Study to Assess Potential Impairments in Estradiol Augmentation of Gonadotropin Secretion in Polycystic Ovary Syndrome

Part of paid clinical trials in Charlottesville, Virginia.

Sponsor
University of Virginia
Study ID
NCT03401047
Phase
EARLY_PHASE1
Status
Recruiting
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Conditions

  • Polycystic Ovary Syndrome

Eligibility Criteria

Sex
FEMALE
Age
18 Years - 30 Years
Healthy Volunteers
Accepted

Interventions

  • Estradiol — DRUG
    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.

Study Details

The purpose of this study is to determine if estradiol augmentation of luteinizing hormone (LH) secretion secretion (primary endpoint) and follicle-stimulating hormone (FSH) secretion (secondary endpoint) is reduced in adult women with polycystic ovary syndrome.

Key Dates

Start date
Nov 30, 2017
Status verified
Jul 2025
Primary completion
Oct 1, 2025
Completion
Dec 1, 2025

Study Design

Enrollment
37 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE

Arms

  • 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).

Primary Outcome Measure

Estradiol-induced change in 24-hour urinary LH excretion [ Time Frame: Change occurring over up to 7 days of estradiol administration ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of Virginia Clinical Research UnitCharlottesvilleVirginia22908
Melissa G Gilrain, B.S.
[email protected]
434-243-6911
Christine Burt Solorzano, M.D.
[email protected]
434-243-6911
Christine Burt Solorzano, M.D. (PRINCIPAL_INVESTIGATOR)
Christopher R McCartney, M.D. (SUB_INVESTIGATOR)

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By research site
University of Virginia Clinical Research Unit· Charlottesville, VA

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