Clinical trial NCT02147158: A Study of the Efficacy and Safety of Ulipristal Acetate Intermittent Treatment for Abnormal Uterine Bleeding Associated With Leiomyomas
Official title: A Randomized, Placebo-Controlled, Parallel Group, Multicenter Study to Evaluate the Efficacy and Safety of Ulipristal Acetate for the Intermittent Treatment of Abnormal Uterine Bleeding Associated With Leiomyomas
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Leiomyoma
Uterine Hemorrhage
Lead sponsor: Allergan
Sponsor class: INDUSTRY
First posted: 2014-05-26
Enrollment: 432
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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


Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Percentage of Participants With Absence of Bleeding During the Last 35 Consecutive Days on Treatment in Treatment Course 1
timeFrame: Last 35 consecutive days on treatment in the 12-Week Treatment Course 1
measure: Time to Absence of Bleeding on Treatment During Treatment Course 1
timeFrame: From first dose up to the end of the 12-Week Treatment Course 1
Secondary outcomes:
measure: Percentage of Participants With Absence of Bleeding From Day 11 Through the End of Treatment Course 1
timeFrame: Day 11 through the end of treatment in the 12-Week Treatment Course 1
measure: Percentage of Participants With Absence of Bleeding During the Last 35 Consecutive Days on Treatment in Treatment Course 2
timeFrame: Last 35 consecutive days on treatment in the 12-Week Treatment Course 2
measure: Time to Absence of Bleeding on Treatment During Treatment Course 2
timeFrame: From first dose up to the end of treatment in the 12-Week Treatment Course 2
measure: Change From Baseline in Uterine Fibroid Symptom and Health-Related Quality of Life Questionnaire (UFS-QOL) Revised Activities Subscale Score at the End of Treatment Course 1
timeFrame: Baseline (Day 1-4) to End of 12-Week Treatment Course 1
Other outcomes:
Locations:
city: Mesa
country: United States
facility: Watson Investigational Site 138
state: Arizona
city: Phoenix
country: United States
facility: Watson Investigational Site 147
state: Arizona
city: Scottsdale
country: United States
facility: Watson Investigational Site 106
state: Arizona
city: Tucson
country: United States
facility: Watson Investigational Site 124
state: Arizona
city: Little Rock
country: United States
facility: Watson Investigational Site 155
state: Arkansas
city: Encino
country: United States
facility: Watson Investigational Site 155
state: California
city: Hawaiian Gardens
country: United States
facility: Watson Investigational Site 157
state: California
city: La Mesa
country: United States
facility: Watson Investigational Site 134
state: California
city: San Diego
country: United States
facility: Watson Investigational Site 127
state: California
city: San Diego
country: United States
facility: Watson Investigational Site 151
state: California
city: Denver
country: United States
facility: Watson Investigational Site 159
state: Colorado
city: Clearwater
country: United States
facility: Watson Investigational Site 131
state: Florida
city: Miramar
country: United States
facility: Watson Investigational Site 135
state: Florida
city: North Miami
country: United States
facility: Watson Investigational Site 132
state: Florida
city: Orlando
country: United States
facility: Watson Investigational Site 161
state: Florida
city: Plantation
country: United States
facility: Watson Investigational Site 123
state: Florida
city: Sarasota
country: United States
facility: Watson Investigational Site 112
state: Florida
city: Wellington
country: United States
facility: Watson Investigational Site 102
state: Florida
city: West Palm Beach
country: United States
facility: Watson Investigational Site 101
state: Florida
city: Atlanta
country: United States
facility: Watson Investigational Site 160
state: Georgia
city: Sandy Springs
country: United States
facility: Watson Investigational Site 103
state: Georgia
city: Savannah
country: United States
facility: Watson Investigational Site 117
state: Georgia
city: Champaign
country: United States
facility: Watson Investigational Site 113
state: Illinois
city: Schaumburg
country: United States
facility: Watson Investigational Site 119
state: Illinois
city: Brownsburg
country: United States
facility: Watson Investigational Site 162
state: Indiana
city: Granger
country: United States
facility: Watson Investigational Site 104
state: Indiana
city: Covington
country: United States
facility: Watson Investigational Site 150
state: Louisiana
city: Metairie
country: United States
facility: Watson Investigational Site 130
state: Louisiana
city: New Orleans
country: United States
facility: Watson Investigational Site 116
state: Louisiana
city: Las Vegas
country: United States
facility: Watson Investigational Site 108
state: Nevada
city: Las Vegas
country: United States
facility: Watson Investigational Site 107
state: Nevada
city: Lawrenceville
country: United States
facility: Watson Investigational Site 111
state: New Jersey
city: Moorestown
country: United States
facility: Watson Investigational Site 158
state: New Jersey
city: Albuquerque
country: United States
facility: Watson Investigational Site 115
state: New Mexico
city: Bronx
country: United States
facility: Watson Investigational Site 155
state: New York
city: Durham
country: United States
facility: Watson Investigational Site 126
state: North Carolina
city: Greensboro
country: United States
facility: Watson Investigational Site 128
state: North Carolina
city: New Bern
country: United States
facility: Watson Investigational Site 145
state: North Carolina
city: Raleigh
country: United States
facility: Watson Investigational Site 146
state: North Carolina
city: Winston-Salem
country: United States
facility: Watson Investigational Site 118
state: North Carolina
city: Cincinnati
country: United States
facility: Watson Investigational Site 155
state: Ohio
city: Cleveland
country: United States
facility: Watson Investigational Site 155
state: Ohio
city: Cleveland
country: United States
facility: Watson Investigational Site 148
state: Ohio
city: Englewood
country: United States
facility: Watson Investigational Site 139
state: Ohio
city: Philadelphia
country: United States
facility: Watson Investigational Site 133
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Watson investigational site 142
state: Pennsylvania
city: West Reading
country: United States
facility: Watson Investigational Site 105
state: Pennsylvania
city: Bluffton
country: United States
facility: Watson Investigational Site 136
state: South Carolina
city: Charleston
country: United States
facility: Watson Investigational Site 110
state: South Carolina
city: Columbia
country: United States
facility: Watson Investigational Site 153
state: South Carolina
city: Greenville
country: United States
facility: Watson Investigational Site 154
state: South Carolina
city: Knoxville
country: United States
facility: Watson Investigational Site 155
state: Tennessee
city: Dallas
country: United States
facility: Watson Investigational Site 122
state: Texas
city: Frisco
country: United States
facility: Watson Investigational Site 114
state: Texas
city: Houston
country: United States
facility: Watson Investigational Site 109
state: Texas
city: Houston
country: United States
facility: Watson Investigational Site 155
state: Texas
city: San Antonio
country: United States
facility: Watson Investigational Site 120
state: Texas
city: Webster
country: United States
facility: Watson Investigational Site 129
state: Texas
city: Norfolk
country: United States
facility: Watson Investigational Site 152
state: Virginia
city: Virginia Beach
country: United States
facility: Watson Investigational Site 137
state: Virginia
city: Seattle
country: United States
facility: Watson Investigational Site 121
state: Washington
city: Hamilton
country: Canada
facility: Watson Investigational Site 140
state: Ontario
city: Ottawa
country: Canada
facility: Watson Investigational Site 144
state: Ontario
Study officials:
affiliation: Allergan
name: Anna Chan
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.
citation: Liu JH, Soper D, Lukes A, Gee P, Kimble T, Kroll R, Mallick M, Chan A, Gillard P, Harrington A, Sniukiene V, Shulman LP. Ulipristal Acetate for Treatment of Uterine Leiomyomas: A Randomized Controlled Trial. Obstet Gynecol. 2018 Nov;132(5):1241-1251. doi: 10.1097/AOG.0000000000002942.