Study of Proellex in Pre-menopausal Women With Symptomatic Uterine Fibroids

Repros Therapeutics

Status and phase: Completed; Phase 2

Conditions: Uterine Fibroids

Treatments: Drug: 25 mg Proellex; Drug: Placebo; Drug: 12.5 mg Proellex

Study type: Interventional

Funder types: Industry

Identifiers

NCT00882258

ZPU-003

Details and patient eligibility

About

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 three month treatment phase.

Full 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 three month treatment phase. At the three-month treatment visit, subjects will be entered into an open-label extension treatment protocol, if deemed eligible. At four months after their first treatment visit, subjects not electing to enter the open-label study will be assessed at a final follow-up visit.

Enrollment: 144 patients

Sex: Female

Ages: 18 to 50 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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 criteria

• Post-menopausal women, as defined as one or more of the following:

  1. six months or more (immediately prior to Screening visit) without a menstrual period, or
  2. prior hysterectomy and/or oophorectomy

• Subjects with documented endometriosis

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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144 participants in 3 patient groups, including a placebo group

12.5 mg Proellex

Experimental group

Description:

Proellex 12.5 mg daily

Treatment:

Drug: 12.5 mg Proellex

25 mg Proellex daily

Experimental group

Description:

Proellex 25 mg

Treatment:

Drug: 25 mg Proellex

Placebo

Placebo Comparator group

Description:

Placebo daily

Treatment:

Drug: Placebo