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Antiandrogen

Hormone Therapy for Polycystic Ovary Syndrome (CRM010 Trial)

Phase < 1
Recruiting
Led By Christopher M 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
Post-pubertal (> 4 years post-menarche) adult woman aged 18-30 years
Willing to strictly avoid pregnancy with use of reliable non-hormonal methods during the study period
Timeline
Screening 3 weeks
Treatment Varies
Follow Up after 4 weeks of flutamide administration
Awards & highlights

CRM010 Trial Summary

This trial is testing if flutamide, a hormone blocker, can help normalize the pituitary gland's function in women with PCOS.

Who is the study for?
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.Check my eligibility
What is being tested?
The study tests if flutamide can improve pituitary function in women with PCOS when pre-treated with estradiol and given progesterone. It's a randomized, placebo-controlled double-blinded crossover study to see if flutamide enhances FSH release.See study design
What are the potential side effects?
Flutamide may cause liver problems; participants will be monitored for this. Other side effects could include allergic reactions to any of the drugs used: micronized progesterone, transdermal estradiol, or flutamide itself.

CRM010 Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am a woman aged 18-30 and have been menstruating for over 4 years.
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I am committed to using non-hormonal birth control methods during the study.
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I am able and willing to agree to the study's procedures.

CRM010 Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~after 4 weeks of flutamide administration
This trial's timeline: 3 weeks for screening, Varies for treatment, and after 4 weeks of flutamide administration for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in mean FSH concentration with progesterone administration
Secondary outcome measures
Change in mean LH concentration with progesterone administration

Side effects data

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

CRM010 Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: FlutamideExperimental Treatment3 Interventions
Prior to the first or second admission (randomly determined), subjects will be pretreated for 4 weeks with Flutamide (250 mg twice daily)
Group II: PlaceboPlacebo Group3 Interventions
Prior to the first or the second admission (randomly determined), participants will be pretreated for 2 weeks with placebo (twice daily).
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Flutamide
2013
Completed Phase 4
~1920
Estradiol patch
2019
Completed Phase 1
~530
Micronized progesterone
2020
Completed Phase 4
~1580

Find a Location

Who is running the clinical trial?

University of VirginiaLead Sponsor
753 Previous Clinical Trials
1,245,030 Total Patients Enrolled
26 Trials studying Polycystic Ovary Syndrome
1,194 Patients Enrolled for Polycystic Ovary Syndrome
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)NIH
1,956 Previous Clinical Trials
2,672,210 Total Patients Enrolled
31 Trials studying Polycystic Ovary Syndrome
5,428 Patients Enrolled for Polycystic Ovary Syndrome
Christopher M McCartney, MDPrincipal InvestigatorUnivsersity of Virginia

Media Library

Flutamide (Antiandrogen) Clinical Trial Eligibility Overview. Trial Name: NCT04597099 — Phase < 1
Polycystic Ovary Syndrome Research Study Groups: Placebo, Flutamide
Polycystic Ovary Syndrome Clinical Trial 2023: Flutamide Highlights & Side Effects. Trial Name: NCT04597099 — Phase < 1
Flutamide (Antiandrogen) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04597099 — Phase < 1

Frequently Asked Questions

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

Is the age requirement for this trial inclusive of geriatric individuals?

"Those wishing to partake in this trial must be aged between 18 and 30 years old. There are an additional 30 slots available for participants below the age of consent, while 45 spots remain open for those over 65."

Answered by AI

Am I eligible to enroll in this research study?

"The requirements for eligibility include a diagnosis of sclerocystic ovaries and being within the age range of 18-30 years old. In total, 10 participants will be invited to join this trial."

Answered by AI

Are new participants still being admitted into this clinical experiment?

"Per the records on clinicaltrials.gov, this ongoing medical trial is looking for participants as of now. The first posting was on December 20th 2022 and it has been updated most recently on May 16th 2022."

Answered by AI

What is the scope of recruitment for this clinical trial?

"Affirmative. On clinicaltrials.gov, we can see that this trial is actively recruiting participants; it was initially posted on December 20th 2022 and last updated in May 16th 2022. The study seeks to enroll 10 patients from one medical site."

Answered by AI

What conditions are usually treated with Flutamide?

"Flutamide is often prescribed to those who have not menstruated in the last 6 months, but it also can be employed for other purposes such as alleviating menopausal vasomotor symptoms and treating hypoestrogenism-related breast issues."

Answered by AI

Are there any previous investigations involving Flutamide?

"Presently, 97 trials related to flutamide are in progress. 23 of these studies have made it past Phase 2 and into the advanced third phase. Although originating from Cheras Kuala Lumpur, 3222 medical centres around the world are running clinical tests for this drug's efficacy."

Answered by AI
~5 spots leftby Oct 2025