Acute Effects of Progesterone on LH Pulses During the Follicular Phase (CRM006)
Status:
Terminated
Trial end date:
2015-07-31
Target enrollment:
Participant gender:
Summary
The rapidity with which progesterone slows LH (and by inference GnRH) pulse frequency in
women is unclear. The investigators hypothesize that progesterone slows LH pulse frequency
within 10 hours. The investigators propose to assess this further with a randomized,
cross-over, placebo-controlled study. Regularly cycling women without hyperandrogenism will
be admitted to the Clinical Research Unit on cycle day 5-9 (mid-follicular phase) for a 10
hour frequent sampling study to observe LH, FSH, estradiol, progesterone, and testosterone.
Either oral micronized progesterone suspension or placebo will be administered at 0900 h.
During a subsequent menstrual cycle, subjects will undergo another study identical to the
first except that oral progesterone will be exchanged for placebo or vice versa in accordance
with a crossover design.
Phase:
Phase 1
Details
Lead Sponsor:
University of Virginia
Collaborator:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)