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

Watson Pharmaceuticals

Status and phase

Withdrawn

Phase 3

Conditions

Leiomyomas

Treatments

Drug: Iron

Drug: Ulipristal Acetate

Study type

Interventional

Funder types

Industry

Identifiers

NCT01553123

UL1104

Details and patient eligibility

About

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.

Full 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.

Sex

Female

Ages

18 to 50 years old

Volunteers

No Healthy Volunteers

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.