Conditions: Uterine Fibroids Anemia
Keywords: Uterine fibroids Anemia
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 56
Healthy volunteers: no

Brief summary:
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.

Detailed description:
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.

Arms:
arm 1: Proellex 25 mg, 1 - 25 mg capsule and 1 placebo capsule daily for 3 months arm 2: Proellex 50 mg, 2 - 25 mg capsules daily for 3 months arm 3: Placebo, 2 capsules daily for 3 months

Interventions: intervention 1: Proellex 25 mg intervention 2: Proellex 50 mg intervention 3: Placebo
Intervention descriptions: intervention 1: Proellex 25 mg, 1 - 25 mg capsule and 1 placebo capsule daily for 3 months intervention 2: Proellex 50 mg, 2 - 25 mg capsules daily for 3 months intervention 3: Placebo, 2 capsules daily for 3 months

Protocol document: