Ignite Creation Date:
2024-05-05 @ 11:21 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00001848
Status:
COMPLETED
Last Update Posted:
2016-09-22
First Post:
1999-11-03
Brief Title:
The Safety and Effectiveness of Surgery With or Without Raloxifene for the Treatment of Pelvic Pain Caused by Endometriosis
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:
The Safety and Effectiveness of Surgery With or Without Raloxifene Evista Trademark Lilly for the Treatment of Pelvic Pain Caused by Endometriosis
Status:
COMPLETED
Status Verified Date:
2016-09
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:
Many women with lower abdominal pain have endometriosis Endometriosis is a condition in which the lining of the uterus endometrium is found outside of the uterus The diagnosis of endometriosis is usually made at surgery The treatment of endometriosis includes medical and surgical approaches alone or in combination The hormone estrogen stimulates the growth of the endometrium and may also stimulate the growth of endometriosis Medical therapies that act to decrease the level of estrogen can reduce the amount of endometriosis and pain When therapies are discontinued symptoms often return In addition medical treatment for endometriosis is expensive and is often associated with weak bones osteoporosis and hot flashes as a result of low levels of estrogen
Surgical treatment is removal or destruction of the endometriosis tissue Studies show the pain from endometriosis is relieved longer with tissue removal than with destruction
This study was developed to see if surgery followed by daily doses of Raloxifene Evista is effective in reducing pain for a longer time than surgery in combination with a placebo inactive sugar pill treatment Raloxifene acts like estrogens in some tissues and not like estrogens in others Postmenopausal women receiving Raloxifene for the prevention of osteoporosis had an increase in bone density and an improvement of their blood lipids fat content in the blood However unlike estrogen Raloxifene does not promote the growth of breast tissue or the uterus If Raloxifene blocks estrogen action in the lining of the uterus endometrium of reproductive age women as it does in post-menopausal women it may also limit the growth of endometriosis and prevent the return of pain
Surgical treatment is removal or destruction of the endometriosis tissue Studies show the pain from endometriosis is relieved longer with tissue removal than with destruction
This study was developed to see if surgery followed by daily doses of Raloxifene Evista is effective in reducing pain for a longer time than surgery in combination with a placebo inactive sugar pill treatment Raloxifene acts like estrogens in some tissues and not like estrogens in others Postmenopausal women receiving Raloxifene for the prevention of osteoporosis had an increase in bone density and an improvement of their blood lipids fat content in the blood However unlike estrogen Raloxifene does not promote the growth of breast tissue or the uterus If Raloxifene blocks estrogen action in the lining of the uterus endometrium of reproductive age women as it does in post-menopausal women it may also limit the growth of endometriosis and prevent the return of pain
Detailed Description:
Many women with pelvic pain have endometriosis a condition in which tissue from the uterine lining endometrium is also outside the uterus Endometriosis pain often returns after medical treatment is stopped Surgical therapies have had varied success in reducing pain with laparoscopic excision of implants one of the most effective methods Raloxifene Evista Trademark Lilly has been approved by the Food and Drug Administration for use in preventing bone loss in postmenopausal women This compound has effects that are both similar to and different from those of the hormone estrogen Unlike estrogen raloxifene does not stimulate growth of the uterus or breast tissue in post-menopausal women If raloxifene blocks estrogen action in the lining of the uterus or endometrium of reproductive age women as it does in postmenopausal women it may also limit growth of endometriosis and prevent the return of pain This phase II randomized placebo-controlled study evaluates whether surgery followed by daily administration of raloxifene for six months reduces pain for a longer time than surgery alone
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 |
|---|---|---|---|
| 99-CH-0012 | None | None | None |