Status:
COMPLETED
Fibroid Growth Study
Lead Sponsor:
National Institute of Environmental Health Sciences (NIEHS)
Conditions:
Uterine Leiomyomas
Eligibility:
FEMALE
18-60 years
Brief Summary
Uterine leiomyomas, commonly called fibroids, are a major health concern for women of reproductive age. The objectives of the study described herein are to investigate the growth dynamics of uterine l...
Detailed Description
Uterine leiomyomas, commonly called fibroids, are a major health concern for women of reproductive age. The objectives of the study described herein are to investigate the growth dynamics of uterine l...
Eligibility Criteria
Inclusion
- INCLUSION CRITERIA:
- Women included in the study must be at least 18 years if age, premenopausal, speak English, and have one or more uterine leiomyomas at least 2 cm in diameter and the utuerus must be enlarged to the size typical during the 8th week of pregnancy. Note that while the selcetion criteia are set to recruit women in which surgical intervention is a likely outcome, surgery is not a requirement for study inclusion.
- EXCLUSION CRITERIA:
- Women will be excluded if they are pregnant because of potential safety concerns associated with imaging and image contrast enhancements. If women become pregnant during the study, they wil have the option to stay in the study, but will have pelvic ultrasound scans in place of MRI scans.
- Women who are taking or likely to start taking GnRH therapy will be excluded because this therapy, which is used as a treatment method for leiomyomas, sometmes induces their regression.
- Women who are greater than 52 inches in circumference or greater than 350 pounds will be excluded because they will be too large to fit in the imaging equipment.
- Women that have an intra-uterine device (IUD) will be excluded because these metal devices create 'shadowing' in MR images, making accurate measurement and interpretation of leiomyomas in the MRIs difficult.
- Women are not excluded if they had a prior myomectomy, or if they are taking oral contraceptives.
- The inclusion of only women of premenopausal age (greater than 18 years old) in this study is dictated by the nature of the condition.
Exclusion
Key Trial Info
Start Date :
June 27 2001
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 18 2019
Estimated Enrollment :
123 Patients enrolled
Trial Details
Trial ID
NCT00340288
Start Date
June 27 2001
End Date
December 18 2019
Last Update
January 6 2020
Active Locations (1)
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1
University of North Carolina Medical Center
Chapel Hill, North Carolina, United States