Effectiveness of Flutamide in Treating Women With Premenstrual Dysphoric Disorder

Weill Cornell Medicine (WCM)

Status and phase

Completed

Phase 4

Conditions

Premenstrual Syndrome

Treatments

Drug: Flutamide

Drug: Placebo

Study type

Interventional

Funder types

Other

NIH

Identifiers

NCT00611923

DATR A5-ETPD

R34MH072878 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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

Full 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, tension, irritability, anger, anxiety, and sleep and appetite problems. Symptoms of PMDD are directly linked with the menstrual cycle, generally beginning in the latter half of the cycle and ending around the start of the next cycle. If left unmanaged, PMDD may interfere with a woman's ability to carry out normal day-to-day functioning. Current treatments for PMDD include medications, psychotherapy, and nutritional modifications. Flutamide, a medication that blocks the action of testosterone and other mood-influencing hormones, may be helpful in alleviating symptoms of PMDD. This study will evaluate the effectiveness of flutamide in reducing symptoms of premenstrual dysphoric disorder.

This two-phase study will last a total of 4 months and will include 7 study visits. Phase 1 will last 2 months and will include Visits 1 through 3. During Phase 1, participants will keep a daily record of symptoms, participate in a diagnostic interview, and undergo a medical history review, a physical exam, and screening laboratory tests. Eligible participants will then enter Phase 2, the treatment phase of the study.

During the treatment phase, participants will be randomly assigned to take flutamide or placebo for 2 months. Study visits will occur every 2 weeks and will include Visits 4 through 7. These visits will include discussion of side effects, symptom rating, and laboratory tests to check for pregnancy and any side effects related to liver function, blood counts, or blood chemistry. At the end of treatment with flutamide or placebo, participants will have the option of receiving treatment with sertraline, an antidepressant known to be effective for many women with PMDD. Sertraline will be given during the 2 premenstrual weeks for two cycles. If participants have already unsuccessfully tried sertraline for PMDD treatment, an alternative treatment can be attempted.

Enrollment

115 patients

Sex

Female

Ages

18 to 48 years old

Volunteers

No Healthy Volunteers

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