Insights in Endocervical Mucus Secretion

Oregon Health & Science University (OHSU)

Status and phase

Enrolling

Phase 4

Conditions

Cervical Mucus

Treatments

Drug: Gonadotropin Releasing Hormone Antagonists Relugolix

Study type

Interventional

Funder types

Other

NIH

Identifiers

NCT07111247

STUDY00028821

R01HD115770-01A1 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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).

Enrollment

15 estimated patients

Sex

Female

Ages

21 to 40 years old

Volunteers

Accepts Healthy Volunteers

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