Effectiveness of Flutamide in Treating Women With Premenstrual Dysphoric Disorder

NCT00611923 | Completed Phase 4 Results FDA Drug

• 2 other identifiers: R34MH072878DATR A5-ETPD
• Study Type: interventional
• Target: 115
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Premenstrual Syndrome

Keywords

Premenstrual Dysphoric Disorder; PMDD; PMS

Outcome Measures

Primary Outcomes (1)

• Change in Premenstrual Symptoms as Measured by the Premenstrual Tension Scale (PMTS)

  Low score on PMTS scale is 0 and high score is 40. Change score is calculated as PMTS score at month 1 or month 2 minus baseline PMTS score. Negative change score is a reduction in symptoms during treatment and positive change score is an increase in symptoms during treatment.

  Measured at Months 1and 2

Secondary Outcomes (3)

• Change in Premenstrual Symptoms as Measured by the Daily Rating of Severity of Problems (DRSP) Scale

  Measured at Months 1 and 2

• Side Effect Burden Measured by Side Effect Questionnaire

  Measured at Months 1 and 2

• Premenstrual Symptoms as Measured by the Clinical Global Improvement Scale at Month 1 and Month 2

  Measured at Months 1 and 2

Other Outcomes (2)

• Change in Clinical Global Severity Scale

  Measured at Month 1 and Month 2

• Change in Premenstrual Symptoms as Measured by the Patient Global Premenstrual Symptoms as Measured by the Patient Global Improvement Scale at Month 1 and Month 2

  Measured at Month 1 and Month 2

Study Arms (2)

B

PLACEBO COMPARATOR

Participants will take placebo flutamide

Drug: Placebo

A

EXPERIMENTAL

Participants will take flutamide

Drug: Flutamide

Interventions

Flutamide DRUG

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.

Also known as: Eulexin

A

Placebo DRUG

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.

B

Eligibility Criteria

• Age: 18 Years - 48 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Weill Medical College of Cornell University: lead
• National Institute of Mental Health (NIMH): collaborator

MeSH Terms

Conditions

Premenstrual Syndrome; Premenstrual Dysphoric Disorder

Interventions

Flutamide

Condition Hierarchy (Ancestors)

Menstruation Disturbances; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Depressive Disorder; Mood Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Results Point of Contact

• Title: Margaret Altemus
• Organization: Weill Cornell Medical College and Yale School of Medicine

maltemus@med.cornell.edu

646-209-6277

Study Officials

• Margaret Altemus, MD

  Weill Medical College of Cornell University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 6, 2008
• First Posted: February 11, 2008
• Study Start: February 1, 2005
• Primary Completion: June 1, 2011
• Study Completion: December 1, 2011
• Last Updated: January 7, 2020
• Results First Posted: November 19, 2019

Record last verified: 2019-12