The Safety and Effectiveness of Surgery With or Without Raloxifene for the Treatment of Pelvic Pain Caused by Endometriosis
Status:
Completed
Trial end date:
2006-01-01
Target enrollment:
Participant gender:
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.
Phase:
Phase 2
Details
Lead Sponsor:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)