Conditions: Uterine Fibroids
Keywords: Uterine fibroids Fibroids
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 10
Healthy volunteers: no

Brief summary:
PK of 25 mg and 50 mg Proellex® administered once daily (QD) over a 4-month period.

Detailed description:
The primary objective is to evaluate the pharmacokinetics (PK) of 25 mg and 50 mg Proellex® administered once daily (QD) over a 4-month period.

Arms:
arm 1: Proellex 25 mg arm 2: Proellex 50 mg arm 3: Lupron Depot

Interventions: intervention 1: Proellex 25 mg intervention 2: Proellex 50 mg intervention 3: Lupron Depot
Intervention descriptions: intervention 1: Proellex 25 mg, 1 capsule daily for 4 months intervention 2: Proellex 50 mg, 2 capsules daily for 4 months intervention 3: Lupron 3.75 mg monthly intramuscular injections for 4 months

Protocol document: