CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 115 enrolled
Drug / intervention
Flutamide +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00611923
NCT00611923Phase 4Completed
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Androgen Hormones in PMDD

Weill Medical College of Cornell University·interventional·Posted Feb 11, 2008·Updated Jan 7, 2020

In Brief

A Phase 4 clinical trial evaluating Flutamide and Placebo for Premenstrual Syndrome. Completed, enrolled 115 participants.

Detailed Summary

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

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPremenstrual Syndrome
Countries--
CollaboratorsNational Institute of Mental Health (NIMH)

Timeline

Phase 4CompletedFinished
20052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedFeb 11, 2008
Enrollment StartFeb 1, 2005
Primary CompletionJun 1, 2011
Study CompletionDec 1, 2011
TodayJul 2, 2026
Enrollment to primary: 6.3 yearsPosted 18.4 years ago

Interventions

Flutamidedrug

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.

Placebodrug

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.