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NCT00073801 · ClinicalTrials.gov registry record
Pelvic Pain in Women With Endometriosis
A clinical trial, sponsored by National Institute of Neurological Disorders and Stroke (NINDS).
- Completed
- Registry status
- 78
- Enrollment target
NCT00073801: Completed study, sponsored by National Institute of Neurological Disorders and Stroke (NINDS).
NCT00073801 is a clinical trial that has completed, run by National Institute of Neurological Disorders and Stroke (NINDS). The registered enrollment target is 78 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00073801 has completed, sponsored by National Institute of Neurological Disorders and Stroke (NINDS).
- COMPLETED
- Registry status
- 78 participants
- Enrollment target
Study 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: 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
Primary Outcome
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
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 78 participants |
| Start Date | 2004-04-22 |
What the finished NCT00073801 record still lists
NCT00073801 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 78 participants, a relatively small participant target.
The record links to 0 conditions, and to 0 interventions.
NCT00073801 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00073801 about?
NCT00073801 is a clinical study titled "Pelvic Pain in Women With Endometriosis". 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 ti...
What is the current status of trial NCT00073801?
This trial is currently completed. The enrollment target is 78 participants. The study started on 2004-04-22.
Who is sponsoring clinical trial NCT00073801?
This trial is sponsored by National Institute of Neurological Disorders and Stroke (NINDS), which has 567 total clinical trials registered on ClinicalTrials.gov.
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