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WITHDRAWNPhase 3NCT01553123

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

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 ev...

Lead sponsor: Watson Pharmaceuticals•47 U.S. locations•View source on ClinicalTrials.gov

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Sponsors

Lead Sponsor

Watson Pharmaceuticals

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.

Age

18 - 50 years

Sex

FEMALE

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.

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Data from ClinicalTrials.govLast updated on ClinicalTrials.gov: February 7, 2013Terms

Trial snapshot

StatusWITHDRAWN

PhasePHASE3

Enrollment—

Start dateApr 2012

Last updatedFeb 7, 2013

Condition

Locations shown

Alabama Clinical Therapeutics

Birmingham, Alabama

Coastal Clinical Research, Inc

Mobile, Alabama

Women's Health Research

Phoenix, Arizona

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 7, 2013Data synced to Clareo: May 25, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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