The combined oral contraceptive (COC) containing estetrol (E4) and drospirenone (DRSP) (E4/DRSP) is a novel oral contraceptive containing a fixed dose of E4 (14.2 mg) and DRSP (3 mg). The proposed study will address post-market requirements for E4/DRSP under section 505(o) in response to the Food and Drug Administration (FDA) request.
The primary objective of the study is to characterize and compare the risks of E4/DRSP with EE/DRSP and E4/DRSP with a pooled cohort of users of EE/LNG, EE/NETA, and EE/NGM combinations (non-DRSP-containing COCs) in a study population of actual users of these preparations under routine clinical practice. The main clinical outcome of interest is VTE.

Start Date01 Mar 2025

Sponsor / Collaborator

Estetra SRL

NCT06308614

/ Active, not recruitingPhase 2

A Phase 2, Randomized, Double-blind, Placebo-controlled Proof-of-Concept Study to Evaluate the Efficacy and Safety of Estetrol in Postmenopausal Subjects With Female Sexual Arousal Disorder

The goal of this clinical trial is investigating estetrol (E4) in women after menopause, suffering from sexual arousal disorder. The main question it aims to answer is: is 20 mg estetrol monohydrate effective in the treatment of sexual arousal disorder in women after their menopause. Participants will visit the clinic 7 times and complete a daily diary while receiving estetrol or placebo for 12 weeks. Placebo is a pill that looks the same as estetrol but has no active ingredient. Researchers will compare estetrol and placebo to see if estetrol has an effect on the sexual arousal of the participants.

Start Date29 Jan 2024

Sponsor / Collaborator

Estetra SRL

NCT06028555

/ RecruitingNot ApplicableIIT

International Active Surveillance Study: Native Estrogen Estetrol (E4) Safety Study

Multinational, comparative, prospective, active surveillance study that follows two cohorts.
The primary objective of the study is to characterize and compare the risks of E4/Drospirenone (DRSP) with levonorgestrel-containing combined oral contraceptives (EE/LNG) in a study population that is representative of the actual users of these preparations. The main clinical outcome of interest is venous thromboembolism (VTE), specifically deep venous thrombosis (DVT) and pulmonary embolism (PE). Secondary objectives include measuring the occurrence of unintended pregnancy, assessing the risk of arterial thromboembolism (ATE), describing the drug utilization pattern, describing the baseline risk profile for VTE and ATE, and investigating outcomes associated with foetal exposure to E4/DRSP.

Start Date28 Jun 2023

Sponsor / Collaborator

Estetra SRL

100 Clinical Results associated with Estetrol

100 Translational Medicine associated with Estetrol

100 Patents (Medical) associated with Estetrol

347

Literatures (Medical) associated with Estetrol

01 May 2025·Contraception

New endocrine method of oral male contraception

Review

Author: Coelingh Bennink, Herjan J T

Essential for hormonal male contraception (HMC) is the inhibition of follicle-stimulating hormone (FSH), the hormone responsible for spermatogenesis. No drugs exist that can selectively suppress FSH without also inhibiting luteinizing hormone (LH), the hormone responsible for the biosynthesis of testosterone (T) and estradiol (E2) in men. The consequences are a loss of T and E2, with the accompanying symptoms and signs of T deficiency and E2 deficiency, respectively. The loss of T causes sexual function problems, including reduced libido and problems with erection and ejaculation. Moreover, T is not orally bioavailable, and there is a lack of suitable, orally bioavailable androgens to replace the loss of T. This has led to the use of nonoral T replacements, such as patches, gels, or parenteral administration of T or other androgens in current methods for HMC under development. In case these new HMC methods do not contain a testosterone preparation that is metabolized into E2, the suppression of LH will cause loss of E2 and symptoms of estrogen deficiency. We propose to investigate a new oral endocrine approach for HMC using a triple hormone drug called MANTE (Male oral contraception by a GnRH ANtagonist, Testosterone and an Estrogen). This method combines three novelties: (1) the use of an oral gonadotrophin-releasing hormone antagonist to suppress FSH and spermatogenesis, (2) a high dose of the natural adrenal androgen dehydroepiandrosterone to replace T, and (3) a low dose of an orally bioavailable estrogen, preferably estetrol (E4), to prevent signs and symptoms of estrogen deficiency.

01 Mar 2025·Contraception

Effects of estetrol/drospirenone on self-reported physical and emotional premenstrual and menstrual symptoms: Data from the phase 3 clinical trial in the United States and Canada

Article

Author: Kaunitz, Andrew M ; Foidart, Jean-Michel ; Creinin, Mitchell D ; Bouchard, Céline ; Jost, Maud ; Jensen, Jeffrey T ; Chen, Melissa J ; Bitzer, Johannes

OBJECTIVETo describe the effects of estetrol 15mg/drospirenone 3 mg on physical and emotional premenstrual and menstrual symptoms in a North American population.STUDY DESIGNWe used Menstrual Distress Questionnaire (MDQ) data from an open-label phase 3 trial conducted in the United States and Canada that enrolled participants 16-50 years to use estetrol/drospirenone for up to 13 cycles. Four most bothersome MDQ domains were evaluated: the physical domains of Pain and Water Retention and the emotional domains of Negative Affect and Impaired concentration. We assessed mean changes from baseline to end of treatment in premenstrual and menstrual scores in starters and switchers (use of hormonal contraception in prior 3 months) and performed a shift analysis on individual symptoms within each domain.RESULTSOf 1864 treated participants, 1308 (70.2%) completed both MDQs of which 676 (51.7%) were starters and 1179 (90.1%) were US participants. Starters reported significant improvements (p < 0.05) for menstrual Pain (-3.3), premenstrual (-1.5) and menstrual (-2.0) Water Retention and premenstrual Negative Affect (-1.2). Switchers reported no significant changes in any of the four domains. We observed a decrease in symptom intensity in >40% of participants within the domain Pain for Headache, Cramps, Backache, Fatigue, and General Aches and Pain; within the domain Water Retention for Weight Gain, Skin Blemish, Painful or Tender Breast, and Swelling; and within the domain Negative Affect for Anxiety, Mood Swings, and Irritability.CONCLUSIONEstetrol/drospirenone starters experienced the most significant improvements in the MDQ domains Pain, Water Retention, and Negative Affect. Domain scores for switchers remained stable.

01 Feb 2025·Best Practice & Research Clinical Obstetrics & Gynaecology

The clinical relevance of having more than one estrogen in combined hormonal contraception to address the needs of women

Review

Author: Gemzell-Danielsson, Kristina ; Kallner, Helena Kopp ; Frisendahl, Caroline

This chapter examines the potential of natural estrogens, particularly estradiol and estetrol, in combined hormonal contraceptive pills as alternatives to the widely used synthetic ethinyl estradiol. Current evidence highlights the promise of these natural estrogens in providing effective contraception with improved safety profiles and maintained tolerability.WHAT WE KNOWEstradiol and estetrol exhibit favorable safety and efficacy profiles compared to ethinyl estradiol.WHAT WE THINK WE KNOWInitial studies suggest that estetrol combined with drosperinone provide effective contraception with a predictable bleeding patternand reduced risk for venous thromboembolism compared to ethinyl estradiol containing pills. Such risk may also be further mitigated by non-oral administration of estradiol.WHAT WE DO NOT KNOWLong-term efficacy and safety data are needed to confirm the benefits of natural estrogens and their impact on diverse populations and comorbid conditions. By addressing these gaps, future research can enhance our understanding of natural estrogens in hormonal contraception, ultimately refining their use in clinical practice.

News (Medical) associated with Estetrol

12 Jun 2024

·www.pharmaceutical-technology.com

Bankrupt Mithra cashes in on remaining assets for $188.2m

Mithra’s efforts to extend its cash runway earlier this year were unsuccessful. Image credit: Shutterstock/Nudphon Phuengsuwan. A day after filing for bankruptcy, Mithra has sold its share in two of its daughter pharmaceutical companies along with rights to its female hormone drug portfolio for €175m ($188.2m). Recommended Buyer's Guides Buyer's Guide Leading Guide to Packaging Materials, Containers and Containment Services for the Pharmaceutical Industry Buyer's Guide Leading Guide to Compliance Software for the Pharmaceutical Industry The deal saw Budapest-headquartered pharma company Gedeon Richter buy all of Mithra’s shares in Neuralis and Estetra – both subsidiaries of the struggling women’s health pharmaceutical company. Gedeon Richter also gained assets related to the manufacturing of estetrol. The funds, after deduction of financial debts, will be used to repay Mithra’s creditors, meaning the sale does not create any value for the shareholders of Mithra Pharmaceuticals , according to a 10 June press release. Belgium-based Mithra has faced severe financial difficulties in the past few years with share prices tanking by more than 90%. Efforts to extend its cash runway , which included raising $13.7m by selling its stake in Mayne Pharma , were unsuccessful, forcing the company to file for bankruptcy and siphon off its remaining holdings. The transfer will see Gedeon Richter gain rights to Mithra’s Estelle (estetrol-E4 / drospirenone), marketed as Nextstellis and Drovelis in the US and EU respectively. Estelle netted Mithra €2.6m in the first half of 2023. See Also: NPX-267 by NextPoint Therapeutics for Triple-Negative Breast Cancer (TNBC): Likelihood of Approval NPX-267 by NextPoint Therapeutics for Non-Small Cell Lung Cancer: Likelihood of Approval Gedeon Richter will also take on development duties for Mithra’s menopause treatment candidate Donesta which produced positive topline Phase III results in mid-2023. The orally administered estetrol (E4) hormone therapy is slated for US approval in 2024 and EU approval in 2025. Mithra said that “all 49 members of the personnel engaged by the transferred entities will be able to pursue their activities with Gedeon Richter,” along with 17 other employees who have been offered jobs by the latter company. Two of Mithra’s other properties – Novalon, a long-acting drug specialist entity it acquired in 2015, and a contract development and manufacturing organisation (CDMO) facility – remain unaffected by the deal with Gedeon Richter and stay under protection. Mithra said it expects offers to come in by mid-month subject to judicial protection measures being extended. In a statement released on 10 June announcing bankruptcy filing, Mithra stated its employees’ research and future progress “will outlive Mithra and will continue under a different banner from now on. We all hope that these efforts will lead to the development of new solutions that will benefit as many people as possible.”

Phase 3AcquisitionClinical Result

11 Jun 2024

·www.gedeonrichter.com

Richter agreed to acquire certain assets from Mithra Pharmaceuticals

Richter agreed to acquire certain assets from Mithra Pharmaceuticals. Richter agreed to acquire certain assets from Mithra Pharmaceuticals SA (“Mithra”) and from its subsidiary Mithra Recherche et Développement SA (”Mithra R&D”) in Belgium. The transaction includes the acquisition of 100% of the shares in Estetra SRL (“Estetra”) and Neuralis SA (“Neuralis”), as well as some assets and licences of Mithra R&D. The enterprise value implied by the transaction is EUR 175mn, including assumed net debt. Mithra’s key asset is its own-developed lead platform, based on Estetrol (E4), a unique, native estrogen. The transaction aims to acquire exclusive rights of this molecule for multiple indications and several synthetic approaches thereof, as well as worldwide rights attached to the linked product/product candidates. The transfer includes the related intellectual property rights, current contracts as well as the commitments related to ESTELLE® (already marketed) and DONESTA® (in development, ahead of filing for marketing authorization). All members of the personnel of Neuralis and Estetra maintain their employment as a result of the transaction. In addition, other members of the personnel of Mithra have also been offered to join Estetra. The transaction has been closed and upfront payments have been made to Mithra Pharmaceuticals SA’s and Estetra SRL’s secured lenders, while part of the purchase price is subject to the occurrence of certain contingent events. The acquired assets represent a unique opportunity for Richter to further expand and deepen its presence in its core Women’s Healthcare (WHC) business worldwide. The ownership of Estetrol opens the way to set foothold in the US, Japan and other geographies, where Richter has had subscale WHC presence. While one of the novel WHC products in contraception has already been successfully marketed, research facilities in Liege will allow Richter to expand the Estetrol platform to other promising WHC areas, such as menopause and fertility. The acquisition marks a first step towards Richter establishing its own original gynaecological research. As a result, Richter will cover the entire value chain in Women’s Healthcare from original research to on-market sales and it is going to be present on all continents with its highly specialised WHC product franchise. Gábor Orbán, CEO of Gedeon Richter, said: “Acquiring Estetrol represents an outstanding strategic opportunity for Richter in one of its core therapeutic areas. I look forward to taking advantage of future synergies between the scientific team about to join Richter and our existing development, manufacturing and marketing platform paving the way to fulfil our target of becoming the leading European player in the field of WHC by the end of this decade.” About Gedeon Richter Plc. Gedeon Richter Plc. (www.gedeonrichter.com), headquartered in Budapest/Hungary, is a major pharmaceutical company in Central Eastern Europe, with an expanding direct presence in Western Europe, China, Latin America, and Australia. Having reached a market capitalization of EUR 4.3bn (USD 4.7bn) by the end of 2023, Richter's consolidated sales were approximately EUR 2.1bn (USD 2.3bn) during the same year. The product portfolio of Richter covers many important therapeutic areas, including Women's Healthcare, Central Nervous System, and Cardiovascular areas. Having the largest R&D unit in Central Eastern Europe, Richter's original research activity focuses on CNS disorders. With its widely acknowledged steroid chemistry expertise, Richter is a significant player in the Women's Healthcare field worldwide. Richter is also active in biosimilar product development.

Acquisition

10 Jun 2024

·www.mithra.com

Mithra files for bankruptcy and continues negotiations with Gedeon Richter for the sale of Neuralis and Estetra

Contact EN FR EN FR Mithra CDMO Newsroom Investor Relations Mithra CDMO Newsroom Investor Relations 10 June 2024 | Corporate, Inside information, Regulated information On Monday morning, the Tribunal de l’Entreprise of Liège opened bankruptcy proceedings against Mithra Pharmaceuticals SA and appointed trustees Mithra CDMO and Novalon SA entities are not affected by the bankruptcy as they are subject to separate judicial reorganization proceedings Liège, Belgium, 10 June 2024 – 19:15 CEST – Mithra (Euronext Brussels: MITRA), a company dedicated to women’s health, today announces that the Tribunal de l’Entreprise of Liège pronounced the opening of the bankruptcy procedure of Mithra Pharmaceuticals SA this morning. Mithra Pharmaceuticals SA was indeed facing major financial difficulties which prevent it from fulfilling its obligations and no longer had the working capital required to pursue its activities. As previously announced, Mithra Pharmaceuticals SA had entered into negotiations with Gedeon Richter. Mithra Pharmaceuticals announces today that it continues negotiations with Gedeon Richter relating to the sale to Gedeon Richter of all shares in Neuralis SA and Estetra SRL held by Mithra Pharmaceuticals SA and specific assets of Mithra R&D SA relating to the manufacture of estetrol. It is expected that the transaction would be signed and completed as soon as reasonably possible. The Mithra CDMO and Novalon SA entities are not affected by the bankruptcy as they are subject to separate judicial reorganization proceedings. The judicial protection measures to which they are subject should, subject to the court’s approval, be extended until 30 June 2024. This extension is intended to allow the different parties interested in Mithra CMDO’s assets to continue their due diligence and submit binding offers by mid-month. The amount to be received from the sale of Neuralis SA and Estetra SRL as well as certain assets of Mithra R&D SA, after deduction of financial debts, will allow to repay some amounts to the creditors as per their legal privilege. As a result, this transaction does not create any value for the shareholders of Mithra Pharmaceuticals SA. Mithra Pharmaceuticals SA was born of the ambition to significantly improve women’s health, Mithra has distinguished itself by the unwavering determination of its employees to push the boundaries of science for the common good. Their research and the progress it heralds will outlive Mithra and will continue under a different banner from now on. We all hope that these efforts will lead to the development of new solutions that will benefit as many people as possible. The management and Board of Directors would like to thank Mithra’s shareholders and partners who have played a decisive role in the scientific advances that Mithra has made possible. Get the latest news: subscribe to our newsletter! ⇧ Back to top Mithra (Euronext: MITRA) is a Belgian biotech company dedicated to transforming women’s health by offering new choices through innovation, with a particular focus on contraception and menopause. Mithra sells Estetra SRL, Neuralis SA and specific assets to Gedeon Richter Mithra (Headquarter) Rue Saint-Georges 5 4000 Liège Belgium +32 (0)4 349 28 22 info@mithra.com Mithra CDMO Rue de l’Expansion 57 4400 Flémalle Belgium +32 (0)4 353 37 00 info@mithracdmo.com Get the latest news: subscribe to our newsletter! © Mithra Pharmaceuticals Legal Mentions - Terms of Use - Cookies - Privacy Policy Cookies settings

100 Deals associated with Estetrol

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KEGG	Wiki	ATC	Drug Bank
D11513	Estetrol	-	DB12235

R&D Status

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Indication	Highest Phase	Country/Location	Organization	Date
Menopausal symptoms	Phase 3	Canada	Estetra SRL	27 Sep 2019
Menopausal symptoms	Phase 3	United States	Estetra SRL	27 Sep 2019
Vasomotor symptom	Phase 3	Canada	Estetra SRL	27 Sep 2019
Vasomotor symptom	Phase 3	United States	Estetra SRL	27 Sep 2019
Menopausal syndrome	Phase 3	-	Mithra Pharmaceuticals SA	-
Hot Flashes	Discovery	Belgium	Donesta Bioscience BV	01 May 2016
Contraception	Discovery	Finland	Estetra SRL	01 Sep 2010

Clinical Result

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT02720224 (CTgov)	Phase 1	Contraception	6	Estetrol	zecddmijxd(rpbqpyassx) = vyrtbncrqp gvatgyskyh (vranshhqkh, puqmxivcgf - gdqioybchy) View more	-	10 Dec 2018

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