What side effects are associated with this type of intervention?

Common treatments for Polycystic Ovary Syndrome (PCOS) include oral contraceptives (OCs), antiandrogens like flutamide and spironolactone, and metformin. OCs are associated with an increased risk of venous thromboembolism (VTE), particularly in women over 40 and those with obesity. Antiandrogens, such as flutamide and spironolactone, can cause side effects like liver toxicity (flutamide) and potential teratogenic effects, necessitating concurrent contraceptive use. Metformin may cause gastrointestinal issues and is minimally effective without weight control. These treatments aim to manage symptoms but come with varying side effects that should be considered in consultation with a healthcare provider.

What prior FDA approvals exist?

The FDA has not specifically approved Flutamide for the treatment of Polycystic Ovary Syndrome (PCOS). However, treatments for PCOS often include combined oral contraceptives (COCs) and antiandrogens like spironolactone, which are used off-label to manage symptoms such as hirsutism and menstrual irregularities. COCs are the first-line therapy for managing hyperandrogenic symptoms and preventing endometrial hyperplasia. While Flutamide, a testosterone receptor blocker, is being studied for its potential benefits in PCOS, it is not yet an FDA-approved treatment for this condition.

What other types of research exist?

Promising novel alternatives to Flutamide for PCOS patients include Letrozole, which is suggested as a first-line therapy for ovulation induction, and Myo-inositol, a dietary supplement that acts as an insulin sensitizer and has shown efficacy in improving ovulatory frequency and weight loss. Both options address key aspects of PCOS management and have demonstrated positive outcomes in clinical studies.

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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 weeks3 visits

Treatment ~ Varies

Follow Up ~ one and two months

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%

hot flushes

15%

insomnia

15%

Diarrhea

fatigue

leg pain

parasthesia

dry mouth

100%

80%

60%

40%

20%

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

0 / 8Eligibility criteria met

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.