Metformin for Polycystic Ovary Syndrome

Recruiting in Palo Alto (17 mi)

Overseen by Christine Burt Solorzano, MD

Age: < 65

Sex: Female

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase < 1

Recruiting

Sponsor: University of Virginia

No Placebo Group

Approved in 6 Jurisdictions

Trial Summary

What is the purpose of this trial?

This study will test whether metformin administration can ameliorate androgen (male hormone) overproduction in overweight pubertal girls with androgen excess. The investigators hypothesize that improvement in insulin sensitivity by 12 weeks of metformin administration will improve androgen levels after adrenal stimulation testing with adrenocorticotropic hormone (ACTH) or ovarian stimulation testing with recombinant human chorionic gonadotropin (rhCG).

Research Team

Christine Burt Solorzano, MD

Principal Investigator

University of Virginia

Eligibility Criteria

This trial is for overweight pubertal girls aged 7-18 with excess male hormones, specifically those who are in the early to late stages of puberty and have higher than normal free testosterone levels. Participants must not be pregnant, lactating, diabetic, or have certain hormonal disorders.

Inclusion Criteria

My blood tests are normal for my age, except for slightly low red blood cell count.

I am a female and my BMI is above the 85th percentile.

You have high levels of a hormone called testosterone.

Exclusion Criteria

Inability to comprehend study procedures

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

I have diabetes or my blood sugar or A1c levels are high.

Treatment Details

Interventions

• Metformin (Biguanide)

Trial Overview The study tests if metformin can reduce androgen overproduction in these girls. It involves a 12-week treatment period where insulin sensitivity is expected to improve and subsequently lower androgen levels after specific hormone stimulation tests.

Participant Groups

Group I: metformin Experimental Treatment 1 Intervention

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

Metformin is already approved in Canada, Japan, China, Switzerland for the following indications:

Approved in Canada as Glucophage for:

• Type 2 diabetes

Approved in Japan as Glucophage for:

• Type 2 diabetes

Approved in China as Glucophage for:

• Type 2 diabetes

Approved in Switzerland as Glucophage for:

• Type 2 diabetes

Who Is Running the Clinical Trial?

University of Virginia

Lead Sponsor

Trials

802

Recruited

1,342,000+

James E. Ryan

University of Virginia

Chief Executive Officer since 2018

J.D. from Harvard Law School

Nikki Hastings

University of Virginia

Chief Medical Officer since 2018

Ph.D. in Biomedical Engineering from University of Virginia