Status:
COMPLETED
Study of Proellex in Pre-menopausal Women With Symptomatic Uterine Fibroids
Lead Sponsor:
Repros Therapeutics Inc.
Conditions:
Uterine Fibroids
Eligibility:
FEMALE
18-50 years
Phase:
PHASE2
Brief Summary
Two (2) dose levels of Proellex or placebo will be administered once-daily for up to 91 days. Following screening and a pre-treatment endometrial biopsy, subjects will be followed monthly for the thre...
Detailed Description
Two (2) dose levels of Proellex or placebo will be administered once-daily for up to 91 days. Following screening and a pre-treatment endometrial biopsy, subjects will be followed monthly for the thre...
Eligibility Criteria
Inclusion
- At least one leiomyoma must have been identifiable and measurable by abdominal/pelvic ultrasound.
- Must have had a history of one or both of the following leiomyomata-associated symptoms, excessive menstrual bleeding, or pain
Exclusion
- Post-menopausal women, as defined as one or more of the following:
- six months or more (immediately prior to Screening visit) without a menstrual period, or
- prior hysterectomy and/or oophorectomy
- Subjects with documented endometriosis
Key Trial Info
Start Date :
March 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2007
Estimated Enrollment :
144 Patients enrolled
Trial Details
Trial ID
NCT00882258
Start Date
March 1 2006
End Date
March 1 2007
Last Update
July 8 2014
Active Locations (16)
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1
Alabama Clinical Therapeutics, LLC
Birmingham, Alabama, United States, 35235
2
Women's Health Research
Phoenix, Arizona, United States, 85015
3
Arizona Wellness Centre for Women
Phoenix, Arizona, United States, 85032
4
Visions Clinical Research Tuscon
Tuscon, Arizona, United States, 85712