A Study of the Efficacy and Safety of Ulipristal Acetate Intermittent Treatment for Abnormal Uterine Bleeding Associated With Leiomyomas

Completed · Phase 3 · Has a placebo group

Conditions studied: Leiomyoma, Uterine Hemorrhage

In brief

This study will evaluate the superiority of ulipristal acetate versus placebo for the treatment of abnormal uterine bleeding associated with uterine fibroids

Key facts

Study ID

NCT02147158

Run by

Allergan

People needed

432

Starts

2014-01-29

Expected to finish

2016-11-24

Last updated by the study team

2019-06-04

Who can join

Age: 18 and older, up to 50. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• Premenopausal women, 18-50 years, inclusive.
• Cyclic abnormal uterine bleeding (heavy or prolonged).
• Menstrual blood loss (MBL) of ≥ 80 mL as measured by the alkaline hematin method in the first 8 days of menses.
• Minimum of one discrete leiomyoma observable by transvaginal ultrasound.
• Endometrial biopsy without evidence of malignancy or atypical or non-atypical hyperplasia.

You may not qualify if…

• History of uterine surgery that would interfere with the study endpoints.
• Known coagulation disorder including bleeding disorder or clotting disorder.
• History of, or current uterine, cervix, ovarian, or breast cancer.
• Alanine transaminase (ALT), aspartate transaminase (AST), alkaline phosphatase (ALP), or total bilirubin two times or greater than the upper limit of normal range.

Where it is running

• Watson Investigational Site 147 — Phoenix, Arizona, United States
• Watson Investigational Site 106 — Scottsdale, Arizona, United States
• Watson Investigational Site 124 — Tucson, Arizona, United States
• Watson Investigational Site 155 — Little Rock, Arkansas, United States
• Watson Investigational Site 155 — Encino, California, United States
• Watson Investigational Site 157 — Hawaiian Gardens, California, United States
• Watson Investigational Site 134 — La Mesa, California, United States
• Watson Investigational Site 127 — San Diego, California, United States
• Watson Investigational Site 151 — San Diego, California, United States
• Watson Investigational Site 159 — Denver, Colorado, United States
• Watson Investigational Site 131 — Clearwater, Florida, United States
• Watson Investigational Site 135 — Miramar, Florida, United States
• Watson Investigational Site 132 — North Miami, Florida, United States
• Watson Investigational Site 161 — Orlando, Florida, United States
• Watson Investigational Site 123 — Plantation, Florida, United States
• Watson Investigational Site 112 — Sarasota, Florida, United States
• Watson Investigational Site 102 — Wellington, Florida, United States
• Watson Investigational Site 101 — West Palm Beach, Florida, United States
• Watson Investigational Site 160 — Atlanta, Georgia, United States
• Watson Investigational Site 103 — Sandy Springs, Georgia, United States
• Watson Investigational Site 117 — Savannah, Georgia, United States
• Watson Investigational Site 113 — Champaign, Illinois, United States
• Watson Investigational Site 119 — Schaumburg, Illinois, United States
• Watson Investigational Site 162 — Brownsburg, Indiana, United States
• Watson Investigational Site 138 — Mesa, Arizona, United States

Full record on ClinicalTrials.gov

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