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
| Type | Name | Description |
|---|---|---|
| DRUG | Gonadotropin Releasing Hormone Antagonists Relugolix | Gonadotropin 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
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT07111247. Inclusion in this directory is not an endorsement.