 2h Oral Glucose Tolerance Test and corresponding insulin values.~Matsuda index = 10,000/square root of [fasting glucose x fasting insulin] x [mean glucose x mean insulin during OGTT]) The Matsuda index is correlated (r = 0.73) with the rate of whole-body glucose disposal during the euglycemic insulin clamp.~Matsuda index <2.5 is considered insulin resistant, higher values indicate less insulin resistance. A decrease in matsuda index over the study period would indicate decreased insulin sensitivity." (NCT02352090)
Timeframe: We calculated the change in Matsuda index from baseline to 9 weeks.

Interventionunits on a scale (Mean)
Synthetic Estrogen + Progestin-1.02
Natural Estrogen + Progestin-0.10
Progestin-Only-1.45

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Thrombin Generation, ETP Endogenous Thrombin Potential

Change from baseline in thrombin generation, measured by thrombin generation assay-Calibrated automated thrombogram (NCT02352090)
Timeframe: baseline and 9 weeks

Interventionpercentage change from baseline (Mean)
Synthetic Estrogen + Progestin63.9
Natural Estrogen + Progestin26.4
Progestin-Only7.1

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Total Cholesterol

Change in concentrations of total cholesterol from baseline to nine weeks (NCT02352090)
Timeframe: baseline and 9 weeks

Interventionmmol/L (Mean)
Synthetic Estrogen + Progestin0.10
Natural Estrogen + Progestin-0.16
Progestin-Only0.11

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Triglyceride

Change in triglyceride concentrations from baseline to nine weeks (NCT02352090)
Timeframe: baseline and 9 weeks

Interventionmmol/L (Mean)
Synthetic Estrogen + Progestin0.45
Natural Estrogen + Progestin0.18
Progestin-Only0.06

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