Pelvic Pain in Women With Endometriosis
CompletedNCT00073801
View the official record on ClinicalTrials.gov Recruiting status changes often. Contact the study team listed on ClinicalTrials.gov, and talk to your doctor before joining a study.
This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.
Brief summary (from the registry)
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 - altering hormone levels to prevent endometrial tissue growth or surgically removing endometrial tissue - treat pelvic pain only temporarily. This study will investigate the role of sex hormones, immune chemicals, stress hormones, and genes in pelvic pain and determine how the nerve, muscle, and skeletal systems are involved in this pain. Women between 18 and 50 years of age who: 1. have endometriosis and chronic pelvic pain, and 2. have chronic pelvic pain without endometriosis, and 3. have neither endometriosis nor chronic pelvic pain and are willing to have a tubal ligation (Healthy Volunteer group), may be eligible for this study. Candidates are screened with a questionnaire to obtain information about their pain and previous treatments and related medical or social issues. Participants will undergo the following tests and procedures: 1. Medical history and physical examination, including pelvic exam, blood tests, urinalysis, and diaphragm fitting. 2. Questionnaires about pain, quality of life, sexuality, psychological attitudes, spiritual experiences, and history of headache and depression. 3. At-home monitoring for 4 to 6 weeks of pain symptoms, menstruation and spotting, medicines taken, and urine collections to test for "LH" surge. LH is the hormone that causes the ovary to release a mature egg. 4. Pre-laparoscopy evaluation to include: * Examination of menstrual blood collected in a diaphragm for 4 hours. * Blood sampling to measure adrenal and pituitary hormones. For this test, corticotrophin-releasing hormone (CRH) is injected through an IV needle. Up to five blood samples are drawn, starting before the injection until 45 minutes after it. Blood is also collected at this time for genetic analysis. * In-depth pain assessment to identify trigger points in musc…
Study details
- Official title
- The Neural Immune Mechanisms and Genetic Influences on Chronic Pelvic Pain in Women With Endometriosis
- Conditions
- Sponsor
- National Institute of Neurological Disorders and Stroke (NINDS)
- Organization
- National Institutes of Health Clinical Center (CC)
- Start date
- 2004-04-22
- Sex
- Female
- Age range
- from 18 Years to 50 Years
- Results posted
- No results posted in this snapshot
- Countries
- United States
- Total sites listed
- 1
Eligibility criteria
Show eligibility criteria (verbatim from the registry)
* 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.
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT00073801