Spironolactone for Polycystic Ovary Syndrome

Recruiting in Palo Alto (17 mi)

Overseen byChristine Burt Solorzano, MD

Age: < 65

Sex: Female

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: University of Virginia

No Placebo Group

Approved in 2 Jurisdictions

Trial Summary

What is the purpose of this trial?

Whether 12 weeks of spironolactone can reduce androgen production from ovaries and adrenal glands of girls with obesity and androgen excess

Research Team

Christine Burt Solorzano, MD

Principal Investigator

University of Virginia

Eligibility Criteria

This trial is for overweight girls aged 7-18 in early to late puberty with excess androgen levels. They must have normal lab results, except for specific hormonal imbalances related to obesity. Girls who are pregnant, lactating, or have certain medical conditions like Cushing syndrome or diabetes cannot participate.

Inclusion Criteria

My blood tests are mostly normal, though I may have slight changes due to being overweight.

Your testosterone levels are very high compared to other people your age.

I am between 7 and 18 years old, experiencing puberty.

See 1 more

Exclusion Criteria

You are pregnant or breastfeeding.

Abnormal laboratory studies will be confirmed by repeat testing to exclude laboratory error

My morning cortisol is low or I have had Cushing syndrome or adrenal issues.

See 15 more

Treatment Details

Interventions

Spironolactone (Corticosteroid)

Trial OverviewThe study tests if a 12-week course of Spironolactone can lower the production of androgens (male hormones) by the ovaries and adrenal glands in pubertal girls with obesity-related hormone issues.

Participant Groups

1Treatment groups

Experimental Treatment

Group I: spironolactoneExperimental Treatment1 Intervention

12 weeks spironolactone with pre- and post-intervention dexamethasone, and ACTH to perform standardized adrenal stimulation testing; dexamethasone and rhCG to perform standardized ovarian stimulation testing