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Phase 4 N=25 Randomized Double-blind Treatment

Effectiveness of Flutamide in Treating Women With Premenstrual Dysphoric Disorder

Premenstrual Syndrome

Bottom Line

View on ClinicalTrials.gov: NCT00611923 ↗
Enrolled (actual)
25
Serious AEs
0.0%
Results posted
Nov 2019
Primary outcome: Primary: Change in Premenstrual Symptoms as Measured by the Premenstrual Tension Scale (PMTS) — -6.9; -5.5; -5.5; -8.3 score on a scale — p== 0.57

Study Design & Population

Study type
Interventional
Phase
Phase 4
Interventions
Flutamide (Drug); Placebo (Drug)
Age
Adult · 18+ yrs
Sex
Female
Sponsor
Weill Medical College of Cornell University
Primary completion
Jun 2011

Outcome Measures

OutcomeResultp-value
PRIMARY
Change in Premenstrual Symptoms as Measured by the Premenstrual Tension Scale (PMTS)		 -6.9; -5.5; -5.5; -8.3 = 0.57
SECONDARY
Change in Premenstrual Symptoms as Measured by the Daily Rating of Severity of Problems (DRSP) Scale		 -21.3; -26.0; -22.2; -35.6 = 0.52
SECONDARY
Side Effect Burden Measured by Side Effect Questionnaire		 3.9; 3.5; 2.2; 5.1 = 0.8
SECONDARY
Premenstrual Symptoms as Measured by the Clinical Global Improvement Scale at Month 1 and Month 2		 3.2; 2.5; 3.1; 2.2 =.15

Summary

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

Eligibility 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
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00611923). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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