Regulation of Cervical Mucus Secretion
Condition: Fertility; Contraception
Intervention: Leuprolide acetate; Estrogen and Progesterone Replacement; Progestin
Intervention description: Following this spontaneous cycle, participants received a single intramuscular injection of leuprolide acetate (11.25mg, LupronVR; Abbvie, Chicago, IL), a dose documented to suppress ovarian function for at least 3 months. Ovarian suppression is confirmed with serum E2 less than or equal to 35 pg/ml 21-28 day post-injection.; Replace hormones exogenously to create an artificial cycle; Synthetic progestin to assess effects on cervical mucus.
Intervention MeSH terms: Leuprolide; Norethindrone; Estradiol; Estrogens; Progesterone; Progestins
Phase: Phase 4
Study type: Interventional
Primary purpose: Basic Science
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Investigator)
Enrollment: 5.0
Sex: Female
Minimum age: 21 Years
Maximum age: 40 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Contraception; Mucus; Cervix; progestin; hormones

Summary:

      The purpose of this study is to help us determine how hormones impact the production of
      cervical mucus which is a fluid secreted by the opening of the uterus, also called the
      cervix. During a normal menstrual cycle, cervical mucus changes in response to two hormones
      that the ovaries make: estrogen and progesterone. Many of the birth control methods women use
      thicken mucus and make it less likely for sperm to enter the uterus. The goal of this study
      is to better understand the effects estrogen and progesterone have on the cervical mucus in
      the body. To do this, the investigators will be using a drug that suppresses natural hormone
      production for 3 months. Estrogen and progesterone will be artificially replaced to better
      understand their effects. The investigators will also be studying the effect of a common
      birth control pill that may work by thickening cervical mucus. Last, the investigators will
      study some of the cells in the cervix that produce mucus.
    

Eligibility criteria:

        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)