Clinical Trial: Sleep-wake Changes of Luteinizing Hormone Frequency in Pubertal Girls With and Without High Testosterone

Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Observational

Official Title: Comparison of Sleep-wake LH Frequency in Peripubertal Girls With and Without Hyperandrogenemia

Brief Summary: The purpose of this study is to determine whether sleep-wake changes of luteinizing hormone pulse frequency are different in early pubertal girls with high testosterone levels compared to early pubertal girls with normal testosterone levels.

Detailed Summary: During early puberty, luteinizing hormone (LH) pulse frequency normally increases during sleep. In contrast, preliminary data suggest that obese girls (who have high testosterone levels in general) demonstrate low LH frequency during the day and night during early puberty; but at mid puberty rapidly transition to a high LH frequency during the day and night. We hypothesize that in early pubertal girls with high testosterone levels, overnight increases of LH frequency are less prominent than those observed in early pubertal girls with normal testosterone levels. We will assess this using a frequent sampling protocol for assessment of LH pulse frequency (with sampling occurring while awake and while asleep) in early pubertal girls with and without high testosterone levels. Sleep will be formally evaluated.
Sponsor: University of Virginia

Current Primary Outcome: Luteinizing hormone pulse frequency (while awake and while asleep) [ Time Frame: Baseline (time zero) ]

Original Primary Outcome: LH pulse frequency (while awake and while asleep) [ Time Frame: Day 1 of study ]

Current Secondary Outcome:

  • Progesterone concentration [ Time Frame: Baseline (time zero) ]
  • Estradiol concentration [ Time Frame: Baseline (time zero) ]
  • Testosterone concentrations [ Time Frame: Baseline (time zero) ]
  • Luteinizing hormone amplitude [ Time Frame: Baseline (time zero) ]
  • Sleep stage parameters [ Time Frame: Baseline (time zero) ]


Original Secondary Outcome:

  • Progesterone concentration [ Time Frame: Day 1 of study ]
  • Estradiol concentration [ Time Frame: Day 1 of study ]
  • Testosterone concentrations [ Time Frame: Day 1 of study ]
  • LH amplitude [ Time Frame: Day 1 of study ]
  • Sleep stage parameters [ Time Frame: Day 1 of study ]


Information By: University of Virginia

Dates:
Date Received: June 24, 2009
Date Started: October 2008
Date Completion: February 2018
Last Updated: February 21, 2017
Last Verified: February 2017