NIH Clinical Research Studies

Protocol Number: 99-CH-0012

Active Accrual, Protocols Recruiting New Patients

Title:
The Safety and Effectiveness of Surgery with or without Raloxifene (Evista™ (Trademark), Lilly) for the Treatment of Pelvic Pain Caused by Endometriosis
Number:
99-CH-0012
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.

Sponsoring Institute:
National Institute of Child Health and Human Development (NICHD)
Recruitment Detail
Type: Active Accrual Of New Subjects
Gender: Female
Referral Letter Required: No
Population Exclusion(s): Male

Eligibility Criteria:
INCLUSION CRITERIA:

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

2. 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.

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

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

5. Willing and able to give informed consent.

6. Willing and able to comply with study requirements.

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

EXCLUSION CRITERIA:

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

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

3. Hysterectomy or bilateral salpingo-oophorectomy.

4. Pregnancy.

5. Lactation.

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

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

8. Untreated abnormal pap smear or other gynecologic condition.

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

10. Allergy to study drug.

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

12. Manic depressive illness or untreated major depression.

INCLUSION/EXCLUSION CRITERIA - REGULARLY CYCLING WOMEN AGED 40 - 50:

Regularly cycling women between the ages of 40 and 50 will have surgically documented endometriosis (preferably biopsy proven, but unequivocal operative reports may allow inclusion) or will be healthy volunteers. Women who are pregnant or lactating or who have abnormalities in the medical history or screening laboratory tests that might contribute to abnormal BMD (e.g. hypercalcemia, renal failure) will not be enrolled. We will not include women who currently or have previously taken medications known to affect bone mineral density (e.g. thyroid hormone suppression, supraphysiologic glucocorticoids, dilantin) or those that suggest menstrual abnormalities (fertility drugs) but we will consider other prescription drug use on a case-by-case basis. Women will be matched by BMI within 5 kg/M(2), ethnicity and by age in two groups: 40-45 years and 45-50 years.

Special Instructions: Currently Not Provided
Keywords:
Estrogen Receptor
Laparoscopy
Surgical Excision
Raloxifene
Selective Estrogen Receptor Modulator
Estrogen
Endometriosis
Recruitment Keywords:
Endometriosis
Pelvic Pain
Conditions:
Endometriosis
Pelvic Pain
Investigational Drug(s):
None
Investigational Device(s):
None

Contacts:
Patient Recruitment and Public Liaison Office
Building 61
10 Cloister Court
Bethesda, Maryland 20892-4754
Toll Free: 1-800-411-1222
TTY: 301-594-9774 (local),1-866-411-1010 (toll free)
Fax: 301-480-9793

Electronic Mail:prpl@mail.cc.nih.gov

Citations:
A profile of women with chronic pelvic pain

Chronic pelvic pain: prevalence, health-related quality of life, and economic correlates

The reproducibility of the revised American Fertility Society classification of endometriosis

Active Accrual, Protocols Recruiting New Patients

If you have:


Command Menu Bar

Search The Studies | Help | Questions |
Clinical Center Home | NIH Home


Clinical Center LogoWarren Grant Magnuson Clinical Center (CC)
National Institutes of Health (NIH)
Bethesda, Maryland 20892. Last update: 10/23/2004

Search The Studies Help Questions