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

Anemia Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00702702
• Other study ID #: ZPU-301
• Status: Terminated
• Phase: Phase 3
• First received: June 18, 2008
• Last updated: August 5, 2014
• Start date: June 2008
• Est. completion date: August 2009

Study information

• Verified date: August 2014
• Source: Repros Therapeutics Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 56
• Est. completion date: August 2009
• Est. primary completion date: August 2009
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Anemia
• Leiomyoma
• Uterine Fibroids

Intervention

Drug:
• Proellex 25 mg
Proellex 25 mg, 1 - 25 mg capsule and 1 placebo capsule daily for 3 months
• Proellex 50 mg
Proellex 50 mg, 2 - 25 mg capsules daily for 3 months
• Placebo
Placebo, 2 capsules daily for 3 months

Locations

Country	Name	City	State
United States	Advanced Clinical Research Institute	Anaheim	California
United States	Alabama Clinical Therapeutics	Birmingham	Alabama
United States	Visions Clinical Research	Boynton Beach	Florida
United States	Central Brooklyn Medical Group (eCast)	Brooklyn	New York
United States	Chattanooga Medical Research, LLC	Chattanooga	Tennessee
United States	Rapid Medical Research, Inc.(Elite)	Cleveland	Ohio
United States	Phoenix Women's Center (eCast)	College Park	Georgia
United States	SC Clinical Research Center	Columbia	South Carolina
United States	Advanced Research Associates	Corpus Christi	Texas
United States	Clinical Trials Select (ecast)	Decatur	Georgia
United States	Dekalb Gynecology Associates/Legacy Obstetrics & Gynecology (eCast)	Decatur	Georgia
United States	Medical Network for Education and Research	Decatur	Georgia
United States	Downtown Women's Health Care	Denver	Colorado
United States	HWC Women's Research Center	Englewood	Ohio
United States	Advances in Health Inc.	Houston	Texas
United States	Centex Research	Houston	Texas
United States	The Women's Hospital of Texas, Clinical Research Center	Houston	Texas
United States	OB-GYN Associates of Mid-Florida, P.A.	Leesburg	Florida
United States	Impact Clinical Trials	Los Angeles	California
United States	National Institute of Clinical Research	Los Angeles	California
United States	Impact Clinical Trials	Los Angeles,	California
United States	Bluegrass Clinical Research, Inc.	Louisville	Kentucky
United States	Segal Institute for Clinical Research	Miami	Florida
United States	Phoenix OB-GYN Associates, LLC	Moorestown	New Jersey
United States	Smith & Hackney	Morrow	Georgia
United States	Women's Health Research	Phoenix	Arizona
United States	Institute for Women's Health	San Antonio	Texas
United States	Seven Oaks Women's Center	San Antonio	Texas
United States	Clinical Trials Select (ecast)	Silver Spring	Maryland
United States	Insignia Clinical Research (Tampa Bay Women's Center)	Tampa	Florida
United States	Comprehensive Clinical Trials, LLC	West Palm Beach	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Repros Therapeutics Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Hemoglobin vs Placebo	Comparison between 50 mg Proellex and placebo of change in hemoglobin at month 3	3 months	Yes