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NCT07111247PHASE4RecruitingAccepts Healthy Volunteers

Insights in Endocervical Mucus Secretion

Oregon Health and Science University

Start Date

1/2/2026

Completion Date

8/1/2027

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).

Eligibility Criteria

Age Range: 21 years to 40 years

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

Interventions

DRUG

Gonadotropin Releasing Hormone Antagonists Relugolix

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Conditions

Cervical Mucus

Locations

Oregon Health & Science University

Portland, Oregon 97239

United States