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

Who is this study for? Adult female patients with Polycystic Ovary Syndrome
What treatments are being studied? Estradiol
Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Early Phase 1
SUMMARY

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.

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 18
Maximum Age: 30
Healthy Volunteers: t
View:

• PCOS group: post-pubertal (\> 4 years post-menarche) adult woman aged 18-30 years with PCOS, defined as clinical and/or laboratory evidence of hyperandrogenism (hirsutism and/or elevated serum \[calculated\] free testosterone concentration) plus ovulatory dysfunction (irregular menses, fewer than 9 per year), but without evidence for other potential causes of hyperandrogenism and/or ovulatory dysfunction

• Control group: post-pubertal (\> 4 years post-menarche) adult woman aged 18-30 years with regular menstrual periods (every 26-35 days) and no evidence of hyperandrogenism (i.e., no hirsutism, normal serum \[calculated\] free testosterone concentration)

• General good health (excepting overweight, obesity, PCOS, and adequately-treated hypothyroidism)

• Capable of and willing to provide informed consent

• Willing to strictly avoid pregnancy with use of reliable non-hormonal methods during the study period

Locations
United States
Virginia
University of Virginia Clinical Research Unit
RECRUITING
Charlottesville
Contact Information
Primary
Melissa G Gilrain, B.S.
pcos@virginia.edu
434-243-6911
Backup
Christine Burt Solorzano, M.D.
pcos@virginia.edu
434-243-6911
Time Frame
Start Date: 2017-11-30
Estimated Completion Date: 2025-12-01
Participants
Target number of participants: 37
Treatments
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).
Sponsors
Leads: University of Virginia

This content was sourced from clinicaltrials.gov

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