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

This study has been terminated.
(Repros stopped the study for safety and FDA put the study on hold for safety.)
Sponsor:
Information provided by (Responsible Party):
Repros Therapeutics Inc.
ClinicalTrials.gov Identifier:
NCT00785356
First received: November 3, 2008
Last updated: August 5, 2014
Last verified: August 2014
  Purpose

Subjects will be randomly assigned to one of 3 treatment groups and receive 325 mg (65 mg elemental iron) iron supplements twice daily.


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:
  • The Comparison Between the 50 mg Proellex® Dose Level and Placebo in the Change in Hemoglobin From Baseline to 3 Months. [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]

Enrollment: 8
Study Start Date: October 2008
Study Completion Date: August 2009
Primary Completion Date: August 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 25 mg Proellex
Proellex 25 mg
Drug: Proellex 25 mg
Proellex 25 mg, 1 - 25 mg capsule and 1 placebo capsule daily for 3 months
Other Name: Telapristone acetate
Experimental: Proellex 50 mg
Proellex 50 mg
Drug: Proellex 50 mg
Proellex 50 mg, 2 - 25 mg capsules daily for 3 months
Other Name: Telapristone acetate
Placebo Comparator: Placebo
Placebo
Drug: Placebo
Placebo, 2 capsules daily for 3 months
Other Names:
  • Sugar pill
  • Dummy

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.

  Eligibility

Ages Eligible for Study:   18 Years to 48 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: NCT00785356

Locations
Mexico
Hospital Perinatal del Estado de Mexico del ISEM
Toluca, Estado de Mexico C.P., Mexico, 50120
Centro Hospitalario Nuevo Sanatorio Durango
Mexico City, Federal District, Mexico, 06700
Comité para la Prevención de la Osteoporosis COMOP
Mexico City, Federal District, Mexico, 06100
Instituto Nacional de Perinatología "Isidro Espinosa de los Reyes"
Mexico City, Federal District, Mexico, 11000
Hospital de la Fe
San Miguel de Allende, Gto, Mexico, 37775
Hospital Universitario "Dr. José Eleuterio González" Facultad de Medicina de la Universidad Autónoma de Nuevo León (UANL)
Monterrey, Nuevo León, Mexico, 64460
MIRC (Monterrey International Research Center)
Monterrey, Nuevo León, Mexico, 64460
Sponsors and Collaborators
Repros Therapeutics Inc.
Investigators
Study Director: Andre van As, MD, PhD Repros Therapeutics Inc.
  More Information

No publications provided

Responsible Party: Repros Therapeutics Inc.
ClinicalTrials.gov Identifier: NCT00785356     History of Changes
Other Study ID Numbers: ZPU-302
Study First Received: November 3, 2008
Results First Received: June 25, 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
Connective Tissue Diseases
Neoplasms
Neoplasms by Histologic Type
Neoplasms, Connective Tissue
Neoplasms, Connective and Soft Tissue
Neoplasms, Muscle Tissue

ClinicalTrials.gov processed this record on November 25, 2014