NCT07111247 Insights in Endocervical Mucus Secretion
| NCT ID | NCT07111247 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | Oregon Health and Science University |
| Condition | Cervical Mucus |
| Study Type | INTERVENTIONAL |
| Enrollment | 15 participants |
| Start Date | 2026-01-02 |
| Primary Completion | 2027-08 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 15 participants in total. It began in 2026-01-02 with a primary completion date of 2027-08.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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
Contact & Investigator
Leo Han, MD
PRINCIPAL INVESTIGATOR
Oregon Health and Science University
Frequently Asked Questions
Who can join the NCT07111247 clinical trial?
This trial is open to female participants only, aged 21 Years or older, up to 40 Years, studying Cervical Mucus. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07111247 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT07111247 currently recruiting?
Yes, NCT07111247 is actively recruiting participants. Contact the research team at whru@ohsu.edu for enrollment information.
Where is the NCT07111247 trial being conducted?
This trial is being conducted at Portland, United States.
Who is sponsoring the NCT07111247 clinical trial?
NCT07111247 is sponsored by Oregon Health and Science University. The principal investigator is Leo Han, MD at Oregon Health and Science University. The trial plans to enroll 15 participants.