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
  Purpose

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.


Condition Intervention Phase
Uterine Fibroids
Anemia
Drug: Proellex 25 mg
Drug: Proellex 50 mg
Drug: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Repros Therapeutics Inc.:

Primary Outcome Measures:
  • 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


Enrollment: 56
Study Start Date: June 2008
Study Completion Date: August 2009
Primary Completion Date: August 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A 25 mg
Proellex 25 mg, 1 - 25 mg capsule and 1 placebo capsule daily for 3 months
Drug: Proellex 25 mg
Proellex 25 mg, 1 - 25 mg capsule and 1 placebo capsule daily for 3 months
Experimental: B 50 mg
Proellex 50 mg, 2 - 25 mg capsules daily for 3 months
Drug: Proellex 50 mg
Proellex 50 mg, 2 - 25 mg capsules daily for 3 months
Placebo Comparator: C Placebo
Placebo, 2 capsules daily for 3 months
Drug: Placebo
Placebo, 2 capsules daily for 3 months

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.

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00702702

  Show 31 Study Locations
Sponsors and Collaborators
Repros Therapeutics Inc.
Investigators
Study Director: Andre vanAs, MD, PhD Repros Therapeutics Inc.
  More Information

No publications provided

Responsible Party: Repros Therapeutics Inc.
ClinicalTrials.gov Identifier: NCT00702702     History of Changes
Other Study ID Numbers: ZPU-301
Study First Received: June 18, 2008
Results First Received: June 23, 2014
Last Updated: August 5, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Repros Therapeutics Inc.:
Uterine fibroids
Anemia

Additional relevant MeSH terms:
Leiomyoma
Myofibroma
Neoplasms, Muscle Tissue
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Connective Tissue
Connective Tissue Diseases

ClinicalTrials.gov processed this record on September 16, 2014