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Last update 16 May 2025
Dienogest/Estradiol Valerate
Last update 16 May 2025
Overview
Basic Info
Drug Type Small molecule drug |
Synonyms ESTRADIOL VALERATE/ESTRADIOL VALERATE/DIENOGEST, BAY86-5027, SH T00658K + [4] |
Target |
Action agonists |
Mechanism ERs agonists(Estrogen receptors agonists), PR agonists(Progesterone receptor agonists) |
Therapeutic Areas |
Active Indication |
Inactive Indication |
Originator Organization |
Active Organization |
Inactive Organization |
License Organization- |
Drug Highest PhaseApproved |
First Approval Date Spain (08 May 2001), |
Regulation- |
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Structure/Sequence
Molecular FormulaC43H57NO5 |
InChIKeyLRHSUZNWLAJWRT-GAJBHWORSA-N |
CAS Registry307334-58-3 |
Sequence Code 27661
The sequence is quoted from: *****
Related
26
Clinical Trials associated with Dienogest/Estradiol ValerateTCTR20240908003
A comparison of menstrual volume and other benefits between Estradiol valerate/dienogest and Ethinyl estradiol/desogestrel: A randomized controlled trial
NCT06396208
"Quick-starting" of a Quadriphasic Contraceptive Pills, 1 - 3 mg Estradiol Valerate/ 2 - 3 mg Dienogest VS 20 mcg Ethinylestradiol/75 mcg Gestodene Focusing on Ovulation Inhibition: A Single-blind, Randomized Controlled, Non-inferiority Trial
NCT05332106
Bioavailability of a Formulation of Estradiol Valerate and Dienogest 2 mg/2 mg Coated Tablets With Regards to the Marketed Reference Product
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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59
Literatures (Medical) associated with Dienogest/Estradiol Valerate01 Oct 2016ContraceptionQ2 · 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: Mawet, Marie ; Coelingh Bennink, Herjan J T ; Maillard, Catherine ; Zimmerman, Yvette ; Foidart, Jean-Michel ; Apter, Dan ; Beekman, Louise
OBJECTIVES:
This 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 DESIGN:
An 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.
RESULTS:
A 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%).
CONCLUSION:
This study showed that, of the four treatment modalities investigated, the 15 mg E4/DRSP combination has the most favourable bleeding pattern and cycle control.
IMPLICATIONS:
Due 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 2015Archives 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: Florin-Andrei Taran ; Birgitt Schönfisch ; Christian W. Wallwiener ; Harald Seeger ; Sara Y. Brucker ; Markus Wallwiener ; Stephan Zipfel ; Alfred O. Mueck ; Lisa-Maria Wallwiener ; Johannes Bitzer
PURPOSE:
To 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.
METHODS:
Female 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.
RESULTS:
We 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.
CONCLUSIONS:
For 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.
01 Jul 2015Gynecological endocrinology : the official journal of the International Society of Gynecological EndocrinologyQ4 · MEDICINE
Effectiveness, tolerability and acceptance of a low-dosed estradiol/dienogest formulation (Lafamme 1 mg/2 mg) for the treatment of menopausal complaints: a non-interventional observational study over 6 cycles of 28 days.
Q4 · MEDICINE
Article
Author: Daniela Rouskova ; Katrin Mittmann ; Thomas Zimmermann ; Ulrike Schumacher ; Horst Dietrich
BACKGROUND:
Concern and controversy characterize nowadays the use of hormone therapy for management of patients with menopausal complaints. This observational non-interventional study examined the use of a marketed oral formulation containing 1 mg estradiol valerate and 2 mg dienogest for treatment of menopausal symptoms in 1292 women visiting 243 gynecological practices in Germany.
METHODS:
Score changes in the Menopausal Rating Scale (MRS) after three and six 28-day cycles were primary endpoints. Subjective reports on skin- and hair-related complaints and satisfaction with treatment effects were assessed. The incidence of adverse drug reactions (ADRs), adverse events (AEs) and vaginal bleeding was evaluated.
RESULTS:
MRS total score decreased substantially and stronger than the clinically relevant change of 5 points (p < 0.0001) as compared with baseline. Subjective skin- and hair-related complaints declined. No unexpected ADRs were reported. AEs (including ADRs) were registered in 8.8% of the participants; most frequent AEs/ADRs were postmenopausal hemorrhage (2.9%) and drug ineffective (1.4%). Nearly 76% of the subjects remained amenorrheic. Approximately 90% of the patients rated the medication's effectiveness/tolerability as good/very good; 84% intended to continue the treatment.
CONCLUSION:
This low-dose estradiol/dienogest formulation proved efficient and well-tolerated option for the alleviation of menopausal symptoms associated with estrogen deficiency.
100 Deals associated with Dienogest/Estradiol Valerate
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External Link
| KEGG | Wiki | ATC | Drug Bank |
|---|---|---|---|
| - | - | - |
R&D Status
Approved
10 top approved records. to view more data
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| Indication | Country/Location | Organization | Date |
|---|---|---|---|
| Menorrhagia | United States | 14 Mar 2012 | |
| Contraception | Australia | 14 May 2009 | |
| Oestrogen deficiency | Netherlands | 08 May 2001 | |
| Oestrogen deficiency | Portugal | 08 May 2001 | |
| Oestrogen deficiency | Spain | 08 May 2001 |
Developing
10 top R&D records. to view more data
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| Indication | Highest Phase | Country/Location | Organization | Date |
|---|---|---|---|---|
| Metrorrhagia | Phase 3 | China | 01 Jun 2012 | |
| Metrorrhagia | Phase 3 | Philippines | 01 Jun 2012 | |
| Metrorrhagia | Phase 3 | Russia | 01 Jun 2012 | |
| Metrorrhagia | Phase 3 | Singapore | 01 Jun 2012 | |
| Metrorrhagia | Phase 3 | Taiwan Province | 01 Jun 2012 | |
| Metrorrhagia | Phase 3 | Thailand | 01 Jun 2012 | |
| Primary dysmenorrhea | Phase 3 | United States | 01 Apr 2009 | |
| Primary dysmenorrhea | Phase 3 | Canada | 01 Apr 2009 | |
| Primary dysmenorrhea | Phase 3 | Chile | 01 Apr 2009 | |
| Primary dysmenorrhea | Phase 3 | Italy | 01 Apr 2009 |
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Clinical Result
Clinical Result
Indication
Phase
Evaluation
View All Results
Phase 4 | 59 | (Synthetic Estrogen + Progestin) | glchcawvlx(uelbgtepzj) = qjmpjqnldu zubvkpstzo (gomgssovvq, gqzacemnam - xraujhzfwr) View more | - | 29 Jun 2021 | ||
(Natural Estrogen + Progestin) | glchcawvlx(uelbgtepzj) = fuhreszyhc zubvkpstzo (gomgssovvq, udfwezvrkc - dhzbhtpysh) View more | ||||||
Phase 3 | - | 954 | dfezokyczd(fixtiucqsd) = pigrtzyvdk ichzweeuuk (iigmimsviq ) | - | 01 Jan 2018 | ||
Phase 3 | 409 | (Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)) | depofcivuu(iltffrgigr) = xozlvxdyon zdxzbwosfl (zdmlccuxhe, 23.58) View more | - | 28 Aug 2012 | ||
(Ortho Tri-Cyclen Lo) | depofcivuu(iltffrgigr) = igjvndaget zdxzbwosfl (zdmlccuxhe, 25.90) View more | ||||||
Phase 3 | 217 | (EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)) | adjrbreeui(yitkqigovk) = ymttjrybql gbiwrdvsoi (gyrrnidqca, 5.33) View more | - | 03 Apr 2012 | ||
Placebo+Microgynon (EE/LNG (Microgynon) + Placebo) | adjrbreeui(yitkqigovk) = ikwwwtoqdv gbiwrdvsoi (gyrrnidqca, 6.22) View more | ||||||
Phase 3 | 507 | Placebo Match to SH T00658ID+Estradiol valerate, Dienogest (Natazia, Qlaira, BAY86-5027) (Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)) | rjjwdjwfav(lzcmdvxigu) = hgzutzssyy hewoqvijmn (lphmawuscw, 4.6) View more | - | 27 Feb 2012 | ||
Placebo Match to SH D593B+Ethinyl estradiol, Levonorgestrel (Miranova) (Ethinyl Estradiol, Levonorgestrel (Miranova)) | rjjwdjwfav(lzcmdvxigu) = lewabluezk hewoqvijmn (lphmawuscw, 4.2) View more | ||||||
Phase 2 | - | 58 | wigwbcwirl(tciwkgtslt) = buezxydeut qmthwqdtoy (whdwnwfwzg ) View more | - | 01 Jan 2011 | ||
wigwbcwirl(tciwkgtslt) = uyfwenvtzp qmthwqdtoy (whdwnwfwzg ) View more | |||||||
Phase 3 | 798 | emzpjpjiin(dkbrtnervq) = wvijafdaop lnnqnpngns (ylewtumvkk ) View more | - | 01 Nov 2009 | |||
emzpjpjiin(dkbrtnervq) = vlnhcvwqmr lnnqnpngns (ylewtumvkk ) View more |
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