Insights in Endocervical Mucus Secretion

NCT07111247 | Recruiting Phase 4 FDA Drug

• 2 other identifiers: STUDY00028821R01HD115770-01A1
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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.

Conditions

Cervical Mucus

Outcome Measures

Primary Outcomes (3)

• Cervical mucus scores

  Average cervical mucus scores at each study time point

  Cervical mucus will be collected and compared across 4 time points during the menstrual cycle (follicular [3-5 days following start of menses], ovulatory, luteal, ovarian suppression [9-11 days following Relugolix initiation])

• Single cell transcriptome analysis

  Single cell transcriptome analysis comparing changes across menstrual time points

  Measured and compared across 4 time points during the menstrual cycle (follicular [3-5 days following start of menses], ovulatory, luteal, ovarian suppression [9-11 days following Relugolix initiation])

• Proteomic analysis

  Proteomic analysis of mucus including Mucin concentration

  Measured and compared across 4 time points during the menstrual cycle (follicular [3-5 days following start of menses], ovulatory, luteal, ovarian suppression [9-11 days following Relugolix initiation])

Study Arms (1)

Relugolix

EXPERIMENTAL

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

Drug: Gonadotropin Releasing Hormone Antagonists Relugolix

Interventions

Gonadotropin Releasing Hormone Antagonists Relugolix DRUG

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

Relugolix

Eligibility Criteria

• Age: 21 Years - 40 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator
• Oregon Health and Science University: lead
• National Institutes of Health (NIH): collaborator

Study Sites (1)

Oregon Health & Science University

Portland, Oregon, 97239, United States

RECRUITING

MeSH Terms

Interventions

relugolix

Study Officials

• Leo Han, MD

  Oregon Health and Science University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Women's Health Research Unit Recruitment Line

CONTACT

503-494-3666; whru@ohsu.edu

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: All participants will receive Relugolix for 10 days starting at the midluteal time point

Study Record Dates

• First Submitted: July 28, 2025
• First Posted: August 8, 2025
• Study Start: January 2, 2026
• Primary Completion (Estimated): August 1, 2027
• Study Completion (Estimated): August 1, 2027
• Last Updated: January 8, 2026

Record last verified: 2026-01

Locations

US (1)