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

Leiomyoma Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02147197
• Other study ID #: UL1309
• Status: Completed
• Phase: Phase 3
• Start date: March 31, 2014
• Est. completion date: March 29, 2016

Study information

• Verified date: April 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: 157
• Est. completion date: March 29, 2016
• Est. primary completion date: March 29, 2016
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Hemorrhage
• Leiomyoma
• Uterine Hemorrhage

Intervention

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

Locations

Country	Name	City	State
United States	Watson Investigational Site 113	Albuquerque	New Mexico
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 131	Brownsburg	Indiana
United States	Watson Investigational Site 101	Chattanooga	Tennessee
United States	Watson Investigational Site 106	Clearwater	Florida
United States	Watson Investigational Site 107	Columbus	Ohio
United States	Watson Investigational Site 112	Denver	Colorado
United States	Watson Investigational Site 124	Idaho Falls	Idaho
United States	Watson Investigational Site 119	Jenkintown	Pennsylvania
United States	Watson Investigational Site 122	Lake Worth	Florida
United States	Watson Investigational Site 115	Lakewood	Colorado
United States	Watson Investigational Site 126	Memphis	Tennessee
United States	Watson Investigational Site 132	Metairie	Louisiana
United States	Watson Investigational Site 130	Miami	Florida
United States	Watson Investigational Site 116	Milford	Connecticut
United States	Watson Investigational Site 108	Myrtle Beach	South Carolina
United States	Watson Investigational Site 105	New Port Richey	Florida
United States	Watson Investigational Site 110	Norfolk	Nebraska
United States	Watson Investigational Site 104	Orlando	Florida
United States	Watson Investigational Site 120	Orlando	Florida
United States	Watson Investigational Site 121	Raleigh	North Carolina
United States	Watson Investigational Site 102	San Diego	California
United States	Watson Investigational Site 129	Shawnee Mission	Kansas
United States	Watson Investigational Site 125	Tucson	Arizona
United States	Watson Investigational Site 114	Washington	District of Columbia
United States	Watson Investigational Site 109	Winston-Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Allergan

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Percentage of Participants With Absence of Bleeding From Day 11 Through the End of 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), starting from Day 11 through the end of the 12-week Treatment Period.	Day 11 through the end of the 12-week Treatment Period
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 Period	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 the end of 12-week Treatment Period