Safety and Efficacy of Proellex in Pre-menopausal Anemic Women With Symptomatic Uterine Fibroids

Repros Therapeutics

Status and phase: Terminated; Phase 3

Conditions: Anemia; Uterine Fibroids

Treatments: Drug: Placebo; Drug: Proellex 50 mg; Drug: Proellex 25 mg

Study type: Interventional

Funder types: Industry

Identifiers

NCT00702702

ZPU-301

Details and patient eligibility

About

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.

Full 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.

Enrollment: 56 patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Female, between the ages of 18 and 48 years with Body Mass Index (BMI) between 18 and 39, inclusive;
• Anemic, defined as hemoglobin levels less than or equal to 10.5 g/dL and uterine fibroid-associated symptoms indicated by a history of excessive menstrual bleeding;
• Surgical interventions for uterine fibroids (e.g. hysterectomy or myomectomy) planned or anticipated after the study;
• Willing to comply with all study procedures, including the endometrial biopsies and blood draws for all visits, including Follow-up Visits

Exclusion criteria

• Post-menopausal women or women likely to become post-menopausal during the study, defined as one or more of the following:

  • Six months or more (immediately prior to Screening Visit) without a menstrual period, or
  • Prior hysterectomy, or
  • Prior bilateral oophorectomy (unilateral oophorectomy is not exclusionary if regular menstruation is occurring);

• Females who have undergone a uterine arterial embolization, or endometrial ablation therapy (previous myomectomy is acceptable) for any cause;

• Documented endometriosis or active pelvic inflammatory disease (PID);

• Having a diagnosis, or suspected diagnosis, of carcinoma of the breast or reproductive organs;

• Known active infection with HIV, Hepatitis A, B or C, Gonorrhea, or Chlamydia;

• Use of prohibited concomitant medications:

  1. Depo-Provera use must cease ten months prior to first dose of study drug, or
  2. GnRH agonists use (e.g. Lupron Depot) must cease six months prior to first dose of study drug, or
  3. Oral contraceptive or other hormonal treatments use must cease for 30 days prior to the start of the study

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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56 participants in 3 patient groups, including a placebo group

A 25 mg

Experimental group

Description:

Proellex 25 mg, 1 - 25 mg capsule and 1 placebo capsule daily for 3 months

Treatment:

Drug: Proellex 25 mg

B 50 mg

Experimental group

Description:

Proellex 50 mg, 2 - 25 mg capsules daily for 3 months

Treatment:

Drug: Proellex 50 mg

C Placebo

Placebo Comparator group

Description:

Placebo, 2 capsules daily for 3 months

Treatment:

Drug: Placebo