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

NCT04901377 / CompletedNot Applicable

A Prospective Multicenter Non-interventional Study to Evaluate User Satisfaction With Estradiol Valerate/ Dienogest in Real Clinical Practice to be Conducted in Russia

Researchers want to learn more about user satisfaction in women in Russia who take estradiol valerate/ dienogest as a contraceptive in real conditions.
Estradiol valerate/ dienogest is a form of birth control. This is also known as a combined oral contraceptive (COC). Earlier studies showed that estradiol valerate/ dienogest has high level of protection from unplanned pregnancy. It is available for doctors to prescribe to women who want to take an oral contraceptive.
Estradiol valerate/ dienogest as a combined oral contraceptive (COC), works by stopping a process called ovulation. This is the process by which the ovaries release an egg. COCs are commonly used by young women to prevent pregnancy.
The researchers in this study will collect information from young women (18-35 years of age) in Russia who will start taking estradiol valerate/ dienogest.
The main purpose of this study is to find out about the women's satisfaction with taking estradiol valerate/ dienogest. To do this, the researchers will ask "how satisfied are you with the birth control method used during the study?". They will ask this question after the women have taken estradiol valerate/ dienogest for 3 and 6 months. The women willanswer this question using a rating scale ranging from 1 to 5, with 1 meaning "very dissatisfied" and 5 meaning "very satisfied".
This study will include young women (18-35 years of age) who want to use oral contraceptives and have been prescribed estradiol valerate/ dienogest by their doctor. None of the women in the study will have taken estradiol valerate/ dienogest within 1 month of joining the study.
In this study, it is expected that each woman will visit her study site 3 times. Each woman will be in the study for up to 6 months. All of the women will take estradiol valerate/ dienogest as prescribed by their doctors. There will be no other required procedures or treatments in this study which is not be used in usual practice.
During the study, the women will answer a question about how satisfied they are with estradiol valerate/ dienogest. They will also respond to some questionnaires. These will include a questionnaire about their menstrual bleeding patterns, sexual function. The doctors will:
ask the women about any medical conditions they may have and what other contraceptives they took before they joined the study
check the women's blood pressure and pulse rate
ask a question about woman's intention to continue to use estradiol valerate/ dienogest and the reasons for discontinuation of estradiol valerate/ dienogest if it has happened

Start Date24 Jun 2021

Sponsor / Collaborator

Bayer AG

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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13

Literatures (Medical) associated with Dienogest/Estradiol Valerate

01 Mar 2018·Journal of assisted reproduction and geneticsQ3 · MEDICINE

Estrogen treatment in infertile women with premature ovarian insufficiency in transitional phase: a retrospective analysis

Q3 · MEDICINE

Article

Author: Cela, Vito ; Obino, Maria Elena Rosa ; Basile, Stefano ; Simi, Giovanna ; Pinelli, Sara ; Giannarelli, Diana ; Sergiampietri, Claudia ; Artini, Paolo Giovanni

PURPOSE:

During the transitional phase of premature ovarian insufficiency (POI), sporadic resumption of ovulation is possible because of fluctuation of hormonal levels but the chance of spontaneous pregnancy is low, and the main perspective of childbearing in these women is egg donation or adoption. The purpose of the study was to verify whether treatment with estrogens in POI patients in transitional phase could reduce FSH levels and to evaluate if this pre-treatment could improve reproductive outcomes of in vitro fertilization (IVF).

METHODS:

Study patients (26) were administered with valerate estradiol 2 mg daily adding dihydrogesterone 10 mg daily during luteal phase for 3 months before IVF. Control group (26 patients) did not receive any pre-treatment. Ovarian stimulation was conducted in both groups with the same short GnRH-antagonist protocol. Clinical and laboratory data of patients were retrospectively analyzed.

RESULTS:

In the study group, 4/26 POI patients became spontaneously pregnant during pre-treatment. In the remaining patients, the mean level of FSH after the pre-treatment was significantly reduced compared with baseline. Levels of circulating estradiol on the day of hCG administration were significantly higher in the study group. The total number of MII oocytes retrieved and fertilized oocytes was significantly higher in the study group, as well as the number of embryos transferred for pickup and clinical pregnancy rate.

CONCLUSIONS:

Treatment with estrogens in infertile POI patients in transitional phase reduces circulating FSH levels, hence causing potential spontaneous conception. Moreover, in these patients, estrogen pre-treatment seems to improve IVF outcomes in a GnRH-antagonist short protocol compared to no pre-treatment.

01 Nov 2014·Gynecological endocrinology : the official journal of the International Society of Gynecological EndocrinologyQ4 · MEDICINE

Effects of estroprogestins containing natural estrogen on vaginal flora

Q4 · MEDICINE

Article

Author: Stefano Restaino ; Rubina Banco ; Rossella De Leo ; Stefano Lello ; Ester Conversano ; Giulia Barbati ; Gianpaolo Maso ; Maddalena Tonon ; Francesco De Seta

Estroprogestins with "natural oestrogen" has represented a new option in terms of combined hormonal contraception. So, the aim of this study is to investigate how estroprogestins with natural estrogen may modify the vaginal niche. In literature, very few studies focused on the interaction between hormonal contraception and vaginal milieu. This is a prospective comparative study. We enrolled 60 women from January 2013 to September 2013, 30 of them were administered estradiol valerate dienogest (E2V+DNG - Klaira®) in a quadriphasic regimen, while the other 30 women were administered 17-β estradiol with nomestrol acetate (EV+NOMAC - Zoely®) in a monophasic regimen. After a baseline study of vaginal milieu at recruitment of patients (Gram stain with Nugent score, vaginal pH, vaginal wet mount for the quantification of leukocytes, Lactobacilli and/or presence of Candida), we performed the same follow-up after six months of estroprogestin therapy. Our results showed that the women treated with E2V+DNG had a trend of an improvement of vaginal health in terms of increase of lactobacillar flora and reduction of vaginal pH in place of women treated with EV+NOMAC that showed a reduction of cervical mucus. Finally, our data about the effects on vaginal flora exerted by two estroprogestin pills (EPs) containing a natural estrogen suggest slight, but interesting differences in terms of vaginal ecology. These differences could be related to the type of estrogen, type of progestin, regimen of administration and, after all, to the net balance between estrogenic and progestin component of the EPs.

01 Sep 2013·ContraceptionQ2 · MEDICINE

Effect of a contraceptive pill containing estradiol valerate and dienogest (E2V/DNG) in women with menstrually-related migraine (MRM)

Q2 · MEDICINE

Article

Author: Silvia Tonani ; Erica Terreno ; Rossella E. Nappi ; Cristina Tassorelli ; Ellis Martini ; Arsenio Spinillo ; Grazia Sances ; Valentina Santamaria

BACKGROUND:

Combined hormonal contraception might worsen migraine in sensitive women, especially during the free-hormone interval, and raise concerns about the vascular risk. The characteristics of a contraceptive pill containing estradiol valerate/dienogest (E2V/DNG) might be of potential benefit in women with menstrually related migraine (MRM) who choose to use oral contraception for birth control.

STUDY DESIGN:

This was a prospective diary-based pilot study. Thirty-two women (age >35 years) [n=18 who had never used combined oral contraceptives (COCs) and n=14 who had previously used COCs] diagnosed with MRMs according to the International Headache Society criteria were included. During the observational period, women filled in a diary with the clinical characteristics of migraine attacks. After a three-cycle run-in period, each subject received a COC containing E2V/DNG (Qlaira®/Natazia®; Bayer HealthCare, Berlin, Germany) administered using an estrogen step-down and progestogen step-up approach. Follow-up evaluations were scheduled at the last cycle of run-in and at the third and sixth cycles of treatment.

RESULTS:

The number of migraine attacks was significantly reduced at the third (p<.001) and sixth cycles (p<.001) in comparison with the run-in period. A similar result was evident for the duration (p<.001 at the third and p<.001 at the sixth cycle) as well as for the severity of head pain (p<.001 at the third and p<.001 at the sixth month). Indeed, a significantly lower number of analgesics were used at the third cycle (p<.001) in comparison with baseline, and a further decrease was evident at the sixth cycle (p<.001) in comparison with the third cycle of E2V/DNG use. Interestingly, duration and severity of head pain were significantly correlated with the number of days of dysmenorrhea at the third cycle (r=.89, p=.000 and r=.67, p=.02; respectively) and at the sixth cycle (r=.76, p=.000 and r=.62, p=.04; respectively) in women without complete remission of menstrual cramps during the study period.

CONCLUSIONS:

The present diary-based pilot study indicates that the use of a pill containing EV2/DNG for six cycles has a positive effect in women with MRM and suggests an association between dysmenorrhea with COCs use as a potential feature of refractory head pain.

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	US	Bayer HealthCare Pharmaceuticals, Inc.	14 Mar 2012
Contraception	US	Bayer HealthCare Pharmaceuticals, Inc.	06 May 2010

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Female sexual dysfunction	Phase 3	AU	Bayer AG	01 Jan 2009
Female sexual dysfunction	Phase 3	AT	Bayer AG	01 Jan 2009
Female sexual dysfunction	Phase 3	BE	Bayer AG	01 Jan 2009
Female sexual dysfunction	Phase 3	DE	Bayer AG	01 Jan 2009
Female sexual dysfunction	Phase 3	IT	Bayer AG	01 Jan 2009
Female sexual dysfunction	Phase 3	ES	Bayer AG	01 Jan 2009
Female sexual dysfunction	Phase 3	TH	Bayer AG	01 Jan 2009
Headache	Phase 3	AU	Bayer AG	01 Dec 2008
Headache	Phase 3	FI	Bayer AG	01 Dec 2008
Headache	Phase 3	FR	Bayer AG	01 Dec 2008

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Clinical Result

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT02352090 (CTgov)	Phase 4	Inflammation \| Contraception	59	Ethinyl estradiol / dienogest (Synthetic Estrogen + Progestin)	tfbqyjcwls(vevhkawnae) = igndscswic kkrudyenrq (okozyzrsdu, pzgihxbakr - errhblacet) View more	-	29 Jun 2021
				Estradiol valerate / dienogest (Natural Estrogen + Progestin)	tfbqyjcwls(vevhkawnae) = wlmeicermu kkrudyenrq (okozyzrsdu, pobxtyrblq - acnpztnysj) View more
NCT01638910 (Pubmed \| Int J Womens Health)	Phase 3	-	954	Estradiol valerate/dienogest	rcglmzbbst(kttenklyya) = agyuyydewn ohjqdhcfda (pevsxwmdug )	-	01 Jan 2018
NCT00764881 (CTgov)	Phase 3	Female sexual dysfunction \| Contraception	217	EV/DNG (Qlaira, BAY86-5027, SH T00658ID) (EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID))	vfzzxevrgp(qozzvzpkvq) = npgoqibxkv wjxsgivtal (hyxumkfeat, yozhncgbwy - xthuxwoxdt) View more	-	03 Apr 2012
				Placebo+Microgynon (EE/LNG (Microgynon) + Placebo)	vfzzxevrgp(qozzvzpkvq) = kwjbcfsxkh wjxsgivtal (hyxumkfeat, qcgjaeszmu - mpikwytvru) 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))	ydxlwesvia(awurkeccaw) = kviclitqif lmowptvnar (udqfrhfnob, yscrpfpthz - lqlgrkmihh) View more	-	27 Feb 2012
				Placebo Match to SH D593B+Ethinyl estradiol, Levonorgestrel (Miranova) (Ethinyl Estradiol, Levonorgestrel (Miranova))	ydxlwesvia(awurkeccaw) = ghpjijgbtx lmowptvnar (udqfrhfnob, mafpdpccpv - ungzdnsltv) View more
NCT00307801 (Pubmed \| Int J Womens Health)	Phase 3	Menorrhagia	231	Estradiol-valerate/dienogest	jyuknjcbpl(gmjpvwlnui) = nrrueddbew ulyahnfjsz (somelycqqb )	-	01 Jan 2012
				Placebo	jyuknjcbpl(gmjpvwlnui) = bbsrqhdwmo ulyahnfjsz (somelycqqb )