Eligible female subjects will be randomly assigned to one of the three treatment groups. Subjects will receive 325 mg (65 mg elemental iron) iron supplements to be taken twice daily during study drug treatment. The study duration is approximately six months, which is comprised of a 4 - 6 week screening period, a three-month drug treatment period, and a one-month follow-up period.
Eligible female subjects will be randomly assigned to one of the three treatment groups. Subjects will receive 325 mg (65 mg elemental iron) iron supplements to be taken twice daily during study drug treatment. The study duration is approximately six months, which is comprised of a 4 - 6 week screening period, a three-month drug treatment period, and a one-month follow-up period. Study was terminated by clinical hold.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
56
Proellex 25 mg, 1 - 25 mg capsule and 1 placebo capsule daily for 3 months
Proellex 50 mg, 2 - 25 mg capsules daily for 3 months
Placebo, 2 capsules daily for 3 months
Change in Hemoglobin vs Placebo
Comparison between 50 mg Proellex and placebo of change in hemoglobin at month 3
Time frame: 3 months
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Alabama Clinical Therapeutics
Birmingham, Alabama, United States
Women's Health Research
Phoenix, Arizona, United States
Advanced Clinical Research Institute
Anaheim, California, United States
Impact Clinical Trials
Los Angeles, California, United States
National Institute of Clinical Research
Los Angeles, California, United States
Downtown Women's Health Care
Denver, Colorado, United States
Visions Clinical Research
Boynton Beach, Florida, United States
OB-GYN Associates of Mid-Florida, P.A.
Leesburg, Florida, United States
Segal Institute for Clinical Research
Miami, Florida, United States
Insignia Clinical Research (Tampa Bay Women's Center)
Tampa, Florida, United States
...and 20 more locations