Hormone Replacement in Young Women With Premature Ovarian Failure
Status:
Completed
Trial end date:
2006-10-01
Target enrollment:
Participant gender:
Summary
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.
Phase:
Phase 2
Details
Lead Sponsor:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)