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Global Study of Women's Health

NCT00849173 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 1459

Last updated 2018-04-05

No results posted yet for this study

Summary

Endometriosis, a condition in which the lining of the uterus grows on nearby tissues, is a common condition that affects women of reproductive age worldwide. The diagnosis of endometriosis is usually made at surgery. The most common symptom is pelvic pain. This pain may occur at the same time as menstrual bleeding, at other times of the cycle, or during or after sexual intercourse. Previous studies reveal the diagnosis of endometriosis is often delayed between 8 and 12 years after the first symptoms. Women with chronic pelvic pain report a lower quality of life. No studies, however, have been conducted to assess whether women with endometriosis-related pelvic pain are affected differently than those with pelvic pain from other or no identifiable causes.

This large-scale study is designed to gather prospective epidemiological data on the impact of and risk factors for endometriosis across countries worldwide. A study of this scale and scope has never been performed; it is anticipated that the study will provide novel insights into the effects of the condition and associated symptoms on women s lives across different countries, as well as explore differences in the effects of various potential risk factors.

This is an international study conducted at more than 20 sites worldwide and coordinated by Oxford University in the United Kingdom. At the National Institutes of Health, 250 premenopausal women between 18 and 45 years of age who are having their first diagnostic laparoscopy or laparoscopy for tubal sterilization will participate. None will have had a prior diagnosis of endometriosis through surgery. Women will be informed about the study when their laparoscopy is scheduled.

Procedures

* Patient completion of an online questionnaire before scheduled surgery. The following will be assessed by the questionnaire:
* Quality of life
* General gynecologic and medical history
* Family history
* General information
* Use of health care services
* Risk factors
* Surgeon completion of questionnaire about surgical findings.
* Follow-up: Women who consent will be contacted every 1 2 years.

Conditions

  • Endometriosis
  • Infertility
  • Chronic Pelvic Pain
  • Tubal Ligation

Sponsors & Collaborators

  • Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

    lead NIH

Principal Investigators

  • Pamela Stratton, M.D. · Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2009-02-17
Completion
2012-11-26

Countries

  • United States

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00849173 on ClinicalTrials.gov