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

This study has been terminated.
(Repros stopped study for safety and FDA put study on hold because of safety.)
Sponsor:
Information provided by (Responsible Party):
Repros Therapeutics Inc.
ClinicalTrials.gov Identifier:
NCT00702702
First received: June 18, 2008
Last updated: August 5, 2014
Last verified: August 2014

June 18, 2008
August 5, 2014
June 2008
August 2009   (final data collection date for primary outcome measure)
Change in Hemoglobin vs Placebo [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]
Comparison between 50 mg Proellex and placebo of change in hemoglobin at month 3
To determine the efficacy of 25 mg and 50 mg daily oral doses of Proellex® versus daily oral doses of placebo in the treatment of anemia in subjects with symptomatic uterine fibroids. [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]
Complete list of historical versions of study NCT00702702 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Safety and Efficacy of Proellex in Pre-menopausal Anemic Women With Symptomatic Uterine Fibroids
A Multi-Center, Placebo Controlled, Safety and Efficacy Study of the Selective Progesterone Receptor Modulator Proellex® (CDB-4124) in Anemic, Pre-Menopausal Women With Symptomatic Uterine Fibroids Requiring Hysterectomy

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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
  • Uterine Fibroids
  • Anemia
  • Drug: Proellex 25 mg
    Proellex 25 mg, 1 - 25 mg capsule and 1 placebo capsule daily for 3 months
  • Drug: Proellex 50 mg
    Proellex 50 mg, 2 - 25 mg capsules daily for 3 months
  • Drug: Placebo
    Placebo, 2 capsules daily for 3 months
  • Experimental: A 25 mg
    Proellex 25 mg, 1 - 25 mg capsule and 1 placebo capsule daily for 3 months
    Intervention: Drug: Proellex 25 mg
  • Experimental: B 50 mg
    Proellex 50 mg, 2 - 25 mg capsules daily for 3 months
    Intervention: Drug: Proellex 50 mg
  • Placebo Comparator: C Placebo
    Placebo, 2 capsules daily for 3 months
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
56
August 2009
August 2009   (final data collection date for primary outcome measure)

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
Female
18 Years to 45 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00702702
ZPU-301
Yes
Repros Therapeutics Inc.
Repros Therapeutics Inc.
Not Provided
Study Director: Andre vanAs, MD, PhD Repros Therapeutics Inc.
Repros Therapeutics Inc.
August 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP