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Progesterone + Estradiol for Polycystic Ovary Syndrome

N/A

Waitlist Available

Led By John C. Marshall, MD, PhD

Research Sponsored by University of Virginia

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Girls ages 8 to 18

Be younger than 65 years old

Must not have

Weight < 31 kg

History of peanut allergy, deep venous thrombosis, breast cancer, endometrial cancer, or cervical cancer

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

No Placebo-Only Group

Summary

This trial will study the effect of 7 days of estrogen and progesterone on GnRH pulses in girls and women with PCOS, in order to understand why some women have higher levels of male hormone and develop PCOS.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

While not explicitly listed in the provided information, common side effects of estrace (estrogen) may include nausea, headache, breast tenderness; progesterone might cause mood swings, bloating or menstrual changes.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am a girl aged between 8 and 18.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I weigh less than 31 kg.

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

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

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I have congenital adrenal hyperplasia.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

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

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Progesterone

2013

Completed Phase 4

~4510

estrace

2009

N/A

~30