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
NCT ID: NCT02147197
Last Updated: 2019-04-30
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
157 participants
INTERVENTIONAL
2014-03-31
2016-03-29
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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UPA 5 mg
Ulipristal acetate (UPA) 5 mg tablet plus matching placebo 10 mg tablet, orally, once daily for 12 weeks.
Ulipristal acetate (UPA)
UPA tablet
Placebo
Matching placebo tablet.
UPA 10 mg
UPA 10 mg tablet plus matching placebo 5 mg tablet, orally, once daily for 12 weeks.
Ulipristal acetate (UPA)
UPA tablet
Placebo
Matching placebo tablet.
Placebo
Matching placebo tablets (5 mg and 10 mg), orally, once daily for 12 weeks.
Placebo
Matching placebo tablet.
Interventions
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Ulipristal acetate (UPA)
UPA tablet
Placebo
Matching placebo tablet.
Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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
18 Years
50 Years
FEMALE
No
Sponsors
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Allergan
INDUSTRY
Responsible Party
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Principal Investigators
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Anna Chan
Role: STUDY_DIRECTOR
Allergan
Locations
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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
Watson Investigational Site 108
Myrtle Beach, South Carolina, United States
Watson Investigational Site 101
Chattanooga, Tennessee, United States
Watson Investigational Site 126
Memphis, Tennessee, United States
Countries
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References
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Coyne KS, Harrington A, Currie BM, Chen J, Gillard P, Spies JB. Psychometric validation of the 1-month recall Uterine Fibroid Symptom and Health-Related Quality of Life questionnaire (UFS-QOL). J Patient Rep Outcomes. 2019 Aug 23;3(1):57. doi: 10.1186/s41687-019-0146-x.
Lukes AS, Soper D, Harrington A, Sniukiene V, Mo Y, Gillard P, Shulman L. Health-Related Quality of Life With Ulipristal Acetate for Treatment of Uterine Leiomyomas: A Randomized Controlled Trial. Obstet Gynecol. 2019 May;133(5):869-878. doi: 10.1097/AOG.0000000000003211.
Simon JA, Catherino W, Segars JH, Blakesley RE, Chan A, Sniukiene V, Al-Hendy A. Ulipristal Acetate for Treatment of Symptomatic Uterine Leiomyomas: A Randomized Controlled Trial. Obstet Gynecol. 2018 Mar;131(3):431-439. doi: 10.1097/AOG.0000000000002462.
Other Identifiers
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UL1309
Identifier Type: -
Identifier Source: org_study_id
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