Pelvic Pain in Women With Endometriosis
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ClinicalTrials.gov Identifier: NCT00073801 |
Recruitment Status :
Completed
First Posted : December 9, 2003
Last Update Posted : May 10, 2024
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Tracking Information | |||||
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First Submitted Date | December 8, 2003 | ||||
First Posted Date | December 9, 2003 | ||||
Last Update Posted Date | May 10, 2024 | ||||
Actual Study Start Date | April 22, 2004 | ||||
Primary Completion Date | Not Provided | ||||
Current Primary Outcome Measures |
To evaluate the menstrual dynamics of systemic cytokine expression in endometriosis, and to measure the expression of pro-inflammatory cytokines, stem cells, immunologic activity, and neurotransmittors in endometriosis lesions and the endometriu... [ Time Frame: Day 1-3 of the menstrual cycle; by twice weekly blood draws between 8 and 9 AM (14 ml/time) over a four-week period; Mid-luteal cervical secretions and endometrium ] menstrual effluent by collecting menses over a four- hour period on day one to three of the menstrual cycle; Menstrual cycle variation in systemic secretion of inflammatory mediators (IL-6) and hormones, estradiol and progesterone;Mid-luteal cervical secretions and endometrium for measurement of pro and anti-inflammatory effectors
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Original Primary Outcome Measures | Not Provided | ||||
Change History | |||||
Current Secondary Outcome Measures |
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Original Secondary Outcome Measures | Not Provided | ||||
Current Other Pre-specified Outcome Measures | Not Provided | ||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||
Descriptive Information | |||||
Brief Title | Pelvic Pain in Women With Endometriosis | ||||
Official Title | The Neural Immune Mechanisms and Genetic Influences on Chronic Pelvic Pain in Women With Endometriosis | ||||
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 - 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:
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:
CPP + Endo or CPP only: Laparoscopy to look for and remove endometrial tissue. This procedure is done under general anesthetic. A viewing instrument called a laparoscope is passed through an incision in the belly button to look for endometriosis. If it is found, two or more incisions are made in the abdomen for other instruments to remove the tissue. A small piece of uterine lining is also obtained for examination and research purposes. Healthy Volunteers: Laparoscopy to perform the tubal ligation. A tubal ligation, commonly known as "getting your tubes tied," is a surgical procedure for women to sterilize them. This procedure closes the fallopian tubes, stopping the egg from traveling from the ovary to the uterus and preventing sperm from reaching the fallopian tube to fertilize an egg. In a tubal ligation, fallopian tubes are cut, burned, or blocked with rings, bands or clips. The surgery is effective immediately. Tubal ligations are 99.5% effective as birth control. This procedure is done under general anesthetic. A viewing instrument called a laparoscope is passed through an incision in the belly button to perform a tubal ligation. Two or more incisions are made in the abdomen for other instruments to perform the procedure. During the laparoscopy, we will look for and remove endometrial tissue. A small piece of uterine lining is also obtained for examination and research purposes. -Follow-up evaluations. Two weeks after surgery, patients return to NIH to discuss the surgical findings and treatment options. Follow-up visits are then scheduled at 1, 3, and 6 months after surgery to complete questionnaires and determine if the treatment is working. Blood samples are drawn at each visit. |
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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 a very common disease of women in their reproductive years, in which endometrial tissue grows outside the uterus. In a recent epidemiologic study, we have shown strong associations among endometriosis, fibromyalgia, and autoimmune disorders. Currently, it is believed that endometriosis causes chronic pelvic pain. Yet, some women with endometriosis do not have any pain and others have pain in areas unrelated to endometriosis disease location. The standard approaches to treating endometriosis pain have been to medically alter hormone levels to prevent endometriosis tissue growth or to surgically remove endometriosis lesions. Pelvic pain is only temporarily treated by either approach, which suggests that the current classification of pain, based on disease and treatment with hormones or surgery is not adequate. The feeling of pain involves many complex processes. Generally, women suffer more frequently from chronic, long-term, painful conditions than men. This suggests that women process pain differently because of differences in sex hormone levels and genes expressed in a sexually dimorphic fashion, as well as in central nervous and immune system function differences. We will examine the relations among sex hormones, pain processing, immune system substances and pain related genes. We will also examine changes in levels of hormonal and immune substances in the blood, endometriosis lesions and normal endometrial tissue. Myofascial pain has been noted in women with endometriosis and chronic pelvic pain. We will study how the nerve, muscle and skeletal systems are involved in pelvic pain by performing an in depth pain assessment. Finally, stress plays an important role generating and perpetuating chronic pain. We will examine how the hormones related to the stress response may be altered in pelvic pain. | ||||
Study Type | Observational | ||||
Study Design | Observational Model: Cohort Time Perspective: Prospective |
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Target Follow-Up Duration | Not Provided | ||||
Biospecimen | Not Provided | ||||
Sampling Method | Non-Probability Sample | ||||
Study Population | We plan to study women of reproductive age with chronic pelvic pain, some of whom have endometriosis and some who do not. Healthy women without chronic pelvic pain and not known to have endometriosis will serve as controls. In the event that endometriosis is found at laparoscopy in the control group, we will include these patients in the study as a separate subset of controls. Controls may choose to complete the study, including laparoscopy with a tubal ligation, complete the study without laparoscopy, or participate in an abbreviated study that includes only screening and chronic stress testing. All women will be protected from pregnancy by non-hormonal contraception such as barrier contraception, abstinence or surgical sterilization for the duration of the study. | ||||
Condition |
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Intervention | Not Provided | ||||
Study Groups/Cohorts |
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Publications * |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||
Recruitment Status | Completed | ||||
Actual Enrollment |
78 | ||||
Original Enrollment |
60 | ||||
Study Completion Date | Not Provided | ||||
Primary Completion Date | Not Provided | ||||
Eligibility 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. |
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Sex/Gender |
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Ages | 18 Years to 50 Years (Adult) | ||||
Accepts Healthy Volunteers | No | ||||
Contacts | Contact information is only displayed when the study is recruiting subjects | ||||
Listed Location Countries | United States | ||||
Removed Location Countries | |||||
Administrative Information | |||||
NCT Number | NCT00073801 | ||||
Other Study ID Numbers | 040056 04-N-0056 |
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Has Data Monitoring Committee | Not Provided | ||||
U.S. FDA-regulated Product |
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IPD Sharing Statement | Not Provided | ||||
Current Responsible Party | National Institutes of Health Clinical Center (CC) ( National Institute of Neurological Disorders and Stroke (NINDS) ) | ||||
Original Responsible Party | Not Provided | ||||
Current Study Sponsor | National Institute of Neurological Disorders and Stroke (NINDS) | ||||
Original Study Sponsor | Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) | ||||
Collaborators | Not Provided | ||||
Investigators |
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PRS Account | National Institutes of Health Clinical Center (CC) | ||||
Verification Date | April 23, 2024 |