Hormone Replacement in Young Women With Premature Ovarian Failure
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|ClinicalTrials.gov Identifier: NCT00001951|
Recruitment Status : Completed
First Posted : January 19, 2000
Last Update Posted : February 27, 2007
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.
|Condition or disease||Intervention/treatment||Phase|
|Healthy Osteoporosis Premature Ovarian Failure||Drug: TMTDS||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||250 participants|
|Official Title:||Hormone Replacement in Young Women With Premature Ovarian Failure|
|Study Start Date :||December 1999|
|Estimated Study Completion Date :||October 2006|
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00001951
|United States, Maryland|
|National Institute of Child Health and Human Development (NICHD)|
|Bethesda, Maryland, United States, 20892|