Clinical trial NCT01553123: 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
Overall status: WITHDRAWN
Phase: PHASE3
Conditions: Leiomyomas
Keywords: Leiomyomas
Lead sponsor: Watson Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2012-03-13
Enrollment: 0
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Change from baseline in hemoglobin levels (g/dL)
timeFrame: Day 1 of the first on-treatment menstrual cycle to the start, or scheduled start of menstrual cycle 3.
Secondary outcomes:
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Alabama Clinical Therapeutics
state: Alabama
city: Mobile
country: United States
facility: Coastal Clinical Research, Inc
state: Alabama
city: Phoenix
country: United States
facility: Women's Health Research
state: Arizona
city: Tucson
country: United States
facility: Visions Clinical Research
state: Arizona
city: Sacramento
country: United States
facility: Benchmark Research
state: California
city: San Diego
country: United States
facility: Sharp Rees-Stealy Medical Group
state: California
city: San Diego
country: United States
facility: Medical Center for Clinical Research
state: California
city: Denver
country: United States
facility: Downtown Women's Health Care
state: Colorado
city: Boynton Beach
country: United States
facility: Visions Clinical Research
state: Florida
city: Jacksonville
country: United States
facility: Jacksonville Center for Clinical Research
state: Florida
city: Lake Worth
country: United States
facility: Altus Research
state: Florida
city: North Miami
country: United States
facility: Healthcare Clinical Data, Inc.
state: Florida
city: Plantation
country: United States
facility: All Women's Healthcare of West Broward
state: Florida
city: Sarasota
country: United States
facility: Physician Care Clinical Research, LLC
state: Florida
city: West Palm Beach
country: United States
facility: Comprehensive Clinical Trials, LLC
state: Florida
city: Atlanta
country: United States
facility: Atlanta Women's Research Institute, Inc
state: Georgia
city: Sandy Springs
country: United States
facility: Mount Vernon Clinical Research, LLC
state: Georgia
city: Savannah
country: United States
facility: Fellows Research Alliance
state: Georgia
city: Champaign
country: United States
facility: Women's Health Practice
state: Illinois
city: Naperville
country: United States
facility: Advanced Gynecologic Surgery Institute
state: Illinois
city: Palos Heights
country: United States
facility: Center for Women's Research
state: Illinois
city: Granger
country: United States
facility: South Bend Clinical
state: Indiana
city: Marrero
country: United States
facility: Praetorian Pharmaceutical Research, LLC
state: Louisiana
city: New Orleans
country: United States
facility: Women Under Study, LLC
state: Louisiana
city: Detroit
country: United States
facility: Hutzel Womens Health Specialists
state: Michigan
city: Lincoln
country: United States
facility: Women's Clinic of Lincoln, P.C.
state: Nebraska
city: Las Vegas
country: United States
facility: Office of Annette Mayes, MD, PC
state: Nevada
city: Las Vegas
country: United States
facility: Office of Edmond Pack, MD
state: Nevada
city: Las Vegas
country: United States
facility: Office of R. Garn Mabey, Jr
state: Nevada
city: Lawrenceville
country: United States
facility: Lawrence Obstetrics-Gynecology Clinical Research
state: New Jersey
city: Albuquerque
country: United States
facility: Southwest Clinical Research
state: New Mexico
city: New York City
country: United States
facility: New York Center for Women's Health Research
state: New York
city: Durham
country: United States
facility: Carolina Women's Research and Wellness Center
state: North Carolina
city: Greensboro
country: United States
facility: Physicians for Women of Greensboro
state: North Carolina
city: New Bern
country: United States
facility: Eastern Carolina Women's Center
state: North Carolina
city: Raleigh
country: United States
facility: Wake Research Associates
state: North Carolina
city: Wilmington
country: United States
facility: PMG Research of Wilmington
state: North Carolina
city: Winston-Salem
country: United States
facility: Hawthorne Medical Research
state: North Carolina
city: Columbus
country: United States
facility: Columbus Center for Women's Health Research
state: Ohio
city: West Reading
country: United States
facility: Advanced Clinical Concepts
state: Pennsylvania
city: Aiken
country: United States
facility: Southeast Regional Research Group
state: South Carolina
city: Columbia
country: United States
facility: South Carolina Clinical Research Center, LLC
state: South Carolina
city: Dallas
country: United States
facility: Discovery Clinical Trials - Genesis Health Central Women's Care
state: Texas
city: Houston
country: United States
facility: Advances in Health Inc
state: Texas
city: Plano
country: United States
facility: Willowbend Health and Wellness Associates
state: Texas
city: San Antonio
country: United States
facility: Clinical Trials of Texas Incorporated Laboratory
state: Texas
city: Newport News
country: United States
facility: Riverside Regional Medical Center
state: Virginia
Study officials:
affiliation: Watson Pharmaceuticals
name: Howard Zobrist, MS, PhD
role: STUDY_DIRECTOR
References: