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

Overview

Basic Info

Drug Type

Small molecule drug

Synonyms

Valette

Target

ER x PR

Action

agonists

Mechanism

ERs agonists(Estrogen receptors agonists), PR agonists(Progesterone receptor agonists)

Therapeutic Areas

Skin and Musculoskeletal DiseasesOther Diseases

Active Indication

Acne, AdultContraception

Inactive Indication-

Originator Organization

Jenapharm GmbH & Co. KG

Active Organization

Bayer Australia Ltd.

Insud Pharma SL

Inactive Organization

Bayer AG

License Organization-

Drug Highest PhaseApproved

First Approval Date

Australia (02 Mar 2006),

Acne, AdultContraception

Regulation-

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Structure/Sequence

Molecular FormulaC40H49NO4

InChIKeyJRGZBMMCVMDOKI-DHLNHIIISA-N

CAS Registry170475-05-5

Sequence Code 27661

The sequence is quoted from: *****

The presence of a thin endometrium plays an important role in enabling the best conditions for hysteroscopic surgery. Recently, for this purpose, many studies have evaluated the effect of preoperative administration of a variety of drugs. We explored the efficacy of random started 14-day administration of Drospirenone/Estetrol or Nomegestrol Acetate/Estradiol or Ethinylestradiol/Dienogest, in rapid preparation of endometrium for hysteroscopic polypectomy.

Start Date01 Jan 2023

Sponsor / Collaborator

University of Palermo

[+1]

NCT06316206

/ CompletedPhase 4IIT

The Use of Ethinylestradiol/Dienogest in Random Start Rapid Preparation of Endometrium Before Office Hysteroscopic Polypectomies: a Multicenter, Prospective, Randomized Study

The presence of a thin endometrium plays an important role in enabling the best conditions for hysteroscopic surgery. Recently, for this purpose, many studies have evaluated the effect of preoperative administration of a variety of drugs. We explored the efficacy of random started 14-day administration of Ethinylestradiol/Dienogest, in rapid preparation of endometrium for hysteroscopic polypectomy.

Start Date01 Jan 2023

Sponsor / Collaborator

University of Palermo

[+1]

NCT03945513

/ CompletedPhase 3

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

The main objective of this trial is to demonstrate the contraceptive efficacy of LPRI424, Additional goals of the trial are to demonstrate the safety and tolerability of LPRI424.

Start Date03 Dec 2019

Sponsor / Collaborator

Insud Pharma SL

[+1]

100 Clinical Results associated with Ethinyl Estradiol/Dienogest

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100 Translational Medicine associated with Ethinyl Estradiol/Dienogest

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100 Patents (Medical) associated with Ethinyl Estradiol/Dienogest

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29

Literatures (Medical) associated with Ethinyl Estradiol/Dienogest

03 May 2024·Chronobiology International

Menstrual cycle phases and dosage of synthetic hormonal contraceptives influence diurnal rhythm characteristics of distal skin temperature

Article

Author: Möllgaard, Leefke ; Engelhard, Felicia ; Dittmar, Manuela

This study aimed to explore how natural menstrual cycle phases and dosage of oral hormonal contraceptives (OC) influence the diurnal rhythm of distal skin temperature (DST) under real-life conditions. Participants were 41 healthy females (23.9 ± 2.48 y), comprising 27 females taking monophasic hormonal oral contraceptives (OC users) and 14 females with menstrual cycles (non-OC users). Wrist DST was continuously recorded and averaged over two consecutive 24-hour days during (pseudo)follicular and (pseudo)luteal menstrual phases. Diurnal rhythm characteristics, i.e. acrophase and amplitude, describing timing and strength of the DST rhythm, respectively, were calculated using cosinor analysis. Results show that non-OC users experienced earlier diurnal DST maximum (acrophase, p = 0.019) and larger amplitude (p = 0.016) during the luteal phase than during the follicular phase. This was observed in most (71.4%) but not all individuals. The OC users showed no differences in acrophase or amplitude between pseudoluteal and pseudofollicular phases. OC users taking a higher dosage of progestin displayed a larger amplitude for DST rhythm during the pseudoluteal phase (p = 0.009), while estrogen dosage had no effect. In conclusion, monophasic OC cause changes in diurnal DST rhythm, similar to those observed in the luteal phase of females with menstrual cycles, suggesting that synthetic progestins act in a similar manner on skin thermoregulation as progesterone does.

01 Jun 2012·Hormone and Metabolic ResearchQ4 · MEDICINE

Proliferative Effects of Estradiol- or Ethinylestradiol-Progestogen Combinations on Human Breast Cancer Cells in an Intermitted and a Long-term Regimen

Q4 · MEDICINE

Article

Author: Mueck, A. ; Merki-Feld, G. ; Seeger, H.

Currently the use of natural estradiol as estrogenic component in oral contraceptives is more and more extended. It is unknown whether the application of this estrogen is associated with a different breast cancer risk as compared to the common use of the synthetic ethinylestradiol. In addition with the intention to reduce menstruation associated symptoms and bleeding periods an extended-cycle regimen is currently considered. In the present in vitro work, we have compared the effect of these different estrogenic compounds and the different treatment regimens on breast cancer risk. Human breast cancer cells (ZR75-1 and HCC1500) were incubated with equimolar concentrations of estradiol or ethinylestradiol combined with various progestogens, dienogest, drospirenone, keto-desogestrel, levonorgestrel, and nomegestrel. Usual and extended cycle was mimicked by incubation periods of 3 days with 1 day hormones off and 4 days, respectively. Molecular markers for proliferation and apoptosis were investigated by Western blot. In both cell lines estradiol and ethinylestradiol elicited a significant increase in the proliferation rate without difference between the 2 estrogens. The effect in the long-term cycle tended to be more pronounced than in the intermitted cycle. Progestogen addition most significantly reduced the estrogen-induced proliferation rate. The molecular markers were influenced by the progestogens mostly in the same manner, reducing the proliferation/apoptosis rate. Our results indicate that both estrogenic based combinations with progestogens may not increase breast cancer risk independent from the regimen, intermitted or long-term cycle. However clinical studies are necessary to prove these in vitro results.

01 Mar 2012·Diabetic MedicineQ2 · MEDICINE

Oral contraception enhances growth hormone responsiveness to hyper‐ and hypoglycaemia

Q2 · MEDICINE

Article

Author: M. Loebig ; K. Diedrich ; K. Jauch-Chara ; S. Tauchert ; S. Rudolf ; A. K. Ludwig ; K. M. Oltmanns ; U. Schweiger ; A. Friedrich

Diabet. Med. 29, 345–350 (2012)AbstractAims Plasma glucose levels influence growth hormone concentrations. Oral contraceptives are known to affect circulating growth hormone levels and glucose metabolism. While growth hormone plays an important role in hypoglycaemia counter‐regulation, it has been shown that oral contraceptives increase growth hormone concentrations. In this context, we tested if serum growth hormone concentrations display a differential response on glycaemic variations in healthy women using oral contraceptives and those not using contraceptives.Methods Fifteen healthy women with oral contraceptive treatment and 10 without participated in a stepwise hyper‐ and hypoglycaemic glucose clamp procedure. Serum growth hormone concentrations were measured at euglycaemic baseline and subsequently at plasma glucose plateaus of 8.8, 6.8, 4.8 and 2.8 mmol/l.Results Growth hormone values were significantly higher in women using oral contraceptives throughout the experiments (P = 0.001). Hyperglycaemia decreased growth hormone concentrations in women using oral contraceptives (P = 0.009), but not in those who were not using oral contraceptives (P = 0.241). Hypoglycaemia significantly elevated growth hormone concentrations in women using oral contraceptives (P = 0.009), but not in those not using oral contraceptives (P = 0.094). Maximum growth hormone values were reached at the end of the hypoglycaemic plateau, with significantly higher concentrations in the group using oral contraceptives than in the group not using oral contraceptives (P = 0.016).Conclusion Healthy women on oral contraceptive treatment display an increased responsiveness of growth hormone to hypoglycaemic, as well as hyperglycaemic conditions and generally higher serum growth hormone concentrations than women without oral contraceptives. Given the known boosting effects of growth hormone on hypoglycaemic hormonal counter‐regulation, oral contraceptives may thus be a pharmacological candidate contributing to combat hypoglycaemia unawareness in women with diabetes in the future.

100 Deals associated with Ethinyl Estradiol/Dienogest

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External Link

KEGG	Wiki	ATC	Drug Bank
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R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Acne, Adult	Australia	Bayer Australia Ltd.	02 Mar 2006
Contraception	Australia	Bayer Australia Ltd.	02 Mar 2006

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Contraception	Phase 3	United States	Insud Pharma SL	03 Dec 2019
Acne Vulgaris	Preclinical	Ukraine	Bayer AG	10 Mar 2004
Acne Vulgaris	Preclinical	Russia	Bayer AG	10 Mar 2004
Acne Vulgaris	Preclinical	Slovakia	Bayer AG	10 Mar 2004
Acne Vulgaris	Preclinical	Czechia	Bayer AG	10 Mar 2004
Acne Vulgaris	Preclinical	Poland	Bayer AG	10 Mar 2004

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Clinical Result

Indication

Phase

Evaluation

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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)	lghotlpbgq(cvfqlofrwa) = wcpzgdlytn rurrbrtswv (ajhsyjpheq, xfydyqbofv - mfjnbdzlxe) View more	-	29 Jun 2021
				Estradiol valerate / dienogest (Natural Estrogen + Progestin)	lghotlpbgq(cvfqlofrwa) = qkxgfpoxtv rurrbrtswv (ajhsyjpheq, wtoxywfnrh - tnrtfkeltj) View more