Progesterone Suppression of Nocturnal LH Increases in Pubertal Girls (JCM017)
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|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] ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
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|