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A Randomized, Placebo Controlled, Parallel Group, Multicenter Study to Evaluate the Efficacy and Safety of Ulipristal Acetate in Women With Anemia Associated With Uterine Leiomyomas

Phase 3
18 Years
50 Years
Not Enrolling

Thank you

Trial Information

A Randomized, Placebo Controlled, Parallel Group, Multicenter Study to Evaluate the Efficacy and Safety of Ulipristal Acetate in Women With Anemia Associated With Uterine Leiomyomas

This is a randomized, placebo controlled, multicenter study with parallel groups in order to
evaluate the efficacy and safety of ulipristal acetate in female subjects with anemia
associated with uterine leiomyomas. The objective of this study is to determine if daily
ulipristal acetate with iron is more effective than iron alone.

Inclusion Criteria:

- Is a pre-menopausal female, 18 - 50 years;

- Has documented leiomyoma(s);

- Has leiomyoma-related anemia;

- Has an endometrial biopsy within the screening period prior to the first dose of the
test article which shows no endometrial hyperplasia;

- Is willing and able to provide written informed consent and authorization to disclose
protected health information.

Exclusion Criteria:

- Has a history of uterine surgery that would interfere with the study;

- Has a condition requiring immediate or intermittent blood transfusions;

- Has a known coagulation disorder;

- Has a history of uterine, cervix, ovarian, or breast cancer;

- Has used a selective progesterone receptor modulator or a gonadotrophin releasing
hormone agonist in previous 6 months;

- Has received blood transfusion within 8 weeks before the screening visit;

- Has abnormal liver functions;

- Is pregnant.

Type of Study:


Study Design:

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

Outcome Measure:

Change from baseline in hemoglobin levels (g/dL)

Outcome Description:

Change from baseline in hemoglobin levels (g/dL)

Outcome Time Frame:

Day 1 of the first on-treatment menstrual cycle to the start, or scheduled start of menstrual cycle 3.

Safety Issue:


Principal Investigator

Howard Zobrist, MS, PhD

Investigator Role:

Study Director

Investigator Affiliation:

Watson Pharmaceuticals


United States: Food and Drug Administration

Study ID:




Start Date:

April 2012

Completion Date:

December 2013

Related Keywords:

  • Leiomyomas
  • Leiomyomas
  • Leiomyoma
  • Myofibroma



Riverside Regional Medical Center Newport News, Virginia  23601
Advanced Clinical Concepts Temple, Pennsylvania  19560
Comprehensive Clinical Trials, LLC West Palm Beach, Florida  33409
Jacksonville Center for Clinical Research Jacksonville, Florida  32216
Alabama Clinical Therapeutics Birmingham, Alabama  35235
Wake Research Associates Raleigh, North Carolina  27612
Medical Center for Clinical Research San Diego, California  92108
Visions Clinical Research Boynton Beach, Florida  33472
Southwest Clinical Research Albuquerque, New Mexico  87102
Mount Vernon Clinical Research, LLC Atlanta, Georgia  30328
Women's Health Research Phoenix, Arizona  85015
Eastern Carolina Women's Center New Bern, North Carolina  28562
Benchmark Research Sacramento, California  95816
Visions Clinical Research Tucson, Arizona  85712
Downtown Women's Health Care Denver, Colorado  80218
Altus Research Lake Worth, Florida  33461
Physician Care Clinical Research, LLC Sarasota, Florida  34329
Carolina Women's Research and Wellness Center Durham, North Carolina  27713
Advances in Health Inc Houston, Texas  77030
Women's Health Practice Champaign, Illinois  61820
Center for Women's Research Chicago, Illinois  60612
Women's Clinic of Lincoln, P.C. Lincoln, Nebraska  68510
Columbus Center for Women's Health Research Columbus, Ohio  43213
PMG Research of Wilmington Wilmington, North Carolina  28401
Coastal Clinical Research, Inc Mobile, Alabama  36608
Sharp Rees-Stealy Medical Group San Diego, California  92101
Healthcare Clinical Data, Inc. North Miami, Florida  33161
All Women's Healthcare of West Broward Plantation, Florida  33324
Atlanta Women's Research Institute, Inc Atlanta, Georgia  30342
Fellows Research Alliance Savannah, Georgia  31406
Advanced Gynecologic Surgery Institute Naperville, Illinois  60540
South Bend Clinical Granger, Indiana  46530
Praetorian Pharmaceutical Research, LLC Marrero, Louisiana  70072
Women Under Study, LLC New Orleans, Louisiana  70115
Hutzel Womens Health Specialists Detroit, Michigan  48201
Office of Edmond Pack, MD Las Vegas, Nevada  89106
Office of Annette Mayes, MD, PC Las Vegas, Nevada  89106
Office of R. Garn Mabey, Jr Las Vegas, Nevada  89128
Lawrence Obstetrics-Gynecology Clinical Research Lawrenceville, New Jersey  08648
New York Center for Women's Health Research New York City, New York  10038
Physicians for Women of Greensboro Greensboro, North Carolina  27408
Hawthorne Medical Research Winston-Salem, North Carolina  27103
Southeast Regional Research Group Aiken, South Carolina  29803
South Carolina Clinical Research Center, LLC Columbia, South Carolina  29201
Discovery Clinical Trials - Genesis Health Central Women's Care Dallas, Texas  75231
Willowbend Health and Wellness Associates Plano, Texas  75093
Clinical Trials of Texas Incorporated Laboratory San Antonio, Texas  78229