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

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ClinicalTrials.gov Identifier: NCT02147158
Recruitment Status : Completed
First Posted : May 26, 2014
Results First Posted : June 4, 2019
Last Update Posted : June 4, 2019
Sponsor:
Information provided by (Responsible Party):
Allergan

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions Leiomyoma
Uterine Hemorrhage
Interventions Drug: Ulipristal acetate (UPA)
Drug: Placebo
Enrollment 432
Recruitment Details  
Pre-assignment Details  
Arm/Group Title 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
Hide Arm/Group 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.
Period Title: Treatment Course 1
Started 55 47 107 110 55 58
Completed 51 38 99 97 49 50
Not Completed 4 9 8 13 6 8
Reason Not Completed
Adverse Event             1             4             3             4             1             2
Lost to Follow-up             2             4             3             3             2             4
Protocol Violation             0             0             1             1             0             0
Withdrawal of Consent             1             1             1             5             3             2
Period Title: Off-Treatment Interval 1
Started 51 38 99 97 49 50
Completed 41 34 84 82 41 45
Not Completed 10 4 15 15 8 5
Reason Not Completed
Adverse Event             1             0             0             1             0             0
Lost to Follow-up             2             1             3             2             4             2
Protocol Violation             1             0             2             0             1             0
Withdrawal of Consent             4             3             5             10             2             3
Lack of Efficacy             0             0             2             0             1             0
Other Miscellaneous Reasons             2             0             3             2             0             0
Period Title: Treatment Course 2
Started 41 34 84 82 41 45
Completed 40 29 79 77 41 43
Not Completed 1 5 5 5 0 2
Reason Not Completed
Adverse Event             0             4             2             1             0             1
Withdrawal of Consent             0             1             2             3             0             0
Lost to Follow-up             1             0             1             1             0             1
Period Title: Off-Treatment Interval 2
Started 40 29 79 77 41 43
Completed 36 25 69 66 39 39
Not Completed 4 4 10 11 2 4
Reason Not Completed
Lack of Efficacy             0             1             1             0             0             0
Withdrawal of Consent             4             0             5             4             0             1
Lost to Follow-up             0             0             3             2             2             2
Protocol Violation             0             0             0             1             0             0
Other Miscellaneous Reasons             0             3             1             4             0             1
Arm/Group Title 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 Total
Hide Arm/Group 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. Total of all reporting groups
Overall Number of Baseline Participants 55 47 107 110 55 58 432
Hide Baseline Analysis Population Description
The Intent-to-Treat (ITT) population included all randomized participants.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 55 participants 47 participants 107 participants 110 participants 55 participants 58 participants 432 participants
41.5  (5.7) 41.8  (5.2) 40.9  (6.6) 41.0  (5.3) 40.8  (5.1) 40.7  (4.6) 41.0  (5.6)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 55 participants 47 participants 107 participants 110 participants 55 participants 58 participants 432 participants
Female
55
 100.0%
47
 100.0%
107
 100.0%
110
 100.0%
55
 100.0%
58
 100.0%
432
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
1.Primary Outcome
Title Percentage of Participants With Absence of Bleeding During the Last 35 Consecutive Days on Treatment in Treatment Course 1
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-Treat (ITT) Population included all randomized participants. Data was summarized as per the treatment assigned.
Arm/Group Title Placebo UPA 5 mg UPA 10 mg
Hide Arm/Group Description:
Matching placebo tablets (5 mg and 10 mg), orally, once daily for 12 weeks in Treatment Course 1.
UPA 5 mg tablet plus matching placebo 10 mg tablet, orally, once daily for 12 weeks in Treatment Course 1.
UPA 10 mg tablet plus matching placebo 5 mg tablet, orally, once daily for 12 weeks in Treatment Course 1.
Overall Number of Participants Analyzed 113 162 157
Measure Type: Number
Number (97.5% Confidence Interval)
Unit of Measure: percentage of participants
0.0
(0.0 to 3.8)
42.0
(33.3 to 51.1)
54.8
(45.5 to 63.8)
2.Primary Outcome
Title Time to Absence of Bleeding on Treatment During Treatment Course 1
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population included all randomized participants. Data was summarized per treatment assigned.
Arm/Group Title Placebo UPA 5 mg UPA 10 mg
Hide Arm/Group Description:
Matching placebo tablets (5 mg and 10 mg), orally, once daily for 12 weeks in Treatment Course 1.
UPA 5 mg tablet plus matching placebo 10 mg tablet, orally, once daily for 12 weeks in Treatment Course 1.
UPA 10 mg tablet plus matching placebo 5 mg tablet, orally, once daily for 12 weeks in Treatment Course 1.
Overall Number of Participants Analyzed 113 162 157
Median (97.5% Confidence Interval)
Unit of Measure: days
NA [1] 
(NA to NA)
NA [2] 
(48.0 to NA)
36.0 [3] 
(7.0 to NA)
[1]
Median and Confidence Interval (CI) were not estimable due to low number of participants with events.
[2]
Median and CI upper limit were not estimable due to low number of participants with events.
[3]
CI upper limit was not estimable due to low number of participants with events.
3.Secondary Outcome
Title Percentage of Participants With Absence of Bleeding From Day 11 Through the End of Treatment Course 1
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population included all randomized participants. Data was summarized as per the treatment assigned.
Arm/Group Title Placebo UPA 5 mg UPA 10 mg
Hide Arm/Group Description:
Matching placebo tablets (5 mg and 10 mg), orally, once daily for 12 weeks in Treatment Course 1.
UPA 5 mg tablet plus matching placebo 10 mg tablet, orally, once daily for 12 weeks in Treatment Course 1.
UPA 10 mg tablet plus matching placebo 5 mg tablet, orally, once daily for 12 weeks in Treatment Course 1.
Overall Number of Participants Analyzed 113 162 157
Measure Type: Number
Number (97.5% Confidence Interval)
Unit of Measure: percentage of participants
0.0
(0.0 to 3.8)
34.6
(26.3 to 43.5)
55.4
(46.2 to 64.4)
4.Secondary Outcome
Title Percentage of Participants With Absence of Bleeding During the Last 35 Consecutive Days on Treatment in Treatment Course 2
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
Data was summarized as per the treatment assigned. Number of participants analyzed are participants with data available for analysis at the given timepoint.
Arm/Group Title Placebo UPA 5 mg UPA 10 mg
Hide Arm/Group Description:
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 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 2.
Overall Number of Participants Analyzed 75 84 82
Measure Type: Number
Number (97.5% Confidence Interval)
Unit of Measure: percentage of participants
8.0
(2.6 to 17.9)
40.5
(28.5 to 53.3)
57.3
(44.4 to 69.6)
5.Secondary Outcome
Title Time to Absence of Bleeding on Treatment During Treatment Course 2
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
Data was summarized as per treatment assigned. Number of participants analyzed are participants with data available for analysis at the given timepoint.
Arm/Group Title Placebo UPA 5 mg UPA 10 mg
Hide Arm/Group Description:
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 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 2.
Overall Number of Participants Analyzed 75 84 82
Median (97.5% Confidence Interval)
Unit of Measure: days
NA [1] 
(NA to NA)
NA [2] 
(37.0 to NA)
7.5 [3] 
(5.0 to NA)
[1]
Median and CI were not estimable due to low number of participants with events.
[2]
Median and CI upper limit were not estimable due to low number of participants with events.
[3]
CI upper limit was not estimable due to low number of participants with events.
6.Secondary Outcome
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
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
Data was summarized as per treatment assigned and included all participants with data at both Baseline and Week 12 in Treatment Course 1.
Arm/Group Title Placebo UPA 5 mg UPA 10 mg
Hide Arm/Group Description:
Matching placebo tablets (5 mg and 10 mg), orally, once daily for 12 weeks in Treatment Course 1.
UPA 5 mg tablet plus matching placebo 10 mg tablet, orally, once daily for 12 weeks in Treatment Course 1.
UPA 10 mg tablet plus matching placebo 5 mg tablet, orally, once daily for 12 weeks in Treatment Course 1.
Overall Number of Participants Analyzed 95 146 132
Mean (Standard Deviation)
Unit of Measure: score on a scale
Baseline 28.70  (24.56) 27.52  (24.05) 33.24  (27.00)
Change from Baseline at Week 12 14.25  (28.77) 50.19  (32.07) 54.73  (32.32)
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)
Adverse Event Reporting 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.
 
Arm/Group Title Placebo (Treatment Course 1) UPA 5 mg (Treatment Course 1) UPA 10 mg (Treatment Course 1) UPA 5 mg:Placebo (Treatment Course 2) UPA 10 mg:Placebo (Treatment Course 2) UPA 5 mg:UPA 5 mg (Treatment Course 2) UPA 10 mg:UPA 10 mg (Treatment Course 2) Placebo:UPA 5 mg (Treatment Course 2) Placebo:UPA 10 mg (Treatment Course 2)
Hide Arm/Group Description 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. 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. 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. 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. 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. 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. 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. 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. 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.
All-Cause Mortality
Placebo (Treatment Course 1) UPA 5 mg (Treatment Course 1) UPA 10 mg (Treatment Course 1) UPA 5 mg:Placebo (Treatment Course 2) UPA 10 mg:Placebo (Treatment Course 2) UPA 5 mg:UPA 5 mg (Treatment Course 2) UPA 10 mg:UPA 10 mg (Treatment Course 2) Placebo:UPA 5 mg (Treatment Course 2) Placebo:UPA 10 mg (Treatment Course 2)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/116 (0.00%)   0/161 (0.00%)   0/155 (0.00%)   0/40 (0.00%)   0/33 (0.00%)   0/84 (0.00%)   0/82 (0.00%)   0/42 (0.00%)   0/44 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
Placebo (Treatment Course 1) UPA 5 mg (Treatment Course 1) UPA 10 mg (Treatment Course 1) UPA 5 mg:Placebo (Treatment Course 2) UPA 10 mg:Placebo (Treatment Course 2) UPA 5 mg:UPA 5 mg (Treatment Course 2) UPA 10 mg:UPA 10 mg (Treatment Course 2) Placebo:UPA 5 mg (Treatment Course 2) Placebo:UPA 10 mg (Treatment Course 2)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   2/116 (1.72%)   3/161 (1.86%)   4/155 (2.58%)   0/40 (0.00%)   2/33 (6.06%)   2/84 (2.38%)   1/82 (1.22%)   1/42 (2.38%)   1/44 (2.27%) 
Blood and lymphatic system disorders                   
Anaemia  1  0/116 (0.00%)  1/161 (0.62%)  0/155 (0.00%)  0/40 (0.00%)  0/33 (0.00%)  0/84 (0.00%)  0/82 (0.00%)  1/42 (2.38%)  0/44 (0.00%) 
Cardiac disorders                   
Diastolic dysfunction  1  0/116 (0.00%)  0/161 (0.00%)  1/155 (0.65%)  0/40 (0.00%)  0/33 (0.00%)  0/84 (0.00%)  0/82 (0.00%)  0/42 (0.00%)  0/44 (0.00%) 
Mitral valve incompetence  1  0/116 (0.00%)  0/161 (0.00%)  1/155 (0.65%)  0/40 (0.00%)  0/33 (0.00%)  0/84 (0.00%)  0/82 (0.00%)  0/42 (0.00%)  0/44 (0.00%) 
Palpitations  1  0/116 (0.00%)  0/161 (0.00%)  1/155 (0.65%)  0/40 (0.00%)  0/33 (0.00%)  0/84 (0.00%)  0/82 (0.00%)  0/42 (0.00%)  0/44 (0.00%) 
Myocardial infarction  1  0/116 (0.00%)  0/161 (0.00%)  1/155 (0.65%)  0/40 (0.00%)  0/33 (0.00%)  0/84 (0.00%)  0/82 (0.00%)  0/42 (0.00%)  0/44 (0.00%) 
Cardiac failure congestive  1  0/116 (0.00%)  0/161 (0.00%)  0/155 (0.00%)  0/40 (0.00%)  0/33 (0.00%)  0/84 (0.00%)  1/82 (1.22%)  0/42 (0.00%)  0/44 (0.00%) 
Endocrine disorders                   
Hyperthyroidism  1  0/116 (0.00%)  0/161 (0.00%)  1/155 (0.65%)  0/40 (0.00%)  0/33 (0.00%)  0/84 (0.00%)  1/82 (1.22%)  0/42 (0.00%)  0/44 (0.00%) 
Gastrointestinal disorders                   
Abdominal pain  1  0/116 (0.00%)  1/161 (0.62%)  0/155 (0.00%)  0/40 (0.00%)  0/33 (0.00%)  0/84 (0.00%)  0/82 (0.00%)  0/42 (0.00%)  0/44 (0.00%) 
Vomiting  1  1/116 (0.86%)  0/161 (0.00%)  0/155 (0.00%)  0/40 (0.00%)  0/33 (0.00%)  0/84 (0.00%)  0/82 (0.00%)  0/42 (0.00%)  0/44 (0.00%) 
General disorders                   
Non-cardiac chest pain  1  1/116 (0.86%)  0/161 (0.00%)  1/155 (0.65%)  0/40 (0.00%)  0/33 (0.00%)  0/84 (0.00%)  0/82 (0.00%)  0/42 (0.00%)  0/44 (0.00%) 
Infections and infestations                   
Appendicitis  1  0/116 (0.00%)  0/161 (0.00%)  1/155 (0.65%)  0/40 (0.00%)  0/33 (0.00%)  0/84 (0.00%)  0/82 (0.00%)  0/42 (0.00%)  0/44 (0.00%) 
Medical device site infection  1  0/116 (0.00%)  0/161 (0.00%)  1/155 (0.65%)  0/40 (0.00%)  0/33 (0.00%)  0/84 (0.00%)  0/82 (0.00%)  0/42 (0.00%)  0/44 (0.00%) 
Meningitis viral  1  1/116 (0.86%)  0/161 (0.00%)  0/155 (0.00%)  0/40 (0.00%)  0/33 (0.00%)  0/84 (0.00%)  0/82 (0.00%)  0/42 (0.00%)  1/44 (2.27%) 
Injury, poisoning and procedural complications                   
Joint dislocation  1  0/116 (0.00%)  1/161 (0.62%)  0/155 (0.00%)  0/40 (0.00%)  0/33 (0.00%)  0/84 (0.00%)  0/82 (0.00%)  0/42 (0.00%)  0/44 (0.00%) 
Investigations                   
Liver function test abnormal  1  1/116 (0.86%)  0/161 (0.00%)  0/155 (0.00%)  0/40 (0.00%)  0/33 (0.00%)  0/84 (0.00%)  0/82 (0.00%)  0/42 (0.00%)  0/44 (0.00%) 
Haemoglobin decreased  1  0/116 (0.00%)  0/161 (0.00%)  0/155 (0.00%)  0/40 (0.00%)  0/33 (0.00%)  1/84 (1.19%)  0/82 (0.00%)  0/42 (0.00%)  0/44 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)                   
Thyroid cancer  1  0/116 (0.00%)  0/161 (0.00%)  1/155 (0.65%)  0/40 (0.00%)  1/33 (3.03%)  0/84 (0.00%)  0/82 (0.00%)  0/42 (0.00%)  0/44 (0.00%) 
Nervous system disorders                   
Dizziness  1  0/116 (0.00%)  0/161 (0.00%)  1/155 (0.65%)  0/40 (0.00%)  0/33 (0.00%)  0/84 (0.00%)  0/82 (0.00%)  0/42 (0.00%)  0/44 (0.00%) 
Hypoaesthesia  1  0/116 (0.00%)  0/161 (0.00%)  1/155 (0.65%)  0/40 (0.00%)  0/33 (0.00%)  0/84 (0.00%)  0/82 (0.00%)  0/42 (0.00%)  0/44 (0.00%) 
Syncope  1  0/116 (0.00%)  0/161 (0.00%)  0/155 (0.00%)  0/40 (0.00%)  1/33 (3.03%)  0/84 (0.00%)  0/82 (0.00%)  0/42 (0.00%)  0/44 (0.00%) 
Psychiatric disorders                   
Confusional state  1  0/116 (0.00%)  0/161 (0.00%)  1/155 (0.65%)  0/40 (0.00%)  0/33 (0.00%)  0/84 (0.00%)  0/82 (0.00%)  0/42 (0.00%)  0/44 (0.00%) 
Reproductive system and breast disorders                   
Menorrhagia  1  1/116 (0.86%)  0/161 (0.00%)  0/155 (0.00%)  0/40 (0.00%)  0/33 (0.00%)  0/84 (0.00%)  0/82 (0.00%)  0/42 (0.00%)  0/44 (0.00%) 
Uterine haemorrhage  1  0/116 (0.00%)  1/161 (0.62%)  0/155 (0.00%)  0/40 (0.00%)  0/33 (0.00%)  1/84 (1.19%)  0/82 (0.00%)  0/42 (0.00%)  0/44 (0.00%) 
Respiratory, thoracic and mediastinal disorders                   
Dyspnoea  1  0/116 (0.00%)  0/161 (0.00%)  1/155 (0.65%)  0/40 (0.00%)  0/33 (0.00%)  0/84 (0.00%)  0/82 (0.00%)  0/42 (0.00%)  0/44 (0.00%) 
1
Term from vocabulary, MedDRA 18.0
Indicates events were collected by systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Placebo (Treatment Course 1) UPA 5 mg (Treatment Course 1) UPA 10 mg (Treatment Course 1) UPA 5 mg:Placebo (Treatment Course 2) UPA 10 mg:Placebo (Treatment Course 2) UPA 5 mg:UPA 5 mg (Treatment Course 2) UPA 10 mg:UPA 10 mg (Treatment Course 2) Placebo:UPA 5 mg (Treatment Course 2) Placebo:UPA 10 mg (Treatment Course 2)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   18/116 (15.52%)   38/161 (23.60%)   46/155 (29.68%)   12/40 (30.00%)   11/33 (33.33%)   20/84 (23.81%)   8/82 (9.76%)   7/42 (16.67%)   9/44 (20.45%) 
Blood and lymphatic system disorders                   
Anaemia  1  0/116 (0.00%)  0/161 (0.00%)  0/155 (0.00%)  3/40 (7.50%)  3/33 (9.09%)  1/84 (1.19%)  0/82 (0.00%)  3/42 (7.14%)  1/44 (2.27%) 
Gastrointestinal disorders                   
Nausea  1  5/116 (4.31%)  13/161 (8.07%)  4/155 (2.58%)  0/40 (0.00%)  2/33 (6.06%)  3/84 (3.57%)  0/82 (0.00%)  0/42 (0.00%)  3/44 (6.82%) 
Vomiting  1  0/116 (0.00%)  0/161 (0.00%)  0/155 (0.00%)  0/40 (0.00%)  2/33 (6.06%)  2/84 (2.38%)  0/82 (0.00%)  0/42 (0.00%)  1/44 (2.27%) 
Abdominal pain lower  1  0/116 (0.00%)  0/161 (0.00%)  0/155 (0.00%)  0/40 (0.00%)  2/33 (6.06%)  0/84 (0.00%)  1/82 (1.22%)  0/42 (0.00%)  0/44 (0.00%) 
Constipation  1  0/116 (0.00%)  0/161 (0.00%)  0/155 (0.00%)  2/40 (5.00%)  0/33 (0.00%)  0/84 (0.00%)  0/82 (0.00%)  0/42 (0.00%)  0/44 (0.00%) 
Diarrhoea  1  0/116 (0.00%)  0/161 (0.00%)  0/155 (0.00%)  2/40 (5.00%)  0/33 (0.00%)  1/84 (1.19%)  0/82 (0.00%)  0/42 (0.00%)  0/44 (0.00%) 
General disorders                   
Fatigue  1  5/116 (4.31%)  6/161 (3.73%)  8/155 (5.16%)  0/40 (0.00%)  0/33 (0.00%)  0/84 (0.00%)  0/82 (0.00%)  0/42 (0.00%)  0/44 (0.00%) 
Infections and infestations                   
Nasopharyngitis  1  2/116 (1.72%)  8/161 (4.97%)  2/155 (1.29%)  0/40 (0.00%)  0/33 (0.00%)  0/84 (0.00%)  0/82 (0.00%)  0/42 (0.00%)  0/44 (0.00%) 
Bacterial vaginosis  1  0/116 (0.00%)  0/161 (0.00%)  0/155 (0.00%)  2/40 (5.00%)  0/33 (0.00%)  2/84 (2.38%)  2/82 (2.44%)  0/42 (0.00%)  1/44 (2.27%) 
Fungal infection  1  0/116 (0.00%)  0/161 (0.00%)  0/155 (0.00%)  3/40 (7.50%)  0/33 (0.00%)  1/84 (1.19%)  0/82 (0.00%)  0/42 (0.00%)  0/44 (0.00%) 
Nervous system disorders                   
Headache  1  6/116 (5.17%)  7/161 (4.35%)  16/155 (10.32%)  0/40 (0.00%)  2/33 (6.06%)  5/84 (5.95%)  1/82 (1.22%)  3/42 (7.14%)  1/44 (2.27%) 
Vascular disorders                   
Hot flush  1  2/116 (1.72%)  12/161 (7.45%)  18/155 (11.61%)  0/40 (0.00%)  0/33 (0.00%)  5/84 (5.95%)  4/82 (4.88%)  1/42 (2.38%)  2/44 (4.55%) 
1
Term from vocabulary, MedDRA 18.0
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
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.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Therapeutic Area, Head
Organization: Allergan
Phone: 714-246-4500
EMail: clinicaltrials@allergan.com
Layout table for additonal information
Responsible Party: Allergan
ClinicalTrials.gov Identifier: NCT02147158     History of Changes
Other Study ID Numbers: UL1208
First Submitted: May 10, 2014
First Posted: May 26, 2014
Results First Submitted: April 4, 2019
Results First Posted: June 4, 2019
Last Update Posted: June 4, 2019