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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

Primary Purpose

Leiomyoma, Uterine Hemorrhage

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Ulipristal acetate (UPA)
Placebo
Sponsored by
Allergan
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Leiomyoma

Eligibility Criteria

18 Years - 50 Years (Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Watson Investigational Site 125
  • Watson Investigational Site 102
  • Watson Investigational Site 112
  • Watson Investigational Site 115
  • Watson Investigational Site 116
  • Watson Investigational Site 114
  • Watson Investigational Site 106
  • Watson Investigational Site 122
  • Watson Investigational Site 130
  • Watson Investigational Site 105
  • Watson Investigational Site 104
  • Watson Investigational Site 120
  • Watson Investigational Site 103
  • Watson Investigational Site 123
  • Watson Investigational Site 111
  • Watson Investigational Site 124
  • Watson Investigational Site 131
  • Watson Investigational Site 129
  • Watson Investigational Site 132
  • Watson Investigational Site 110
  • Watson Investigational Site 113
  • Watson Investigational Site 121
  • Watson Investigational Site 109
  • Watson Investigational Site 107
  • Watson Investigational Site 119
  • Watson Investigational Site 108
  • Watson Investigational Site 101
  • Watson Investigational Site 126

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Placebo Comparator

Arm Label

UPA 5 mg

UPA 10 mg

Placebo

Arm Description

Ulipristal acetate (UPA) 5 mg tablet plus matching placebo 10 mg tablet, orally, once daily for 12 weeks.

UPA 10 mg tablet plus matching placebo 5 mg tablet, orally, once daily for 12 weeks.

Matching placebo tablets (5 mg and 10 mg), orally, once daily for 12 weeks.

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

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.
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.

Full Information

First Posted
May 21, 2014
Last Updated
April 19, 2019
Sponsor
Allergan
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1. Study Identification

Unique Protocol Identification Number
NCT02147197
Brief Title
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

2. Study Status

Record Verification Date
April 2019
Overall Recruitment Status
Completed
Study Start Date
March 31, 2014 (Actual)
Primary Completion Date
March 29, 2016 (Actual)
Study Completion Date
March 29, 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Allergan

4. Oversight

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Leiomyoma, Uterine Hemorrhage

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
157 (Actual)

8. Arms, Groups, and Interventions

Arm Title
UPA 5 mg
Arm Type
Experimental
Arm Description
Ulipristal acetate (UPA) 5 mg tablet plus matching placebo 10 mg tablet, orally, once daily for 12 weeks.
Arm Title
UPA 10 mg
Arm Type
Experimental
Arm Description
UPA 10 mg tablet plus matching placebo 5 mg tablet, orally, once daily for 12 weeks.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Matching placebo tablets (5 mg and 10 mg), orally, once daily for 12 weeks.
Intervention Type
Drug
Intervention Name(s)
Ulipristal acetate (UPA)
Intervention Description
UPA tablet
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Matching placebo tablet.
Primary Outcome Measure Information:
Title
Percentage of Participants With Absence of Bleeding During the Last 35 Consecutive Days on Treatment
Description
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.
Time Frame
Last 35 consecutive days on treatment in the 12-week Treatment Period
Title
Time to Absence of Bleeding on Treatment
Description
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.
Time Frame
From first dose up to the end of the 12-week Treatment Period
Secondary Outcome Measure Information:
Title
Percentage of Participants With Absence of Bleeding From Day 11 Through the End of Treatment
Description
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.
Time Frame
Day 11 through the end of the 12-week Treatment Period
Title
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
Description
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.
Time Frame
Baseline (Day 1-4) to the end of 12-week Treatment Period

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
Females with abnormal uterine bleeding associated with leiomyomas were treated in this study.
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anna Chan
Organizational Affiliation
Allergan
Official's Role
Study Director
Facility Information:
Facility Name
Watson Investigational Site 125
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85710
Country
United States
Facility Name
Watson Investigational Site 102
City
San Diego
State/Province
California
ZIP/Postal Code
92103
Country
United States
Facility Name
Watson Investigational Site 112
City
Denver
State/Province
Colorado
ZIP/Postal Code
80209
Country
United States
Facility Name
Watson Investigational Site 115
City
Lakewood
State/Province
Colorado
ZIP/Postal Code
80228
Country
United States
Facility Name
Watson Investigational Site 116
City
Milford
State/Province
Connecticut
ZIP/Postal Code
06460
Country
United States
Facility Name
Watson Investigational Site 114
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20036
Country
United States
Facility Name
Watson Investigational Site 106
City
Clearwater
State/Province
Florida
ZIP/Postal Code
33765
Country
United States
Facility Name
Watson Investigational Site 122
City
Lake Worth
State/Province
Florida
ZIP/Postal Code
33461
Country
United States
Facility Name
Watson Investigational Site 130
City
Miami
State/Province
Florida
ZIP/Postal Code
33176
Country
United States
Facility Name
Watson Investigational Site 105
City
New Port Richey
State/Province
Florida
ZIP/Postal Code
34652
Country
United States
Facility Name
Watson Investigational Site 104
City
Orlando
State/Province
Florida
ZIP/Postal Code
32806
Country
United States
Facility Name
Watson Investigational Site 120
City
Orlando
State/Province
Florida
ZIP/Postal Code
32806
Country
United States
Facility Name
Watson Investigational Site 103
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30338
Country
United States
Facility Name
Watson Investigational Site 123
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30342
Country
United States
Facility Name
Watson Investigational Site 111
City
Augusta
State/Province
Georgia
ZIP/Postal Code
30912
Country
United States
Facility Name
Watson Investigational Site 124
City
Idaho Falls
State/Province
Idaho
ZIP/Postal Code
83404
Country
United States
Facility Name
Watson Investigational Site 131
City
Brownsburg
State/Province
Indiana
ZIP/Postal Code
46112
Country
United States
Facility Name
Watson Investigational Site 129
City
Shawnee Mission
State/Province
Kansas
ZIP/Postal Code
66218
Country
United States
Facility Name
Watson Investigational Site 132
City
Metairie
State/Province
Louisiana
ZIP/Postal Code
70006
Country
United States
Facility Name
Watson Investigational Site 110
City
Norfolk
State/Province
Nebraska
ZIP/Postal Code
68701
Country
United States
Facility Name
Watson Investigational Site 113
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87109
Country
United States
Facility Name
Watson Investigational Site 121
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27607
Country
United States
Facility Name
Watson Investigational Site 109
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27103
Country
United States
Facility Name
Watson Investigational Site 107
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43231
Country
United States
Facility Name
Watson Investigational Site 119
City
Jenkintown
State/Province
Pennsylvania
ZIP/Postal Code
19046
Country
United States
Facility Name
Watson Investigational Site 108
City
Myrtle Beach
State/Province
South Carolina
ZIP/Postal Code
29572
Country
United States
Facility Name
Watson Investigational Site 101
City
Chattanooga
State/Province
Tennessee
ZIP/Postal Code
37404
Country
United States
Facility Name
Watson Investigational Site 126
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38119
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
31444600
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.
Results Reference
derived
PubMed Identifier
30969201
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.
Results Reference
derived
PubMed Identifier
29420395
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.
Results Reference
derived

Learn more about this trial

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

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