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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


Phase 3
18 Years
45 Years
Not Enrolling
Female
Uterine Fibroids, Anemia

Thank you

Trial Information

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


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

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

The comparison between the 50 mg Proellex® dose level and placebo in the change in hemoglobin from baseline to 3 months.

Outcome Time Frame:

3 months

Safety Issue:

Yes

Principal Investigator

Andre vanAs, MD, PhD

Investigator Role:

Study Director

Investigator Affiliation:

Repros Therapeutics Inc.

Authority:

United States: Food and Drug Administration

Study ID:

ZPU-301

NCT ID:

NCT00702702

Start Date:

June 2008

Completion Date:

August 2009

Related Keywords:

  • Uterine Fibroids
  • Anemia
  • Uterine fibroids
  • Anemia
  • Anemia
  • Leiomyoma
  • Myofibroma

Name

Location

Advanced Clinical Research Institute Anaheim, California  92801
Comprehensive Clinical Trials, LLC West Palm Beach, Florida  33409
Phoenix OB-GYN Associates, LLC Moorestown, New Jersey  08057
Alabama Clinical Therapeutics Birmingham, Alabama  35235
Visions Clinical Research Boynton Beach, Florida  33472
Women's Health Research Phoenix, Arizona  85015
HWC Women's Research Center Miamisburg, Ohio  45342
National Institute of Clinical Research Los Angeles, California  90017
Segal Institute for Clinical Research North Miami, Florida  33161
Impact Clinical Trials Los Angeles, California  90057
Downtown Women's Health Care Denver, Colorado  80218
OB-GYN Associates of Mid-Florida, P.A. Leesburg, Florida  34748
Insignia Clinical Research (Tampa Bay Women's Center) Tampa, Florida  33607
Phoenix Women's Center (eCast) College Park, Georgia  30349
Clinical Trials Select (ecast) Decatur, Georgia  30030
Medical Network for Education and Research Decatur, Georgia  30333
Dekalb Gynecology Associates/Legacy Obstetrics & Gynecology (eCast) Decatur, Georgia  30035
Smith & Hackney Morrow, Georgia  30260
Bluegrass Clinical Research, Inc. Louisville, Kentucky  40291
Clinical Trials Select (ecast) Silver Spring, Maryland  20903
Central Brooklyn Medical Group (eCast) Brooklyn, New York  11205
Rapid Medical Research, Inc.(Elite) Cleveland, Ohio  44122
SC Clinical Research Center Columbia, South Carolina  29201
Chattanooga Medical Research, LLC Chattanooga, Tennessee  37404
Advanced Research Associates Corpus Christi, Texas  78414
Advances in Health Inc. Houston, Texas  77030
Centex Research Houston, Texas  77079
The Women's Hospital of Texas, Clinical Research Center Houston, Texas  77054
Institute for Women's Health San Antonio, Texas  78229
Seven Oaks Women's Center San Antonio, Texas  78229