The Effect of a Novel Combined Hormonal Treatment Containing a GnRH-antagonist for Uterine Fibroids and Endometriosis on Hemostasis Parameters: a Prospective Cohort Study

Uterine fibroids and endometriosis are two frequent diseases among women of reproductive age. They can be responsible for chronic and/or menstrual pelvic pain and abnormal uterine bleeding. The first-line management of these conditions relies on medical treatment. Hormonal treatment with contraceptive pill can be effective, although up to 30% of patients do not respond to this line of treatment. In this context, GnRH antagonists have been introduced. By suppressing ovulation, they inhibit the action of the gonadal axis and thus can reduce bleeding and pain associated with uterine fibroids and endometriosis. More recently, the GnRH antagonist known as Relugolix has been associated with a low-dose oestradiol and progesteron-line molecule, a medication known as Ryeqo. The goal of this type of treatment is to suppress ovulation while also minimizing symptôms which may derive from lack of oestrogen and progesterone in reproductive age women.
While Ryeqo's efficacy has been proven by multiple large randomized controlled trials, its impact on blood coagulation has yet to be determined. Venous thromboembolism (VTE) is the main, potentially fatal, dleterious effect of oestrogen-containing hormonal treatmen, such as combined oral contraceptives (COC). Several epidemiological studies have found a 3-6 increase in the risk of VTE among women on COC. The thrombogenic risk can be assessed by measuring specific blood biomarkers, which are known to be correlated to the thrombogenic phenotype and allow an overview of the VTE risk prior to conducting large population-scale studies directly measuring the adverse event's prevalence.
The aim of this study is to document the effects of Ryeqo® on hemostasis parameters in order to estimate the risk of VTE associated with its employ. An improved understanding of the VTE risk associated with Ryeqo® will allow to adapt hormonal treatment based on each woman's personal risk profile.
The study will be explained to all women whose medical condition allows the prescription of Ryeqo. All women who give their consent to participate in the study will have a urinary pregnancy test and a blood sample drawn before beginning treatment with Ryeqo. A second visit will be scheduled at 3 months, throughout which a second blood sample will be drawn. A questionnaire including socio-demographic data and clinical symptoms will be completed both on the first and the second visit.

开始日期2025-09-30

申办/合作机构

Les Hôpitaux Universitaires de Genève

JPRN-jRCT2031250206

/ Recruiting临床3期

A phase 3, randomized, multicenter, double-blind, placebo controlled, parallel-group study to evaluate the efficacy and safety of AKP-022 administered for 24 weeks in patients with endometriosis (LENA)

开始日期2025-06-01

申办/合作机构

ASKA Pharmaceutical Co., Ltd.

NCT06953076

/ RecruitingN/AIIT

MyomaS Aspect Transformation at Ultrasound During Relugolix Estradiol Noretisterone Treatment: MySaturn Study

Uterine fibroids are benign tumors originating from the uterine muscle, affecting up to 70% of women by their 50s. Risk factors include African descent, nulliparity, obesity, and diabetes. While many fibroids are asymptomatic, 25-50% of affected women experience symptoms like heavy menstrual bleeding, pelvic pain, and pressure-related issues. Accurate diagnosis and differentiation from rare malignant tumors (e.g., uterine sarcomas) remain challenging, particularly before surgery.
Ultrasound is the first-line tool for evaluating fibroids, with specific features (e.g., shape, vascularity) helping distinguish benign from suspicious lesions. The MUSA guidelines standardize ultrasound terminology for myometrial assessments. Current treatment options vary based on symptoms and malignancy risk. Among pharmacologic options, the combination of relugolix, estradiol, and norethisterone has shown efficacy in reducing bleeding and pain in symptomatic fibroids, with a favorable safety profile. However, its impact on fibroid morphology and ultrasound appearance is not yet well understood.

开始日期2025-05-02

申办/合作机构-

100 项与瑞卢戈利/雌二醇/醋酸炔诺酮相关的临床结果

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100 项与瑞卢戈利/雌二醇/醋酸炔诺酮相关的转化医学

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100 项与瑞卢戈利/雌二醇/醋酸炔诺酮相关的专利（医药）

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项与瑞卢戈利/雌二醇/醋酸炔诺酮相关的文献（医药）

2026-06-01·Clinical Pharmacology in Drug Development

Bioequivalence of a Fixed‐Dose Combination of Relugolix, Estradiol, and Norethindrone Acetate: An Open‐Label, Randomized, Fully Replicate Crossover Study in Healthy Postmenopausal Women Under Fasting Conditions

Article

作者: Khuroo, Arshad ; Kotadia, Ravi ; Dharmadhikari, Shruti ; Narayana, Goru N. V. S. Satya ; Kumar, Sudershan ; Shahi, Pradeep ; Reyar, Simrit

Abstract:

Uterine fibroids are the most common benign gynecological tumors, often causing heavy menstrual bleeding (HMB), anemia, and impaired quality of life. A fixed‐dose combination (FDC) of relugolix (40 mg), estradiol (1 mg), and norethindrone acetate (0.5 mg) was developed to address these limitations. This open‐label, randomized, two‐treatment, two‐sequence, four‐period, crossover bioequivalence study was conducted in 48 healthy postmenopausal women under fasting conditions. Participants received a single oral dose of either the RELUEASE (Sun Pharmaceutical Industries Limited, India) or the reference product (MYFEMBREE) (Patheon Inc., Mississauga, Ontario), with a 21‐day washout. Pharmacokinetics parameters were derived using non‐compartmental analysis. Bioequivalence assessment was performed using a linear mixed‐effects model applied to ln‐transformed pharmacokinetic parameters. A total of 39 participants completed all study periods. The point estimates and 90% confidence intervals (CIs), or the 95% upper bound for the pharmacokinetic parameters (C max and AUC) of relugolix, estradiol, norethindrone, and estrone met the predefined bioequivalence acceptance criteria. Six adverse events were reported, all mild, transient in nature, and resolving without sequelae. No clinically significant safety concerns were observed during the study. The relugolix/estradiol/norethindrone acetate FDC demonstrated bioequivalence to the globally approved reference product (MYFEMBREE) with comparable tolerability. This provides a safe, effective, reversible non‐surgical therapy for fibroid‐related HMB, fulfilling an unmet need beyond surgery.

2025-09-01·FERTILITY AND STERILITY

Efficacy and safety of relugolix combination therapy in women with uterine fibroids and adenomyosis: subgroup analysis of LIBERTY 1 and LIBERTY 2

Article

作者: Bouzegaou, Nadia ; Stewart, Elizabeth A ; Rakov, Viatcheslav G ; Venturella, Roberta ; Catherino, William H ; Vannuccini, Silvia ; Zaim, Souhil ; Munro, Malcolm G ; Perry, Julie S ; Wu, Rui ; Al-Hendy, Ayman

OBJECTIVE:

To assess the effects of relugolix combination therapy in women with uterine fibroids (UFs) and concomitant ultrasound-diagnosed adenomyosis.

DESIGN:

This post hoc analysis used pooled data from completers of the pivotal LIBERTY studies. The subgroup of women with adenomyosis and UFs was compared with the overall study population on selected efficacy and safety endpoints.

SUBJECTS:

Premenopausal women (aged 18-50 years) with diagnosed UFs (confirmed by ultrasonography) and heavy menstrual bleeding (assessed by the alkaline hematin method).

INTERVENTION:

Once-daily relugolix combination therapy (40 mg relugolix, 1 mg estradiol, and 0.5 mg of norethindrone acetate) or placebo for 24 weeks, or delayed relugolix combination therapy (40 mg of relugolix monotherapy for 12 weeks, followed by relugolix combination therapy for 12 weeks).

MAIN OUTCOME MEASURES:

Endpoints included the percentage of women with concomitant adenomyosis, the proportion of treatment responders (achieved or maintained a menstrual blood loss <80 mL and ≥50% reduction in menstrual blood loss volume from baseline over the last 35 days of treatment), the proportion of women achieving or maintaining amenorrhea over the last 35 days of treatment, and the change from baseline to week 24 in uterine volume and adverse events.

RESULTS:

A total of 111 women (18.2%) had a baseline diagnosis of concomitant adenomyosis (37 in the relugolix combination therapy group, 45 in the delayed relugolix combination therapy group, 29 in the placebo group) and were included in this analysis. Of women with adenomyosis, 83.8% in the relugolix combination therapy group were treatment responders compared with 27.6% in the placebo group. Amenorrhea was achieved in 64.9% of women with adenomyosis treated with relugolix combination therapy and in 6.9% of women treated with placebo. The least square mean uterine volume of women with adenomyosis decreased by 22.2% and 5.8% in the relugolix combination therapy and placebo groups, respectively. Results for the above outcomes in the relugolix combination therapy population were similar to the delayed relugolix combination therapy group.

CONCLUSION:

Efficacy outcomes in women with adenomyosis and UFs were comparable with those in women from the overall LIBERTY study population.

CLINICAL TRIAL IDENTIFICATION NUMBER:

LIBERTY 1, 2016-003727-27 (EudraCT) and NCT03049735; LIBERTY 2, 2016-005113-50 (EudraCT) and NCT03103087.

2025-01-01·Drug and therapeutics bulletin

▼Ryeqo for treatment of uterine fibroids

Article

项与瑞卢戈利/雌二醇/醋酸炔诺酮相关的新闻（医药）

2026-08-07

·gedeonrichter.com

Richter publishes Q2/H1 2026 results

CER Pharma revenues grew by 8.7%, driven by CNS and BIO and also reflecting improving WHC and GenMed dynamics in Q2. Reported Pharma revenues declined by 0.5% YoY to HUF 455bn in H1 2026, implying around 9ppt currency headwind. CER Clean EBIT (pharma) growth was outstanding at 21%, driven by the outperformance of cariprazine and the benefits of our multi-year efficiency initiatives; reported Clean EBIT (pharma) grew by only 3% to HUF 151.8bn. Net profit was HUF 103.5bn in H1 2026, down by 14% YoY due to large, HUF 27.1bn FX losses burdening the period. Free Cash Flow generation was up by a solid 24% YoY to HUF 137bn. 2026 Clean EBIT guidance (at constant exchange rates, CER) is upgraded to “double-digit growth” on the back of the strong H1 profitability. Budapest, 7 August 2026 - Gedeon Richter Plc. (“Richter”) announced today its Q2/H1 2026 financial results. CER (constant exchange rate) Pharma revenues grew by 8.7% in H1 2026, in line with the high-single-digit growth guidance for the full year and reflected improving dynamics in Q2. FX remains a major drag on reported revenues and represented around 9ppt headwind in H1 (primarily due to the strong HUF). Hence, reported Pharma revenues declined by 0.5% YoY to HUF 455bn in H1 2026. CNS revenues increased by 7% in H1 2026 YoY, as currency movements partly offset the impressive performance of Vraylar® (AbbVie’s net sales increased by 19% YoY to USD 1.98bn reflecting strong demand growth and market share gains in both bipolar disorder and adjunctive MDD) and jumping Reagila® sales (+25% CER, driven by higher supply revenues and high-performing countries in both Richter and partner territories). Women’s Healthcare sales growth (+7% CER in H1) accelerated in Q2 as Endometriosis and Menopause consistently outperform expectations. Lower Eastern European sales and slower dynamics in traditional OC products continue to affect top-line growth. The underlying strength of the leading products (Drovelis®, Ryeqo®, Lenzetto® and Bemfola®) remains intact. BIO revenues jumped in H1 (+30% CER), driven by biosimilar revenues (very strong teriparatide sales and new product launches). GenMed revenues fell by 5% in H1 YoY (CER) although sales dynamics have incrementally been improving. The lack of flu season (weak OTC), a high base and the ongoing rationalization of distributors’ inventory holding affected top-line. Gross profit (pharma) fell by 2.2% YoY to HUF 314bn in H1 2026; gross margin declined to 69% (-1.2ppt), despite improving trends in Q2. CER Clean EBIT (pharma) growth was outstanding at 21% in H1 2026, driven by the outperformance of cariprazine, improving WHC profitability and also supported by lower opex. Reported Clean EBIT (pharma) grew by only 3% to HUF 151.8bn due to the FX headwind. Reported EBIT stood at HUF 143.5bn in H1 2026, 2.2% higher YoY. Net profit (attributable to the owners of the parent) was HUF 103.5bn in H1 2026, declining by 14% YoY, as a result of large, HUF 27.1bn FX losses (mostly unrealized yet) burdening the period as financial expenses. Free cash flow (before M&A) was at another record-high of HUF 137bn in H1 2026, up 24% YoY, driven by lower Net Working Capital funding need vs. a year ago, and higher operating profits, partly offset by FX losses. The multi-year project to optimize and centralize API (active pharmaceutical ingredient) manufacturing in Hungary was completed. The project reduces duplications, improves efficiency, leads to a more compact site structure in Budapest and makes Dorog the API manufacturing site of Richter. Centralizing API manufacturing not only brought in much improved operational efficiency, but also delivered significant environmental benefits. This includes significantly lower energy consumption, materially less overall wastewater and hazardous waste generation, reduced net operational areas and an improved industrial footprint. Gábor Orbán, CEO commented the results: “Top-line growth accelerated in Q2, fully in line with our high-single-digit (CER) growth target for the year, driven by improving dynamics in both Women’s Healthcare and GenMed alongside sustained strength in CNS and BIO revenues. We are upgrading our profitability guidance for 2026 to double-digit Clean EBIT growth (CER), reflecting the outstanding performance of Vraylar® and visible benefits of our multi-year efficiency initiatives. Reported financial results continue to be affected by currency trends. We successfully launched Fylrevy®, an innovative hormone therapy for menopause, in selected pilot markets in Europe; Tuyory®, our tocilizumab biosimilar is now being commercialized; another CNS molecule (RGH-202) is entering Phase II clinical trials; and we further expand our GLP-1 portfolio through global partnerships.” About Gedeon Richter Plc. Richter aspires to be a global innovator in some key scientific fields, while dedicated to making medicines more accessible worldwide. Founded in 1901, headquartered in Hungary, with a market capitalization of EUR 4.8bn and sales of EUR 2.3bn in 2025, it operates Central Europe's largest R&D hub. Its research drives breakthroughs in Neuropsychiatry and Women's Healthcare, while Biotechnology and General Medicines strengthen its affordable treatment portfolio. Committed to sustainable growth, Richter invests in R&D, manufacturing excellence, and digitalization to advance medical innovation. Learn more at www.gedeonrichter.com For further information: Investors: Róbert Réthy, CFA +36 20 342 2555 Media: Zsuzsa Beke +36 20 916 4507

临床2期财报

2026-07-06

·Business Wire

AbCellera Appoints Dr. Lynn Seely to its Board of Directors

VANCOUVER, British Columbia--(BUSINESS WIRE)--AbCellera (Nasdaq: ABCL) today announced the appointment of Lynn Seely, M.D., to its Board of Directors as an independent director. “Dr. Seely is a respected executive leader with a proven track record of successfully developing new medicines in endocrinology, oncology, and women’s health. I am pleased to welcome her to AbCellera’s Board of Directors and look forward to having her on our team,” said Carl Hansen, Ph.D., founder and CEO of AbCellera. Dr. Seely’s experience as a biopharmaceutical executive and board member includes an extensive background in strategic, clinical, and commercial execution, which are highly relevant to AbCellera's work in discovering and developing impactful antibody-based medicines. Dr. Seely currently serves as president and CEO of Lyell Immunopharma Inc., a late-stage clinical company advancing a pipeline of next-generation CAR T-cell therapies for patients with hematologic malignancies and solid tumors. Prior to Lyell, she was president, CEO, board member, and first employee of Myovant Sciences Inc., where she successfully commercialized innovative therapies for women’s and men’s health, including Myfembree® (relugolix, estradiol, and norethindrone acetate) and Orgovyx® (relugolix). Dr. Seely also served as the chief medical officer of Medivation Inc., where she led the clinical development of the oncology drug Xtandi® (enzalutamide) from first-in-human trials through global approvals, prior to its $14 billion acquisition by Pfizer Inc. “I look forward to serving on AbCellera’s Board of Directors as the Company advances its mission of discovering and developing first-in-class antibody-based medicines,” said Dr. Seely. “AbCellera is well positioned for growth as it moves multiple product candidates, developed by its exceptional research team and designed to bring meaningful new treatments to patients, into early- and late-stage clinical development.” Dr. Seely currently serves on the Board of Managers of Life Science Cares Bay Area. She previously served as the lead independent director for Blueprint Medicines Corp. prior to its $9.1 billion acquisition by Sanofi, and was a member of the Board of Managers for TORL BioTherapeutics LLC. Dr. Seely received her M.D. from the University of Oklahoma College of Medicine. She completed her residency and served as chief resident in internal medicine at Yale-New Haven Hospital, and completed a basic science and clinical fellowship in endocrinology and metabolism at the University of California, San Diego. About AbCellera Biologics Inc. AbCellera (Nasdaq: ABCL) is a clinical-stage biotechnology company focused on discovering and developing first-in-class antibody-based medicines in the areas of endocrinology, women’s health, immunology, oncology, and more. For more information, please visit www.abcellera.com.

高管变更并购免疫疗法

2026-06-02

·FiercePharma

Marilyn Monroe and Amy Schumer profiled in endometriosis awareness push

Part of the poster for The Endometriosis Collective's "End of the Cycle" documentary. A nonprofit has launched to change how endometriosis is researched, treated and understood, starting with a documentary that features the stories of people, including Amy Schumer and Marilyn Monroe.The nonprofit, The Endometriosis Collective, has included Schumer and Monroe in the feature-length documentary “End of the Cycle,” which will premiere in New York Tuesday. Schumer, a comedian, writer and actress, has previously spoken of how endometriosis left her “on the floor in pain, vomiting from the pain, the pain that nobody can see.”Schumer is one of several celebrities included in the documentary. Other contributors include the dancer Julianne Hough, Olympic medalist Brittany Brown and actresses Janel Parrish and Folake Olowofoyeku.The Endometriosis Collective timed the documentary premiere to coincide with the 100th anniversary of Monroe’s birth. Monroe, who died in 1962, starred in movies such as “Some Like It Hot” and “Gentlemen Prefer Blondes.” The star’s endometriosis was so severe “that it destroyed her marriages, her wish for children, her career and ultimately her life,” according to a biography published in 1985. The Endometriosis Collective said the documentary shares newly uncovered information about Monroe’s experience with endometriosis. The information connects Monroe’s story to the experiences of women across generations, highlighting how far awareness, research and care still have to go, the nonprofit said.“By sharing this part of her story through ‘End of the Cycle,’ we hope to honor her legacy in a way that brings visibility to endometriosis, encourages more open dialogue and helps inspire the research needed to create change,” a representative of the Marilyn Monroe Estate said in a statement.As part of the premiere, The Endometriosis Collective is holding a panel discussion. Schumer, Brown and Olowofoyeku, the documentary’s co-directors Sammy Jaye and Soraya Simi, and medical experts are due to be part of the premiere. The Endometriosis Collective is making the film free to stream online. AbbVie’s Orilissa and Sumitomo Pharma’s Myfembree are among the approved drugs for endometriosis pain. Hough, one of the participants in the documentary, starred in an Orilissa campaign in 2017.

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100 项与瑞卢戈利/雌二醇/醋酸炔诺酮相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
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研发状态

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10 条最早获批的记录,

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适应症	国家/地区	公司	日期
疼痛	加拿大	Sumitomo Pharma Switzerland GmbH	2023-10-17
出血	加拿大	Sumitomo Pharma Switzerland GmbH	2023-09-22
子宫内膜异位症	美国	Sumitomo Pharma America, Inc.	2022-08-05
月经过多	美国	Sumitomo Pharma America, Inc.	2021-05-26
子宫肌瘤	美国	Sumitomo Pharma America, Inc.	2021-05-26

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适应症	最高研发状态	国家/地区	公司	日期
避孕	临床3期	美国	Sumitomo Pharma Co., Ltd.	2021-03-18
痛经	临床3期	美国	Sumitomo Pharma Switzerland GmbH	2017-11-01
痛经	临床3期	澳大利亚	Sumitomo Pharma Switzerland GmbH	2017-11-01
痛经	临床3期	巴西	Sumitomo Pharma Switzerland GmbH	2017-11-01
痛经	临床3期	智利	Sumitomo Pharma Switzerland GmbH	2017-11-01
痛经	临床3期	捷克	Sumitomo Pharma Switzerland GmbH	2017-11-01
痛经	临床3期	意大利	Sumitomo Pharma Switzerland GmbH	2017-11-01
痛经	临床3期	新西兰	Sumitomo Pharma Switzerland GmbH	2017-11-01
痛经	临床3期	波兰	Sumitomo Pharma Switzerland GmbH	2017-11-01
痛经	临床3期	罗马尼亚	Sumitomo Pharma Switzerland GmbH	2017-11-01

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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


NCT04756037 (SERENE, CTgov)	临床3期	子宫内膜异位症 \| 避孕 \| 子宫肌瘤	1,164	Relugolix Combination Therapy	範衊鬱齋襯鹽範範壓襯 = 鬱願顧鏇鹽鏇網廠膚構願觸鑰獵簾簾構膚製積 (觸積壓餘製蓋鹹糧艱醖, 鏇齋廠簾製蓋選製壓鹹 ~ 繭構遞鹹壓鹽憲壓構醖) 更多	-	2026-05-13
NCT03103087 \| NCT03049735 (LIBERTY 1, Pubmed \| Fertil Steril)	临床3期	子宫腺肌病 \| 子宫肌瘤	111	Relugolix combination therapy	鏇範積鬱鹽憲繭鏇淵憲(衊鏇壓範選鏇鹽選醖築) = 獵顧糧願蓋鬱構齋鬱鏇糧遞餘衊網觸獵廠製鹹 (願憲顧窪網膚鑰鏇簾範 ) 更多	积极	2025-09-01
				Placebo	鏇範積鬱鹽憲繭鏇淵憲(衊鏇壓範選鏇鹽選醖築) = 廠糧衊繭繭鑰繭窪鏇鹽糧遞餘衊網觸獵廠製鹹 (願憲顧窪網膚鑰鏇簾範 ) 更多
NCT03103087 (CTgov)	临床3期	月经过多 \| 子宫肌瘤	382	Relugolix+Estradiol/norethindrone acetate (Relugolix Plus E2/NETA (Group A))	壓遞襯繭願廠鹽鑰範窪 = 積壓膚獵構衊淵鹽鹽積衊獵艱網齋選遞製鏇築 (衊積構衊顧願簾膚鏇壓, 製齋獵餘鏇鏇糧鏇鹽鹽 ~ 糧鬱顧淵壓艱遞窪繭淵) 更多	-	2022-04-20
				Estradiol/norethindrone acetate placebo (Placebo (Group C))	壓遞襯繭願廠鹽鑰範窪 = 夢獵衊壓淵觸鏇願鑰積衊獵艱網齋選遞製鏇築 (衊積構衊顧願簾膚鏇壓, 製鹽醖廠膚憲蓋膚餘餘 ~ 憲襯製鹽艱鬱構積構淵) 更多
NCT03049735 (LIBERTY 1, CTgov)	临床3期	月经过多 \| 子宫肌瘤	388	Relugolix+Estradiol/norethindrone acetate (Relugolix Plus E2/NETA (Group A))	襯願蓋膚繭鏇廠構鑰選 = 鏇遞鬱夢積鹹憲壓選範餘顧醖築顧願膚範壓夢 (鬱艱鹽齋窪壓夢淵艱蓋, 築廠鏇願襯顧鏇構鏇齋 ~ 壓淵鹽壓衊蓋獵糧築餘) 更多	-	2022-04-19
				Estradiol/norethindrone acetate placebo (Placebo (Group C))	襯願蓋膚繭鏇廠構鑰選 = 鹹簾鹹淵選膚範鬱窪壓餘顧醖築顧願膚範壓夢 (鬱艱鹽齋窪壓夢淵艱蓋, 築艱膚艱艱遞願壓鏇簾 ~ 齋鏇願積膚遞夢壓鹹觸) 更多