Loading search results
The Neural Immune Mechanisms and Genetic Influences on Chronic Pelvic Pain in Women With Endometriosis
Sponsor study identifier
Secondary identifiers
observational
78
1 country
1
Study Start
April 22, 2004
Actual (reported)Primary Completion
Not reported
Date not reportedStudy Completion
Not reported
Date not reportedThis 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:
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
Not reported
Date not reportedClick on a node to explore related trials.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
December 8, 2003
Actual (reported)December 9, 2003
Actual (reported)April 22, 2004
Actual (reported)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...
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
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
To evaluate the relation between chronic pelvic pain and the HPA axis in women
Follicular phase of the menstrual cycle
To evaluate whether routine Pain and Palliative Care services of medication adjustment, psychosocial and spiritual counseling, and mind- body techniques offered post- operatively contribute to relief from pain
post-operative over six months
To investigate the influence of genetic polymorphisms in pain pathways, pro-inflammatory cytokines, and mediators of sensitization on chronic musculoskeletal pain in women.
preoperative evaluation
to quantitatively and qualitatively characterize the musculoskeletal components of chronic pelvic pain associated with endometriosis by a standardized neuromusculo-skeletal evaluation.
Follicular phase of the menstrual Cycle
Women with chronic pelvic pain and endometriosis found at study surgery
Women with chronic pelvic pain and NO endometriosis found at study surgery
Women without no chronic pelvic pain and no symptoms of endometriosis
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.
National Institutes of Health Clinical Center
Bethesda, Maryland, 20892, United States
Al-Harthi L, Spear GT, Hashemi FB, Landay A, Sha BE, Roebuck KA. A human immunodeficiency virus (HIV)-inducing factor from the female genital tract activates HIV-1 gene expression through the kappaB enhancer. J Infect Dis. 1998 Nov;178(5):1343-51. doi: 10.1086/314444.
Al-Harthi L, Wright DJ, Anderson D, Cohen M, Matity Ahu D, Cohn J, Cu-Unvin S, Burns D, Reichelderfer P, Lewis S, Beckner S, Kovacs A, Landay A. The impact of the ovulatory cycle on cytokine production: evaluation of systemic, cervicovaginal, and salivary compartments. J Interferon Cytokine Res. 2000 Aug;20(8):719-24. doi: 10.1089/10799900050116426.
Avindra Nath, M.D.
National Institute of Neurological Disorders and Stroke (NINDS)
78 participants (actual enrollment reported by the registry).
First Submitted
December 8, 2003
First Posted
December 9, 2003
Study Start
April 22, 2004
Actual (reported)Contact the study team to confirm eligibility.
Berkley KJ. Sex differences in pain. Behav Brain Sci. 1997 Sep;20(3):371-80; discussion 435-513. doi: 10.1017/s0140525x97221485.
Stratton P, Khachikyan I, Sinaii N, Ortiz R, Shah J. Association of chronic pelvic pain and endometriosis with signs of sensitization and myofascial pain. Obstet Gynecol. 2015 Mar;125(3):719-728. doi: 10.1097/AOG.0000000000000663.
Last Updated
October 29, 2026
Record last verified: 2026-01-28
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.
Source retrieved: