Study to Assess Potential Impairments in Estradiol Augmentation of Gonadotropin Secretion in Polycystic Ovary Syndrome (CRM009)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03401047|
Recruitment Status : Recruiting
First Posted : January 17, 2018
Last Update Posted : October 11, 2019
|Condition or disease||Intervention/treatment||Phase|
|Polycystic Ovary Syndrome||Drug: Estradiol||Early Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||37 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||This is a prospective interventional cohort study. Women with PCOS and controls will receive identical treatment (transdermal estradiol) and will be monitored using the same surveillance protocol. The study does not involve randomization, and it is not blinded.|
|Masking:||None (Open Label)|
|Primary Purpose:||Basic Science|
|Official Title:||Study to Assess Potential Impairments in Estradiol Augmentation of Gonadotropin Secretion in Polycystic Ovary Syndrome|
|Actual Study Start Date :||November 30, 2017|
|Estimated Primary Completion Date :||April 1, 2025|
|Estimated Study Completion Date :||December 1, 2025|
Experimental: Transdermal Estradiol
Subjects will undergo estradiol administration for up to 9 days. Transdermal estradiol patches will be applied each day by study staff during study days two through nine (patches deliver 0.1 mg/day for a total dose of up to 0.6 mg/day).
Subjects will receive graded doses of transdermal estradiol patches for up to 7 days. Blood estradiol tests will be performed daily, and the number of estradiol patches used will be adjusted to maintain serum estradiol levels of 250-400 pg/ml. Estradiol is a natural hormone.
Other Name: Vivelle
- Estradiol-induced change in 24-hour urinary LH excretion [ Time Frame: Change occurring over up to 7 days of estradiol administration ]The estradiol-induced change in 24-hour urinary LH excretion is defined as the 24-hour urinary LH excretion immediately prior to estradiol administration vs. the peak 24-hour urinary LH excretion during estradiol administration.
- Estradiol-induced change in 24-hour urinary FSH excretion [ Time Frame: Change occurring over up to 7 days of estradiol administration ]The estradiol-induced change in 24-hour urinary FSH excretion is defined as the 24-hour urinary FSH excretion immediately prior to estradiol administration vs. the peak 24-hour urinary FSH excretion during estradiol administration.
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): NCT03401047
|Contact: Melissa G Gilrain, B.S.||email@example.com|
|Contact: Christopher McCartney, M.D.||firstname.lastname@example.org|
|United States, Virginia|
|University of Virginia Clinical Research Unit||Recruiting|
|Charlottesville, Virginia, United States, 22908|
|Contact: Melissa G Gilrain, B.S. 434-243-6911 email@example.com|
|Contact: Christopher R McCartney, M.D. 434-923-0329 firstname.lastname@example.org|
|Principal Investigator: Christopher R McCartney, M.D.|
|Sub-Investigator: Christine M Burt Solorzano, M.D.|
|Sub-Investigator: Jessica A Lundgren, M.D.|
|Sub-Investigator: Su H Kim, M.D|
|Sub-Investigator: John C Marshall, M.D.|
|Principal Investigator:||Christopher McCartney, M.D.||University of Virginia|