A Study of the Efficacy and Safety of Ulipristal Acetate... | NCT02147158 | Trialant
NCT02147158
Sponsor
Allergan
Status
Completed
Last Update Posted
Jun 4, 2019Actual
Enrollment
432Actual
Phase
Phase 3
Conditions
Leiomyoma
Uterine Hemorrhage
Interventions
Ulipristal acetate (UPA)
Placebo
Countries
United States
Canada
Protocol Section
Identification Module
NCT ID
NCT02147158
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
UL1208
Secondary IDs
Not provided
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
Acronym
Not provided
Organization
AllerganINDUSTRY
Status Module
Record Verification Date
May 2019
Overall Recruitment Status or Expanded Access Status
Completed
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Not provided
Expanded Access Info
No
Start Date
Jan 29, 2014Actual
Primary Completion Date
Nov 24, 2016Actual
Completion Date
Nov 24, 2016Actual
First Submitted Date
May 10, 2014
First Submission Date that Met QC Criteria
May 21, 2014
First Posted Date
May 26, 2014Estimated
Results Waived
Not provided
Results First Submitted Date
Apr 4, 2019
Results First Submitted that Met QC Criteria
May 15, 2019
Results First Posted Date
Jun 4, 2019Actual
Certification/Extension (aka Delayed Results) First Submitted Date
Nov 3, 2017
Certification/Extension First Submitted that Passed QC Review
Nov 3, 2017
Certification/Extension First Posted Date
Nov 7, 2017Actual
Last Update Submitted Date
May 15, 2019
Last Update Posted Date
Jun 4, 2019Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
AllerganINDUSTRY
Collaborators
Not provided
Oversight Module
Has Data Monitoring Committee (DMC)
No
Is FDA Regulated Drug
Yes
Is FDA Regulated Device
No
Is Unapproved Device
Not provided
Pediatric Postmarket Surveillance of a Device Product
Not provided
Product Exported from US
Not provided
FDAAA801 Violation
Not provided
Description Module
Brief Summary
This study will evaluate the superiority of ulipristal acetate versus placebo for the treatment of abnormal uterine bleeding associated with uterine fibroids
Detailed Description
Not provided
Conditions Module
Conditions
Leiomyoma
Uterine Hemorrhage
Keywords
Not provided
Design Module
Study Type
Interventional
Number of References to an Expanded Access Study
Not provided
Expanded Access Types
Not provided
Patient Registry
Not provided
Target Follow-Up Duration
Not provided
Phases
Phase 3
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
432Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
UPA 5 mg:Placebo
Experimental
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.
Drug: Ulipristal acetate (UPA)
Drug: Placebo
UPA 10 mg:Placebo
Experimental
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.
Drug: Ulipristal acetate (UPA)
Drug: Placebo
UPA 5 mg:UPA 5 mg
Experimental
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.
Drug: Ulipristal acetate (UPA)
Drug: Placebo
UPA 10 mg:UPA 10 mg
Experimental
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.
Drug: Ulipristal acetate (UPA)
Drug: Placebo
Placebo:UPA 5 mg
Interventions
Name
Type
Description
Arm Group Labels
Other Names
Ulipristal acetate (UPA)
Drug
Ulipristal acetate (UPA) tablet.
Placebo:UPA 10 mg
Placebo:UPA 5 mg
UPA 10 mg:Placebo
UPA 10 mg:UPA 10 mg
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
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
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 Outcomes
Measure
Description
Time Frame
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
Other Outcomes
Not provided
Eligibility Module
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.
Accepts Healthy Volunteers
No
Sex
Female
Sex/Gender Based
Yes
Sex/Gender Description
Females suffering with abnormal uterine bleeding associated with leiomyomas were treated in this study.
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.
See Also Links
Not provided
Available IPD Information
Not provided
IPD Sharing Statement Module
No data available
No data is available for this block.
Results Section
Participant Flow Module
Pre-assignment Details
Not provided
Recruitment Details
Not provided
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
UPA 5 mg:Placebo
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.
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.
Drug: Ulipristal acetate (UPA)
Drug: Placebo
Placebo:UPA 10 mg
Experimental
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.
Drug: Ulipristal acetate (UPA)
Drug: Placebo
UPA 5 mg:Placebo
UPA 5 mg:UPA 5 mg
Placebo
Drug
Matching placebo tablet.
Placebo:UPA 10 mg
Placebo:UPA 5 mg
UPA 10 mg:Placebo
UPA 10 mg:UPA 10 mg
UPA 5 mg:Placebo
UPA 5 mg:UPA 5 mg
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
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
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
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.
UPA 10 mg:Placebo
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.
FG002
UPA 5 mg:UPA 5 mg
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.
FG003
UPA 10 mg:UPA 10 mg
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.
FG004
Placebo:UPA 5 mg
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.
FG005
Placebo:UPA 10 mg
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.
FG00055 subjects
FG00147 subjects
FG002107 subjects
FG003110 subjects
FG00455 subjects
FG00558 subjects
COMPLETED
FG00051 subjects
FG00138 subjects
FG00299 subjects
FG00397 subjects
FG00449 subjects
FG00550 subjects
NOT COMPLETED
FG0004 subjects
FG0019 subjects
FG0028 subjects
FG00313 subjects
FG0046 subjects
FG0058 subjects
Type
Comment
Reasons
Adverse Event
FG0001 subjects
FG0014 subjects
FG0023 subjects
FG0034 subjects
FG0041 subjects
FG0052 subjects
Lost to Follow-up
FG0002 subjects
FG0014 subjects
FG0023 subjects
FG0033 subjects
FG004
Protocol Violation
FG0000 subjects
FG0010 subjects
FG0021 subjects
FG0031 subjects
FG004
Withdrawal of Consent
FG0001 subjects
FG0011 subjects
FG0021 subjects
FG0035 subjects
FG004
Off-Treatment Interval 1
Type
Comment
Milestone Data
STARTED
FG00051 subjects
FG00138 subjects
FG00299 subjects
FG00397 subjects
FG00449 subjects
FG00550 subjects
COMPLETED
FG00041 subjects
FG00134 subjects
FG00284 subjects
FG00382 subjects
FG004
NOT COMPLETED
FG00010 subjects
FG0014 subjects
FG00215 subjects
FG00315 subjects
FG004
Type
Comment
Reasons
Adverse Event
FG0001 subjects
FG0010 subjects
FG0020 subjects
FG003
Treatment Course 2
Type
Comment
Milestone Data
STARTED
FG00041 subjects
FG00134 subjects
FG00284 subjects
FG00382 subjects
FG00441 subjects
FG00545 subjects
COMPLETED
FG00040 subjects
FG00129 subjects
FG00279 subjects
FG00377 subjects
FG004
NOT COMPLETED
FG0001 subjects
FG0015 subjects
FG0025 subjects
FG0035 subjects
FG004
Type
Comment
Reasons
Adverse Event
FG0000 subjects
FG0014 subjects
FG0022 subjects
FG003
Off-Treatment Interval 2
Type
Comment
Milestone Data
STARTED
FG00040 subjects
FG00129 subjects
FG00279 subjects
FG00377 subjects
FG00441 subjects
FG00543 subjects
COMPLETED
FG00036 subjects
FG00125 subjects
FG00269 subjects
FG00366 subjects
FG004
NOT COMPLETED
FG0004 subjects
FG0014 subjects
FG00210 subjects
FG00311 subjects
FG004
Type
Comment
Reasons
Lack of Efficacy
FG0000 subjects
FG0011 subjects
FG0021 subjects
FG003
The Intent-to-Treat (ITT) population included all randomized participants.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
UPA 5 mg:Placebo
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.
BG001
UPA 10 mg:Placebo
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.
BG002
UPA 5 mg:UPA 5 mg
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.
BG003
UPA 10 mg:UPA 10 mg
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.
BG004
Placebo:UPA 5 mg
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.
BG005
Placebo:UPA 10 mg
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.
BG006
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG00055
BG00147
BG002107
BG003110
BG00455
BG00558
BG006432
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Continuous
Mean
Standard Deviation
years
Title
Denominators
Categories
Title
Measurements
BG00041.5± 5.7
BG00141.8± 5.2
BG00240.9± 6.6
BG003
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG00055
BG00147
BG002
Type
Title
Description
Population Description
Reporting Status
Anticipated Posting Date
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Time Frame
Units Analyzed
Denominator Units Selected
Arm/Group Information
Denominators
Classes
Analyses
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.
Intent-to-Treat (ITT) Population included all randomized participants. Data was summarized as per the treatment assigned.
Posted
Number
97.5% Confidence Interval
percentage of participants
Last 35 consecutive days on treatment in the 12-Week Treatment Course 1
ID
Title
Description
OG000
Placebo
Matching placebo tablets (5 mg and 10 mg), orally, once daily for 12 weeks in Treatment Course 1.
OG001
UPA 5 mg
UPA 5 mg tablet plus matching placebo 10 mg tablet, orally, once daily for 12 weeks in Treatment Course 1.
OG002
UPA 10 mg
UPA 10 mg tablet plus matching placebo 5 mg tablet, orally, once daily for 12 weeks in Treatment Course 1.
Units
Counts
Participants
OG000113
OG001162
OG002157
Title
Denominators
Categories
Title
Measurements
OG0000.0(0.0 to 3.8)
OG00142.0(33.3 to 51.1)
OG00254.8(45.5 to 63.8)
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.
ITT population included all randomized participants. Data was summarized per treatment assigned.
Posted
Median
97.5% Confidence Interval
days
From first dose up to the end of the 12-Week Treatment Course 1
ID
Title
Description
OG000
Placebo
Matching placebo tablets (5 mg and 10 mg), orally, once daily for 12 weeks in Treatment Course 1.
OG001
UPA 5 mg
UPA 5 mg tablet plus matching placebo 10 mg tablet, orally, once daily for 12 weeks in Treatment Course 1.
OG002
UPA 10 mg
UPA 10 mg tablet plus matching placebo 5 mg tablet, orally, once daily for 12 weeks in 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.
ITT population included all randomized participants. Data was summarized as per the treatment assigned.
Posted
Number
97.5% Confidence Interval
percentage of participants
Day 11 through the end of treatment in the 12-Week Treatment Course 1
ID
Title
Description
OG000
Placebo
Matching placebo tablets (5 mg and 10 mg), orally, once daily for 12 weeks in Treatment Course 1.
OG001
UPA 5 mg
UPA 5 mg tablet plus matching placebo 10 mg tablet, orally, once daily for 12 weeks in Treatment Course 1.
OG002
UPA 10 mg
UPA 10 mg tablet plus matching placebo 5 mg tablet, orally, once daily for 12 weeks in 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.
Data was summarized as per the treatment assigned. Number of participants analyzed are participants with data available for analysis at the given timepoint.
Posted
Number
97.5% Confidence Interval
percentage of participants
Last 35 consecutive days on treatment in the 12-Week Treatment Course 2
ID
Title
Description
OG000
Placebo
Matching placebo tablets (5 mg and 10 mg), orally, once daily for 12 weeks in Treatment Course 2.
OG001
UPA 5 mg
UPA 5 mg tablet plus matching placebo 10 mg tablet, orally, once daily for 12 weeks in Treatment Course 2.
OG002
UPA 10 mg
UPA 10 mg tablet plus matching placebo 5 mg tablet, orally, once daily for 12 weeks in 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.
Data was summarized as per treatment assigned. Number of participants analyzed are participants with data available for analysis at the given timepoint.
Posted
Median
97.5% Confidence Interval
days
From first dose up to the end of treatment in the 12-Week Treatment Course 2
ID
Title
Description
OG000
Placebo
Matching placebo tablets (5 mg and 10 mg), orally, once daily for 12 weeks in Treatment Course 2.
OG001
UPA 5 mg
UPA 5 mg tablet plus matching placebo 10 mg tablet, orally, once daily for 12 weeks in Treatment Course 2.
OG002
UPA 10 mg
UPA 10 mg tablet plus matching placebo 5 mg tablet, orally, once daily for 12 weeks in 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.
Data was summarized as per treatment assigned and included all participants with data at both Baseline and Week 12 in Treatment Course 1.
Posted
Mean
Standard Deviation
score on a scale
Baseline (Day 1-4) to End of 12-Week Treatment Course 1
ID
Title
Description
OG000
Placebo
Matching placebo tablets (5 mg and 10 mg), orally, once daily for 12 weeks in Treatment Course 1.
OG001
UPA 5 mg
Time Frame
From study drug administration in Treatment Course 1 until the end of the 12-week off-treatment follow-up period after Treatment Course 2 (Up to 42 weeks)
Description
Safety population included all participants who received study drug analyzed per treatment actually received. 1 patient randomized to UPA 5 mg:Placebo and 2 patients randomized to UPA 10 mg:Placebo actually received placebo in Treatment Course 1; are included in Placebo arm. 1 patient randomized to UPA 5 mg:Placebo actually received Placebo:UPA 5 mg; is included in Placebo:UPA 5 mg arm and 3 patients who received placebo in both courses are not included in safety analyses in Treatment Course 2.
All-Cause Mortality Comment
Not provided
Arm/Groups
ID
Title
Description
Deaths (Affected)
Deaths (At Risk)
Serious Events (Affected)
Serious Events (At Risk)
Other Events (Affected)
Other Events (At Risk)
EG000
Placebo (Treatment Course 1)
Matching placebo tablets, orally, once daily for 12 weeks in Treatment Course 1. Includes AEs that occurred in Treatment Course 1 and the 2 menses drug-free interval.
0
116
2
116
18
116
EG001
UPA 5 mg (Treatment Course 1)
UPA 5 mg tablet plus matching placebo 10 mg tablet, orally, once daily in Treatment Course 1. Includes AEs that occurred in Treatment Course 1 and the 2 menses drug-free interval.
0
161
3
161
38
161
EG002
UPA 10 mg (Treatment Course 1)
UPA 10 mg tablet plus matching placebo 5 mg tablet, orally, once daily in Treatment Course 1. Includes AEs that occurred in Treatment Course 1 and the 2 menses drug-free interval.
0
155
4
155
46
155
EG003
UPA 5 mg:Placebo (Treatment Course 2)
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 placebo matching tablets (5 mg and 10 mg), orally, once daily for 12 weeks in Treatment Course 2. Includes AEs that occurred in Treatment Course 2 and 12 week follow-up.
0
40
0
40
12
40
EG004
UPA 10 mg:Placebo (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. Includes AEs that occurred in Treatment Course 2 and 12 week follow-up.
0
33
2
33
11
33
EG005
UPA 5 mg:UPA 5 mg (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. Includes AEs that occurred in Treatment Course 2 and 12 week follow-up.
0
84
2
84
20
84
EG006
UPA 10 mg:UPA 10 mg (Treatment Course 2)
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. Includes AEs that occurred in Treatment Course 2 and 12 week follow-up.
0
82
1
82
8
82
EG007
Placebo:UPA 5 mg (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 5 mg tablet plus matching placebo 10 mg tablet, orally, once daily for 12 weeks in Treatment Course 2. Includes AEs that occurred in Treatment Course 2 and 12 week follow-up.
0
42
1
42
7
42
EG008
Placebo:UPA 10 mg (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. Includes AEs that occurred in Treatment Course 2 and 12 week follow-up.
0
44
1
44
9
44
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Abdominal pain
Gastrointestinal disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected116 at risk
EG0011 affected161 at risk
EG0020 affected155 at risk
EG0030 affected40 at risk
EG0040 affected33 at risk
EG0050 affected84 at risk
EG0060 affected82 at risk
EG0070 affected42 at risk
EG0080 affected44 at risk
Anaemia
Blood and lymphatic system disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected116 at risk
EG0011 affected161 at risk
EG0020 affected155 at risk
EG003
Appendicitis
Infections and infestations
MedDRA 18.0
Systematic Assessment
EG0000 affected116 at risk
EG0010 affected161 at risk
EG0021 affected155 at risk
EG003
Confusional state
Psychiatric disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected116 at risk
EG0010 affected161 at risk
EG0021 affected155 at risk
EG003
Diastolic dysfunction
Cardiac disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected116 at risk
EG0010 affected161 at risk
EG0021 affected155 at risk
EG003
Dizziness
Nervous system disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected116 at risk
EG0010 affected161 at risk
EG0021 affected155 at risk
EG003
Dyspnoea
Respiratory, thoracic and mediastinal disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected116 at risk
EG0010 affected161 at risk
EG0021 affected155 at risk
EG003
Hyperthyroidism
Endocrine disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected116 at risk
EG0010 affected161 at risk
EG0021 affected155 at risk
EG003
Joint dislocation
Injury, poisoning and procedural complications
MedDRA 18.0
Systematic Assessment
EG0000 affected116 at risk
EG0011 affected161 at risk
EG0020 affected155 at risk
EG003
Liver function test abnormal
Investigations
MedDRA 18.0
Systematic Assessment
EG0001 affected116 at risk
EG0010 affected161 at risk
EG0020 affected155 at risk
EG003
Medical device site infection
Infections and infestations
MedDRA 18.0
Systematic Assessment
EG0000 affected116 at risk
EG0010 affected161 at risk
EG0021 affected155 at risk
EG003
Meningitis viral
Infections and infestations
MedDRA 18.0
Systematic Assessment
EG0001 affected116 at risk
EG0010 affected161 at risk
EG0020 affected155 at risk
EG003
Menorrhagia
Reproductive system and breast disorders
MedDRA 18.0
Systematic Assessment
EG0001 affected116 at risk
EG0010 affected161 at risk
EG0020 affected155 at risk
EG003
Mitral valve incompetence
Cardiac disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected116 at risk
EG0010 affected161 at risk
EG0021 affected155 at risk
EG003
Non-cardiac chest pain
General disorders
MedDRA 18.0
Systematic Assessment
EG0001 affected116 at risk
EG0010 affected161 at risk
EG0021 affected155 at risk
EG003
Palpitations
Cardiac disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected116 at risk
EG0010 affected161 at risk
EG0021 affected155 at risk
EG003
Thyroid cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 18.0
Systematic Assessment
EG0000 affected116 at risk
EG0010 affected161 at risk
EG0021 affected155 at risk
EG003
Uterine haemorrhage
Reproductive system and breast disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected116 at risk
EG0011 affected161 at risk
EG0020 affected155 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRA 18.0
Systematic Assessment
EG0001 affected116 at risk
EG0010 affected161 at risk
EG0020 affected155 at risk
EG003
Myocardial infarction
Cardiac disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected116 at risk
EG0010 affected161 at risk
EG0021 affected155 at risk
EG003
Hypoaesthesia
Nervous system disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected116 at risk
EG0010 affected161 at risk
EG0021 affected155 at risk
EG003
Cardiac failure congestive
Cardiac disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected116 at risk
EG0010 affected161 at risk
EG0020 affected155 at risk
EG003
Haemoglobin decreased
Investigations
MedDRA 18.0
Systematic Assessment
EG0000 affected116 at risk
EG0010 affected161 at risk
EG0020 affected155 at risk
EG003
Syncope
Nervous system disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected116 at risk
EG0010 affected161 at risk
EG0020 affected155 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Nausea
Gastrointestinal disorders
MedDRA 18.0
Systematic Assessment
EG0005 affected116 at risk
EG00113 affected161 at risk
EG0024 affected155 at risk
EG0030 affected40 at risk
EG0042 affected33 at risk
EG0053 affected84 at risk
EG0060 affected82 at risk
EG0070 affected42 at risk
EG0083 affected44 at risk
Fatigue
General disorders
MedDRA 18.0
Systematic Assessment
EG0005 affected116 at risk
EG0016 affected161 at risk
EG0028 affected155 at risk
EG003
Nasopharyngitis
Infections and infestations
MedDRA 18.0
Systematic Assessment
EG0002 affected116 at risk
EG0018 affected161 at risk
EG0022 affected155 at risk
EG003
Headache
Nervous system disorders
MedDRA 18.0
Systematic Assessment
EG0006 affected116 at risk
EG0017 affected161 at risk
EG00216 affected155 at risk
EG003
Hot flush
Vascular disorders
MedDRA 18.0
Systematic Assessment
EG0002 affected116 at risk
EG00112 affected161 at risk
EG00218 affected155 at risk
EG003
Anaemia
Blood and lymphatic system disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected116 at risk
EG0010 affected161 at risk
EG0020 affected155 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected116 at risk
EG0010 affected161 at risk
EG0020 affected155 at risk
EG003
Abdominal pain lower
Gastrointestinal disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected116 at risk
EG0010 affected161 at risk
EG0020 affected155 at risk
EG003
Constipation
Gastrointestinal disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected116 at risk
EG0010 affected161 at risk
EG0020 affected155 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected116 at risk
EG0010 affected161 at risk
EG0020 affected155 at risk
EG003
Bacterial vaginosis
Infections and infestations
MedDRA 18.0
Systematic Assessment
EG0000 affected116 at risk
EG0010 affected161 at risk
EG0020 affected155 at risk
EG003
Fungal infection
Infections and infestations
MedDRA 18.0
Systematic Assessment
EG0000 affected116 at risk
EG0010 affected161 at risk
EG0020 affected155 at risk
EG003
Certain Agreements
Are all PI(s) employees of the sponsor?
No
Restriction Type
OTHER
Results Disclosure Restriction on PI(s)?
Yes
Other Details
A disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 90 days from the time submitted to the sponsor for review. The sponsor cannot require changes to the communication and cannot extend the embargo.
Point of Contact
Title
Organization
Phone
Extension
Email
Therapeutic Area, Head
Allergan
714-246-4500
clinicaltrials@allergan.com
ID
Term
D007889
Leiomyoma
D014592
Uterine Hemorrhage
Ancestor Terms
ID
Term
D009379
Neoplasms, Muscle Tissue
D018204
Neoplasms, Connective and Soft Tissue
D009370
Neoplasms by Histologic Type
D009369
Neoplasms
D014591
Uterine Diseases
D005831
Genital Diseases, Female
D052776
Female Urogenital Diseases
D005261
Female Urogenital Diseases and Pregnancy Complications
D000091642
Urogenital Diseases
D000091662
Genital Diseases
D006470
Hemorrhage
D010335
Pathologic Processes
D013568
Pathological Conditions, Signs and Symptoms
Browse Leaves
Not provided
Browse Branches
Not provided
ID
Term
C555622
ulipristal acetate
Ancestor Terms
Not provided
Browse Leaves
Not provided
Browse Branches
Not provided
2 subjects
FG0054 subjects
0 subjects
FG0050 subjects
3 subjects
FG0052 subjects
41 subjects
FG00545 subjects
8 subjects
FG0055 subjects
1 subjects
FG0040 subjects
FG0050 subjects
Lost to Follow-up
FG0002 subjects
FG0011 subjects
FG0023 subjects
FG0032 subjects
FG0044 subjects
FG0052 subjects
Protocol Violation
FG0001 subjects
FG0010 subjects
FG0022 subjects
FG0030 subjects
FG0041 subjects
FG0050 subjects
Withdrawal of Consent
FG0004 subjects
FG0013 subjects
FG0025 subjects
FG00310 subjects
FG0042 subjects
FG0053 subjects
Lack of Efficacy
FG0000 subjects
FG0010 subjects
FG0022 subjects
FG0030 subjects
FG0041 subjects
FG0050 subjects
Other Miscellaneous Reasons
FG0002 subjects
FG0010 subjects
FG0023 subjects
FG0032 subjects
FG0040 subjects
FG0050 subjects
41 subjects
FG00543 subjects
0 subjects
FG0052 subjects
1 subjects
FG0040 subjects
FG0051 subjects
Withdrawal of Consent
FG0000 subjects
FG0011 subjects
FG0022 subjects
FG0033 subjects
FG0040 subjects
FG0050 subjects
Lost to Follow-up
FG0001 subjects
FG0010 subjects
FG0021 subjects
FG0031 subjects
FG0040 subjects
FG0051 subjects
39 subjects
FG00539 subjects
2 subjects
FG0054 subjects
0 subjects
FG0040 subjects
FG0050 subjects
Withdrawal of Consent
FG0004 subjects
FG0010 subjects
FG0025 subjects
FG0034 subjects
FG0040 subjects
FG0051 subjects
Lost to Follow-up
FG0000 subjects
FG0010 subjects
FG0023 subjects
FG0032 subjects
FG0042 subjects
FG0052 subjects
Protocol Violation
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0031 subjects
FG0040 subjects
FG0050 subjects
Other Miscellaneous Reasons
FG0000 subjects
FG0013 subjects
FG0021 subjects
FG0034 subjects
FG0040 subjects
FG0051 subjects
41.0
± 5.3
BG00440.8± 5.1
BG00540.7± 4.6
BG00641.0± 5.6
107
BG003110
BG00455
BG00558
BG006432
Male
BG0000
BG0010
BG0020
BG0030
BG0040
BG0050
BG0060
Units
Counts
Participants
OG000113
OG001162
OG002157
Title
Denominators
Categories
Title
Measurements
OG000NA(NA to NA)Median and Confidence Interval (CI) were not estimable due to low number of participants with events.
OG001NA(48.0 to NA)Median and CI upper limit were not estimable due to low number of participants with events.
OG00236.0(7.0 to NA)CI upper limit was not estimable due to low number of participants with events.
Units
Counts
Participants
OG000113
OG001162
OG002157
Title
Denominators
Categories
Title
Measurements
OG0000.0(0.0 to 3.8)
OG00134.6(26.3 to 43.5)
OG00255.4(46.2 to 64.4)
Units
Counts
Participants
OG00075
OG00184
OG00282
Title
Denominators
Categories
Title
Measurements
OG0008.0(2.6 to 17.9)
OG00140.5(28.5 to 53.3)
OG00257.3(44.4 to 69.6)
Units
Counts
Participants
OG00075
OG00184
OG00282
Title
Denominators
Categories
Title
Measurements
OG000NA(NA to NA)Median and CI were not estimable due to low number of participants with events.
OG001NA(37.0 to NA)Median and CI upper limit were not estimable due to low number of participants with events.
OG0027.5(5.0 to NA)CI upper limit was not estimable due to low number of participants with events.
UPA 5 mg tablet plus matching placebo 10 mg tablet, orally, once daily for 12 weeks in Treatment Course 1.
OG002
UPA 10 mg
UPA 10 mg tablet plus matching placebo 5 mg tablet, orally, once daily for 12 weeks in Treatment Course 1.