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

Phase 3

Withdrawn

• Conditions: Leiomyomas
• Interventions: Drug: Ulipristal Acetate; Drug: Iron

• Registration Number: NCT01553123
• Lead Sponsor: Watson Pharmaceuticals

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.

Study Timeline

• Study First Submitted: 2012-03-02
• Study First Submitted QC: 2012-03-09
• Study First Posted: 2012-03-13
• Study Start: 2012-04
• Status Verified: 2013-02
• Last Update Submitted: 2013-02-05
• Last Update Posted: 2013-02-07
• Primary Completion: 2013-11
• Study Completion: 2013-12

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: Female
• Target Recruitment: Not specified

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Ulipristal with iron	Ulipristal Acetate	-
Ulipristal with iron	Iron	-
Placebo	Iron	Placebo with iron

Primary Outcome Measures

Name	Time	Method
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.	Change from baseline in hemoglobin levels (g/dL)

Trial Locations

Locations (46)

Alabama Clinical Therapeutics; 🇺🇸 Birmingham, Alabama, United States

Coastal Clinical Research, Inc; 🇺🇸 Mobile, Alabama, United States

Women's Health Research; 🇺🇸 Phoenix, Arizona, United States

Visions Clinical Research; 🇺🇸 Boynton Beach, Florida, United States

Benchmark Research; 🇺🇸 Sacramento, California, United States

Sharp Rees-Stealy Medical Group; 🇺🇸 San Diego, California, United States

Medical Center for Clinical Research; 🇺🇸 San Diego, California, United States

Downtown Women's Health Care; 🇺🇸 Denver, Colorado, United States

Jacksonville Center for Clinical Research; 🇺🇸 Jacksonville, Florida, United States

Altus Research; 🇺🇸 Lake Worth, Florida, United States

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