Does Treatment of Androgen Excess Using Spironolactone Improve Ovulatory Rates in Girls With Androgen Excess?

Who is this study for? Patients with Polycystic Ovary Syndrome, Puberty Disorders, Ovulation Disorder
What treatments are being studied? Drug: Spironolactone
Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Early Phase 1
SUMMARY

Adolescent girls with androgen excess have a higher rate of irregular periods and decreased ovulation rates compared to normal girls, and are considered at-risk for developing polycystic ovary syndrome (PCOS). This pilot study will look at whether giving spironolactone might improve ovulation rates in girls with androgen excess, ages 13-19. If this is true, spironolactone treatment to young girls might prevent PCOS from developing and avoid future infertility.

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 13
Maximum Age: 19
Healthy Volunteers: f
View:

• Girls age 13 - 19 years, with clinical or biochemical HA (defined as hirsutism and/or elevated Tanner stage-specific free testosterone concentrations) that are 4-6 years post-menarche

• Screening labs within age-appropriate normal range

• Volunteers who are 18-19 y old must be willing and able to provide written informed consent.

• When the subject is a minor (i.e., age \< 18 y), the subject and custodial parents must be willing and able to provide written informed assent and consent, respectively.

• Willingness to strictly avoid pregnancy (using non-hormonal methods) during the time of study.

Locations
United States
Virginia
University of Virginia Center for Research in Reproduction
RECRUITING
Charlottesville
Contact Information
Primary
Melissa Gilrain, BS
pcos@virginia.edu
434-243-6911
Backup
Christine Burt Solorzano, MD
pcos@virginia.edu
434-243-6911
Time Frame
Start Date: 2019-12-18
Estimated Completion Date: 2024-09-01
Participants
Target number of participants: 24
Treatments
Experimental: Spironolactone
16 weeks without medication, then 16 weeks with medication, then 12 months without medication; spironolactone 50 mg tablets: 50-100 mg orally twice daily (1.7-3.3 mg/kg/24 hr)
Sponsors
Leads: University of Virginia
Collaborators: The Waterloo Foundation

This content was sourced from clinicaltrials.gov