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

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

Status

Withdrawn

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01553123

Enrollment

Registered

2012-03-13

Start date

2012-04-30

Completion date

2013-12-31

Last updated

2013-02-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Leiomyomas

Keywords

Leiomyomas

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.

Interventions

DRUGUlipristal Acetate

once daily, oral

DRUGIron

once daily, dried ferrous sulfate

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 50 Years

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.

Design outcomes

Primary

Measure	Time frame	Description
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)

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026