Status:
COMPLETED
Pelvic Pain in Women With Endometriosis
Lead Sponsor:
National Institute of Neurological Disorders and Stroke (NINDS)
Conditions:
Endometriosis
Chronic Pelvic Pain
Eligibility:
FEMALE
18-50 years
Brief Summary
This study will examine pelvic pain associated with endometriosis and explore better approaches to treatment. In women with endometriosis, uterine tissue grows outside the uterus. Standard treatments ...
Detailed Description
Chronic pelvic pain associated with endometriosis is poorly understood. This study is an effort to better understand pelvic pain and identify novel medical approaches for treating it. Endometriosis is...
Eligibility Criteria
Inclusion
- INCLUSION CRITERIA:
- Women between the ages of 18 and 50 years, who have their reproductive organs. Those undergoing tubal ligation must be at least 21 years old.
- 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 Principal Investigator (PI). 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.
- BMI \< than 32 kg/m\^2.
- History of regular cyclic menses.
- EXCLUSION CRITERIA:
- Women with other causes of chronic pelvic pain including infectious, gastrointestinal, psychologic disorders, fibromyalgia and chronic fatigue syndrome.
- 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.
- Manic-depressive illness or untreated major depression.
- HIV infection.
Exclusion
Key Trial Info
Start Date :
April 22 2004
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
78 Patients enrolled
Trial Details
Trial ID
NCT00073801
Start Date
April 22 2004
Last Update
December 26 2025
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
National Institutes of Health Clinical Center
Bethesda, Maryland, United States, 20892