A Study of the Efficacy and Safety of a 3-month Treatment Course of Ulipristal Acetate for the Treatment of 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

NCT02147197

Run by

Allergan

People needed

157

Starts

2014-03-31

Expected to finish

2016-03-29

Last updated by the study team

2019-04-30

Who can join

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

You may qualify if…

• Pre-menopausal 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 rang

Where it is running

• Watson Investigational Site 125 — Tucson, Arizona, United States
• Watson Investigational Site 102 — San Diego, California, United States
• Watson Investigational Site 112 — Denver, Colorado, United States
• Watson Investigational Site 115 — Lakewood, Colorado, United States
• Watson Investigational Site 116 — Milford, Connecticut, United States
• Watson Investigational Site 114 — Washington D.C., District of Columbia, United States
• Watson Investigational Site 106 — Clearwater, Florida, United States
• Watson Investigational Site 122 — Lake Worth, Florida, United States
• Watson Investigational Site 130 — Miami, Florida, United States
• Watson Investigational Site 105 — New Port Richey, Florida, United States
• Watson Investigational Site 104 — Orlando, Florida, United States
• Watson Investigational Site 120 — Orlando, Florida, United States
• Watson Investigational Site 103 — Atlanta, Georgia, United States
• Watson Investigational Site 123 — Atlanta, Georgia, United States
• Watson Investigational Site 111 — Augusta, Georgia, United States
• Watson Investigational Site 124 — Idaho Falls, Idaho, United States
• Watson Investigational Site 131 — Brownsburg, Indiana, United States
• Watson Investigational Site 129 — Shawnee Mission, Kansas, United States
• Watson Investigational Site 132 — Metairie, Louisiana, United States
• Watson Investigational Site 110 — Norfolk, Nebraska, United States
• Watson Investigational Site 113 — Albuquerque, New Mexico, United States
• Watson Investigational Site 121 — Raleigh, North Carolina, United States
• Watson Investigational Site 109 — Winston-Salem, North Carolina, United States
• Watson Investigational Site 107 — Columbus, Ohio, United States
• Watson Investigational Site 119 — Jenkintown, Pennsylvania, United States

Full record on ClinicalTrials.gov

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