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

Primary Purpose

Leiomyoma, Uterine Hemorrhage

Status
Completed
Phase
Phase 3
Locations
International
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:

  • 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.

Sites / Locations

  • Watson Investigational Site 138
  • Watson Investigational Site 147
  • Watson Investigational Site 106
  • Watson Investigational Site 124
  • Watson Investigational Site 155
  • Watson Investigational Site 155
  • Watson Investigational Site 157
  • Watson Investigational Site 134
  • Watson Investigational Site 127
  • Watson Investigational Site 151
  • Watson Investigational Site 159
  • Watson Investigational Site 131
  • Watson Investigational Site 135
  • Watson Investigational Site 132
  • Watson Investigational Site 161
  • Watson Investigational Site 123
  • Watson Investigational Site 112
  • Watson Investigational Site 102
  • Watson Investigational Site 101
  • Watson Investigational Site 160
  • Watson Investigational Site 103
  • Watson Investigational Site 117
  • Watson Investigational Site 113
  • Watson Investigational Site 119
  • Watson Investigational Site 162
  • Watson Investigational Site 104
  • Watson Investigational Site 150
  • Watson Investigational Site 130
  • Watson Investigational Site 116
  • Watson Investigational Site 108
  • Watson Investigational Site 107
  • Watson Investigational Site 111
  • Watson Investigational Site 158
  • Watson Investigational Site 115
  • Watson Investigational Site 155
  • Watson Investigational Site 126
  • Watson Investigational Site 128
  • Watson Investigational Site 145
  • Watson Investigational Site 146
  • Watson Investigational Site 118
  • Watson Investigational Site 155
  • Watson Investigational Site 155
  • Watson Investigational Site 148
  • Watson Investigational Site 139
  • Watson Investigational Site 133
  • Watson investigational site 142
  • Watson Investigational Site 105
  • Watson Investigational Site 136
  • Watson Investigational Site 110
  • Watson Investigational Site 153
  • Watson Investigational Site 154
  • Watson Investigational Site 155
  • Watson Investigational Site 122
  • Watson Investigational Site 114
  • Watson Investigational Site 109
  • Watson Investigational Site 155
  • Watson Investigational Site 120
  • Watson Investigational Site 129
  • Watson Investigational Site 152
  • Watson Investigational Site 137
  • Watson Investigational Site 121
  • Watson Investigational Site 140
  • Watson Investigational Site 144

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm Type

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Arm Label

UPA 5 mg:Placebo

UPA 10 mg:Placebo

UPA 5 mg:UPA 5 mg

UPA 10 mg:UPA 10 mg

Placebo:UPA 5 mg

Placebo:UPA 10 mg

Arm Description

Ulipristal Acetate (UPA) 5 mg tablet plus matching placebo 10 mg tablet, orally, once daily for 12 weeks in Treatment Course 1; followed by a 2 menses drug-free interval; followed by matching placebo tablets (5 mg and 10 mg), orally, once daily for 12 weeks in Treatment Course 2.

UPA 10 mg tablet plus matching placebo 5 mg tablet, orally, once daily for 12 weeks in Treatment Course 1; followed by a 2 menses drug-free interval; followed by matching placebo tablets (5 mg and 10 mg), orally, once daily for 12 weeks in Treatment Course 2.

UPA 5 mg tablet plus matching placebo 10 mg tablet, orally, once daily in both Treatment Course 1 and Treatment Course 2. There was a 2 menses drug-free interval in between courses.

UPA 10 mg tablet plus matching placebo 5 mg tablet, orally, once daily in both Treatment Course 1 and Treatment Course 2. There was a 2 menses drug-free interval in between courses.

Matching placebo tablets (5 mg and 10 mg) orally, once daily for 12 weeks in Treatment Course 1; followed by a 2 menses drug-free interval; followed by UPA 5 mg tablet plus matching placebo 10 mg tablet, orally, once daily for 12 weeks in Treatment Course 2.

Matching placebo tablets (5 mg and 10 mg), orally, once daily for 12 weeks in Treatment Course 1; followed by a 2 menses drug-free interval; followed by UPA 10 mg tablet plus matching placebo 5 mg tablet, orally, once daily for 12 weeks in Treatment Course 2.

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

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.
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.
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.
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.

Full Information

First Posted
May 10, 2014
Last Updated
May 15, 2019
Sponsor
Allergan
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1. Study Identification

Unique Protocol Identification Number
NCT02147158
Brief Title
A Study of the Efficacy and Safety of Ulipristal Acetate Intermittent Treatment for 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 Intermittent Treatment of Abnormal Uterine Bleeding Associated With Leiomyomas
Study Type
Interventional

2. Study Status

Record Verification Date
May 2019
Overall Recruitment Status
Completed
Study Start Date
January 29, 2014 (Actual)
Primary Completion Date
November 24, 2016 (Actual)
Study Completion Date
November 24, 2016 (Actual)

3. Sponsor/Collaborators

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

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

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
Crossover Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
432 (Actual)

8. Arms, Groups, and Interventions

Arm Title
UPA 5 mg:Placebo
Arm Type
Experimental
Arm Description
Ulipristal Acetate (UPA) 5 mg tablet plus matching placebo 10 mg tablet, orally, once daily for 12 weeks in Treatment Course 1; followed by a 2 menses drug-free interval; followed by matching placebo tablets (5 mg and 10 mg), orally, once daily for 12 weeks in Treatment Course 2.
Arm Title
UPA 10 mg:Placebo
Arm Type
Experimental
Arm Description
UPA 10 mg tablet plus matching placebo 5 mg tablet, orally, once daily for 12 weeks in Treatment Course 1; followed by a 2 menses drug-free interval; followed by matching placebo tablets (5 mg and 10 mg), orally, once daily for 12 weeks in Treatment Course 2.
Arm Title
UPA 5 mg:UPA 5 mg
Arm Type
Experimental
Arm Description
UPA 5 mg tablet plus matching placebo 10 mg tablet, orally, once daily in both Treatment Course 1 and Treatment Course 2. There was a 2 menses drug-free interval in between courses.
Arm Title
UPA 10 mg:UPA 10 mg
Arm Type
Experimental
Arm Description
UPA 10 mg tablet plus matching placebo 5 mg tablet, orally, once daily in both Treatment Course 1 and Treatment Course 2. There was a 2 menses drug-free interval in between courses.
Arm Title
Placebo:UPA 5 mg
Arm Type
Experimental
Arm Description
Matching placebo tablets (5 mg and 10 mg) orally, once daily for 12 weeks in Treatment Course 1; followed by a 2 menses drug-free interval; followed by UPA 5 mg tablet plus matching placebo 10 mg tablet, orally, once daily for 12 weeks in Treatment Course 2.
Arm Title
Placebo:UPA 10 mg
Arm Type
Experimental
Arm Description
Matching placebo tablets (5 mg and 10 mg), orally, once daily for 12 weeks in Treatment Course 1; followed by a 2 menses drug-free interval; followed by UPA 10 mg tablet plus matching placebo 5 mg tablet, orally, once daily for 12 weeks in Treatment Course 2.
Intervention Type
Drug
Intervention Name(s)
Ulipristal acetate (UPA)
Intervention Description
Ulipristal acetate (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 in Treatment Course 1
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 Treatment Course 1.
Time Frame
Last 35 consecutive days on treatment in the 12-Week Treatment Course 1
Title
Time to Absence of Bleeding on Treatment During Treatment Course 1
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 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.
Time Frame
From first dose up to the end of the 12-Week Treatment Course 1
Secondary Outcome Measure Information:
Title
Percentage of Participants With Absence of Bleeding From Day 11 Through the End of Treatment Course 1
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), from Day 11 to the end of treatment in Treatment Course 1.
Time Frame
Day 11 through the end of treatment in the 12-Week Treatment Course 1
Title
Percentage of Participants With Absence of Bleeding During the Last 35 Consecutive Days on Treatment in Treatment Course 2
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 Treatment Course 2.
Time Frame
Last 35 consecutive days on treatment in the 12-Week Treatment Course 2
Title
Time to Absence of Bleeding on Treatment During Treatment Course 2
Description
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.
Time Frame
From first dose up to the end of treatment in the 12-Week Treatment Course 2
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 Course 1
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 End of 12-Week Treatment Course 1

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
Females suffering 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: 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.
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 138
City
Mesa
State/Province
Arizona
ZIP/Postal Code
85209
Country
United States
Facility Name
Watson Investigational Site 147
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85032
Country
United States
Facility Name
Watson Investigational Site 106
City
Scottsdale
State/Province
Arizona
ZIP/Postal Code
85251
Country
United States
Facility Name
Watson Investigational Site 124
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85712
Country
United States
Facility Name
Watson Investigational Site 155
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72205
Country
United States
Facility Name
Watson Investigational Site 155
City
Encino
State/Province
California
ZIP/Postal Code
91436
Country
United States
Facility Name
Watson Investigational Site 157
City
Hawaiian Gardens
State/Province
California
ZIP/Postal Code
90716
Country
United States
Facility Name
Watson Investigational Site 134
City
La Mesa
State/Province
California
ZIP/Postal Code
91942
Country
United States
Facility Name
Watson Investigational Site 127
City
San Diego
State/Province
California
ZIP/Postal Code
92111
Country
United States
Facility Name
Watson Investigational Site 151
City
San Diego
State/Province
California
ZIP/Postal Code
92114
Country
United States
Facility Name
Watson Investigational Site 159
City
Denver
State/Province
Colorado
ZIP/Postal Code
80209
Country
United States
Facility Name
Watson Investigational Site 131
City
Clearwater
State/Province
Florida
ZIP/Postal Code
33759
Country
United States
Facility Name
Watson Investigational Site 135
City
Miramar
State/Province
Florida
ZIP/Postal Code
33027
Country
United States
Facility Name
Watson Investigational Site 132
City
North Miami
State/Province
Florida
ZIP/Postal Code
33161
Country
United States
Facility Name
Watson Investigational Site 161
City
Orlando
State/Province
Florida
ZIP/Postal Code
32806
Country
United States
Facility Name
Watson Investigational Site 123
City
Plantation
State/Province
Florida
ZIP/Postal Code
33324
Country
United States
Facility Name
Watson Investigational Site 112
City
Sarasota
State/Province
Florida
ZIP/Postal Code
34239
Country
United States
Facility Name
Watson Investigational Site 102
City
Wellington
State/Province
Florida
ZIP/Postal Code
33414
Country
United States
Facility Name
Watson Investigational Site 101
City
West Palm Beach
State/Province
Florida
ZIP/Postal Code
33409
Country
United States
Facility Name
Watson Investigational Site 160
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30342
Country
United States
Facility Name
Watson Investigational Site 103
City
Sandy Springs
State/Province
Georgia
ZIP/Postal Code
30328
Country
United States
Facility Name
Watson Investigational Site 117
City
Savannah
State/Province
Georgia
ZIP/Postal Code
31406
Country
United States
Facility Name
Watson Investigational Site 113
City
Champaign
State/Province
Illinois
ZIP/Postal Code
61820
Country
United States
Facility Name
Watson Investigational Site 119
City
Schaumburg
State/Province
Illinois
ZIP/Postal Code
60173
Country
United States
Facility Name
Watson Investigational Site 162
City
Brownsburg
State/Province
Indiana
ZIP/Postal Code
46112
Country
United States
Facility Name
Watson Investigational Site 104
City
Granger
State/Province
Indiana
ZIP/Postal Code
46530
Country
United States
Facility Name
Watson Investigational Site 150
City
Covington
State/Province
Louisiana
ZIP/Postal Code
70433
Country
United States
Facility Name
Watson Investigational Site 130
City
Metairie
State/Province
Louisiana
ZIP/Postal Code
70001
Country
United States
Facility Name
Watson Investigational Site 116
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70115
Country
United States
Facility Name
Watson Investigational Site 108
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89109
Country
United States
Facility Name
Watson Investigational Site 107
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89128
Country
United States
Facility Name
Watson Investigational Site 111
City
Lawrenceville
State/Province
New Jersey
ZIP/Postal Code
08648
Country
United States
Facility Name
Watson Investigational Site 158
City
Moorestown
State/Province
New Jersey
ZIP/Postal Code
08057
Country
United States
Facility Name
Watson Investigational Site 115
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87109
Country
United States
Facility Name
Watson Investigational Site 155
City
Bronx
State/Province
New York
ZIP/Postal Code
10461
Country
United States
Facility Name
Watson Investigational Site 126
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27713
Country
United States
Facility Name
Watson Investigational Site 128
City
Greensboro
State/Province
North Carolina
ZIP/Postal Code
27408
Country
United States
Facility Name
Watson Investigational Site 145
City
New Bern
State/Province
North Carolina
ZIP/Postal Code
28562
Country
United States
Facility Name
Watson Investigational Site 146
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27612
Country
United States
Facility Name
Watson Investigational Site 118
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27103
Country
United States
Facility Name
Watson Investigational Site 155
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45267
Country
United States
Facility Name
Watson Investigational Site 155
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106
Country
United States
Facility Name
Watson Investigational Site 148
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44122
Country
United States
Facility Name
Watson Investigational Site 139
City
Englewood
State/Province
Ohio
ZIP/Postal Code
45322
Country
United States
Facility Name
Watson Investigational Site 133
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19114
Country
United States
Facility Name
Watson investigational site 142
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15206
Country
United States
Facility Name
Watson Investigational Site 105
City
West Reading
State/Province
Pennsylvania
ZIP/Postal Code
19611
Country
United States
Facility Name
Watson Investigational Site 136
City
Bluffton
State/Province
South Carolina
ZIP/Postal Code
29910
Country
United States
Facility Name
Watson Investigational Site 110
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States
Facility Name
Watson Investigational Site 153
City
Columbia
State/Province
South Carolina
ZIP/Postal Code
29201
Country
United States
Facility Name
Watson Investigational Site 154
City
Greenville
State/Province
South Carolina
ZIP/Postal Code
29615
Country
United States
Facility Name
Watson Investigational Site 155
City
Knoxville
State/Province
Tennessee
ZIP/Postal Code
37920
Country
United States
Facility Name
Watson Investigational Site 122
City
Dallas
State/Province
Texas
ZIP/Postal Code
75231
Country
United States
Facility Name
Watson Investigational Site 114
City
Frisco
State/Province
Texas
ZIP/Postal Code
75035
Country
United States
Facility Name
Watson Investigational Site 109
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Watson Investigational Site 155
City
Houston
State/Province
Texas
ZIP/Postal Code
77054
Country
United States
Facility Name
Watson Investigational Site 120
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
Watson Investigational Site 129
City
Webster
State/Province
Texas
ZIP/Postal Code
77598
Country
United States
Facility Name
Watson Investigational Site 152
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23507-1627
Country
United States
Facility Name
Watson Investigational Site 137
City
Virginia Beach
State/Province
Virginia
ZIP/Postal Code
23456
Country
United States
Facility Name
Watson Investigational Site 121
City
Seattle
State/Province
Washington
ZIP/Postal Code
98105
Country
United States
Facility Name
Watson Investigational Site 140
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8S4L8
Country
Canada
Facility Name
Watson Investigational Site 144
City
Ottawa
State/Province
Ontario
ZIP/Postal Code
K1H7W9
Country
Canada

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
30303900
Citation
Liu JH, Soper D, Lukes A, Gee P, Kimble T, Kroll R, Mallick M, Chan A, Gillard P, Harrington A, Sniukiene V, Shulman LP. Ulipristal Acetate for Treatment of Uterine Leiomyomas: A Randomized Controlled Trial. Obstet Gynecol. 2018 Nov;132(5):1241-1251. doi: 10.1097/AOG.0000000000002942.
Results Reference
derived

Learn more about this trial

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

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