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

Primary Purpose

Leiomyomas

Status
Withdrawn
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Ulipristal Acetate
Iron
Sponsored by
Watson Pharmaceuticals
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Leiomyomas focused on measuring Leiomyomas

Eligibility Criteria

18 Years - 50 Years (Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

  • Alabama Clinical Therapeutics
  • Coastal Clinical Research, Inc
  • Women's Health Research
  • Visions Clinical Research
  • Benchmark Research
  • Sharp Rees-Stealy Medical Group
  • Medical Center for Clinical Research
  • Downtown Women's Health Care
  • Visions Clinical Research
  • Jacksonville Center for Clinical Research
  • Altus Research
  • Healthcare Clinical Data, Inc.
  • All Women's Healthcare of West Broward
  • Physician Care Clinical Research, LLC
  • Comprehensive Clinical Trials, LLC
  • Atlanta Women's Research Institute, Inc
  • Mount Vernon Clinical Research, LLC
  • Fellows Research Alliance
  • Women's Health Practice
  • Advanced Gynecologic Surgery Institute
  • Center for Women's Research
  • South Bend Clinical
  • Praetorian Pharmaceutical Research, LLC
  • Women Under Study, LLC
  • Hutzel Womens Health Specialists
  • Women's Clinic of Lincoln, P.C.
  • Office of Annette Mayes, MD, PC
  • Office of Edmond Pack, MD
  • Office of R. Garn Mabey, Jr
  • Lawrence Obstetrics-Gynecology Clinical Research
  • Southwest Clinical Research
  • New York Center for Women's Health Research
  • Carolina Women's Research and Wellness Center
  • Physicians for Women of Greensboro
  • Eastern Carolina Women's Center
  • Wake Research Associates
  • PMG Research of Wilmington
  • Hawthorne Medical Research
  • Columbus Center for Women's Health Research
  • Advanced Clinical Concepts
  • Southeast Regional Research Group
  • South Carolina Clinical Research Center, LLC
  • Discovery Clinical Trials - Genesis Health Central Women's Care
  • Advances in Health Inc
  • Willowbend Health and Wellness Associates
  • Clinical Trials of Texas Incorporated Laboratory
  • Riverside Regional Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Ulipristal with iron

Placebo

Arm Description

Placebo with iron

Outcomes

Primary Outcome Measures

Change from baseline in hemoglobin levels (g/dL)
Change from baseline in hemoglobin levels (g/dL)

Secondary Outcome Measures

Full Information

First Posted
March 2, 2012
Last Updated
February 5, 2013
Sponsor
Watson Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT01553123
Brief Title
Efficacy and Safety Study of Ulipristal Acetate in Females With Anemia Associated With Uterine Leiomyoma
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 Type
Interventional

2. Study Status

Record Verification Date
February 2013
Overall Recruitment Status
Withdrawn
Study Start Date
April 2012 (undefined)
Primary Completion Date
November 2013 (Anticipated)
Study Completion Date
December 2013 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Watson Pharmaceuticals

4. Oversight

Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Leiomyomas
Keywords
Leiomyomas

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Ulipristal with iron
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo with iron
Intervention Type
Drug
Intervention Name(s)
Ulipristal Acetate
Other Intervention Name(s)
UPA
Intervention Description
once daily, oral
Intervention Type
Drug
Intervention Name(s)
Iron
Intervention Description
once daily, dried ferrous sulfate
Primary Outcome Measure Information:
Title
Change from baseline in hemoglobin levels (g/dL)
Description
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.

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Howard Zobrist, MS, PhD
Organizational Affiliation
Watson Pharmaceuticals
Official's Role
Study Director
Facility Information:
Facility Name
Alabama Clinical Therapeutics
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35235
Country
United States
Facility Name
Coastal Clinical Research, Inc
City
Mobile
State/Province
Alabama
ZIP/Postal Code
36608
Country
United States
Facility Name
Women's Health Research
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85015
Country
United States
Facility Name
Visions Clinical Research
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85712
Country
United States
Facility Name
Benchmark Research
City
Sacramento
State/Province
California
ZIP/Postal Code
95816
Country
United States
Facility Name
Sharp Rees-Stealy Medical Group
City
San Diego
State/Province
California
ZIP/Postal Code
92101
Country
United States
Facility Name
Medical Center for Clinical Research
City
San Diego
State/Province
California
ZIP/Postal Code
92108
Country
United States
Facility Name
Downtown Women's Health Care
City
Denver
State/Province
Colorado
ZIP/Postal Code
80218
Country
United States
Facility Name
Visions Clinical Research
City
Boynton Beach
State/Province
Florida
ZIP/Postal Code
33472
Country
United States
Facility Name
Jacksonville Center for Clinical Research
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32216
Country
United States
Facility Name
Altus Research
City
Lake Worth
State/Province
Florida
ZIP/Postal Code
33461
Country
United States
Facility Name
Healthcare Clinical Data, Inc.
City
North Miami
State/Province
Florida
ZIP/Postal Code
33161
Country
United States
Facility Name
All Women's Healthcare of West Broward
City
Plantation
State/Province
Florida
ZIP/Postal Code
33324
Country
United States
Facility Name
Physician Care Clinical Research, LLC
City
Sarasota
State/Province
Florida
ZIP/Postal Code
34321
Country
United States
Facility Name
Comprehensive Clinical Trials, LLC
City
West Palm Beach
State/Province
Florida
ZIP/Postal Code
33409
Country
United States
Facility Name
Atlanta Women's Research Institute, Inc
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30342
Country
United States
Facility Name
Mount Vernon Clinical Research, LLC
City
Sandy Springs
State/Province
Georgia
ZIP/Postal Code
30328
Country
United States
Facility Name
Fellows Research Alliance
City
Savannah
State/Province
Georgia
ZIP/Postal Code
31406
Country
United States
Facility Name
Women's Health Practice
City
Champaign
State/Province
Illinois
ZIP/Postal Code
61820
Country
United States
Facility Name
Advanced Gynecologic Surgery Institute
City
Naperville
State/Province
Illinois
ZIP/Postal Code
60540
Country
United States
Facility Name
Center for Women's Research
City
Palos Heights
State/Province
Illinois
ZIP/Postal Code
60463
Country
United States
Facility Name
South Bend Clinical
City
Granger
State/Province
Indiana
ZIP/Postal Code
46530
Country
United States
Facility Name
Praetorian Pharmaceutical Research, LLC
City
Marrero
State/Province
Louisiana
ZIP/Postal Code
70072
Country
United States
Facility Name
Women Under Study, LLC
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70115
Country
United States
Facility Name
Hutzel Womens Health Specialists
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48201
Country
United States
Facility Name
Women's Clinic of Lincoln, P.C.
City
Lincoln
State/Province
Nebraska
ZIP/Postal Code
68510
Country
United States
Facility Name
Office of Annette Mayes, MD, PC
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89106
Country
United States
Facility Name
Office of Edmond Pack, MD
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89106
Country
United States
Facility Name
Office of R. Garn Mabey, Jr
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89128
Country
United States
Facility Name
Lawrence Obstetrics-Gynecology Clinical Research
City
Lawrenceville
State/Province
New Jersey
ZIP/Postal Code
08648
Country
United States
Facility Name
Southwest Clinical Research
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87102
Country
United States
Facility Name
New York Center for Women's Health Research
City
New York City
State/Province
New York
ZIP/Postal Code
10038
Country
United States
Facility Name
Carolina Women's Research and Wellness Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27713
Country
United States
Facility Name
Physicians for Women of Greensboro
City
Greensboro
State/Province
North Carolina
ZIP/Postal Code
27408
Country
United States
Facility Name
Eastern Carolina Women's Center
City
New Bern
State/Province
North Carolina
ZIP/Postal Code
28562
Country
United States
Facility Name
Wake Research Associates
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27612
Country
United States
Facility Name
PMG Research of Wilmington
City
Wilmington
State/Province
North Carolina
ZIP/Postal Code
28401
Country
United States
Facility Name
Hawthorne Medical Research
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27103
Country
United States
Facility Name
Columbus Center for Women's Health Research
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43213
Country
United States
Facility Name
Advanced Clinical Concepts
City
West Reading
State/Province
Pennsylvania
ZIP/Postal Code
19611
Country
United States
Facility Name
Southeast Regional Research Group
City
Aiken
State/Province
South Carolina
ZIP/Postal Code
29803
Country
United States
Facility Name
South Carolina Clinical Research Center, LLC
City
Columbia
State/Province
South Carolina
ZIP/Postal Code
29201
Country
United States
Facility Name
Discovery Clinical Trials - Genesis Health Central Women's Care
City
Dallas
State/Province
Texas
ZIP/Postal Code
75231
Country
United States
Facility Name
Advances in Health Inc
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Willowbend Health and Wellness Associates
City
Plano
State/Province
Texas
ZIP/Postal Code
75093
Country
United States
Facility Name
Clinical Trials of Texas Incorporated Laboratory
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
Riverside Regional Medical Center
City
Newport News
State/Province
Virginia
ZIP/Postal Code
23601
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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