Treatment of Menstrually Related Disorders With Continuous v. Interrupted Oral Contraceptives
Status:
Terminated
Trial end date:
2010-06-01
Target enrollment:
Participant gender:
Summary
This study will determine whether uninterrupted treatment with birth control pills over
several menstrual cycles prevents severe premenstrual syndrome (PMDD).
Previous studies have shown that the hormones estrogen and progesterone regulate mood in
women with MRMD. This study will use various treatment regimens with birth control pills and
placebo (sugar pill) to clarify the relationships among estrogen and progesterone, the
menstrual cycle, and mood.
Healthy women between 18 and 45 years of age who menstruate may be eligible for this 15-week
study. Candidates are screened with a physical examination, blood and urine tests, an
electrocardiogram, and 3 months of symptoms ratings to confirm MRMD.
Participants are randomly assigned to one of three treatment groups. Group 1 takes a birth
control pill every day and on three occasions takes a placebo capsule. Group 2 takes a birth
control pill most but not all days and on three occasions takes a placebo capsule. Group 3
takes a birth control pill every day and on three occasions takes another medication called
CDB-2914 that causes menstrual bleeding to occur.
Participants come to the NIH clinic every other week for blood tests and measurement of vital
signs (blood pressure, pulse, and temperature) and to complete symptoms ratings scales.
Subjects who develop breakthrough bleeding (menstruation earlier than expected) will have a
transvaginal ultrasound. For this procedure, a probe is inserted into the vagina for about 10
minutes. The probe gives off and receives sound waves that can be used to form a picture of
the endometrium (lining of the uterus).
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