The purpose of this study is to determine the safety, pharmacokinetics and efficacy of four doses of vaginally administered Proellex in premenopausal women with uterine fibroids confirmed by ultrasound.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
48
12 mg, vaginal capsule, once daily for 4 months
3 mg, vaginal capsule, once daily for 3 months
6 mg, vaginal capsule, once daily for 3 months
Unnamed facility
Miami Gardens, Florida, United States
Unnamed facility
Houston, Texas, United States
Bleeding Scores
The primary efficacy endpoint will be bleeding assessed using the change in PBAC scores from the 4 weeks prior to Visit 2 to the 4 weeks prior to Visit 10
Time frame: 3 or 4 months depending on treatment arm
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
12 mg, vaginal capsule, once daily, for 3 months
24 mg, vaginal capsule, once daily for 4 months