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

This study has been withdrawn prior to enrollment.
Sponsor:
Information provided by (Responsible Party):
Watson Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT01553123
First received: March 2, 2012
Last updated: February 5, 2013
Last verified: February 2013
  Purpose

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 Intervention Phase
Leiomyomas
Drug: Ulipristal Acetate
Drug: Iron
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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

Resource links provided by NLM:


Further study details as provided by Watson Pharmaceuticals:

Primary Outcome Measures:
  • 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. ] [ Designated as safety issue: No ]
    Change from baseline in hemoglobin levels (g/dL)


Enrollment: 0
Study Start Date: April 2012
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: November 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Ulipristal with iron Drug: Ulipristal Acetate
once daily, oral
Other Name: UPA
Drug: Iron
once daily, dried ferrous sulfate
Placebo Comparator: Placebo
Placebo with iron
Drug: Iron
once daily, dried ferrous sulfate

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

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01553123

  Show 47 Study Locations
Sponsors and Collaborators
Watson Pharmaceuticals
Investigators
Study Director: Howard Zobrist, MS, PhD Watson Pharmaceuticals
  More Information

Additional Information:
No publications provided

Responsible Party: Watson Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01553123     History of Changes
Other Study ID Numbers: UL1104
Study First Received: March 2, 2012
Last Updated: February 5, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Watson Pharmaceuticals:
Leiomyomas

Additional relevant MeSH terms:
Leiomyoma
Myofibroma
Neoplasms, Muscle Tissue
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Connective Tissue
Connective Tissue Diseases
Iron
Trace Elements
Micronutrients
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 28, 2014