Endometriosis, a chronic gynecological disorder associated with pain and infertility, is a common condition affecting approximately one in ten women. Up to 50% of patients with endometriosis have ovarian endometriomas (or "chocolate cysts"). These cysts directly impact fertility and ovarian reserve (ie. ability to have children) and can cause additional symptoms in women such as added pain, discomfort, and surgical emergencies (cyst rupture, or more rarely twisting). While endometriomas tend to require surgical excision as a solution, medical management with a variety of medications has been shown to be effective in reducing their size.
Medical management (ie. medications and treatments that don't involve surgery) to reduce cyst size can help relieve symptoms either as a long term solution, before fertility treatments, or temporarily until surgery can be offered. Because the COVID-19 pandemic caused significantly reduced access to surgery and resources, medical management has become important for relief of the overburdened healthcare network.
The purpose of this study is to see how effective Estetrol/drospirenone, a combined oral contraceptive (COC), is in the reduction of ovarian endometriomas after a 3- and 6-month period of treatment.
This single arm interventional study will recruit women 18 years or older with an ovarian endometrioma of at least 3cm, who are seeking a hormonal treatment for their endometrioma(s). Consenting participants of the study will take Estetrol/drospirenone once daily, orally, for a 6 month duration. An ultrasound assessment of ovarian endometrioma(s) will be performed before starting the drug (0 months), and will be repeated at 3-months and 6-months time. At each of these hospital visits (0, 3 & 6 months), participants will have their weight and blood pressure measured, and they will complete questionnaires regarding their endometriosis symptoms, incidence of amenorrhea, compliance and incidence of any adverse effects.

开始日期2024-10-01

申办/合作机构-

NCT06396221 / RecruitingN/AIIT

"Quick-starting" of a New Combined Hormonal Contraceptive Pills, 15 mg Estetrol/3 mg Drospirenone VS 20 mcg Ethinylestradiol/75 mcg Gestodene Focusing on Ovulation Inhibition: A Single-blind, Randomized Controlled, Non-inferiority Trial

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:
1. Does Estetrol/Drospirenone inhibit ovulation inferior to Ethinyl estradiol/Gestodene when starting on Day 7-9 of menstrual cycle?
2. What are the impacts of Estetrol/Drospirenone on ovarian activities when starting on Day 7-9 of menstrual cycle?
3. How does the cervical mucus change when starting Estetrol/Drospirenone on Day 7-9 of menstrual cycle?
4. What are the adverse effects when starting Estetrol/Drospirenone on Day 7-9 of menstrual cycle?
Researchers will compare Estetrol/Drospirenone to Ethinyl estradiol/Gestodene to see if Estetrol/Drospirenone inhibit ovulation in quick-starting method.

开始日期2024-05-01

申办/合作机构

University of Chulalongkorn

CTIS2023-507842-10-00 / Not yet recruitingIIT

Brain effects of hormonal contraceptives. A randomized, double-blind, longitudinal study comparing two combined oral contraceptives (Estetrol/drospirenone vs ethinylestradiol/levonorgestrel).

开始日期2024-01-18

申办/合作机构-

100 项与雌四醇/屈螺酮相关的临床结果

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100 项与雌四醇/屈螺酮相关的转化医学

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100 项与雌四醇/屈螺酮相关的专利（医药）

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项与雌四醇/屈螺酮相关的文献（医药）

2024-07-03·EUROPEAN JOURNAL OF CONTRACEPTION AND REPRODUCTIVE HEALTH CARE

Effects of E4/DRSP on self-reported physical and emotional premenstrual and menstrual symptoms: data from the phase 3 clinical trial in Europe and Russia

Article

作者: Bouchard, Céline ; Foidart, Jean-Michel ; Apolikhina, Inna ; Gemzell-Danielsson, Kristina ; Bitzer, Johannes ; Piltonen, Terhi ; Zatik, János ; Weyers, Steven ; Creinin, Mitchell D. ; Suturina, Larisa ; Jost, Maud

PURPOSE:

To describe the effects of estetrol (E4) 15 mg/drospirenone (DRSP) 3 mg on physical and emotional premenstrual and menstrual symptoms.

MATERIALS AND METHODS:

We used Menstrual Distress Questionnaire (MDQ) data from a phase-3 trial (NCT02817828) in Europe and Russia with participants (18 - 50 years) using E4/DRSP for up to 13 cycles. We assessed mean changes in MDQ-t-scores from baseline to end of treatment in premenstrual (4 days before most recent flow) and menstrual (most recent flow) scores for 4 MDQ domains in starters and switchers (use of hormonal contraception in prior 3 months) and performed a shift analysis on individual symptoms within each domain.

RESULTS:

Of 1,553 treated participants, 1,398(90.0%), including 531(38%) starters, completed both MDQs. Starters reported improvements for premenstrual Pain (-1.4), Water Retention (-3.3) and Negative Affect (-2.5); and for menstrual Pain (-3.5), Water Retention (-3.4), and Negative Affect (-2.7) (all p < 0.01). For switchers, no changes were significant except an increase in premenstrual (+1.0, p = 0.02) and menstrual (+1.5, p = 0.003) Water Retention. We observed a change in symptom intensity in >40% of participants for Cramps, Backache and Fatigue (domain Pain), Painful or Tender Breast and Swelling (domain Water Retention) and Mood Swings and Irritability (domain Negative Affect).

CONCLUSION:

E4/DRSP starters experienced significant improvements in the domains Pain, Water Retention and Negative Affect particularly benefiting those with more severe baseline symptoms. Switchers showed minimal changes.

2023-12-02·Expert opinion on drug metabolism & toxicology

Combined oral contraceptive with estetrol plus drospirenone: from pharmacokinetics to clinical applications

Review

作者: Facchinetti, Fabio ; Genazzani, Alessandro D. ; Feliciello, Lia ; Battipaglia, Christian ; Grandi, Giovanni

INTRODUCTION:

Drospirenone/estetrol (DRSP/E4) is a combined oral contraceptive (COC) recently approved in several countries. It is composed of 15 mg of E4, a natural estrogen produced by human fetal liver throughout pregnancy, and 3 mg of DRSP, the first synthetic progestin used in oral contraception derived from 17-α-spirolactone. E4 and DRSP synergistically prevent pregnancy by inhibiting ovulation. E4 differs from 17-β-estradiol or ethinylestradiol because it represents a native estrogen with selective action in tissues (NEST), therefore it displays both agonist and antagonist estrogenic effects in different tissues.

AREAS COVERED:

In this paper, we reviewed the scientific literature published in English prior to April 2023 and gathered information on the pharmacodynamics and pharmacokinetics of DRSP, E4 and their combination for contraception. We also proposed possible clinical applications based on the characteristics of the components of this COC.

EXPERT OPINION:

E4/DRSP-based COC has shown high tolerability, safety and satisfaction and may represent a viable choice in young girls in need of oral contraception and pill users who suffer from high cholesterol, breast tenderness or water retention. Moreover, this new COC shows higher scheduled bleeding rate compared to other pills containing natural estrogens. All the data are reassuring, permitting long-term use.

2022-12-01·Contraception

Tolerability and safety of the estetrol/drospirenone combined oral contraceptive: Pooled analysis of two multicenter, open-label phase 3 trials

Article

作者: Apolikhina, Inna ; Achilles, Sharon L ; Kaunitz, Andrew M ; Chen, Melissa J ; Jensen, Jeffrey T ; Foidart, Jean-Michel ; Suturina, Larisa ; Jost, Maud ; Zatik, János ; Archer, David F ; Piltonen, Terhi ; Creinin, Mitchell ; Weyers, Steven ; Bouchard, Celine

OBJECTIVES:

To evaluate tolerability and safety of estetrol (E4) 15 mg/drospirenone (DRSP) 3 mg oral contraceptive using pooled data from two, multicenter, phase 3 trials.

STUDY DESIGN:

The two trials enrolled participants aged 16-50 years with a body mass index ≤35.0 kg/m² to use E4/DRSP in a 24/4-day regimen for up to 13 cycles. We pooled data from participants who used at least one E4/DRSP dose and had a follow-up assessment to analyze adverse events (AEs), vital signs, and laboratory parameters, including serum lipids, glucose, glycated hemoglobin, and potassium. We consolidated similar Medical Dictionary for Regulatory Activities preferred terms into groupings.

RESULTS:

Of 3725 participants enrolled, we included 3417 in the analyses of whom 1786 (52.3%) reported ≥1 AE. Most participants with reported AEs had AEs that investigators rated as mild or moderate (n = 1665, 93.2%); of participants reporting AEs, 1105 (61.9%) did so during cycles 1 to 3. In total, 981 (28.7%) participants experienced ≥1 treatment-related AE, most frequently related to bleeding complaints (n = 323, 9.5%), breast pain or tenderness (n = 136, 4.0%), acne (n = 113, 3.3%), and mood disturbance (n = 111, 3.2%). Discontinuation due to treatment-related AEs occurred in 272 participants (8.0%), with only bleeding complaints (n = 97, 2.8%) and mood disturbance (n = 38, 1.1%) at rates exceeding 1%. Three participants experienced serious AEs, which the site investigators considered treatment-related: one venous thromboembolism, one worsening of depression, and one ectopic pregnancy. We found no clinically relevant changes in weight, blood pressure, heart rate, or laboratory parameters during treatment.

CONCLUSIONS:

E4/DRSP is associated with a favorable tolerability and safety profile.

IMPLICATIONS STATEMENT:

Pooling data allowed for a robust assessment of tolerability and safety, including relatively infrequent events. Other than bleeding complaints and mood disturbance, no adverse event resulted in E4/DRSP discontinuation at rates >1%. Post-marketing surveillance studies are needed to evaluate long-term safety of the E4/DRSP COC and population-based venous thromboembolism risks.

项与雌四醇/屈螺酮相关的新闻（医药）

2024-06-12

·Pharmaceutical Technology

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.”

临床3期并购临床结果

2024-05-28

·GlobeNewswire-Health Care

Mithra postpones its annual general meeting

Liege, Belgium, 28 May 2024 – 15:00 CEST – Mithra (Euronext Brussels: MITRA), a company dedicated to women’s health, today announces that in the context of the monetization process and the uncertainties related thereto, Mithra postpones its Annual General Shareholders’ Meeting, previously planned for 30 May 2024, to a later date to be determined. Background Information: On 5 March 2024, Mithra announced the launch of a comprehensive monetization process, exploring potential sales of selected assets, notably Estetra SRL, and potentially the entire business. Additionally, Mithra announced the entry into a secured bridge loan facility (“the Facility”) for an amount of up to EUR 13.5 million to be drawn in multiple tranches upon the satisfaction of certain milestones, as well as an uncommitted EUR 5 million "accordion" facility (which could be used once the committed amount has been fully drawn and only if the lenders consent). The lenders under the Facility consist of funds managed by Highbridge Capital Management, LLC and funds managed by Whitebox Advisors, LLC. The monetization process for Mithra’s CDMO and Novalon SA assets are proceeding under court protection measures from the Liege Company Courts. The Mithra CDMO asset in Flemalle, Belgium was granted “Transfer under Judicial Supervision” with court-designated trustees to oversee negotiations with potential bidders and select the best offer while safeguarding the interests of the company, its creditors, and its employees. The Judicial reorganization proceedings to restructure the debt of Novalon SA, Mithra’s complex therapeutics business, involves reaching an amicable agreement with some creditors and implementing a court-sanctioned debt-restructuring plan therewith. The protection measures are expected to remain in effect until 19 June 2024. For more information, please contact: Mithra Pharmaceuticals SAAlex Sokolowski, PhDHead of IR & Communicationsinvestorrelations@mithra.com +32 (0)4 349 28 22 Frédérique Depraetere Communications Directorinfo@mithra.com+32 (0)4 349 28 22 About Mithra Mithra Pharmaceuticals SA (Euronext: MITRA) is a Belgian biopharmaceutical company dedicated to transforming women’s health by offering new choices through innovation, with a particular focus on contraception and menopause. Mithra’s goal is to develop products offering better efficacy, safety and convenience, meeting women’s needs throughout their life span. Mithra explores the potential of the unique native estrogen estetrol in a wide range of applications in women health and beyond. After having successfully launched the first estetrol-based product in 2021, the contraceptive pill ESTELLE®, Mithra is now focusing on its second product DONESTA®, the next-generation hormone therapy. Mithra also offers partners a complete spectrum of solutions from early drug development, clinical batches and commercial manufacturing of complex polymeric products (vaginal ring, implants) and complex liquid injectables and biologicals (vials, pre-filled syringes or cartridges) at its technological platform Mithra CDMO. Active in more than 100 countries around the world, is headquartered in Liège, Belgium. www.mithra.comESTELLE® and DONESTA® are registered trademarks of Mithra Pharmaceuticals or one of its affiliates. Important informationThe contents of this announcement include statements that are, or may be deemed to be, "forward-looking statements". These forward-looking statements can be identified by the use of forward-looking terminology, including the words "believes", "estimates," "anticipates", "expects", "intends", "may", "will", "plans", "continue", "ongoing", "potential", "predict", "project", "target", "seek" or "should", and include statements the Company makes concerning the intended results of its strategy. By their nature, forward-looking statements involve risks and uncertainties, and readers are cautioned that any such forward-looking statements are not guarantees of future performance. The Company's actual results may differ materially from those predicted by the forward-looking statements. The Company undertakes no obligation to publicly update or revise forward-looking statements, except as may be required by law.

2024-04-29

·GlobeNewswire-Health Care

Mithra updates on offers received in the context of its monetization process and on its Annual Report 2023

Mithra has received binding offers for selected assets, including Estetra SRL, as part of its monetization process. As it stands, the aggregate amount of these offers is insufficient to ensure full repayment of all creditors of Mithra, and, therefore, the offers do not allow to create value for Mithra’s shareholders at the present time.Mithra has requested the suspension of trading of its shares on Euronext Brussels pending continuing negotiations with offering parties.Mithra postpones the publication of its Annual Report 2023 to a later date due to the current circumstances to reflect a situation in discontinuity. LIEGE, Belgium, April 29, 2024 (GLOBE NEWSWIRE) -- Mithra (Euronext Brussels: MITRA), a company dedicated to women’s health, announces that it has received several binding offers1 for selected Mithra assets (particularly Estetra SRL) during the week of 22 April 2024, as part of its ongoing monetization process— first announced on 05 March 2024. In collaboration with Stifel Investment Bank and other expert advisors, Mithra is diligently analyzing these offers, which include all shares in Estetra SRL and certain other activities and assets within the Mithra group. Mithra continues to seek potential buyers for all its activities and assets (i.e., Mithra CDMO, Novalon, Mithra R&D, Neuralis, Mithra parent co.). As it stands, the aggregate amount of these offers is insufficient to ensure full repayment of all creditors of Mithra. Therefore, the offers received will not create value for the shareholders of Mithra. Mithra remains committed to negotiating with the offering parties to enhance the value offered, acting in the best interest of all stakeholders. The Company is also considering taking appropriate action, including continuing negotiations for the relevant assets under court proceedings (as is the case for other assets of the Mithra group), to advance these discussions further if necessary. Consequently, Mithra has requested the Financial Services and Markets Authority (FSMA) to suspend trading of the Company’s shares on Euronext Brussels pending the on-going negotiations. Mithra remains committed to executing its monetization process with diligence and transparency representing the interests of all stakeholders and will continue providing timely updates to the market and stakeholders as appropriate. Additionally, Mithra will postpone the publication of its Annual Report 2023 (originally scheduled for 30 April 2024) as it was prepared based on a going concern assumption. Instead, considering the recent events, an annual report will be prepared and published for Mithra reflecting a situation "in discontinuity" at a later date, which will be announced in a subsequent communication. About MithraMithra Pharmaceuticals SA (Euronext: MITRA) is a Belgian biopharmaceutical company dedicated to transforming women’s health by offering new choices through innovation, with a particular focus on contraception and menopause. Mithra’s goal is to develop products offering better efficacy, safety and convenience, meeting women’s needs throughout their life span. Mithra explores the potential of the unique native estrogen estetrol in a wide range of applications in women health and beyond. After having successfully launched the first estetrol-based product in 2021, the contraceptive pill ESTELLE®, Mithra is now focusing on its second product DONESTA®, the next-generation hormone therapy. Mithra also offers partners a complete spectrum of solutions from early drug development, clinical batches and commercial manufacturing of complex polymeric products (vaginal ring, implants) and complex liquid injectables and biologicals (vials, pre-filled syringes or cartridges) at its technological platform Mithra CDMO. Active in more than 100 countries around the world, is headquartered in Liège, Belgium. www.mithra.com ESTELLE® and DONESTA® are registered trademarks of Mithra Pharmaceuticals or one of its affiliates. Important informationThe contents of this announcement include statements that are, or may be deemed to be, "forward-looking statements". These forward-looking statements can be identified by the use of forward-looking terminology, including the words "believes", "estimates," "anticipates", "expects", "intends", "may", "will", "plans", "continue", "ongoing", "potential", "predict", "project", "target", "seek" or "should", and include statements the Company makes concerning the intended results of its strategy. By their nature, forward-looking statements involve risks and uncertainties, and readers are cautioned that any such forward-looking statements are not guarantees of future performance. The Company's actual results may differ materially from those predicted by the forward-looking statements. The Company undertakes no obligation to publicly update or revise forward-looking statements, except as may be required by law. 1 subject to certain / customary conditions

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100 项与雌四醇/屈螺酮相关的药物交易

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适应症	国家/地区	公司	日期
痛经	日本	Fuji Pharma Co., Ltd.	2024-09-24
避孕	美国	Mayne Pharma Ltd.	2021-04-15
潮热	美国	Bayer HealthCare Pharmaceuticals, Inc.	2005-09-28

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适应症	最高研发状态	国家/地区	公司	日期
血管舒缩症	临床2期	比利时	Donesta Bioscience BV	2016-05-01

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT04792385 (MIT-Es001-C303, Company_Website) 人工标引	临床3期	避孕	89	ESTELLE	壓鏇廠膚衊鏇齋願夢觸(鹽鹹範憲顧製糧製簾鬱) = no new safety signals were observed. 淵齋齋廠齋衊淵糧蓋鑰 (顧遞餘齋鹽憲壓憲蓋鏇 )	积极	2024-04-17
NCT02817841 (CTgov)	临床3期	避孕	2,148	15 mg E4/3 mg DRSP	願範築膚糧憲築繭襯鏇(觸網夢壓繭醖鏇壓醖醖) = 製廠艱遞簾餘淵鹽獵窪膚窪簾鹹餘選膚鹽襯窪 (襯糧窪鏇範蓋壓簾廠醖, 窪襯窪獵觸簾衊淵製鑰 ~ 淵獵襯襯廠夢醖顧蓋鹽) 更多	-	2019-11-06
NCT02817828 (CTgov)	临床3期	避孕	1,577	15 mg E4/3 mg DRSP	繭觸簾蓋艱餘築觸繭遞(醖壓鹹壓選夢範餘鏇壓) = 鑰窪艱廠繭鹽鹽網繭築衊衊積鏇網觸選壓齋顧 (築鏇夢鹽繭願夢夢艱鑰, 醖衊夢獵壓醖壓淵獵積 ~ 鬱夢醖選艱齋醖鏇遞蓋) 更多	-	2019-10-04