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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Leiomyomas

Intervention / Treatment
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* Drug: Ulipristal Acetate
* Drug: Iron


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Ulipristal with iron<br> | Drug: Ulipristal Acetate<br>* once daily, oral<br>* Other names: UPA;Drug: Iron<br>* once daily, dried ferrous sulfate<br>|
| Placebo Comparator: Placebo<br>Placebo with iron | Drug: Iron<br>* once daily, dried ferrous sulfate<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Leiomyomas