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

Status

Indicates the current recruitment status or the expanded access status.
Withdrawn

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Watson Pharmaceuticals

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 1, 2012

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 1, 2013

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2013

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 2, 2012

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 9, 2012

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 13, 2012

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 7, 2013

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 5, 2013

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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