Use of the Synthetic Hormone CDB-2914 in Treating Symptoms of Menopause
Status:
Completed
Trial end date:
2001-12-01
Target enrollment:
Participant gender:
Summary
This study will examine the safety and effectiveness of a synthetic hormone, CDB-2914, for
treating symptoms of menopause. It will compare the effects of estrogen and CDB-2914 with
those of estrogen and progesterone in postmenopausal women. The study will also evaluate
whether CDB-2914 affects adrenal gland function. CDB-2914 is chemically similar to cortisol,
a hormone that is produced by the adrenal glands and regulates the body's response to
stresses, such as infection or injury.
Healthy women volunteers between the ages of 45 and 70 who have not had a menstrual period
for over a year, are not currently taking hormone replacement therapy, do not smoke and have
not had a hysterectomy may be eligible for this study. Candidates will provide a medical
history and have a physical examination, including a breast and pelvic exam. They will also
provide a blood sample, have a mammogram and pap smear, and be instructed in dietary sources
and/or supplements required to be sure they consume at least 1,000 mg. of calcium each day.
Participants will be randomly assigned to take: a) estrogen plus CDB-2914, b) estrogen plus
progesterone, or c) estrogen plus a placebo (look-alike tablet with no active ingredient)
daily by mouth for 6 weeks. During the study period, they will keep a record of any symptoms,
vaginal bleeding, and other medicines they take. They will return to the NIH Clinical Center
weekly for blood tests and to fill out a questionnaire on mood, appetite, sleep patterns,
menopausal symptoms, and other quality of life issues. At the 6-week visit, participants
will:
- Bring a 24-hour urine collection
- Have a vaginal ultrasound to evaluate the effects of the medication on the thickness of
the endometrium (lining of the uterus)
- Bring all bottles of study medication for a pill count
- Discuss any unusual or troubling symptoms with the study nurse or physician
A final visit will be scheduled 1 to 3 weeks after the 6-week visit, when participants will
turn in their calendar of daily symptoms and return unused progesterone pills.
Phase:
Phase 2
Details
Lead Sponsor:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)