The Impact of a Novel GnRH Antagonist With Add-back Therapy for Treatment of Uterine Fibroids and Endometriosis on Hemostasis Parameters

NCT07173127 | Recruiting

• 2 other identifiers: 2024-0160971434
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Uterine Fibroid

Keywords

Uterine fibroids; Endometriosis; GnRh Antagonist; Hemostasis markers

Outcome Measures

Primary Outcomes (1)

• Change from baseline in the mean value of normalized activated protein C resistance (nAPCsr) at 3 months of treatment with Ryeqo

  Blood dosage of normalized activated protein C resistance (nAPCsr)

  At baseline and after 3 months of treatment

Secondary Outcomes (10)

• Mean change from baseline to 3 months of treament in the value of sexual hormone-binding globulin (SHBG)

  At baseline and after 3 months of treatment

• Mean change from baseline to 3 months of treament in the value of normalized thrombomodulin sensitivity ratios (nTMSR)

  At baseline and after 3 months of treatment

• Mean change from baseline to 3 months of treament in the value of D-Dimers

  At baseline and after 3 months of treatment

• Mean change from baseline to 3 months of treament in the value of thrombin generation markers

  At baseline and after 3 months of treatment

• Mean change from baseline to 3 months of treament in the value of antithrombin activity

  At baseline and after 3 months of treatment

Other Outcomes (4)

• Mean days of headache at 3 months of treatment

  At 3 months of treatment

• Mean number of days with pelvic pain at 3 months of treatment

  At 3 months of treatment

• Mean difference from baseline on the Higham scale of bleeding at 3 months of treatment

  At baseline and after 3 months of treatment

Study Arms (1)

Hemostasis markers dosage

OTHER

Drug: Ryeqo treatment

Interventions

Ryeqo treatment DRUG

Ryeqo treatment will be administered and hemostasis markers will be measured at T0 and T1

Hemostasis markers dosage

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Women consulting at the DFEA of the HUG, who are prescribed Ryeqo® for a qualified medical condition
• Age ≥ 18 years

You may not qualify if:

• Unable to speak and/or read French
• Having used either an oestro-progestin pill (oral, patch or vaginal ring) or oral estrogens in the past 3 months, or DMPA or nomegestrol acetate
• Women not having given their consent to participate in the study

Sponsors & Collaborators

• University Hospital, Geneva: lead

Study Sites (1)

Hôpitaux Universitaires de Genève

Geneva, Canton of Geneva, 1205, Switzerland

RECRUITING

Related Publications (1)

• Hugon-Rodin J, Fontana P, Poncet A, Streuli I, Casini A, Blondon M. Longitudinal profile of estrogen-related thrombotic biomarkers after cessation of combined hormonal contraceptives. Blood. 2024 Jan 4;143(1):70-78. doi: 10.1182/blood.2023021717.

  PMID: 37939264 BACKGROUND

MeSH Terms

Conditions

Leiomyoma; Endometriosis

Condition Hierarchy (Ancestors)

Neoplasms, Muscle Tissue; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Study Officials

• Patrick Petignat, Prof

  University Hospital, Geneva

  STUDY DIRECTOR

Central Study Contacts

Manuela Viviano, MD

CONTACT

+41 79 55 35 385; manuela.viviano@hug.ch

Justine Hugon-Rodin

CONTACT

jhugon@ghpsj.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: August 20, 2025
• First Posted: September 15, 2025
• Study Start: September 30, 2025
• Primary Completion (Estimated): December 30, 2026
• Study Completion (Estimated): March 30, 2027
• Last Updated: April 29, 2026

Record last verified: 2026-04

Locations

CH (1)