A Study of the Efficacy and Safety of Ulipristal Acetate Intermittent Treatment for Abnormal Uterine Bleeding Associated With Leiomyomas

Leiomyoma Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02147158
• Other study ID #: UL1208
• Status: Completed
• Phase: Phase 3
• Start date: January 29, 2014
• Est. completion date: November 24, 2016

Study information

• Verified date: May 2019
• Source: Allergan
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 432
• Est. completion date: November 24, 2016
• Est. primary completion date: November 24, 2016
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

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.

Related Conditions & MeSH terms

• Hemorrhage
• Leiomyoma
• Uterine Hemorrhage

Intervention

Drug:
• Ulipristal acetate (UPA)
Ulipristal acetate (UPA) tablet.
• Placebo
Matching placebo tablet.

Locations

Country	Name	City	State
Canada	Watson Investigational Site 140	Hamilton	Ontario
Canada	Watson Investigational Site 144	Ottawa	Ontario
United States	Watson Investigational Site 115	Albuquerque	New Mexico
United States	Watson Investigational Site 160	Atlanta	Georgia
United States	Watson Investigational Site 136	Bluffton	South Carolina
United States	Watson Investigational Site 155	Bronx	New York
United States	Watson Investigational Site 162	Brownsburg	Indiana
United States	Watson Investigational Site 113	Champaign	Illinois
United States	Watson Investigational Site 110	Charleston	South Carolina
United States	Watson Investigational Site 155	Cincinnati	Ohio
United States	Watson Investigational Site 131	Clearwater	Florida
United States	Watson Investigational Site 148	Cleveland	Ohio
United States	Watson Investigational Site 155	Cleveland	Ohio
United States	Watson Investigational Site 153	Columbia	South Carolina
United States	Watson Investigational Site 150	Covington	Louisiana
United States	Watson Investigational Site 122	Dallas	Texas
United States	Watson Investigational Site 159	Denver	Colorado
United States	Watson Investigational Site 126	Durham	North Carolina
United States	Watson Investigational Site 155	Encino	California
United States	Watson Investigational Site 139	Englewood	Ohio
United States	Watson Investigational Site 114	Frisco	Texas
United States	Watson Investigational Site 104	Granger	Indiana
United States	Watson Investigational Site 128	Greensboro	North Carolina
United States	Watson Investigational Site 154	Greenville	South Carolina
United States	Watson Investigational Site 157	Hawaiian Gardens	California
United States	Watson Investigational Site 109	Houston	Texas
United States	Watson Investigational Site 155	Houston	Texas
United States	Watson Investigational Site 155	Knoxville	Tennessee
United States	Watson Investigational Site 134	La Mesa	California
United States	Watson Investigational Site 107	Las Vegas	Nevada
United States	Watson Investigational Site 108	Las Vegas	Nevada
United States	Watson Investigational Site 111	Lawrenceville	New Jersey
United States	Watson Investigational Site 155	Little Rock	Arkansas
United States	Watson Investigational Site 138	Mesa	Arizona
United States	Watson Investigational Site 130	Metairie	Louisiana
United States	Watson Investigational Site 135	Miramar	Florida
United States	Watson Investigational Site 158	Moorestown	New Jersey
United States	Watson Investigational Site 145	New Bern	North Carolina
United States	Watson Investigational Site 116	New Orleans	Louisiana
United States	Watson Investigational Site 152	Norfolk	Virginia
United States	Watson Investigational Site 132	North Miami	Florida
United States	Watson Investigational Site 161	Orlando	Florida
United States	Watson Investigational Site 133	Philadelphia	Pennsylvania
United States	Watson Investigational Site 147	Phoenix	Arizona
United States	Watson investigational site 142	Pittsburgh	Pennsylvania
United States	Watson Investigational Site 123	Plantation	Florida
United States	Watson Investigational Site 146	Raleigh	North Carolina
United States	Watson Investigational Site 120	San Antonio	Texas
United States	Watson Investigational Site 127	San Diego	California
United States	Watson Investigational Site 151	San Diego	California
United States	Watson Investigational Site 103	Sandy Springs	Georgia
United States	Watson Investigational Site 112	Sarasota	Florida
United States	Watson Investigational Site 117	Savannah	Georgia
United States	Watson Investigational Site 119	Schaumburg	Illinois
United States	Watson Investigational Site 106	Scottsdale	Arizona
United States	Watson Investigational Site 121	Seattle	Washington
United States	Watson Investigational Site 124	Tucson	Arizona
United States	Watson Investigational Site 137	Virginia Beach	Virginia
United States	Watson Investigational Site 129	Webster	Texas
United States	Watson Investigational Site 102	Wellington	Florida
United States	Watson Investigational Site 101	West Palm Beach	Florida
United States	Watson Investigational Site 105	West Reading	Pennsylvania
United States	Watson Investigational Site 118	Winston-Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Allergan

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Participants With Absence of Bleeding During the Last 35 Consecutive Days on Treatment in Treatment Course 1	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 Treatment Course 1.	Last 35 consecutive days on treatment in the 12-Week Treatment Course 1
Primary	Time to Absence of Bleeding on Treatment During Treatment Course 1	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 in the first treatment course. The persistence of absence of bleeding occurred for a minimum of 35 consecutive days counting backward from the last dose in Treatment Course 1.	From first dose up to the end of the 12-Week Treatment Course 1
Secondary	Percentage of Participants With Absence of Bleeding From Day 11 Through the End of Treatment Course 1	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), from Day 11 to the end of treatment in Treatment Course 1.	Day 11 through the end of treatment in the 12-Week Treatment Course 1
Secondary	Percentage of Participants With Absence of Bleeding During the Last 35 Consecutive Days on Treatment in Treatment Course 2	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 Treatment Course 2.	Last 35 consecutive days on treatment in the 12-Week Treatment Course 2
Secondary	Time to Absence of Bleeding on Treatment During Treatment Course 2	Time to absence of bleeding is defined as the duration in days from first dose in treatment course 2 to the first day in the time interval in which absence of bleeding occurs and persists through the last dose in the second treatment course. The persistence of absence of bleeding occurred for a minimum of 35 consecutive days counting backward from the last dose in Treatment Course 2.	From first dose up to the end of treatment in the 12-Week Treatment Course 2
Secondary	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	The UFS-QOL is a uterine fibroid-specific questionnaire consisting of 37 questions developed to evaluate symptoms of uterine fibroids and their impact on health-related quality of life in women with leiomyomas. The first 8 questions comprise the Symptom Severity subscale to assess symptoms experienced by women with uterine leiomyomas, the remaining 29 questions comprise 6 subscales (Concern, Activities, Energy/mood, Control, Self-consciousness, Sexual Function) which overall deal with women's feelings and experiences regarding impact of uterine leiomyoma symptoms on her life. Each item is scored between 1 and 5, where 1=none of the time or not at all and 5=all of the time or a very great deal. A Revised Activities subscale was created to include the most relevant items pertaining to physical and social activities with a total possible score of 0 to 100. Higher Revised Activities subscale scores indicate less impact on activities. A positive change from Baseline indicates improvement.	Baseline (Day 1-4) to End of 12-Week Treatment Course 1