Clinical Trial: Time Course of Waking Versus Sleep-associated Luteinizing Hormone (LH) Pulse Frequency Suppression in Response to Progesterone in Late Pubertal Girls With and Without Hyperandrogenemia
Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional
Official Title: Time Course of Waking vs. Sleep-associated LH Pulse Frequency Suppression in Response to Progesterone in Late Pubertal Girls With and Without Hyperandrogenemia
Brief Summary: The purpose of this study is to determine if in late pubertal girls without hyperandrogenemia (HA), progesterone (P) will acutely reduce waking lutenizing hormone (LH) frequency to a greater extent than sleep-associated LH frequency. We hypothesize that in late pubertal girls with HA: (a) waking and sleep-associated LH frequency will be elevated (compared to controls); and (b) P will suppress waking LH frequency to a lesser degree than it does in girls without HA.
Detailed Summary: During early puberty, LH frequency increases during sleep; but in late puberty, LH frequency decreases overnight. Nonetheless, nocturnal LH frequency is similar (~0.5 pulses per hour) in early and late pubertal girls. Preliminary data in early pubertal girls suggests that progesterone acutely slows waking LH frequency, but does not acutely change nocturnal LH frequency. We hypothesize that daytime LH frequency is regulated primarily by sex steroid negative feedback, while sleep-associated LH frequency is not; and that androgens interfere with sex steroid suppression of daytime LH frequency. We propose to assess this further using a protocol in which short-term Progesterone and placebo is given to late pubertal girls (in a cross-over fashion), with subsequent assessment of LH pulse frequency (with sampling occurring while awake and while asleep). We propose that any effect of Progesterone will be blunted or absent in late pubertal girls with hyperandrogenemia.
Sponsor: University of Virginia
Current Primary Outcome: Luteinizing hormone pulse frequency [ Time Frame: Baseline and 2 months ]
Original Primary Outcome: LH pulse frequency [ Time Frame: 4 hour time blocks from the 24 hour admission (1900-2300hr; 2300-0300hr; 0300-0700hr; 0700-1100hr) ]
Current Secondary Outcome:
- Luteinizing hormone pulse amplitude [ Time Frame: Baseline and 2 months ]
- Sleep parameters (e.g., sleep period) [ Time Frame: Baseline and 2 months ]Sleep parameters such as sleep stages will be assessed when available
Original Secondary Outcome:
Information By: University of Virginia
Dates:
Date Received: June 23, 2009
Date Started: June 2008
Date Completion: December 2018
Last Updated: February 23, 2017
Last Verified: February 2017
