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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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up one and two months

Awards & highlights

CRM004 Trial Summary

This trial will study whether a medication can normalize hormone levels in women with polycystic ovary syndrome, which can cause irregular sleep patterns.

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.Check my eligibility

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).See study design

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.

CRM004 Trial Eligibility Criteria

Inclusion Criteria

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

Select...

I am a healthy woman with regular periods and no signs of excessive male hormones.

CRM004 Trial 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Luteinizing hormone pulse frequency

Secondary outcome measures

Luteinizing hormone pulse amplitude

Mean follicle stimulating hormone level

Mean luteinizing hormone level

+1 more

Side effects data

From 2011 Phase 4 trial • 115 Patients • NCT00611923

38%

headache

31%

stomach pain

23%

dry skin

15%

insomnia

15%

hot flushes

15%

nausea

15%

Diarrhea

fatigue

dry mouth

leg pain

parasthesia

100%

80%

60%

40%

20%

Study treatment Arm

Placebo

Flutamide

CRM004 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

~1920

0 / 1Eligibility criteria met

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

753 Previous Clinical Trials

1,244,959 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

Frequently Asked Questions

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

Are new participants still able to join this experiment?

"As per clinicaltrials.gov, this trial is not presently enrolling patients; it was initially posted on the 1st of January 2009 and updated lastly on May 16th 2022. Though no longer recruiting candidates, there are currently 1436 other medical studies actively seeking participants."

Answered by AI

Are there any precedents of experimentation with Flutamide?

"Currently, there are 16 clinical trials being conducted to determine the efficacy of Flutamide. 8 of them have moved beyond Phase 2 and into their final stage. A large concentration is found in Shanghai though multiple other sites around the world also host studies for this medication with a total 2372 locations enrolling patients."

Answered by AI

How many participants are participating in this research endeavor?

"At this moment, recruitment has closed for the trial in question. It was initially posted on January 1st 2009 and its details were last edited on May 16th 2022. However, if you are looking to join a different study, there are currently 1420 clinical trials searching for patients with sclerocystic ovaries and 16 studies actively accepting participants who have been prescribed Flutamide."

Answered by AI

Has the Federal Drug Administration endorsed Flutamide?

"The team at Power has assigned Flutamide a score of 1 due to its current Phase 1 status, implying that there is minimal evidence proving both safety and efficacy."

Answered by AI

What qualifications must individuals possess in order to participate in this research trial?

"This clinical trial is recruiting 72 patients with polycystic ovary syndrome, aged between 18 and 35 years old. Candidates need to have irregular or absent periods yearly, no additional endocrinopathies such as Cushing's Syndrome of hyperprolactinemia, be willing to use non-hormonal contraception during the study period and provide informed consent. In addition, healthy women with regular menstrual cycles will also participate in this research program. Diagnosis for PCOS follows NIH consensus criteria that includes manifestations of elevated testosterone levels (biochemical) or hirsutism (clinical)."

Answered by AI