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Androgen Receptor Blocker

Flutamide for Polycystic Ovary Syndrome (CRM004 Trial)

Phase 1
Waitlist Available
Led By Christopher R McCartney, MD
Research Sponsored by University of Virginia
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Controls will be healthy women with regular menstrual cycles and no evidence of hyperandrogenism.
Be between 18 and 65 years old
Must not have
Hematocrit < 36% or hemoglobin < 12 g/dl (that is not reversed by iron treatment).
Significant history of cardiac or pulmonary dysfunction (e.g., known or suspected congestive heart failure; asthma requiring intermittent systemic corticosteroids; etc.)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up one and two months

Summary

This trial is testing if flutamide, a drug that blocks testosterone, can help normalize hormone patterns in women with PCOS. The study will compare hormone levels during sleep to see if it makes a difference.

Who is the study for?
This trial is for women aged 18-35 with Polycystic Ovary Syndrome (PCOS) who have irregular or infrequent periods and high testosterone levels, either observed through symptoms like excess hair growth or confirmed by tests. Participants should not have other health issues, must avoid pregnancy using non-hormonal methods during the study, and cannot be menopausal. Healthy women with regular cycles can join as controls.
What is being tested?
The study is testing if flutamide, a drug that blocks testosterone receptors, can normalize the relationship between sleep-wake patterns and luteinizing hormone pulse frequency in women with PCOS compared to a placebo (a substance with no therapeutic effect).
What are the potential side effects?
Flutamide may cause side effects such as upset stomach, hot flashes, reduced sex drive, oily skin or hair loss. It might also change liver enzyme levels which will be monitored closely.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am a healthy woman with regular periods and no signs of excessive male hormones.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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My blood levels are low and not improved with iron.
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I have a serious heart or lung condition.
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I weigh at least 110 lbs.
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I am not a man.
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I have signs or a history of Cushing's syndrome.
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I have diabetes or my blood sugar/A1c levels are high.
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My testosterone levels are above 150 ng/dl, confirmed by tests.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~one and two months
This trial's timeline: 3 weeks for screening, Varies for treatment, and one and two months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Secondary study objectives
Sleep study parameters

Side effects data

From 2011 Phase 4 trial • 115 Patients • NCT00611923
38%
headache
31%
stomach pain
23%
dry skin
15%
nausea
15%
insomnia
15%
hot flushes
15%
Diarrhea
8%
fatigue
8%
parasthesia
8%
leg pain
8%
dry mouth
100%
80%
60%
40%
20%
0%
Study treatment Arm
Placebo
Flutamide

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: FlutamideExperimental Treatment1 Intervention
Flutamide 250 mg taken by mouth twice a day for 4 weeks. Flutamide is an androgen-receptor blocker.
Group II: PlaceboPlacebo Group1 Intervention
Placebo contains only inert ingredients and is not expected to exert any direct physiological effects.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Flutamide
2013
Completed Phase 4
~2110

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Common treatments for Polycystic Ovary Syndrome (PCOS) include antiandrogens like flutamide, combined oral contraceptives (COCs), and insulin sensitizers like metformin. Flutamide works by blocking androgen receptors, reducing the effects of excess androgens, which helps alleviate symptoms like hirsutism and acne. COCs regulate menstrual cycles and decrease androgen production by suppressing luteinizing hormone (LH) and follicle-stimulating hormone (FSH) levels. Metformin improves insulin sensitivity, which can help reduce insulin levels and subsequently lower androgen levels. These treatments are important as they address the hormonal imbalances and metabolic issues central to PCOS, improving both symptoms and long-term health outcomes.
First-line ovulation induction for polycystic ovary syndrome: an individual participant data meta-analysis.Targets to treat androgen excess in polycystic ovary syndrome.Combined oral contraceptives and/or antiandrogens versus insulin sensitizers for polycystic ovary syndrome: a systematic review and meta-analysis.

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

University of VirginiaLead Sponsor
775 Previous Clinical Trials
1,284,810 Total Patients Enrolled
26 Trials studying Polycystic Ovary Syndrome
1,132 Patients Enrolled for Polycystic Ovary Syndrome
Christopher R McCartney, MDPrincipal InvestigatorUniversity of Virginia
2 Previous Clinical Trials
130 Total Patients Enrolled
1 Trials studying Polycystic Ovary Syndrome
40 Patients Enrolled for Polycystic Ovary Syndrome
~4 spots leftby Oct 2025