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NCT Number: NCT07111247

Insights in Endocervical Mucus Secretion

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.

Recruiting

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Key information

Conditions

Age range

21 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

Oregon Health & Science University

Portland, Oregon, 97239, United States

Location status: Recruiting

Location contact

Leo Han, MD

CONTACT

About this study

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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Gonadotropin Releasing Hormone Antagonists Relugolix

Drug

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

Primary outcomes

  1. Cervical mucus scores

    Time frame: 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])

    Average cervical mucus scores at each study time point

  2. Single cell transcriptome analysis

    Time frame: 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])

    Single cell transcriptome analysis comparing changes across menstrual time points

  3. Proteomic analysis

    Time frame: 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 of mucus including Mucin concentration

Study contacts

Contact information is provided by the study sponsor or research team.

Women's Health Research Unit Recruitment Line

CONTACT

[email protected]

503-494-3666

Sponsors and collaborators

Lead sponsor

Oregon Health and Science University

Other

Collaborators

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

Registry information

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Aug 8, 2025
Registry last updated
Jan 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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