Hormone Therapy for Polycystic Ovary Syndrome
(CRM010 Trial)
Trial Summary
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. However, if you have stable and adequately treated hypothyroidism, you can continue your thyroid medication.
What data supports the effectiveness of the drug for treating polycystic ovary syndrome?
Research shows that flutamide, one of the drugs in the treatment, significantly reduces hirsutism (excessive hair growth) in women with polycystic ovary syndrome (PCOS) without major side effects. Additionally, oral micronized progesterone, another component, is effective in hormonal replacement therapy, which may help manage symptoms of PCOS.12345
Is micronized progesterone safe for use in humans?
How does the drug flutamide with micronized progesterone differ from other treatments for polycystic ovary syndrome?
This drug combination is unique because flutamide, an antiandrogen, effectively reduces hirsutism (excessive hair growth) in women with polycystic ovary syndrome without significant side effects, while micronized progesterone provides hormonal balance without the rapid liver inactivation seen in other forms of progesterone.123510
What is the purpose of this trial?
This trial is testing if flutamide, which blocks testosterone, can help women with PCOS improve their hormone regulation. The study aims to see if this medication can enhance the body's response to progesterone. Flutamide has been used to treat high levels of male hormones in women with PCOS, but its use is limited by potential liver damage and cost.
Research Team
Christopher M McCartney, MD
Principal Investigator
Univsersity of Virginia
Eligibility Criteria
This trial is for post-pubertal women aged 18-30 with PCOS, showing signs of excess male hormones and irregular periods. Participants must be in good health, not pregnant or lactating, avoid pregnancy during the study, and have no liver issues or significant medical history like diabetes or cancer. They should weigh over 110 pounds without severe blood disorders.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Pretreatment
Participants are pretreated with transdermal estradiol for 3 days before CRU admission
Treatment
Participants undergo two assessments of progesterone positive feedback after 4 weeks of pretreatment with flutamide or placebo
Washout
A washout period of at least 2 months to ensure adequate clearance of flutamide
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- Flutamide
- Micronized progesterone
Flutamide is already approved in United States, European Union, Canada, Japan for the following indications:
- Prostate cancer
- Prostate cancer
- Prostate cancer
- Prostate cancer
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Virginia
Lead Sponsor
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Collaborator