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.

Start Date03 Dec 2024

Sponsor / Collaborator

Mcgill University Health Centre

NCT06396221 / RecruitingNot ApplicableIIT

"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.

Start Date01 May 2024

Sponsor / Collaborator

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).

Start Date18 Jan 2024

Sponsor / Collaborator-

100 Clinical Results associated with Drospirenone/Estetrol

100 Translational Medicine associated with Drospirenone/Estetrol

100 Patents (Medical) associated with Drospirenone/Estetrol

Literatures (Medical) associated with Drospirenone/Estetrol

01 Nov 2024·FERTILITY AND STERILITY

Efficacy and safety of estetrol (15 mg)/drospirenone (3 mg) combination in a cyclic regimen for the treatment of primary and secondary dysmenorrhea: a multicenter, placebo-controlled, double-blind, randomized study

Article

Author: Mochiyama, Takayuki ; Osuga, Yutaka ; Hirakawa, Akihiro ; Hirayama, Masashi ; Takayanagi, Toshiaki ; Nogami, Masayoshi ; Kobayashi, Takao ; Harada, Tasuku ; Foidart, Jean-Michel ; Tayzar, Kyaw

OBJECTIVE:

To evaluate the efficacy and safety of the estetrol (E4) (15 mg)/drospirenone (DRSP) (3 mg) combination in a cyclic regimen in Japanese women with primary and secondary dysmenorrhea.

DESIGN:

A 16-week, multicenter, randomized, double-blind, placebo-controlled, parallel-group study, followed by a 36-week, open-label, extension study.

SETTING:

Double-blined study.

PATIENT(S):

A total of 162 Japanese women with primary and secondary dysmenorrhea.

INTERVENTION(S):

Participants were randomly allocated to either the E4/DRSP group or the placebo group. In the E4/DRSP group, participants orally received one tablet containing E4 (15 mg) and DRSP (3 mg daily) for 24 days, followed by a placebo tablet for 4 days, constituting one cycle. The placebo group was given one placebo tablet daily for 28 days. After 16 weeks, participants in the placebo group were switched to receive E4/DRSP for 36 weeks.

MAIN OUTCOME MEASURE(S):

Absolute change in the most severe total dysmenorrhea score from baseline to the end of the 16-week double-blinded period.

RESULT(S):

Estetrol/drospirenone reduced the most severe total dysmenorrhea score by 2.3 points from baseline at week 16. The between-group difference was significant (-1.4, two-sided 95% confidence interval, -1.8 to -1.0), showing superiority to placebo. The responder rate, the proportion of participants who achieved a ≥2.0-point reduction in the most severe total dysmenorrhea score from baseline, was 64.3% in the E4/DRSP group, significantly higher than in the placebo group, 28.4%. In the E4/DRSP group, visual analogue scale scores for pelvic pain and dysmenorrhea symptoms during the menstrual bleeding periods were decreased by 44.2 and 42.3 mm, respectively, from baseline at week 16, significantly more than in the placebo group. Objective gynecological examinations suggested amelioration of pelvic tenderness, uterine mobility, and cul-de sac induration in the E4/DRSP group. Estetrol/drospirenone improved the quality of life-related questionnaires (interference with daily activities and sleeping) and global impression scores. Intermenstrual bleeding was the primary treatment-emergent adverse event in the E4/DRSP group, similar to combined oral contraceptives. There were no cases of venous thromboembolism and less impact on hemostasis parameters in the E4/DRSP group.

CONCLUSION(S):

Estetrol/drospirenone is an effective treatment for dysmenorrhea, offering a safe, new treatment option with potentially reduced thromboembolic risk.

CLINICAL TRIAL REGISTRATION NUMBER:

This study was registered in Clinical Trials Registry of jRCT with registration number jRCT2011210023 (https://jrct.niph.go.jp/latest-detail/jRCT2011210023; date of registration: July 28, 2021; date of enrollment of the first subject: August 2, 2021).

03 Jul 2024·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

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

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.

02 Dec 2023·Expert opinion on drug metabolism & toxicology

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

Review

Author: Facchinetti, Fabio ; Genazzani, Alessandro D. ; Battipaglia, Christian ; Feliciello, Lia ; 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.

News (Medical) associated with Drospirenone/Estetrol

27 Aug 2024

·www.prnewswire.com

Hall of Fame College Football Coach, Mark Richt, Honorary Chair for Atlanta Neuroscience Foundation's 22nd Annual Charity Golf Tournament at TPC Sugarloaf Golf Club

ATLANTA, Aug. 27, 2024 /PRNewswire/ -- The Atlanta Neuroscience Foundation ("ANF") welcomes Mark Richt, renowned former head coach of the University of Georgia and University of Miami football teams, as Honorary Chair for the 22nd Annual Charity Golf Tournament. The event is set to take place at the prestigious TPC Sugarloaf Golf Club on Monday, September 23, 2024. Continue Reading Hall of Fame College Football Coach, Mark Richt, Honorary Chair for Atlanta Neuroscience Foundation's 22nd Annual Charity Golf Tournament at TPC Sugarloaf Golf Club Hall of Fame College Football Coach, Mark Richt, Honorary Chair for Atlanta Neuroscience Foundation's 22nd Annual Charity Golf Tournament at TPC Sugarloaf Golf Club Coach Richt established himself in the top echelon of college football coaching during his 18 years as a head coach, winning nearly 73 percent of his games and never failing to make the postseason. His involvement in the tournament underscores his passion and devotion to supporting causes that create a meaningful impact in peoples' lives and the greater community. ANF's 22nd Annual Charity Golf Tournament will unite business leaders, philanthropists, and sports enthusiasts in a common cause to enhance awareness and drive progress in neurological sciences. The funds raised will benefit research, education, and patient treatment options for Parkinson's, Multiple Sclerosis, Alzheimer's, and Epilepsy. Participants will have the opportunity to interact with Coach Richt, enjoy a round of golf, have a chance to win a BMW Z4 in our Hole in One Competition, compete against an LPGA player, and vie for other awards and prizes. Coach Richt expressed his enthusiasm, stating, "I am honored to serve as the Honorary Chair for the Atlanta Neuroscience Foundation's Annual Charity Golf Tournament. The work they do in advancing and improving access to personalized, affordable, high-quality neurological care is crucial, and I am eager to support their efforts to continuing to improve the lives of individuals affected by Parkinson's and other neurological disorders." Sponsorship opportunities and player registrations are still available. For more information, click here, or contact Roy A. Rangel at [email protected] or 404-609-5404. Seize the opportunity to be part of an exciting day of golf and contribute to advancing neuroscience research. For media inquiries, please contact: Alyssa McElrone [email protected] 404-895-7725 About Atlanta Neuroscience Foundation: The Atlanta Neuroscience Foundation is a non-profit organization dedicated to advancing neuroscience research, education, and patient care. Through fundraising initiatives like the Annual Charity Golf Tournament, the foundation strives to make significant strides in understanding and treating neurological disorders including Parkinson's disease, Alzheimer's, MS and Epilepsy. About Mark Richt: Mark Richt is a beloved college football coach, devoted husband and father, motivational speaker, philanthropist, and author. Richt is a highly respected figure in the world of college football. With an illustrious coaching career that includes stints at the University of Georgia and the University of Miami, Richt is not only recognized for his success on the field but also for his commitment to community service and philanthropy. SOURCE Atlanta Neuroscience Foundation

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

28 May 2024

·www.globenewswire.com

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.

100 Deals associated with Drospirenone/Estetrol

External Link

KEGG	Wiki	ATC	Drug Bank
-	Drospirenone/Estetrol	G03AA	-

R&D Status

10 top approved records.

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Indication	Country/Location	Organization	Date
Dysmenorrhea	JP	Fuji Pharma Co., Ltd.	24 Sep 2024
Contraception	US	Mayne Pharma Ltd.	15 Apr 2021
Hot Flashes	US	Bayer HealthCare Pharmaceuticals, Inc.	28 Sep 2005

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT04792385 (MIT-Es001-C303, Company_Website) Manual	Phase 3	Contraception	89	ESTELLE	ucussdcaes(eqfljantni) = no new safety signals were observed. pogkrsfezr (nyrsgwayla )	Positive	17 Apr 2024
NCT02817841 (CTgov)	Phase 3	Contraception	2,148	15 mg E4/3 mg DRSP	gvybrsxprc(pqmxloirrz) = bizpkpiwhf kmdxobdoiw (nvlzodhooz, dyzbepjpbk - hvdghhkbfp) View more	-	06 Nov 2019
NCT02817828 (CTgov)	Phase 3	Contraception	1,577	15 mg E4/3 mg DRSP	ksicokriyd(edcsgefoci) = ycazmypewm lrsywbaucy (kuxavsmzxm, aqqdgjkika - ocwuldzhlf) View more	-	04 Oct 2019

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