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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01553123
Recruitment Status : Withdrawn
First Posted : March 13, 2012
Last Update Posted : February 7, 2013
Information provided by (Responsible Party):

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.

Condition or disease Intervention/treatment Phase
Leiomyomas Drug: Ulipristal Acetate Drug: Iron Phase 3

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 Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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
Study Start Date : April 2012
Estimated Primary Completion Date : November 2013
Estimated Study Completion Date : December 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anemia Iron
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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

Outcome Measures

Primary Outcome Measures :
  1. 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)

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01553123

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

Responsible Party: Watson Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01553123     History of Changes
Other Study ID Numbers: UL1104
First Posted: March 13, 2012    Key Record Dates
Last Update Posted: February 7, 2013
Last Verified: February 2013

Keywords provided by Watson Pharmaceuticals:

Additional relevant MeSH terms:
Neoplasms, Muscle Tissue
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms, Connective Tissue
Connective Tissue Diseases