Effectiveness of Flutamide in Treating Women With Premenstrual Dysphoric Disorder

• Status: Completed
• Trial end date: 2011-12-01
• Target enrollment: 0
• Participant gender: Female

Summary

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

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Weill Medical College of Cornell University
• Collaborator: National Institute of Mental Health (NIMH)
• Treatments: Flutamide

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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