Clinical trial NCT00702702: Safety and Efficacy of Proellex in Pre-menopausal Anemic Women With Symptomatic Uterine Fibroids
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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Uterine Fibroids
Anemia
Keywords: Uterine fibroids
Anemia
Lead sponsor: Repros Therapeutics Inc.
Sponsor class: INDUSTRY
First posted: 2008-06-20
Enrollment: 56
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

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 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

Primary outcomes:
measure: Change in Hemoglobin vs Placebo
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Alabama Clinical Therapeutics
state: Alabama
city: Phoenix
country: United States
facility: Women's Health Research
state: Arizona
city: Anaheim
country: United States
facility: Advanced Clinical Research Institute
state: California
city: Los Angeles,
country: United States
facility: Impact Clinical Trials
state: California
city: Los Angeles
country: United States
facility: Impact Clinical Trials
state: California
city: Los Angeles
country: United States
facility: National Institute of Clinical Research
state: California
city: Denver
country: United States
facility: Downtown Women's Health Care
state: Colorado
city: Boynton Beach
country: United States
facility: Visions Clinical Research
state: Florida
city: Leesburg
country: United States
facility: OB-GYN Associates of Mid-Florida, P.A.
state: Florida
city: Miami
country: United States
facility: Segal Institute for Clinical Research
state: Florida
city: Tampa
country: United States
facility: Insignia Clinical Research (Tampa Bay Women's Center)
state: Florida
city: West Palm Beach
country: United States
facility: Comprehensive Clinical Trials, LLC
state: Florida
city: College Park
country: United States
facility: Phoenix Women's Center (eCast)
state: Georgia
city: Decatur
country: United States
facility: Clinical Trials Select (ecast)
state: Georgia
city: Decatur
country: United States
facility: Dekalb Gynecology Associates/Legacy Obstetrics & Gynecology (eCast)
state: Georgia
city: Decatur
country: United States
facility: Medical Network for Education and Research
state: Georgia
city: Morrow
country: United States
facility: Smith & Hackney
state: Georgia
city: Louisville
country: United States
facility: Bluegrass Clinical Research, Inc.
state: Kentucky
city: Silver Spring
country: United States
facility: Clinical Trials Select (ecast)
state: Maryland
city: Moorestown
country: United States
facility: Phoenix OB-GYN Associates, LLC
state: New Jersey
city: Brooklyn
country: United States
facility: Central Brooklyn Medical Group (eCast)
state: New York
city: Cleveland
country: United States
facility: Rapid Medical Research, Inc.(Elite)
state: Ohio
city: Englewood
country: United States
facility: HWC Women's Research Center
state: Ohio
city: Columbia
country: United States
facility: SC Clinical Research Center
state: South Carolina
city: Chattanooga
country: United States
facility: Chattanooga Medical Research, LLC
state: Tennessee
city: Corpus Christi
country: United States
facility: Advanced Research Associates
state: Texas
city: Houston
country: United States
facility: Advances in Health Inc.
state: Texas
city: Houston
country: United States
facility: The Women's Hospital of Texas, Clinical Research Center
state: Texas
city: Houston
country: United States
facility: Centex Research
state: Texas
city: San Antonio
country: United States
facility: Institute for Women's Health
state: Texas
city: San Antonio
country: United States
facility: Seven Oaks Women's Center
state: Texas
Study officials:
affiliation: Repros Therapeutics Inc.
name: Andre vanAs, MD, PhD
role: STUDY_DIRECTOR
References: