Relugolix (Ryeqo) with low‑dose add-back hormones for uterine fibroids and endometriosis and its effects on blood clotting
The Effect of a Novel Combined Hormonal Treatment Containing a GnRH-antagonist for Uterine Fibroids and Endometriosis on Hemostasis Parameters: a Prospective Cohort Study
This trial will test whether the GnRH antagonist Relugolix combined with low‑dose estradiol and progestin (Ryeqo) changes blood clotting markers in adult women treated for uterine fibroids or endometriosis.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | University Hospital, Geneva Academic / other |
| Locations | 1 site (Geneva, Canton of Geneva) |
| Trial ID | NCT07173127 on ClinicalTrials.gov |
What this trial studies
This is an interventional, single‑center study at Hôpitaux Universitaires de Genève that gives prescribed Ryeqo to eligible adult women and measures hemostasis parameters over treatment. Ryeqo combines relugolix with low‑dose estradiol and progesterone to suppress ovulation while limiting hypoestrogenic symptoms. Patients must be ≥18, French‑speaking, and not have used certain hormonal therapies in the prior three months. Blood markers of coagulation and related hemostasis measures are collected to detect potential changes associated with the medication.
Who should consider this trial
Good fit: Adult women (age ≥18) with uterine fibroids or endometriosis attending the Geneva University Hospital who are prescribed Ryeqo and can read and speak French are ideal candidates.
Not a fit: Patients who cannot read or speak French, those who recently used combined hormonal therapies or certain injectables, or women not prescribed Ryeqo will not be eligible and therefore will not benefit from this study.
Why it matters
Potential benefit: If successful, the study could show Ryeqo controls symptoms without causing harmful changes in blood clotting, supporting its safety for women with fibroids or endometriosis.
How similar studies have performed: Previous clinical trials have shown relugolix with add‑back (Ryeqo) reduces bleeding and pain from fibroids and endometriosis, but effects specifically on hemostasis markers have been less thoroughly studied.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Women consulting at the DFEA of the HUG, who are prescribed Ryeqo® for a qualified medical condition * Age ≥ 18 years Exclusion Criteria: * 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
Where this trial is running
Geneva, Canton of Geneva
- Hôpitaux Universitaires de Genève — Geneva, Canton of Geneva, Switzerland (Recruiting)
Study contacts
- Study coordinator: Manuela Viviano, MD
- Email: manuela.viviano@hug.ch
- Phone: +41 79 55 35 385
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.