Efficacy and Safety Study of Ulipristal Acetate in Females With Anemia Associated With Uterine Leiomyoma

February 5, 2013 updated by: Watson Pharmaceuticals

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

The purpose of this study is to determine whether ulipristal acetate is effective in the treatment of females with anemia associated with uterine leiomyomas. The safety of this product will also be evaluated.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35235
        • Alabama Clinical Therapeutics
      • Mobile, Alabama, United States, 36608
        • Coastal Clinical Research, Inc
    • Arizona
      • Phoenix, Arizona, United States, 85015
        • Women's Health Research
      • Tucson, Arizona, United States, 85712
        • Visions Clinical Research
    • California
      • Sacramento, California, United States, 95816
        • Benchmark Research
      • San Diego, California, United States, 92101
        • Sharp Rees-Stealy Medical Group
      • San Diego, California, United States, 92108
        • Medical Center for Clinical Research
    • Colorado
      • Denver, Colorado, United States, 80218
        • Downtown Women's Health Care
    • Florida
      • Boynton Beach, Florida, United States, 33472
        • Visions Clinical Research
      • Jacksonville, Florida, United States, 32216
        • Jacksonville Center for Clinical Research
      • Lake Worth, Florida, United States, 33461
        • Altus Research
      • North Miami, Florida, United States, 33161
        • Healthcare Clinical Data, Inc.
      • Plantation, Florida, United States, 33324
        • All Women's Healthcare of West Broward
      • Sarasota, Florida, United States, 34321
        • Physician Care Clinical Research, LLC
      • West Palm Beach, Florida, United States, 33409
        • Comprehensive Clinical Trials, Llc
    • Georgia
      • Atlanta, Georgia, United States, 30342
        • Atlanta Women's Research Institute, Inc
      • Sandy Springs, Georgia, United States, 30328
        • Mount Vernon Clinical Research, LLC
      • Savannah, Georgia, United States, 31406
        • Fellows Research Alliance
    • Illinois
      • Champaign, Illinois, United States, 61820
        • Women's Health Practice
      • Naperville, Illinois, United States, 60540
        • Advanced Gynecologic Surgery Institute
      • Palos Heights, Illinois, United States, 60463
        • Center For Women's Research
    • Indiana
      • Granger, Indiana, United States, 46530
        • South Bend Clinical
    • Louisiana
      • Marrero, Louisiana, United States, 70072
        • Praetorian Pharmaceutical Research, LLC
      • New Orleans, Louisiana, United States, 70115
        • Women Under Study, LLC
    • Michigan
      • Detroit, Michigan, United States, 48201
        • Hutzel Womens Health Specialists
    • Nebraska
      • Lincoln, Nebraska, United States, 68510
        • Women's Clinic of Lincoln, P.C.
    • Nevada
      • Las Vegas, Nevada, United States, 89106
        • Office of Annette Mayes, MD, PC
      • Las Vegas, Nevada, United States, 89106
        • Office of Edmond Pack, MD
      • Las Vegas, Nevada, United States, 89128
        • Office of R. Garn Mabey, Jr
    • New Jersey
      • Lawrenceville, New Jersey, United States, 08648
        • Lawrence Obstetrics-Gynecology Clinical Research
    • New Mexico
      • Albuquerque, New Mexico, United States, 87102
        • Southwest Clinical Research
    • New York
      • New York City, New York, United States, 10038
        • New York Center for Women's Health Research
    • North Carolina
      • Durham, North Carolina, United States, 27713
        • Carolina Women's Research and Wellness Center
      • Greensboro, North Carolina, United States, 27408
        • Physicians for Women of Greensboro
      • New Bern, North Carolina, United States, 28562
        • Eastern Carolina Women's Center
      • Raleigh, North Carolina, United States, 27612
        • Wake Research Associates
      • Wilmington, North Carolina, United States, 28401
        • PMG Research of Wilmington
      • Winston-Salem, North Carolina, United States, 27103
        • Hawthorne Medical Research
    • Ohio
      • Columbus, Ohio, United States, 43213
        • Columbus Center for Women's Health Research
    • Pennsylvania
      • West Reading, Pennsylvania, United States, 19611
        • Advanced Clinical Concepts
    • South Carolina
      • Aiken, South Carolina, United States, 29803
        • Southeast Regional Research Group
      • Columbia, South Carolina, United States, 29201
        • South Carolina Clinical Research Center, LLC
    • Texas
      • Dallas, Texas, United States, 75231
        • Discovery Clinical Trials - Genesis Health Central Women's Care
      • Houston, Texas, United States, 77030
        • Advances In Health Inc
      • Plano, Texas, United States, 75093
        • Willowbend Health and Wellness Associates
      • San Antonio, Texas, United States, 78229
        • Clinical Trials of Texas Incorporated Laboratory
    • Virginia
      • Newport News, Virginia, United States, 23601
        • Riverside Regional Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 50 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Ulipristal with iron
Drug: Ulipristal Acetate
once daily, oral
Other Names:
  • UPA
Drug: Iron
once daily, dried ferrous sulfate
Placebo Comparator: Placebo
Placebo with iron
Drug: Iron
once daily, dried ferrous sulfate

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from baseline in hemoglobin levels (g/dL)
Time Frame: Day 1 of the first on-treatment menstrual cycle to the start, or scheduled start of menstrual cycle 3.
Change from baseline in hemoglobin levels (g/dL)
Day 1 of the first on-treatment menstrual cycle to the start, or scheduled start of menstrual cycle 3.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Watson Pharmaceuticals

Investigators

  • Study Director: Howard Zobrist, MS, PhD, Watson Pharmaceuticals

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2012

Primary Completion (Anticipated)

November 1, 2013

Study Completion (Anticipated)

December 1, 2013

Study Registration Dates

First Submitted

March 2, 2012

First Submitted That Met QC Criteria

March 9, 2012

First Posted (Estimate)

March 13, 2012

Study Record Updates

Last Update Posted (Estimate)

February 7, 2013

Last Update Submitted That Met QC Criteria

February 5, 2013

Last Verified

February 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UL1104

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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