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Antiandrogen

Flutamide for Polycystic Ovarian Syndrome

Phase 2
Waitlist Available
Led By Daniel Dumesic, MD
Research Sponsored by University of California, Los Angeles
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 months
Awards & highlights

Study Summary

This trial will study 32 women, 16 with PCOS and 16 without, over the course of 6 months. All participants will have physicals, blood tests, and ultrasounds at the beginning of the study. If they qualify, they will have additional blood tests and fat removal, as well as monthly physicals and blood tests while taking either flutamide or placebo. Quality of life assessments will be done at the beginning and end of the study for those taking medication. After six months, all participants will have the final series of tests, and those taking medication will be followed up with a phone call.

Eligible Conditions
  • Polycystic Ovarian Syndrome

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 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
Six-month flutamide (antiandrogen) administration to lean women with polycystic ovary syndrome (PCOS) will improve impaired glucose tolerance by glucose tolerance testing and normalize subcutaneous (SC) fat cells by fat biopsy.
Secondary outcome measures
Quality of Life Questionnaires
Other outcome measures
Liver transaminases (serum glutamic oxaloacetic transaminase [SGOT]; serum glutamic-pyruvic transaminase [SGPT])

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
8%
fatigue
8%
dry mouth
8%
leg pain
8%
parasthesia
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 125 mg orally daily for six 28-day cycles.
Group II: Sugar pillPlacebo Group1 Intervention
Placebo intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Flutamide
2013
Completed Phase 4
~1920

Find a Location

Who is running the clinical trial?

University of California, Los AngelesLead Sponsor
1,528 Previous Clinical Trials
10,276,806 Total Patients Enrolled
Oregon Health and Science UniversityOTHER
973 Previous Clinical Trials
6,845,984 Total Patients Enrolled
Daniel Dumesic, MDPrincipal InvestigatorUniversity of California, Los Angeles

Frequently Asked Questions

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

What sort of participants is this research endeavor seeking?

"Individuals between 18 and 35 years of age, who have been diagnosed with Polycystic Ovary Syndrome, can apply for this clinical trial. Up to 32 participants are being recruited in total."

Answered by AI

What other research efforts have been made to explore the efficacy of Flutamide?

"To date, 8 Phase 3 studies on Flutamide are taking place with an additional eight trials underway. Primarily situated in Shanghai, China there is a total of 2372 locations running research into this medication."

Answered by AI

Is Flutamide consumption associated with any safety concerns?

"Flutamide has been given an estimated safety rating of 2 due to the lack of efficacy data in Phase 2 clinical trials."

Answered by AI

How many individuals have enrolled in this research endeavor?

"Affirmative. Clinicaltrials.gov records suggest that the recruitment phase for this trial is ongoing, having been first advertised on April 1st 2013 and most recently updated on May 16th 2022. 32 patients are required from one medical centre to complete the study."

Answered by AI

Is enrollment for this trial still available?

"According to clinicaltrials.gov, this research endeavour is still seeking patients. The protocol was initially published on April 1st 2013 and recently amended on May 16th 2022."

Answered by AI

Does the criteria for this study accommodate individuals below sixty years of age?

"This clinical trial is accessible to participants aged between 18 and 35. Additionally, there are separate trials available for people younger than 18 and those over 65 years old with a combined total of 36 studies altogether."

Answered by AI

Who else is applying?

What state do they live in?
California
How old are they?
18 - 65
What site did they apply to?
UCaliforniaLA
What portion of applicants met pre-screening criteria?
Met criteria
Recent research and studies
clinicaltrials.govStudy
Androgen Excess as a Cause for Adipogenic Dysfunction in PCOS Women
Daniel A. Dumesic, MD 2013. "Androgen Excess as a Cause for Adipogenic Dysfunction in PCOS Women". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT01889199.
~4 spots leftby Apr 2025
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