Delving into the Latest Updates on Dienogest/Estradiol Valerate with Synapse

The goal of this clinical trial is to learn if Estetrol/Drospirenone inhibit ovulation in quick-starting method. It will also learn about the safety of Estetrol/Drospirenone. The main questions it aims to answer are:
Does Estradiol valerate/Dienogest inhibit ovulation inferior to Ethinyl estradiol/Gestodene when starting on Day 7-9 of menstrual cycle? What are the impacts of Estradiol valerate/Dienogest on ovarian activities when starting on Day 7-9 of menstrual cycle? How does the cervical mucus change when starting Estradiol valerate/Dienogest on Day 7-9 of menstrual cycle? What are the adverse effects when starting Estradiol valerate/Dienogest on Day 7-9 of menstrual cycle? Researchers will compare Estradiol valerate/Dienogest to Ethinyl estradiol/Gestodene to see if Estradiol valerate/Dienogest inhibit ovulation in quick-starting method.

Start Date01 May 2024

Sponsor / Collaborator

University of Chulalongkorn

NCT05332106

/ CompletedPhase 1

Bioavailability of a Formulation of Estradiol Valerate and Dienogest 2 mg/2 mg Coated Tablets With Regards to the Marketed Reference Product

This study will investigate the bioavailability in fasting healthy, adult, human post-menopausal female subjects of 1 tablet formulation containing Estradiol Valerate and Dienogest 2 mg/ 2mg.
The study will be performed at a single site with 10 subjects. Participants will take 1 tablet of the test product and reference product in 2 periods and 2 sequences (either test after reference or reference after test). There will be a washout of at least 7 days between each study period.

Start Date12 Mar 2022

Sponsor / Collaborator

Laboratorios Andrómaco SA

100 Clinical Results associated with Dienogest/Estradiol Valerate

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100 Translational Medicine associated with Dienogest/Estradiol Valerate

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100 Patents (Medical) associated with Dienogest/Estradiol Valerate

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60

Literatures (Medical) associated with Dienogest/Estradiol Valerate

01 Mar 2024·Obstetrics & Gynecology

Venous Thromboembolic Risk of Estradiol Valerate–Dienogest Compared with Ethinyl Estradiol–Levonorgestrel Combined Oral Contraceptives

Article

Author: Heinemann, Klaas ; Bauerfeind, Anja ; von Stockum, Sophia ; Boehnke, Tanja

This pooled analysis compared the risk of venous thromboembolism (VTE) associated with combined oral contraceptives (COCs) containing estradiol (E2) valerate–dienogest with those containing ethinyl E2–levonorgestrel. Data were retrieved from two large, prospective, observational cohort studies. Propensity score subclassification was applied to balance baseline parameters between the COC user cohorts. Crude and adjusted hazard ratios (HRs) were calculated based on the extended Cox model. The pooled data set included 11,616 E2 valerate–dienogest users and 18,681 ethinyl E2–levonorgestrel users, contributing 17,932 and 29,140 women-years of observation, respectively. A significantly decreased VTE risk in E2 valerate–dienogest COCs compared with ethinyl E2–levonorgestrel COCs was observed (propensity score–stratified HR 0.46, 95% CI, 0.22–0.98). This pooled analysis expands data from a previous postauthorization safety study and provides valuable real-world safety information on the relative safety of current COCs.

01 Oct 2016·ContraceptionQ2 · MEDICINE

Bleeding pattern and cycle control with estetrol-containing combined oral contraceptives: results from a phase II, randomised, dose-finding study (FIESTA)

Q2 · MEDICINE

Article

Author: Foidart, Jean-Michel ; Coelingh Bennink, Herjan J T ; Apter, Dan ; Mawet, Marie ; Maillard, Catherine ; Zimmerman, Yvette ; Beekman, Louise

OBJECTIVESThis study aims to assess vaginal bleeding patterns and cycle control of oral contraceptives containing estetrol (E4) combined with either drospirenone (DRSP) or levonorgestrel (LNG).STUDY DESIGNAn open-label, multicentre, randomised, dose-finding study lasting six cycles in healthy women aged 18-35 years was used. Four treatments (15 mg or 20 mg E4, combined with either 3 mg DRSP or 150 mcg LNG) were administered in a 24/4-day regimen. A marketed dosing regimen of estradiol valerate with dienogest (E2V/DNG) served as reference since it contains (like E4) a natural oestrogen.RESULTSA total of 396 women were randomised, of whom 389 received study medication, and 316 completed the study. By cycle 6, the frequencies of unscheduled bleeding and/or spotting and absence of withdrawal bleeding were the lowest in the 15 mg E4/DRSP group (33.8% and 3.5%, respectively). In the E2V/DNG reference group, these frequencies were 47.8% and 27.1%, respectively. By cycle 6, the frequency of women with absence of withdrawal bleeding was <20% for all E4 treatment groups: 3.5-3.8% combined with DRSP and 14.0-18.5% combined with LNG. By cycle 6, unscheduled intracyclic bleeding was reported by <20% of women in the 20 mg E4/LNG group (18.9%) and in the 15 mg E4/DRSP group (16.9%).CONCLUSIONThis study showed that, of the four treatment modalities investigated, the 15 mg E4/DRSP combination has the most favourable bleeding pattern and cycle control.IMPLICATIONSDue to its favourable bleeding pattern and cycle control, the 15 mg E4/DRSP combination is the preferred combination for further phase III clinical development.

01 Oct 2015·Archives of Gynecology and ObstetricsQ4 · MEDICINE

Are hormonal components of oral contraceptives associated with impaired female sexual function? A questionnaire-based online survey of medical students in Germany, Austria, and Switzerland

Q4 · MEDICINE

Article

Author: Markus Wallwiener ; Florin-Andrei Taran ; Harald Seeger ; Alfred O. Mueck ; Sara Y. Brucker ; Johannes Bitzer ; Christian W. Wallwiener ; Stephan Zipfel ; Lisa-Maria Wallwiener ; Birgitt Schönfisch

PURPOSETo investigate in a large cohort of young university women whether different progestins and different ethinyl estradiol (EE) dosages in oral hormonal contraceptives (OHCs) adversely affect sexual function.METHODSFemale medical students from German, Austrian, and Swiss universities (14/1/1) completed an anonymous online questionnaire comprising the 19 Female Sexual Function Index (FSFI) questions and 17 additional questions concerning demographics, lifestyle, sexual activity, and contraceptive use. OHCs were categorized by EE dose (≤20, <20 to ≤30, and >30 µg) and partially androgenic or antiandrogenic progestins. FSFI scores were analyzed by contraceptive method using descriptive statistics and standard nonparametric tests.RESULTSWe analyzed 2612 questionnaires submitted by respondents aged ≤30 years [mean age (SD) 23.5 (2.5) years]. Of 2126 contraceptive users, 1535 (72.2 %) used OHCs. Median FSFI total scores (ranges) were 28.2 (2.0-36.0) for all respondents. Median FSFI was significantly lower in non-users (24.4) versus users (28.7) of contraception (p < 0.001). Stratified analysis showed that 279/486 (57.4 %) respondents using no contraceptives, 563/1535 (36.7 %) using OHCs, 71/227 (31.3 %) using non-oral hormonal contraceptives, and 96/351 (27.4 %) using non-hormonal contraceptives were at risk for female sexual dysfunction (FSFI total score <26.55). FSFI scores for the three EE dosage categories and progestin components did not differ significantly.CONCLUSIONSFor OHCs, the FSFI score was lower than for other contraceptives but there was no significant association with EE dose or progestins, possibly due to small sample sizes. Further research needs to clarify the role of OHCs in female sexual function.

100 Deals associated with Dienogest/Estradiol Valerate

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R&D Status

Approved

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Indication	Country/Location	Organization	Date
Menorrhagia	United States	Bayer HealthCare Pharmaceuticals, Inc.	14 Mar 2012
Contraception	Australia	Bayer Australia Ltd.	14 May 2009
Oestrogen deficiency	Netherlands	Bayer BV	08 May 2001

Developing

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Indication	Highest Phase	Country/Location	Organization	Date
Pelvic Pain	Discovery	Switzerland	Bayer AG	01 Dec 2008
Pelvic Pain	Discovery	Spain	Bayer AG	01 Dec 2008
Pelvic Pain	Discovery	Australia	Bayer AG	01 Dec 2008
Pelvic Pain	Discovery	France	Bayer AG	01 Dec 2008
Pelvic Pain	Discovery	Thailand	Bayer AG	01 Dec 2008
Pelvic Pain	Discovery	United Kingdom	Bayer AG	01 Dec 2008
Pelvic Pain	Discovery	Germany	Bayer AG	01 Dec 2008
Contraception	Discovery	Spain	Bayer AG	01 Apr 2004
Contraception	Discovery	Germany	Bayer AG	01 Apr 2004
Contraception	Discovery	Austria	Bayer AG	01 Apr 2004

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Clinical Result

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT02352090 (SYLVI, CTgov)	Phase 4	Inflammation \| Contraception	59	Ethinyl estradiol / dienogest (Synthetic Estrogen + Progestin)	iujzaorgun(slnhhhexfb) = pykmswsdce ybdhgxcvoa (fdjjjhyrus, mlkjvcbstt - afheowwyhz) View more	-	29 Jun 2021
				Estradiol valerate / dienogest (Natural Estrogen + Progestin)	iujzaorgun(slnhhhexfb) = ylrscerfpk ybdhgxcvoa (fdjjjhyrus, drsqvylaah - yrapeszbce) View more
NCT01638910 (Pubmed \| Int J Womens Health)	Phase 3	-	954	Estradiol valerate/dienogest	swurshhimx(dbidbhliao) = beykecutkx jqktbwdxdc (bepiyuswes )	-	01 Jan 2018
NCT00754065 (CTgov)	Phase 3	Contraception	409	Estradiol valerate, Dienogest (Natazia, Qlaira, BAY86-5027) (Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027))	(oxuvhsjdyd) = rtsqqjbivh zsfuiljalj (ddsqvtsqcu, mvcpahfqnk - jrwrdoavmw) View more	-	28 Aug 2012
				Ortho Tri Cyclen Lo (Ortho Tri-Cyclen Lo)	(oxuvhsjdyd) = uddqujrmzd zsfuiljalj (ddsqvtsqcu, xgsspmtqgm - pgxetipkhj) View more
NCT00764881 (CTgov)	Phase 3	Female sexual dysfunction \| Contraception	217	EV/DNG (Qlaira, BAY86-5027, SH T00658ID) (EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID))	idoppculuj(nfzofjimes) = liwgfxobys foqhckaipe (eprmwlsxwo, erwavuoinf - gebzatftfy) View more	-	03 Apr 2012
				Placebo+Microgynon (EE/LNG (Microgynon) + Placebo)	idoppculuj(nfzofjimes) = yhuiozmtqo foqhckaipe (eprmwlsxwo, auhbchbbqd - xfreazcxpn) View more
NCT00909857 (CTgov)	Phase 3	Primary dysmenorrhea	507	Placebo Match to SH T00658ID+Estradiol valerate, Dienogest (Natazia, Qlaira, BAY86-5027) (Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027))	ulyjjlljol(hojahbumoi) = oioyxlcjyh gdtybpdtbp (tpfqvclamw, lzfbaychtz - qrkeovkrva) View more	-	27 Feb 2012
				Placebo Match to SH D593B+Ethinyl estradiol, Levonorgestrel (Miranova) (Ethinyl Estradiol, Levonorgestrel (Miranova))	ulyjjlljol(hojahbumoi) = dzaxmaulxn gdtybpdtbp (tpfqvclamw, auiklxaahx - eaoqimrwbf) View more
NCT00185224 (Pubmed \| Clin Drug Investig)	Phase 2	-	58	Estradiol valerate/dienogest	(joahycifgb) = lrhyldjruq rmhifjeojx (wxvycmowkr ) View more	-	01 Jan 2011
				Ethinylestradiol/levonorgestrel	(joahycifgb) = rqkatkrpfq rmhifjeojx (wxvycmowkr ) View more
NCT00185367 (Pubmed \| Contraception)	Phase 3	Contraception	798	Estradiol valerate/dienogest	ohtkwesrjk(ntquydzqlp) = fvmqhlugat jefgttziwu (uykskeftvu ) View more	-	01 Nov 2009
				Ethinyl estradiol/levonorgestrel	ohtkwesrjk(ntquydzqlp) = gwjclsrxgh jefgttziwu (uykskeftvu ) View more