Endocervical mucus changes across the menstrual cycle and after a short course of relugolix
Insights in Endocervical Mucus Secretion
This trial will test whether a 10-day course of the oral GnRH antagonist relugolix changes endocervical mucus, blood markers, and tissue samples in people with regular 25–35 day menstrual cycles.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 15 (estimated) |
| Ages | 21 Years to 40 Years |
| Sex | Female |
| Sponsor | Oregon Health and Science University Academic / other |
| Locations | 1 site (Portland, Oregon) |
| Trial ID | NCT07111247 on ClinicalTrials.gov |
What this trial studies
This is a single-arm interventional Phase 4 protocol that collects biological samples at four predefined time points across one menstrual cycle: early follicular, peri-ovulation, mid-luteal, and after stopping relugolix. Participants will start monitoring on the first day of menstruation and use urinary ovulation tests (E3G/LH metabolites) to time peri-ovulation sampling. At the mid-luteal sampling window subjects begin a 10-day course of relugolix, with additional sampling at the end of that course. Collected specimens include whole blood, endocervical mucus, endocervical biopsy, and vaginal swab to characterize hormonal and local mucosal changes.
Who should consider this trial
Good fit: Ideal candidates are people with regular menstrual cycles (25–35 days) who have BMI between 18 and 35, are not using hormonal contraception or an IUD, can attend in-person visits on short notice, and agree to non-hormonal contraception and the sampling requirements.
Not a fit: People who are pregnant, using hormonal birth control or an IUD, have current cervical infection or abnormal cervical cytology, or cannot comply with the timing and visit requirements are unlikely to receive benefit from participation.
Why it matters
Potential benefit: If successful, this could clarify how short-term GnRH antagonism alters cervical mucus and related biomarkers, informing future fertility or contraceptive approaches.
How similar studies have performed: GnRH antagonists have been used before to suppress ovarian hormones and study reproductive tract biology, but combining relugolix with serial mucus, biopsy, and blood sampling across four cycle time points is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Normal menstrual cycles of 25-35 days in length for at least the previous 3 cycles * BMI \>18 and \<35 * Serum p4 \>= 3 ng/ml on single sample collected between days 18-25 of self-reported menstrual cycle * Flexible schedule allowing blood draws on less than 48 hour notice * In good general health * Commit to using non-hormonal contraceptive methods without spermicide during study period except those prescribed in the experimental protocol * No objections to taking study drugs * No objections to refraining from intercourse the night before any sampling and willing to use condoms during vaginal intercourse Exclusion Criteria: * Oral contraceptive use or other hormone supplement within the preceding 2 months * Current cervical infection * Evidence of abnormal cervical cytology * Use of any IUD for contraception * Long-acting hormonal contraceptive use in the past 12 months (e.g., Depo-Provera) * Contraindications to study drugs * Current or past pregnancy within the previous 6 months or currently trying to conceive * Desiring to conceive in the next 8 months * Breastfeeding in the past 2 months * Diagnosed diabetes or metabolic syndrome * Diagnosed Polycystic Ovary Syndrome * History of, or self-reported, substance abuse * Smoker * Previous infertility treatment excluding male factor issues * Use of an investigational drug within the past 2 months * History of excisional or ablative treatment procedure on cervix (i.e., LEEP, Cryotherapy, Cold Knife Cone) * Current treatment for a vaginal infection such as bacterial vaginosis * History of venous thromboembolism (VTE) or inherited thrombophilias
Where this trial is running
Portland, Oregon
- Oregon Health & Science University — Portland, Oregon, United States (Recruiting)
Study contacts
- Principal investigator: Leo Han, MD — Oregon Health and Science University
- Study coordinator: Women's Health Research Unit Recruitment Line
- Email: whru@ohsu.edu
- Phone: 503-494-3666
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.