Progesterone + Estradiol for Polycystic Ovary Syndrome

Palo Alto (17 mi)

Overseen byJohn C. Marshall, MD, PhD

Age: < 65

Sex: Female

Travel: May be covered

Time Reimbursement: Varies

Trial Phase: N/A

Waitlist Available

Sponsor: University of Virginia

No Placebo Group

Trial Summary

What is the purpose of this trial?Girls with high levels of the male hormone testosterone often develop polycystic ovary syndrome (PCOS) as adults. Women with PCOS often have irregular menstrual periods, excess facial and body hair, and weight gain. Women with PCOS also have difficulty becoming pregnant. Some, girls with high levels of male hormone will develop normal hormone levels as they grow up. Most girls continue to have high levels of male hormone as adults. In addition, girls with elevated levels of male hormones often have lower fertility rates in adulthood. In this study the investigators will aim to discover the effect of 7 days of estrogen and progesterone on GnRH pulses in girls and women with the goal of understanding how and why some girls and women have higher levels of male hormone and the causes of PCOS. If investigators understand the causes of these disorders, they may be able to better treat them and perhaps even learn how to prevent the development of PCOS.

Eligibility Criteria

This trial is for girls aged 8 to 18 with high male hormone levels, specifically testosterone >0.4 ng/mL or signs of excess hair growth. They must have normal lab results except for those related to high male hormones and weigh over 31 kg. Girls can't join if they've had certain cancers, are on hormonal treatments, pregnant/breastfeeding, smoke cigarettes, or have specific medical conditions.

Inclusion Criteria

I am a girl aged between 8 and 18.

Exclusion Criteria

I weigh less than 31 kg.

I have a history of peanut allergy, deep vein thrombosis, or certain types of cancer.

I had surgery that needed bed rest in the last 30 days.

I have congenital adrenal hyperplasia.

Treatment Details

The study tests how a week-long treatment with estrogen (estrace) and progesterone affects the GnRH pulses in young females with elevated male hormones. The goal is to understand the development of PCOS and potential treatments by monitoring changes in hormone patterns.

1Treatment groups

Experimental Treatment

Group I: estrogen, progesteroneExperimental Treatment2 Interventions

Estrace, 0.5-1 mg once a day Micronized progesterone powder (Spectrum Chemical Manufacturing Corporation, Irving, CA), Three times a day at 0700, 1500, and 2300 hr