Premenstrual Syndrome Clinical Trial
Official title:
Androgen Hormones in PMDD
This study will evaluate the effectiveness of flutamide in reducing symptoms of premenstrual dysphoric disorder.
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.
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