Suppression of Daytime and Nighttime Luteinizing Hormone Frequency by Progesterone
During childhood, the levels of certain hormones: gonadotropin-releasing hormone (GnRH), luteinizing hormone (LH), follicle-stimulating hormone (FSH), estrogen, and progesterone are very low. However, when puberty starts, GnRH and LH pulses begin to increase, but they initially do so at night only. It is unknown why GnRH and LH pulses increase at night and then decrease during the day (instead of being increased all the time). The purpose of this study is to see how quickly progesterone reduces LH pulses. The study is also meant to find out whether too much testosterone (also a hormone) in the blood causes problems with the ability of progesterone to reduce LH pulses. In this study, the investigators aim to discover whether or not giving 3 small doses of progesterone to pubertal girls will prevent the nighttime increase of 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 the investigators understand these normal processes, 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:||Suppression of Daytime and Nighttime LH Frequency by Progesterone in Early Pubertal Girls With and Without Hyperandrogenemia (JCM024)|
- Average luteinizing hormone (LH) interpulse interval and the total number of LH pulses [ Time Frame: 1100hr to 0700 hr ] [ Designated as safety issue: No ]
- Hourly hormone measurements during sampling period. [ Time Frame: 1100hr to 0700 hr ] [ Designated as safety issue: No ]The hourly measurements of progesterone, FSH, estrogen, and testosterone will be analyzed in a similar manner as the LH interpulse interval data.
|Study Start Date:||May 2008|
|Estimated Study Completion Date:||April 2015|
|Estimated Primary Completion Date:||April 2015 (Final data collection date for primary outcome measure)|
Subjects will take 5-25 mg oral micronized P (based on body weight, to achieve mean plasma P 1-2 ng/ml)
Subjects will take 5-25 mg oral micronized P (based on body weight, to achieve mean plasma P 1-2 ng/ml) or placebo at 1100, 1500, and 1900 h.
Placebo Comparator: placebo
placebo at 1100, 1500, and 1900 h.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01428089
|Contact: Anne C Gabel, BScemail@example.com|
|Contact: John C Marshall, MD, PhDfirstname.lastname@example.org|
|United States, Virginia|
|Center for Research in Reproduction, University of Virginia||Recruiting|
|Charlottesville, Virginia, United States, 22908|
|Contact: Anne C Gabel, BSc 434-243-6911 email@example.com|
|Principal Investigator: John C. Marshall, MD, PhD|
|Principal Investigator:||John C. Marshall, MD, PhD||University of Virginia|