Suppression of Daytime and Nighttime Luteinizing Hormone Frequency by Progesterone
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|ClinicalTrials.gov Identifier: NCT01428089|
Recruitment Status : Recruiting
First Posted : September 2, 2011
Last Update Posted : October 14, 2020
|Condition or disease||Intervention/treatment||Phase|
|Polycystic Ovary Syndrome Hyperandrogenism Normal Puberty||Drug: Progesterone Drug: Placebo||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||40 participants|
|Intervention Model:||Single Group Assignment|
|Primary Purpose:||Basic Science|
|Official Title:||Suppression of Daytime and Nighttime LH Frequency by Progesterone in Early Pubertal Girls With and Without Hyperandrogenemia (JCM024)|
|Actual Study Start Date :||March 11, 2011|
|Estimated Primary Completion Date :||December 2021|
|Estimated Study Completion Date :||December 2021|
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.
- Average luteinizing hormone (LH) interpulse interval and the total number of LH pulses [ Time Frame: 1100hr to 0700 hr ]
- Hourly hormone measurements during sampling period. [ Time Frame: 1100hr to 0700 hr ]The hourly measurements of progesterone, FSH, estrogen, and testosterone will be analyzed in a similar manner as the LH interpulse interval data.
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): NCT01428089
|Contact: Melissa Gilrainemail@example.com|
|Contact: Christopher R McCartney, MDfirstname.lastname@example.org|
|United States, Virginia|
|Center for Research in Reproduction, University of Virginia||Recruiting|
|Charlottesville, Virginia, United States, 22908|
|Contact: Melissa Gilrain 434-243-6911 email@example.com|
|Sub-Investigator: John C. Marshall, MD, PhD|
|Principal Investigator: Christopher R. McCartney, MD|
|Principal Investigator:||Christopher R McCartney, MD||University of Virginia|