Progesterone Suppression of Nocturnal LH Increases in Pubertal Girls (JCM017)
|ClinicalTrials.gov Identifier: NCT01773772|
Recruitment Status : Active, not recruiting
First Posted : January 23, 2013
Last Update Posted : April 16, 2019
|Condition or disease||Intervention/treatment||Phase|
|Female Puberty||Drug: Progesterone Drug: Placebo||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||24 participants|
|Intervention Model:||Single Group Assignment|
|Primary Purpose:||Basic Science|
|Official Title:||Progesterone Suppression of Nocturnal LH Increases in Pubertal Girls (JCM017)|
|Study Start Date :||June 2003|
|Actual Primary Completion Date :||January 2012|
|Estimated Study Completion Date :||December 2019|
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 pulse frequency (number of LH pulses per hour) [ Time Frame: 19 hours [from 1400 hr to 0900 hr] ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01773772
|United States, Virginia|
|University of Virginia Center for Research in Reproduction|
|Charlottesville, Virginia, United States, 22908|
|Principal Investigator:||Christopher R. McCartney, MD||University of Virginia|