Effectiveness of Flutamide in Treating Women With Premenstrual Dysphoric Disorder
Condition: Premenstrual Syndrome
MeSH terms: Premenstrual Syndrome; Premenstrual Dysphoric Disorder
Study type: Interventional
Phase: Phase 4

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

Detailed 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.
    

Intervention name(s): Flutamide; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): 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.; 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.
Other intervention name(s): Eulexin
Intervention MeSH terms: Flutamide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Premenstrual Dysphoric Disorder; PMDD; PMS