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
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
1 other identifier
interventional
157
1 country
28
Brief Summary
This study will evaluate the superiority of ulipristal acetate versus placebo for the treatment of abnormal uterine bleeding associated with uterine fibroids
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Mar 2014
28 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 31, 2014
CompletedFirst Submitted
Initial submission to the registry
May 21, 2014
CompletedFirst Posted
Study publicly available on registry
May 26, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 29, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
March 29, 2016
CompletedResults Posted
Study results publicly available
April 5, 2019
CompletedApril 30, 2019
April 1, 2019
2 years
May 21, 2014
March 15, 2019
April 19, 2019
Conditions
Outcome Measures
Primary Outcomes (2)
Percentage of Participants With Absence of Bleeding During the Last 35 Consecutive Days on Treatment
Participants recorded bleeding in a daily diary. Absence of bleeding was defined as no bleeding days (i.e. no entries for bleeding or heavy bleeding; however, spotting was allowed), during the last 35 consecutive days on treatment in the 12-week Treatment Period.
Last 35 consecutive days on treatment in the 12-week Treatment Period
Time to Absence of Bleeding on Treatment
Time to absence of bleeding was defined as the duration in days from first dose to the first day in the time interval in which absence of bleeding occurs and persists through the last dose on treatment. The persistence of absence of bleeding occurred for a minimum of 35 consecutive days counting backward from the last dose on treatment in the 12-week Treatment Period.
From first dose up to the end of the 12-week Treatment Period
Secondary Outcomes (2)
Percentage of Participants With Absence of Bleeding From Day 11 Through the End of Treatment
Day 11 through the end of the 12-week Treatment Period
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
Baseline (Day 1-4) to the end of 12-week Treatment Period
Study Arms (3)
UPA 5 mg
EXPERIMENTALUlipristal acetate (UPA) 5 mg tablet plus matching placebo 10 mg tablet, orally, once daily for 12 weeks.
UPA 10 mg
EXPERIMENTALUPA 10 mg tablet plus matching placebo 5 mg tablet, orally, once daily for 12 weeks.
Placebo
PLACEBO COMPARATORMatching placebo tablets (5 mg and 10 mg), orally, once daily for 12 weeks.
Interventions
Eligibility Criteria
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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Allerganlead
Study Sites (28)
Watson Investigational Site 125
Tucson, Arizona, 85710, United States
Watson Investigational Site 102
San Diego, California, 92103, United States
Watson Investigational Site 112
Denver, Colorado, 80209, United States
Watson Investigational Site 115
Lakewood, Colorado, 80228, United States
Watson Investigational Site 116
Milford, Connecticut, 06460, United States
Watson Investigational Site 114
Washington D.C., District of Columbia, 20036, United States
Watson Investigational Site 106
Clearwater, Florida, 33765, United States
Watson Investigational Site 122
Lake Worth, Florida, 33461, United States
Watson Investigational Site 130
Miami, Florida, 33176, United States
Watson Investigational Site 105
New Port Richey, Florida, 34652, United States
Watson Investigational Site 104
Orlando, Florida, 32806, United States
Watson Investigational Site 120
Orlando, Florida, 32806, United States
Watson Investigational Site 103
Atlanta, Georgia, 30338, United States
Watson Investigational Site 123
Atlanta, Georgia, 30342, United States
Watson Investigational Site 111
Augusta, Georgia, 30912, United States
Watson Investigational Site 124
Idaho Falls, Idaho, 83404, United States
Watson Investigational Site 131
Brownsburg, Indiana, 46112, United States
Watson Investigational Site 129
Shawnee Mission, Kansas, 66218, United States
Watson Investigational Site 132
Metairie, Louisiana, 70006, United States
Watson Investigational Site 110
Norfolk, Nebraska, 68701, United States
Watson Investigational Site 113
Albuquerque, New Mexico, 87109, United States
Watson Investigational Site 121
Raleigh, North Carolina, 27607, United States
Watson Investigational Site 109
Winston-Salem, North Carolina, 27103, United States
Watson Investigational Site 107
Columbus, Ohio, 43231, United States
Watson Investigational Site 119
Jenkintown, Pennsylvania, 19046, United States
Watson Investigational Site 108
Myrtle Beach, South Carolina, 29572, United States
Watson Investigational Site 101
Chattanooga, Tennessee, 37404, United States
Watson Investigational Site 126
Memphis, Tennessee, 38119, United States
Related Publications (3)
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.
PMID: 31444600DERIVEDLukes 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.
PMID: 30969201DERIVEDSimon 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.
PMID: 29420395DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Therapeutic Area, Head
- Organization
- Allergan
Study Officials
- STUDY DIRECTOR
Anna Chan
Allergan
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 21, 2014
First Posted
May 26, 2014
Study Start
March 31, 2014
Primary Completion
March 29, 2016
Study Completion
March 29, 2016
Last Updated
April 30, 2019
Results First Posted
April 5, 2019
Record last verified: 2019-04