Insights in Endocervical Mucus Secretion

NCT ID: NCT07111247

Last Updated: 2026-01-08

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE4
• Total Enrollment: 15 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2026-01-02
• Study Completion Date: 2027-08-31

Brief 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

Cervical Mucus

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

Relugolix

Participants will take Reugolix for 10 days starting at the midluteal time point (6-9 days after "high fertility" based on ovulation test)

Group Type: EXPERIMENTAL

Gonadotropin Releasing Hormone Antagonists Relugolix

Intervention Type: DRUG

Gonadotropin releasing hormone antagonist (gnRH) taken for 10 days starting during the midluteal phase.

Interventions

Gonadotropin Releasing Hormone Antagonists Relugolix

Gonadotropin releasing hormone antagonist (gnRH) taken for 10 days starting during the midluteal phase.

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

National Institutes of Health (NIH)

NIH

Sponsor Role: collaborator

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

NIH

Sponsor Role: collaborator

Oregon Health and Science University

OTHER

Sponsor Role: lead

Responsible Party

Leo Han

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Leo Han, MD

Role: PRINCIPAL_INVESTIGATOR

Oregon Health and Science University

Locations

Oregon Health & Science University

Portland, Oregon, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Women's Health Research Unit Recruitment Line

Role: CONTACT

whru@ohsu.edu

503-494-3666

Facility Contacts

Leo Han, MD

Role: primary

Other Identifiers

R01HD115770-01A1

Identifier Type: NIH

Identifier Source: secondary_id

View Link

STUDY00028821

Identifier Type: -

Identifier Source: org_study_id