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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 7 days following estradiol and progesterone treatment
Awards & highlights

Study 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.Check my eligibility
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.See study design
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
Select...
I am a girl aged between 8 and 18.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~7 days following estradiol and progesterone treatment
This trial's timeline: 3 weeks for screening, Varies for treatment, and 7 days following estradiol and progesterone treatment for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Reduction in luteinizing hormone pulse frequency after one week of estradiol and progesterone

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

Find a Location

Who is running the clinical trial?

University of VirginiaLead Sponsor
748 Previous Clinical Trials
1,235,943 Total Patients Enrolled
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)NIH
1,952 Previous Clinical Trials
2,660,784 Total Patients Enrolled
John C. Marshall, MD, PhDPrincipal InvestigatorUniversity of Virginia
2 Previous Clinical Trials
28 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many people have consented to participate in this research?

"At this juncture, the trial is not recruiting patients. The study was first listed on April 1st 2000 and edited for the last time on June 23rd 2022. There are currently 96 trials searching for participants with sclerocystic ovaries and 82 studies looking to recruit volunteers taking Progesterone medication."

Answered by AI

In what medical scenarios is Progesterone typically recommended?

"Progesterone is a viable treatment option for women with hypoestrogenism and vasomotor symptoms associated with menopause who have not had their menstrual period in the past 6 months."

Answered by AI

Could you elaborate on the prior research done with Progesterone?

"Presently, 82 clinical trials pertaining to progesterone are underway. Fifteen of these studies have entered Phase 3 and 851 separate medical sites are participating in the research. Cheras, Kuala Lumpur appears to be a primary hub for Progesterone-related investigations."

Answered by AI

Is this research project open to participants who are over the age of 30?

"As per the study's criteria, only those aged 8-18 are eligible for enrolment."

Answered by AI

What criteria makes someone an ideal candidate for this research project?

"This research is searching for 60 pre-adolescents and adolescents with sclerocystic ovaries. The ideal candidate should be between 8 to 18 years old, hyperandrogenemic (elevated testosterone levels or hirsutism), and have standard laboratory values (excluding the hormonal abnormalities associated with hyperandrogenemia)."

Answered by AI

Are there any vacancies within this trial for prospective volunteers?

"This clinical trial is no longer seeking applicants. It was first announced on April 1st 2000 and its registration details were last updated on June 23rd 2022. For those searching for other medical trials, 96 are actively recruiting patients with sclerocystic ovaries and 82 are currently looking for participants that can receive Progesterone treatment."

Answered by AI
~3 spots leftby Aug 2025