Endocervical mucus changes across the menstrual cycle and after a short course of relugolix
Official title: Insights in Endocervical Mucus Secretion
Run by Oregon Health and Science University · NCT07111247 · Data updated 2026-11-12
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 |
| Ages | 21 Years to 40 Years |
| Sex | Women only |
| Enrollment | 15 (estimated) |
| Sponsor | Oregon Health and Science University Academic / other |
| Locations | 1 site (Portland, Oregon) |
| Status | Recruiting |
| Started | January 2, 2026 |
| Main results expected | August 2027 |
| Study ends | August 2027 |
| Registry record updated | January 8, 2026 |
| Trial ID | NCT07111247 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a 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.
✕Probably 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.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: 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.
Who can join: the full rules
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 it's running
-
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
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.