Regulation of Cervical Mucus Secretion
Condition: Fertility; Contraception
Study type: Interventional
Phase: Phase 4

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.
    

Detailed description: 
      This proposed study is to evaluate the temporal changes in human cervical mucus in response
      to progesterone and progestins as an initial step toward clarifying these relationships. Our
      hypothesis is that direct effects of progesterone on the endocervix, independent of estrogen
      withdrawal, cause contraceptive changes to cervical mucus. To study this, a randomized,
      prospective, crossover study will be conducted by examining cervical mucus changes in a small
      cohort of women in whom investigators will suppress circulating hormonal levels by
      administering a GnRH antagonist. Investigators will then artificially replace Estrogen and
      Progesterone in order to differentiate their effects on clinical and laboratory measurements
      of mucus quality. The investigators will be looking closely at the immediate changes in mucus
      when .35 mg of norethindrone, a marketed drug is administered in this experimental setting.
      Cervical cell samples will also be collected at various time points and perform RT-PCR to
      determine whether genes for membrane bound progesterone receptor are expressed and regulated
      by Estrogen and Progesterone.
    

Intervention name(s): Leuprolide acetate; Estrogen and Progesterone Replacement; Progestin
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 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.
Other intervention name(s): Lupron; Estradiol (vivelle-dot); Progesterone (prometrium, progestin); Norethindrone; NET
Intervention MeSH terms: Leuprolide; Norethindrone; Estradiol; Estrogens; Progesterone; Progestins
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Investigator)
Primary purpose: Basic Science
Keywords: Contraception; Mucus; Cervix; progestin; hormones