Status:
COMPLETED
Effectiveness of Flutamide in Treating Women With Premenstrual Dysphoric Disorder
Lead Sponsor:
Weill Medical College of Cornell University
Collaborating Sponsors:
National Institute of Mental Health (NIMH)
Conditions:
Premenstrual Syndrome
Eligibility:
FEMALE
18-48 years
Phase:
PHASE4
Brief Summary
This study will evaluate the effectiveness of flutamide in reducing symptoms of premenstrual dysphoric disorder.
Detailed Description
Premenstrual dysphoric disorder (PMDD) is a condition that affects about 5% of menstruating women. Women with PMDD experience serious emotional and physical disturbances, which may include depression,...
Eligibility Criteria
Inclusion
- Meets DSM-IV criteria for PMDD by history
- Regular menstrual cycles that are 25 to 35 days in length during the year prior to study entry
- Willing to use barrier methods of birth control during the study if sexually active
- If engaged in psychotherapy for at least 3 months before study entry, participation will be allowed if the intensity of psychotherapy remains the same during the study
- Normal PAP and physical exam, including pelvic exam, within the 1 year prior to study entry
Exclusion
- Use of oral contraceptives or other exogenous hormone preparations within the 3 months prior to study entry
- Suicide attempt or severe suicidal ideation within the 2 years prior to study entry
- History of any psychotic disorder or bipolar disorder
- Substance abuse, except nicotine, within the 6 months prior to study entry
- Use of pharmacological treatment for PMDD symptoms (e.g., antidepressants, hormones, gonadotropin-releasing hormone agonists, anxiolytics, calcium, herbal preparations, diuretics) within the 3 months prior to study entry
- Daily use of psychotropic or anticonvulsant medications within the 3 months prior to study entry
- Use of sleeping pills more than once per week
- Consumption of more than 50 ounces of alcohol per week
- Pregnant or breastfeeding
- Hepatic, renal, autoimmune, or chronic inflammatory disease
- Seizure disorder
- Inability to read or follow instructions in English
Key Trial Info
Start Date :
February 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2011
Estimated Enrollment :
115 Patients enrolled
Trial Details
Trial ID
NCT00611923
Start Date
February 1 2005
End Date
December 1 2011
Last Update
January 7 2020
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