RecruitingPhase 4NCT07111247
Insights in Endocervical Mucus Secretion
Sponsor
Oregon Health and Science University
Enrollment
15 participants
Start Date
Jan 2, 2026
Study Type
INTERVENTIONAL
Conditions
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.
Eligibility
Sex: FEMALEMin Age: 21 YearsMax Age: 40 Years
Inclusion Criteria8
- 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 Criteria18
- 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
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Interventions
DRUGGonadotropin Releasing Hormone Antagonists Relugolix
Gonadotropin releasing hormone antagonist (gnRH) taken for 10 days starting during the midluteal phase.
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT07111247