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Trials / Recruiting

RecruitingNCT07111247

Insights in Endocervical Mucus Secretion

Status
Recruiting
Phase
Phase 4
Study type
Interventional
Enrollment
15 (estimated)
Sponsor
Oregon Health and Science University · Academic / Other
Sex
Female
Age
21 Years – 40 Years
Healthy volunteers
Accepted

Summary

Single arm interventional study looking at biological outcomes at 4 time points throughout the cycle before and after taking an oral gonadotropin-releasing hormone antagonist (gnRH). Samples of whole blood, endocervical mucus, endocervical biopsy, and vaginal swab will be collected.

Detailed description

This study will enroll participants and obtain biological samples at 4 time points. The study will begin on the first day of menstruation following enrollment. Patients will monitor for peri-ovulation using an ovulation test that monitors for urinary metabolites for luteinizing hormone (LH). At the midluteal time point for sampling (days 6-9 after "high fertility" on ovulation test) subjects will begin taking an oral gonadotropin-releasing hormone antagonist (gnRH) (relugolix) for 10 days. Samples of whole blood, endocervical mucus, endocervical biopsy, and vaginal swab will be collected during the early follicular phase (3-5 days following the start of menstruation), peri-ovulation (9-14 days following the start of menstruation based on estriol glucuronide (E3G) urinary metabolite), mid-luteal (6-9 days following mid-cycle draw), and upon stoppage of relugolix (9-11 days following relugolix initiation).

Conditions

Interventions

TypeNameDescription
DRUGGonadotropin Releasing Hormone Antagonists RelugolixGonadotropin releasing hormone antagonist (gnRH) taken for 10 days starting during the midluteal phase.

Timeline

Start date
2026-01-02
Primary completion
2027-08-01
Completion
2027-08-01
First posted
2025-08-08
Last updated
2026-01-08

Locations

1 site across 1 country: United States

Regulatory

Source: ClinicalTrials.gov record NCT07111247. Inclusion in this directory is not an endorsement.