Ignite Creation Date:
2024-05-05 @ 11:20 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00001951
Status:
COMPLETED
Last Update Posted:
2007-02-27
First Post:
2000-01-18
Brief Title:
Hormone Replacement in Young Women With Premature Ovarian Failure
Sponsor:
Eunice Kennedy Shriver National Institute of Child Health and Human Development NICHD
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
Hormone Replacement in Young Women With Premature Ovarian Failure
Status:
COMPLETED
Status Verified Date:
2006-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 patients 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 patients 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
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 patients 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 patients 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
Detailed Description:
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 00-CH-0045 | None | None | None |