Progesterone Suppression of Nocturnal LH Increases in Pubertal Girls (JCM017)
The purpose of this study is to learn more about how gonadotropin-releasing hormone (GnRH) and luteinizing hormone (LH) pulses are controlled during puberty. In this study, the investigators aim to discover whether or not giving 2 small doses of progesterone to early pubertal girls will prevent the nighttime increase of GnRH and LH pulses. From the information gathered in this study, the investigators may be able to learn more about how menstrual cycles are normally established in girls during puberty. Ultimately, if these normal processes can be understood, the investigators may be able to better understand abnormalities of puberty.
|Study Design:||Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single Blind (Subject)
Primary Purpose: Basic Science
|Official Title:||Progesterone Suppression of Nocturnal LH Increases in Pubertal Girls (JCM017)|
- LH pulse frequency (number of LH pulses per hour) [ Time Frame: 19 hours [from 1400 hr to 0900 hr] ] [ Designated as safety issue: No ]
|Study Start Date:||June 2003|
|Estimated Study Completion Date:||April 2015|
|Estimated Primary Completion Date:||April 2015 (Final data collection date for primary outcome measure)|
Subjects will take 25-50 mg oral micronized P or placebo at 1600 h and again at 2000 h. P dosing will be based on weight, with 25 mg administered to girls < 42kg and 50 mg given to those > or = 42 kg.
Subjects will take 25-50 mg oral micronized progesterone at 1600 h and again at 2000 h. Progesterone dosing will be based on weight, with 25 mg administered to girls < 42kg and 50 mg given to those or = to 42 kg.
Placebo Comparator: Placebo
Subjects will take placebo at 1600 h and again at 2000 h.
Subjects will take oral placebo suspension at 1600 h and again at 2000 h.
LH exhibits diurnal changes during early puberty, with nocturnal increases in LH pulse frequency and amplitude, but subsequent reduction during the following day. Progesterone (P) levels increase overnight in peripubertal girls, and P is the primary effector of LH pulse frequency slowing in adult women. The investigators hypothesize that nocturnal LH increases stimulate ovarian P, which in turn suppresses LH pulsatility during the following day. The investigators will assess this further using a protocol in which two doses of P or placebo are given to early pubertal girls, with subsequent assessment of LH pulses over 14 hours. The investigators hypothesize that in early pubertal girls, LH pulse frequency will be lower in girls receiving P compared to girls receiving placebo.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01773772
|Contact: Anne C Gabel, BScfirstname.lastname@example.org|
|Contact: Christopher R. McCartney, MDemail@example.com|
|United States, Virginia|
|University of Virginia Center for Research in Reproduction||Recruiting|
|Charlottesville, Virginia, United States, 22908|
|Contact: Anne Gabel, BSc 434-243-6911 firstname.lastname@example.org|
|Principal Investigator: Christopher R. McCartney, MD|
|Principal Investigator:||Christopher R. McCartney, MD||University of Virginia|