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

Leiomyomas Clinical Trial

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01553123
• Other study ID #: UL1104
• Status: Withdrawn
• Phase: Phase 3
• First received: March 2, 2012
• Last updated: February 5, 2013
• Start date: April 2012
• Est. completion date: December 2013

Study information

• Verified date: February 2013
• Source: Watson Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 2013
• Est. primary completion date: November 2013
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Leiomyoma
• Leiomyomas

Intervention

Drug:
• Ulipristal Acetate
once daily, oral
• Iron
once daily, dried ferrous sulfate

Locations

Country	Name	City	State
United States	Southeast Regional Research Group	Aiken	South Carolina
United States	Southwest Clinical Research	Albuquerque	New Mexico
United States	Atlanta Women's Research Institute, Inc	Atlanta	Georgia
United States	Alabama Clinical Therapeutics	Birmingham	Alabama
United States	Visions Clinical Research	Boynton Beach	Florida
United States	Women's Health Practice	Champaign	Illinois
United States	South Carolina Clinical Research Center, LLC	Columbia	South Carolina
United States	Columbus Center for Women's Health Research	Columbus	Ohio
United States	Discovery Clinical Trials - Genesis Health Central Women's Care	Dallas	Texas
United States	Downtown Women's Health Care	Denver	Colorado
United States	Hutzel Womens Health Specialists	Detroit	Michigan
United States	Carolina Women's Research and Wellness Center	Durham	North Carolina
United States	South Bend Clinical	Granger	Indiana
United States	Physicians for Women of Greensboro	Greensboro	North Carolina
United States	Advances in Health Inc	Houston	Texas
United States	Jacksonville Center for Clinical Research	Jacksonville	Florida
United States	Altus Research	Lake Worth	Florida
United States	Office of Annette Mayes, MD, PC	Las Vegas	Nevada
United States	Office of Edmond Pack, MD	Las Vegas	Nevada
United States	Office of R. Garn Mabey, Jr	Las Vegas	Nevada
United States	Lawrence Obstetrics-Gynecology Clinical Research	Lawrenceville	New Jersey
United States	Women's Clinic of Lincoln, P.C.	Lincoln	Nebraska
United States	Praetorian Pharmaceutical Research, LLC	Marrero	Louisiana
United States	Coastal Clinical Research, Inc	Mobile	Alabama
United States	Advanced Gynecologic Surgery Institute	Naperville	Illinois
United States	Eastern Carolina Women's Center	New Bern	North Carolina
United States	Women Under Study, LLC	New Orleans	Louisiana
United States	New York Center for Women's Health Research	New York City	New York
United States	Riverside Regional Medical Center	Newport News	Virginia
United States	Healthcare Clinical Data, Inc.	North Miami	Florida
United States	Center for Women's Research	Palos Heights	Illinois
United States	Women's Health Research	Phoenix	Arizona
United States	Willowbend Health and Wellness Associates	Plano	Texas
United States	All Women's Healthcare of West Broward	Plantation	Florida
United States	Wake Research Associates	Raleigh	North Carolina
United States	Benchmark Research	Sacramento	California
United States	Clinical Trials of Texas Incorporated Laboratory	San Antonio	Texas
United States	Medical Center for Clinical Research	San Diego	California
United States	Sharp Rees-Stealy Medical Group	San Diego	California
United States	Mount Vernon Clinical Research, LLC	Sandy Springs	Georgia
United States	Physician Care Clinical Research, LLC	Sarasota	Florida
United States	Fellows Research Alliance	Savannah	Georgia
United States	Visions Clinical Research	Tucson	Arizona
United States	Comprehensive Clinical Trials, LLC	West Palm Beach	Florida
United States	Advanced Clinical Concepts	West Reading	Pennsylvania
United States	PMG Research of Wilmington	Wilmington	North Carolina
United States	Hawthorne Medical Research	Winston-Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Watson Pharmaceuticals

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline in hemoglobin levels (g/dL)	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.	No

External Links

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