Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 1:32 AM
Ignite Modification Date:
2025-12-25 @ 1:32 AM
NCT ID:
NCT00390494
Eligibility Criteria:
Inclusion Criteria: Fibroid Treatment Group
* Pre-menopausal
* Between the ages of 35 and 50, inclusive
* Scheduled to undergo hysterectomy, myomectomy, or uterine fibroid embolization for treatment of uterine fibroids at one of the participating institutions
* Willing to provide written informed consent
* Able to speak and read English
Inclusion Criteria: Normal Control Group (patients not diagnosed with fibroids)
* Pre-menopausal
* Between the ages of 35 and 50, inclusive
* Normal gynecologic examination at time of enrollment with regular menstrual cycle at the time of enrollment
* Willing to provide written informed consent
* Able to read and speak English
Exclusion Criteria: Fibroid Treatment Group
* Currently pregnant
* Cognitive impairment that would interfere with completing the questionnaire
* Severe psychiatric co-morbidity
* Co-morbid or life-threatening condition with life expectancy to be less than 1 year
* Active duty military healthcare beneficiary
Exclusion Criteria: Normal Control Group
* Currently pregnant
* Presence of other gynecologic-related diseases (e.g. endometriosis, pelvic inflammatory disease)
* Cognitive impairment that would interfere with completing the questionnaire
* Severe psychiatric co-morbidity
* Co-morbid or life-threatening condition with life expectancy to be less than 1 year
* Active duty military healthcare beneficiary
Healthy Volunteers:
True
Sex:
FEMALE
Minimum Age:
35 Years
Maximum Age:
50 Years
Study:
NCT00390494
Study Brief:
Protocol Section:
NCT00390494