The Safety and Effectiveness of Surgery With or Without Raloxifene for the Treatment of Pelvic Pain Caused by Endometriosis
The Safety and Effectiveness of Surgery With or Without Raloxifene for the Treatment of Pelvic Pain Caused by Endometriosis
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.
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.
INCLUSION CRITERIA:

 -  Women between the ages of 18 and 45 years, who have their reproductive organs.

 -  Excellent health other than a three month history of pelvic pain and documented
 endometriosis at laparoscopy. Chronic medications may be acceptable at the discretion
 of the internist associate investigator (LN). Use of antidepressants, medications for
 migraines and headaches, allergy medications, and treatment of bowel symptoms such as
 irritable bowel disease will be allowed.

 -  Do not desire pregnancy for the duration of the study.

 -  Are using abstinence, mechanical (condoms, diaphragms) or sterilization methods of
 contraception and are willing to continue using them throughout the study.

 -  Willing and able to give informed consent.

 -  Willing and able to comply with study requirements.

 -  Less than grade III overweight or BMI less than 40 kg/m(2).

 EXCLUSION CRITERIA:

 -  Women with other causes of chronic pelvic pain including infectious, gastrointestinal,
 musculoskeletal, neurologic or psychiatric.

 -  Significant abnormalities in the physical or laboratory examination including renal
 and liver function more than twice the normal range.

 -  Hysterectomy or bilateral salpingo-oophorectomy.

 -  Pregnancy.

 -  Lactation.

 -  Use of hormonal contraception, selective estrogen receptor modulators, progestins,
 estrogens, steroids, or ovulation induction in the last 3 months.

 -  Other medical or surgical treatment for endometriosis in the last 6 months.

 -  Untreated abnormal pap smear or other gynecologic condition.

 -  History of venous thrombosis events including deep vein thrombosis, pulmonary
 embolism, and retinal vein thrombosis.

 -  Allergy to study drug.

 -  History of stroke, complicated migraine, or documented transient ischemic attack.

 -  Manic depressive illness or untreated major depression.