Pelvic Pain in Women With Endometriosis

NCT00073801 | Completed

• 2 other identifiers: 04005604-N-0056
• Study Type: observational
• Target: 78
• Locations: 1 country
• Sites: 1

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:

• 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 muscles associated with pelvic pain, regions of skin sensitivity, and bone pain. Some women will undergo microdialysis, which uses an acupuncture-type needle to collect chemicals from two different muscles.
• Blood sampling twice a week for 1 month to measure changes in blood substances during the menstrual cycle.
• Blood sampling after the LH surge to measure progesterone levels.
• Cervicovaginal lavage (washing of the cervix with saline and collecting the fluid) to obtain secretions for research.
• Ultrasound of the ovaries and uterus. This examination uses a probe inserted into the vagina that emits sound waves that are used to form pictures of the internal structures. A small piece of uterine lining is also obtained for examination and research purposes.
• A visit with the members of the Pain and Palliative care service to evaluate the pain in anticipation of offering other treatments for pain after surgery.
• Surgery: 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.

Conditions

Endometriosis; Chronic Pelvic Pain

Keywords

Myofascial Dysfunction; Sensitization; Healthy Volunteers; Overlapping Pain Conditions; Hypothalamic-Pituitary-Adrenal Axis; Natural History

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (4)

• 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

Study Arms (3)

Chronic Pelvic Pain and Endometriosis

Women with chronic pelvic pain and endometriosis found at study surgery

Chronic Pelvic Pain and No Endometriosis

Women with chronic pelvic pain and NO endometriosis found at study surgery

Healthy Volunteers

Women without no chronic pelvic pain and no symptoms of endometriosis

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• National Institute of Neurological Disorders and Stroke (NINDS): lead

Study Sites (1)

National Institutes of Health Clinical Center

Bethesda, Maryland, 20892, United States

Location

Related Publications (4)

• 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.

  PMID: 9780254 BACKGROUND

• 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.

  PMID: 10954915 BACKGROUND

• Berkley KJ. Sex differences in pain. Behav Brain Sci. 1997 Sep;20(3):371-80; discussion 435-513. doi: 10.1017/s0140525x97221485.

  PMID: 10097000 BACKGROUND

• 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.

  PMID: 25730237 DERIVED

Related Links

• NIH Clinical Center Detailed Web Page

MeSH Terms

Conditions

Endometriosis

Condition Hierarchy (Ancestors)

Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Study Officials

• Avindra Nath, M.D.

  National Institute of Neurological Disorders and Stroke (NINDS)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 8, 2003
• First Posted: December 9, 2003
• Study Start: April 22, 2004
• Last Updated: April 1, 2026

Record last verified: 2026-01-28

Locations

US (1)