Effectiveness of Flutamide in Treating Women With Premenstrual Dysphoric Disorder (NCT00611923) | Clinical Trial Compass
CompletedPhase 4
Effectiveness of Flutamide in Treating Women With Premenstrual Dysphoric Disorder
115 participantsStarted 2005-02
Plain-language summary
This study will evaluate the effectiveness of flutamide in reducing symptoms of premenstrual dysphoric disorder.
Who can participate
Age range18 Years – 48 Years
SexFEMALE
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
What they're measuring
1
Change in Premenstrual Symptoms as Measured by the Premenstrual Tension Scale (PMTS)
Timeframe: Measured at Months 1and 2
Trial details
NCT IDNCT00611923
SponsorWeill Medical College of Cornell University