Healthy Clinical Trial
Official title:
Hormone Replacement in Young Women With Premature Ovarian Failure
The human ovary produces male sex hormones (androgen) and female sex hormones (estrogen).
Currently, androgen is not included in hormone replacement therapy for women with premature
ovarian failure. Present hormone replacement therapy (HRT) was designed to treat women who
experience ovarian failure at menopause (around the age of 50). However, 1% of women will
experience premature failure of the ovaries before the age of 40. There have been no studies
conducted to determine proper hormone replacement therapies for these younger women. Some
research suggests that the usual menopausal hormone replacement therapy is not adequate to
protect young women with premature ovarian failure from developing osteoporosis. Women with
premature ovarian failure have abnormally low levels of androgens circulating in their
blood. This may contribute to the increase risk for osteoporosis.
This study will compare two treatment plans for women with premature ovarian failure.
Treatment plan one will be physiological estrogen hormone replacement. Treatment plan two
will be physiological estrogen hormone replacement plus androgen. The study will attempt to
determine which plan is more beneficial to women in relation to osteoporosis and heart
disease.
The hormones will be contained in patches and given by placing the patches against the
patient's skin. The patches were designed to deliver the same amount of hormone as would be
normally produced by the ovary in young women.
The success of the treatment will be measured by periodically checking the density of
patient's bone in the leg (femoral neck bone) . Researchers will take an initial (baseline)
measurement of bone density before beginning treatment and then once a year, for 3
additional years, during treatment. The study will also consider bone density of the spine,
bone turnover, heart disease risk factors, and psychological state.
Present menopausal hormone replacement therapy regimens were designed for women who experience ovarian failure around age 50. At least 1% of women, however, experience premature ovarian failure before the age of 40, but there have been no studies establishing optimal hormone replacement therapy regimens for these younger women. Available evidence suggests that the usual menopausal hormone replacement therapy is not adequate to protect young women with premature ovarian failure from developing osteoporosis. Women with premature ovarian failure have abnormally low circulating androgen levels, which may contribute to their risk for osteoporosis. We plan to compare physiological estrogen replacement with physiological estrogen plus androgen replacement in young women with premature ovarian failure to determine which regimen is more beneficial for bone mineral density and other metabolic parameters related to the risk for cardiovascular disease. This study employs transdermal estradiol and testosterone "patches" designed to deliver the same amount for each sex steroid normally produced by the ovary in young women in a physiological manner. Women with premature ovarian failure will be randomized to receive either estradiol plus placebo patches or estradiol plus testosterone patches. Both groups will receive cyclic progestin treatment. A group of age-matched women with normal ovarian function will serve as contemporaneous controls for bone density and other study measures. The primary outcome parameter is femoral neck bone mineral density, to be assessed at baseline, and after 1, 2, and 3 years of treatment. Other outcome parameters include lumbar spine bone mineral density, markers of bone turnover, cardiovascular disease risk factors, and cognitive function. ;
Primary Purpose: Treatment
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