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

Sponsor
Watson Pharmaceuticals (Industry)
Overall Status
Withdrawn
CT.gov ID
NCT01553123
Collaborator
(none)
0
Enrollment
47
Locations
2
Arms
20
Duration (Months)
0
Patients Per Site
0
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
Phase 3

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 Design

Study Type:
Interventional
Actual Enrollment :
0 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Treatment
Official Title:
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
Study Start Date :
Apr 1, 2012
Anticipated Primary Completion Date :
Nov 1, 2013
Anticipated Study Completion Date :
Dec 1, 2013

Arms and Interventions

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

    Outcome Measures

    Primary Outcome Measures

    1. 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.]

      Change from baseline in hemoglobin levels (g/dL)

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 50 Years
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Alabama Clinical Therapeutics Birmingham Alabama United States 35235
    2 Coastal Clinical Research, Inc Mobile Alabama United States 36608
    3 Women's Health Research Phoenix Arizona United States 85015
    4 Visions Clinical Research Tucson Arizona United States 85712
    5 Benchmark Research Sacramento California United States 95816
    6 Sharp Rees-Stealy Medical Group San Diego California United States 92101
    7 Medical Center for Clinical Research San Diego California United States 92108
    8 Downtown Women's Health Care Denver Colorado United States 80218
    9 Visions Clinical Research Boynton Beach Florida United States 33472
    10 Jacksonville Center for Clinical Research Jacksonville Florida United States 32216
    11 Altus Research Lake Worth Florida United States 33461
    12 Healthcare Clinical Data, Inc. North Miami Florida United States 33161
    13 All Women's Healthcare of West Broward Plantation Florida United States 33324
    14 Physician Care Clinical Research, LLC Sarasota Florida United States 34321
    15 Comprehensive Clinical Trials, LLC West Palm Beach Florida United States 33409
    16 Atlanta Women's Research Institute, Inc Atlanta Georgia United States 30342
    17 Mount Vernon Clinical Research, LLC Sandy Springs Georgia United States 30328
    18 Fellows Research Alliance Savannah Georgia United States 31406
    19 Women's Health Practice Champaign Illinois United States 61820
    20 Advanced Gynecologic Surgery Institute Naperville Illinois United States 60540
    21 Center for Women's Research Palos Heights Illinois United States 60463
    22 South Bend Clinical Granger Indiana United States 46530
    23 Praetorian Pharmaceutical Research, LLC Marrero Louisiana United States 70072
    24 Women Under Study, LLC New Orleans Louisiana United States 70115
    25 Hutzel Womens Health Specialists Detroit Michigan United States 48201
    26 Women's Clinic of Lincoln, P.C. Lincoln Nebraska United States 68510
    27 Office of Annette Mayes, MD, PC Las Vegas Nevada United States 89106
    28 Office of Edmond Pack, MD Las Vegas Nevada United States 89106
    29 Office of R. Garn Mabey, Jr Las Vegas Nevada United States 89128
    30 Lawrence Obstetrics-Gynecology Clinical Research Lawrenceville New Jersey United States 08648
    31 Southwest Clinical Research Albuquerque New Mexico United States 87102
    32 New York Center for Women's Health Research New York City New York United States 10038
    33 Carolina Women's Research and Wellness Center Durham North Carolina United States 27713
    34 Physicians for Women of Greensboro Greensboro North Carolina United States 27408
    35 Eastern Carolina Women's Center New Bern North Carolina United States 28562
    36 Wake Research Associates Raleigh North Carolina United States 27612
    37 PMG Research of Wilmington Wilmington North Carolina United States 28401
    38 Hawthorne Medical Research Winston-Salem North Carolina United States 27103
    39 Columbus Center for Women's Health Research Columbus Ohio United States 43213
    40 Advanced Clinical Concepts West Reading Pennsylvania United States 19611
    41 Southeast Regional Research Group Aiken South Carolina United States 29803
    42 South Carolina Clinical Research Center, LLC Columbia South Carolina United States 29201
    43 Discovery Clinical Trials - Genesis Health Central Women's Care Dallas Texas United States 75231
    44 Advances in Health Inc Houston Texas United States 77030
    45 Willowbend Health and Wellness Associates Plano Texas United States 75093
    46 Clinical Trials of Texas Incorporated Laboratory San Antonio Texas United States 78229
    47 Riverside Regional Medical Center Newport News Virginia United States 23601

    Sponsors and Collaborators

    • Watson Pharmaceuticals

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Watson Pharmaceuticals
    ClinicalTrials.gov Identifier:
    NCT01553123
    Other Study ID Numbers:
    • UL1104
    First Posted:
    Mar 13, 2012
    Last Update Posted:
    Feb 7, 2013
    Last Verified:
    Feb 1, 2013
    Keywords provided by Watson Pharmaceuticals
    Leiomyomas
    Additional relevant MeSH terms:
    Leiomyoma
    Myofibroma
    Ulipristal acetate

    Study Results

    No Results Posted as of Feb 7, 2013