Dutasteride to Treat Women With Menstrually Related Mood Disorders
Status:
Completed
Trial end date:
2014-03-06
Target enrollment:
Participant gender:
Summary
This study will explore the effects of dutasteride on mood and the stress response across the
menstrual cycle. Dutasteride blocks production of neurosteroids-hormones that help regulate
the stress response systems. These systems may be disturbed in women with menstrually related
mood disorders (MRMD). The effects of the drug will be compared in women with and without
MRMD to determine how neurosteroids regulate mood and the stress response across the
menstrual cycle. Dutasteride is approved by the Food and Drug Administration to treat benign
prostatic hyperplasia (excess growth of the prostate gland) in men.
Menstruating women 30 to 45 years of age with and without MRMD may be eligible for this
study. Candidates are screened with a medical and psychiatric history, physical examination,
screening for symptoms of depression, and routine blood and urine tests. Participants are
required to use barrier contraception (condoms or diaphragm) during the 3-month study and
6-month follow-up.
Participants undergo the following tests and procedures:
- Dutasteride or placebo treatment: Participants receive 1 month of dutasteride and 2
months of placebo. Neither the participants nor the investigators know when the subject
is taking the active medication or the placebo.
- Biweekly follow-up visits: Every 2 weeks during the 3-month treatment period, patients
come to the NIH Clinical Center to have blood drawn and to complete mood symptoms
ratings.
- Monthly follow-up visits: Participants return to the Clinical Center once a month for 6
months after the end of the treatment period to monitor hormone levels and pregnancy
status.