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This study looked at how hormones regulate the secretion of cervical mucus. Participants received hormone treatments including Leuprolide acetate, estrogen, progesterone and a progestin. Healthy women aged 21-40 with regular menstrual cycles were able to take part. The study was carried out in Phase 4 and has been completed.
The summary above is a plain-language rendering of the official record. The original English title is shown for reference.
Criteria are reproduced from the ClinicalTrials.gov record in the original English. Only the trial team can determine eligibility.
Inclusion Criteria: * Normal menstrual cycles of 25-35 days in length for at least previous 3 cycles * 21-40 years of age * BMI \>18, \<30 * Serum P4 ≥ 3 ng/ml on single sample collected between days 18-25 of self-reported menstrual cycle * Flexible schedule allowing morning blood draws on less than 48 hour notice * In good general health * Commit to remain on stable diet during study period (no changes to normal dietary habits) * Commit to using non-hormonal contraceptive methods 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 using condoms during vaginal intercourse. Exclusion Criteria: * Oral contraceptive use or other hormone supplement within the preceding 2 months * Women with current cervical infection * Evidence of abnormal cervical cytology * Use of Paragard 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 * Current or previous use of cholesterol lowering drugs within the preceding 12 months * 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 (ie. LEEP, Cryotherapy, Cold Knife Cone)