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

Launched by EUNICE KENNEDY SHRIVER NATIONAL INSTITUTE OF CHILD HEALTH AND HUMAN DEVELOPMENT (NICHD) · Nov 3, 1999

Keywords

ClinConnect Summary

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....

Gender

FEMALE

Eligibility criteria

• 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.