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Effectiveness of Flutamide in Treating Women With Premenstrual Dysphoric Disorder

NCT00611923 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 115

Last updated 2020-01-07

Study results available
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Summary

This study will evaluate the effectiveness of flutamide in reducing symptoms of premenstrual dysphoric disorder.

Conditions

  • Premenstrual Syndrome

Interventions

DRUG

Flutamide

Participants will take one 125-mg flutamide capsule twice a day for two menstrual cycles. If a participant is unable to tolerate a twice-daily dose due to side effects, the dose will be reduced to one capsule per day.

DRUG

Placebo

Participants will take a lactose capsule twice a day for two menstrual cycles. If a participant is unable to tolerate a twice-daily dose due to side effects, the dose will be reduced to one capsule per day.

Sponsors & Collaborators

  • National Institute of Mental Health (NIMH)

    collaborator NIH

  • Weill Medical College of Cornell University

    lead OTHER

Principal Investigators

  • Margaret Altemus, MD · Weill Medical College of Cornell University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
48 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-02-28
Primary Completion
2011-06-30
Completion
2011-12-31
FDA Drug
Yes

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00611923 on ClinicalTrials.gov