Clinical trial NCT02147197: 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
Official title: A Randomized, Placebo-Controlled, Parallel Group, Multicenter Study to Evaluate the Efficacy and Safety of Ulipristal Acetate for the 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: 157
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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:

* 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

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 rang

Primary outcomes:
measure: Percentage of Participants With Absence of Bleeding During the Last 35 Consecutive Days on Treatment
timeFrame: Last 35 consecutive days on treatment in the 12-week Treatment Period
measure: Time to Absence of Bleeding on Treatment
timeFrame: From first dose up to the end of the 12-week Treatment Period
Secondary outcomes:
measure: Percentage of Participants With Absence of Bleeding From Day 11 Through the End of Treatment
timeFrame: Day 11 through the end of the 12-week Treatment Period
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 Period
timeFrame: Baseline (Day 1-4) to the end of 12-week Treatment Period
Other outcomes:
Locations:
city: Tucson
country: United States
facility: Watson Investigational Site 125
state: Arizona
city: San Diego
country: United States
facility: Watson Investigational Site 102
state: California
city: Denver
country: United States
facility: Watson Investigational Site 112
state: Colorado
city: Lakewood
country: United States
facility: Watson Investigational Site 115
state: Colorado
city: Milford
country: United States
facility: Watson Investigational Site 116
state: Connecticut
city: Washington
country: United States
facility: Watson Investigational Site 114
state: District of Columbia
city: Clearwater
country: United States
facility: Watson Investigational Site 106
state: Florida
city: Lake Worth
country: United States
facility: Watson Investigational Site 122
state: Florida
city: Miami
country: United States
facility: Watson Investigational Site 130
state: Florida
city: New Port Richey
country: United States
facility: Watson Investigational Site 105
state: Florida
city: Orlando
country: United States
facility: Watson Investigational Site 104
state: Florida
city: Orlando
country: United States
facility: Watson Investigational Site 120
state: Florida
city: Atlanta
country: United States
facility: Watson Investigational Site 103
state: Georgia
city: Atlanta
country: United States
facility: Watson Investigational Site 123
state: Georgia
city: Augusta
country: United States
facility: Watson Investigational Site 111
state: Georgia
city: Idaho Falls
country: United States
facility: Watson Investigational Site 124
state: Idaho
city: Brownsburg
country: United States
facility: Watson Investigational Site 131
state: Indiana
city: Shawnee Mission
country: United States
facility: Watson Investigational Site 129
state: Kansas
city: Metairie
country: United States
facility: Watson Investigational Site 132
state: Louisiana
city: Norfolk
country: United States
facility: Watson Investigational Site 110
state: Nebraska
city: Albuquerque
country: United States
facility: Watson Investigational Site 113
state: New Mexico
city: Raleigh
country: United States
facility: Watson Investigational Site 121
state: North Carolina
city: Winston-Salem
country: United States
facility: Watson Investigational Site 109
state: North Carolina
city: Columbus
country: United States
facility: Watson Investigational Site 107
state: Ohio
city: Jenkintown
country: United States
facility: Watson Investigational Site 119
state: Pennsylvania
city: Myrtle Beach
country: United States
facility: Watson Investigational Site 108
state: South Carolina
city: Chattanooga
country: United States
facility: Watson Investigational Site 101
state: Tennessee
city: Memphis
country: United States
facility: Watson Investigational Site 126
state: Tennessee
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: 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.