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A Safety and Efficacy Study of OnabotulinumtoxinA in Premature Ejaculation

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01917006
Recruitment Status : Terminated (Strategic business decision was made to terminate the program. There were no safety concerns.)
First Posted : August 6, 2013
Results First Posted : October 18, 2018
Last Update Posted : October 18, 2018
Sponsor:
Information provided by (Responsible Party):
Allergan

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Single Group Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition Premature Ejaculation
Interventions Drug: OnabotulinumtoxinA
Drug: Normal Saline
Enrollment 59
Recruitment Details  
Pre-assignment Details Participants received a single treatment of either placebo or OnabotulinumtoxinA (Doses 1, 2, 3, 4, 5, 6), delivered bilaterally to the bulbospongiosus muscle in randomized-treatment period. Participants who completed 12 weeks of randomized period were eligible to receive second injection with OnabotulinumtoxinA Dose 2 in Open-label Period.
Arm/Group Title OnabotulinumtoxinA Dose 1 OnabotulinumtoxinA Dose 2 OnabotulinumtoxinA Dose 3 OnabotulinumtoxinA Dose 4 OnabotulinumtoxinA Dose 5 OnabotulinumtoxinA Dose 6 Placebo OnabotulinumtoxinA Dose 2 (Open-label Period)
Hide Arm/Group Description OnabotulinumtoxinA Dose 1 injected into specified muscle per protocol on Day 1. OnabotulinumtoxinA Dose 2 injected into specified muscle per protocol on Day 1. Participants were eligible for another treatment after 12 weeks. OnabotulinumtoxinA Dose 3 injected into specified muscle per protocol on Day 1. OnabotulinumtoxinA Dose 4 injected into specified muscle per protocol on Day 1. OnabotulinumtoxinA Dose 5 injected into specified muscle per protocol on Day 1. OnabotulinumtoxinA Dose 6 injected into specified muscle per protocol on Day 1. Placebo (normal saline) injected into specified muscle per protocol on Day 1. Participants who completed 12 weeks of randomized period were eligible to receive a second injection with active drug in the Open-label Period.
Period Title: Randomized-treatment Period
Started 5 7 8 8 8 8 15 0
Completed 3 7 8 7 8 7 14 0
Not Completed 2 0 0 1 0 1 1 0
Reason Not Completed
Lost to Follow-up             1             0             0             1             0             0             0             0
Personal Reasons             0             0             0             0             0             1             0             0
Protocol Violation             1             0             0             0             0             0             0             0
Other Miscellaneous Reasons             0             0             0             0             0             0             1             0
Period Title: Open-label Period
Started 0 0 0 0 0 0 0 8
Completed 0 0 0 0 0 0 0 6
Not Completed 0 0 0 0 0 0 0 2
Reason Not Completed
Adverse Event             0             0             0             0             0             0             0             1
Lost to Follow-up             0             0             0             0             0             0             0             1
Arm/Group Title OnabotulinumtoxinA Dose 1 OnabotulinumtoxinA Dose 2 OnabotulinumtoxinA Dose 3 OnabotulinumtoxinA Dose 4 OnabotulinumtoxinA Dose 5 OnabotulinumtoxinA Dose 6 Placebo Total
Hide Arm/Group Description OnabotulinumtoxinA Dose 1 injected into specified muscle per protocol on Day 1. OnabotulinumtoxinA Dose 2 injected into specified muscle per protocol on Day 1. Participants were eligible for another treatment after 12 weeks. OnabotulinumtoxinA Dose 3 injected into specified muscle per protocol on Day 1. OnabotulinumtoxinA Dose 4 injected into specified muscle per protocol on Day 1. OnabotulinumtoxinA Dose 5 injected into specified muscle per protocol on Day 1. OnabotulinumtoxinA Dose 6 injected into specified muscle per protocol on Day 1. Placebo (normal saline) injected into specified muscle per protocol on Day 1. Total of all reporting groups
Overall Number of Baseline Participants 5 7 8 7 8 7 15 57
Hide Baseline Analysis Population Description
The modified intent-to-treat (mITT) population included all randomized participants who received study treatment and had post-baseline intravaginal ejaculatory latency time (IELT) data available based on the dose actually received by the participants.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 5 participants 7 participants 8 participants 7 participants 8 participants 7 participants 15 participants 57 participants
41.2  (10.83) 41.9  (11.65) 39.1  (5.62) 39.3  (9.05) 40.1  (6.53) 39.9  (5.96) 41.0  (6.08) 40.4  (7.41)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 5 participants 7 participants 8 participants 7 participants 8 participants 7 participants 15 participants 57 participants
Female
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Male
5
 100.0%
7
 100.0%
8
 100.0%
7
 100.0%
8
 100.0%
7
 100.0%
15
 100.0%
57
 100.0%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 5 participants 7 participants 8 participants 7 participants 8 participants 7 participants 15 participants 57 participants
Caucasian 3 4 5 5 5 6 9 37
Black 1 2 1 1 1 0 3 9
Asian 0 1 0 1 1 0 1 4
Hispanic 1 0 0 0 1 1 2 5
Other 0 0 2 0 0 0 0 2
1.Primary Outcome
Title Change From Baseline in Geometric Mean Intravaginal Ejaculatory Latency Time (IELT)
Hide Description IELT, the time from vaginal penetration to ejaculation, was measured by a stopwatch and was recorded in the sexual intercourse diary (SID). The Logarithm Value of the Geometric Mean of each individual participant's IELT recorded in the SID up to each time point was calculated. The mean and standard deviation (SD) of log-transformed geometric mean IELTs are then calculated for each treatment group. An Analysis of Covariance (ANCOVA) Model with treatment as the fixed effect and baseline geometric mean IELT as the covariate was used for analyses. A positive change from Baseline indicates improvement.
Time Frame Baseline (Day 1) to Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
The modified intent-to-treat (mITT) population included all randomized participants who received study treatment and had post-baseline intravaginal ejaculatory latency time (IELT) data available based on the dose actually received by the participant. Number analyzed is the number of participants with available data at the given time-point.
Arm/Group Title OnabotulinumtoxinA Dose 1 OnabotulinumtoxinA Dose 2 OnabotulinumtoxinA Dose 3 OnabotulinumtoxinA Dose 4 OnabotulinumtoxinA Dose 5 OnabotulinumtoxinA Dose 6 Placebo
Hide Arm/Group Description:
OnabotulinumtoxinA Dose 1 injected into specified muscle per protocol on Day 1.
OnabotulinumtoxinA Dose 2 injected into specified muscle per protocol on Day 1. Participants were eligible for another treatment after 12 weeks.
OnabotulinumtoxinA Dose 3 injected into specified muscle per protocol on Day 1.
OnabotulinumtoxinA Dose 4 injected into specified muscle per protocol on Day 1.
OnabotulinumtoxinA Dose 5 injected into specified muscle per protocol on Day 1.
OnabotulinumtoxinA Dose 6 injected into specified muscle per protocol on Day 1.
Placebo (normal saline) injected into specified muscle per protocol on Day 1.
Overall Number of Participants Analyzed 5 7 8 7 8 7 15
Mean (Standard Deviation)
Unit of Measure: log(seconds)
Baseline Number Analyzed 5 participants 6 participants 8 participants 7 participants 8 participants 7 participants 15 participants
3.57  (0.283) 3.50  (0.631) 3.46  (0.371) 3.52  (0.531) 3.53  (0.475) 3.54  (0.505) 3.46  (0.610)
Change from Baseline to Week 12 Number Analyzed 5 participants 6 participants 8 participants 7 participants 8 participants 7 participants 15 participants
0.55  (1.037) 0.69  (1.426) 0.05  (0.856) 0.30  (0.472) 0.31  (0.525) 0.59  (0.719) 0.44  (0.615)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection OnabotulinumtoxinA Dose 1, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.393
Comments Least square mean and one-sided p-value of mean difference vs placebo for each active OnabotulinumtoxinA dose level is calculated from analysis of covariance (ANCOVA) Model with treatment as fixed effect and baseline geometric mean IELT as covariate.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Least square mean difference
Estimated Value 0.11
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection OnabotulinumtoxinA Dose 2, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.263
Comments Least square mean and one-sided p-value of mean difference vs placebo for each active OnabotulinumtoxinA dose level is calculated from the ANCOVA Model with treatment as the fixed effect and baseline geometric mean IELT as the covariate.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Least Square Mean Difference
Estimated Value 0.25
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection OnabotulinumtoxinA Dose 3, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.861
Comments Least square mean and one-sided p-value of mean difference vs placebo for each active OnabotulinumtoxinA dose level is calculated from the ANCOVA Model with treatment as the fixed effect and baseline geometric mean IELT as the covariate.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Least square mean difference
Estimated Value -0.39
Estimation Comments [Not Specified]
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection OnabotulinumtoxinA Dose 4, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.647
Comments Least square mean and one-sided p-value of mean difference vs placebo for each active OnabotulinumtoxinA dose level is calculated from the ANCOVA Model with treatment as the fixed effect and baseline geometric mean IELT as the covariate.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Least square mean difference
Estimated Value -0.14
Estimation Comments [Not Specified]
Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection OnabotulinumtoxinA Dose 5, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.645
Comments Least square mean and one-sided p-value of mean difference vs placebo for each active OnabotulinumtoxinA dose level is calculated from the ANCOVA Model with treatment as the fixed effect and baseline geometric mean IELT as the covariate.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Least square mean difference
Estimated Value -0.13
Estimation Comments [Not Specified]
Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection OnabotulinumtoxinA Dose 6, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.343
Comments Least square mean and one-sided p-value of mean difference vs placebo for each active OnabotulinumtoxinA dose level is calculated from the ANCOVA Model with treatment as the fixed effect and baseline geometric mean IELT as the covariate.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Least square mean difference
Estimated Value 0.15
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Change From Baseline in Average IELT
Hide Description IELT, the time from vaginal penetration to ejaculation, was measured by a stopwatch and was recorded in the SID. The average of each individual participant's IELT recorded in the SID up to each time point was calculated. The mean and SD of average IELTs were then calculated for each treatment group. An ANCOVA Model with treatment as the fixed effect and baseline average mean IELT as the covariate was used for analyses. A positive change from Baseline indicates improvement.
Time Frame Baseline (Day 1) to Weeks 2, 4, 6, 8, 10, and 12
Hide Outcome Measure Data
Hide Analysis Population Description
The mITT population included all randomized participants who received study treatment and had post-baseline IELT data available based on the dose actually received by the participants. Number analyzed is the number of participants with available data at the given time-point.
Arm/Group Title OnabotulinumtoxinA Dose 1 OnabotulinumtoxinA Dose 2 OnabotulinumtoxinA Dose 3 OnabotulinumtoxinA Dose 4 OnabotulinumtoxinA Dose 5 OnabotulinumtoxinA Dose 6 Placebo
Hide Arm/Group Description:
OnabotulinumtoxinA Dose 1 injected into specified muscle per protocol on Day 1.
OnabotulinumtoxinA Dose 2 injected into specified muscle per protocol on Day 1. Participants were eligible for another treatment after 12 weeks.
OnabotulinumtoxinA Dose 3 injected into specified muscle per protocol on Day 1.
OnabotulinumtoxinA Dose 4 injected into specified muscle per protocol on Day 1.
OnabotulinumtoxinA Dose 5 injected into specified muscle per protocol on Day 1.
OnabotulinumtoxinA Dose 6 injected into specified muscle per protocol on Day 1.
Placebo (normal saline) injected into specified muscle per protocol on Day 1.
Overall Number of Participants Analyzed 5 7 8 7 8 7 15
Mean (Standard Deviation)
Unit of Measure: seconds
Baseline Number Analyzed 5 participants 6 participants 8 participants 7 participants 8 participants 7 participants 15 participants
37.25  (10.518) 39.42  (21.504) 34.41  (10.194) 38.00  (16.008) 40.88  (16.435) 38.75  (15.596) 37.92  (16.656)
Change from Baseline to Week 2 Number Analyzed 5 participants 6 participants 8 participants 7 participants 8 participants 7 participants 14 participants
66.25  (101.132) 180.31  (317.657) 24.73  (59.725) 34.87  (74.842) 28.04  (31.298) 55.77  (65.549) 11.25  (23.985)
Change from Baseline to Week 4 Number Analyzed 5 participants 6 participants 8 participants 7 participants 8 participants 7 participants 14 participants
61.94  (100.446) 176.71  (367.665) 24.06  (59.472) 35.00  (73.475) 28.46  (36.881) 64.97  (67.471) 29.30  (69.073)
Change from Baseline to Week 6 Number Analyzed 5 participants 6 participants 8 participants 7 participants 8 participants 7 participants 14 participants
61.42  (100.446) 183.44  (374.404) 20.75  (55.850) 36.95  (71.996) 29.35  (39.334) 64.49  (66.546) 47.62  (89.847)
Change from Baseline to Week 8 Number Analyzed 5 participants 6 participants 8 participants 7 participants 8 participants 7 participants 14 participants
59.55  (100.896) 176.59  (349.777) 17.08  (44.158) 37.69  (71.873) 29.48  (44.505) 65.19  (65.612) 65.57  (128.470)
Change from Baseline to Week 10 Number Analyzed 5 participants 6 participants 8 participants 7 participants 8 participants 7 participants 15 participants
56.13  (101.447) 170.65  (331.039) 15.55  (39.149) 37.45  (71.782) 27.49  (45.365) 63.91  (67.725) 68.26  (146.330)
Change from Baseline to Week 12 Number Analyzed 5 participants 6 participants 8 participants 7 participants 8 participants 7 participants 15 participants
53.65  (102.527) 152.74  (295.219) 12.95  (30.930) 28.32  (48.965) 27.51  (48.720) 66.01  (71.489) 68.49  (151.680)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection OnabotulinumtoxinA Dose 1, Placebo
Comments OnabotulinumtoxinA Dose 1 versus (vs) Placebo at Week 2
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.184
Comments Least square mean and one-sided p-value of mean difference vs placebo for each active OnabotulinumtoxinA dose level is calculated from the ANCOVA Model with treatment as the fixed effect and baseline average IELT as the covariate.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Least square mean difference
Estimated Value 55.33
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection OnabotulinumtoxinA Dose 2, Placebo
Comments OnabotulinumtoxinA Dose 2 vs Placebo at Week 2
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.002
Comments Least square mean and one-sided p-value of mean difference vs placebo for each active OnabotulinumtoxinA dose level is calculated from the ANCOVA Model with treatment as the fixed effect and baseline average IELT as the covariate.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Least square mean difference
Estimated Value 170.21
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection OnabotulinumtoxinA Dose 3, Placebo
Comments OnabotulinumtoxinA Dose 3 vs Placebo at Week 2
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.404
Comments Least square mean and one-sided p-value of mean difference vs placebo for each active OnabotulinumtoxinA dose level is calculated from the ANCOVA Model with treatment as the fixed effect and baseline average IELT as the covariate.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Least square mean difference
Estimated Value 12.73
Estimation Comments [Not Specified]
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection OnabotulinumtoxinA Dose 4, Placebo
Comments OnabotulinumtoxinA Dose 4 vs Placebo at Week 2
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.328
Comments Least square mean and one-sided p-value of mean difference vs placebo for each active OnabotulinumtoxinA dose level is calculated from the ANCOVA Model with treatment as the fixed effect and baseline average IELT as the covariate.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Least square mean difference
Estimated Value 24.23
Estimation Comments [Not Specified]
Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection OnabotulinumtoxinA Dose 5, Placebo
Comments OnabotulinumtoxinA Dose 5 vs Placebo at Week 2
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.362
Comments Least square mean and one-sided p-value of mean difference vs placebo for each active OnabotulinumtoxinA dose level is calculated from the ANCOVA Model with treatment as the fixed effect and baseline average IELT as the covariate.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Least square mean difference
Estimated Value 18.48
Estimation Comments [Not Specified]
Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection OnabotulinumtoxinA Dose 6, Placebo
Comments OnabotulinumtoxinA Dose 6 vs Placebo at Week 2
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.203
Comments Least square mean and one-sided p-value of mean difference vs placebo for each active OnabotulinumtoxinA dose level is calculated from the ANCOVA Model with treatment as the fixed effect and baseline average IELT as the covariate.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Least square mean difference
Estimated Value 45.42
Estimation Comments [Not Specified]
Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection OnabotulinumtoxinA Dose 1, Placebo
Comments OnabotulinumtoxinA Dose 1 vs Placebo at Week 4
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.322
Comments Least square mean and one-sided p-value of mean difference vs placebo for each active OnabotulinumtoxinA dose level is calculated from the ANCOVA Model with treatment as the fixed effect and baseline average IELT as the covariate.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Least square mean difference
Estimated Value 33.05
Estimation Comments [Not Specified]
Hide Statistical Analysis 8
Statistical Analysis Overview Comparison Group Selection OnabotulinumtoxinA Dose 2, Placebo
Comments OnabotulinumtoxinA Dose 2 vs Placebo at Week 4
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.015
Comments Least square mean and one-sided p-value of mean difference vs placebo for each active OnabotulinumtoxinA dose level is calculated from the ANCOVA Model with treatment as the fixed effect and baseline average IELT as the covariate.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Least square mean difference
Estimated Value 148.86
Estimation Comments [Not Specified]
Hide Statistical Analysis 9
Statistical Analysis Overview Comparison Group Selection OnabotulinumtoxinA Dose 3, Placebo
Comments OnabotulinumtoxinA Dose 3 vs Placebo at Week 4
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.541
Comments Least square mean and one-sided p-value of mean difference vs placebo for each active OnabotulinumtoxinA dose level is calculated from the ANCOVA Model with treatment as the fixed effect and baseline average IELT as the covariate.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Least square mean difference
Estimated Value -6.20
Estimation Comments [Not Specified]
Hide Statistical Analysis 10
Statistical Analysis Overview Comparison Group Selection OnabotulinumtoxinA Dose 4, Placebo
Comments OnabotulinumtoxinA Dose 4 vs Placebo at Week 4
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.459
Comments Least square mean and one-sided p-value of mean difference vs placebo for each active OnabotulinumtoxinA dose level is calculated from the ANCOVA Model with treatment as the fixed effect and baseline average IELT as the covariate.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Least square mean difference
Estimated Value 6.47
Estimation Comments [Not Specified]
Hide Statistical Analysis 11
Statistical Analysis Overview Comparison Group Selection OnabotulinumtoxinA Dose 5, Placebo
Comments OnabotulinumtoxinA Dose 5 vs Placebo at Week 4
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.491
Comments Least square mean and one-sided p-value of mean difference vs placebo for each active OnabotulinumtoxinA dose level is calculated from the ANCOVA Model with treatment as the fixed effect and baseline average IELT as the covariate.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Least square mean difference
Estimated Value 1.32
Estimation Comments [Not Specified]
Hide Statistical Analysis 12
Statistical Analysis Overview Comparison Group Selection OnabotulinumtoxinA Dose 6, Placebo
Comments OnabotulinumtoxinA Dose 6 vs Placebo at Week 4
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.281
Comments Least square mean and one-sided p-value of mean difference vs placebo for each active OnabotulinumtoxinA dose level is calculated from the ANCOVA Model with treatment as the fixed effect and baseline average IELT as the covariate.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Least square mean difference
Estimated Value 36.80
Estimation Comments [Not Specified]
Hide Statistical Analysis 13
Statistical Analysis Overview Comparison Group Selection OnabotulinumtoxinA Dose 1, Placebo
Comments OnabotulinumtoxinA Dose 1 vs Placebo at Week 6
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.424
Comments Least square mean and one-sided p-value of mean difference vs placebo for each active OnabotulinumtoxinA dose level is calculated from the ANCOVA Model with treatment as the fixed effect and baseline average IELT as the covariate.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Least square mean difference
Estimated Value 14.12
Estimation Comments [Not Specified]
Hide Statistical Analysis 14
Statistical Analysis Overview Comparison Group Selection OnabotulinumtoxinA Dose 2, Placebo
Comments OnabotulinumtoxinA Dose 2 vs Placebo at Week 6
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.026
Comments Least square mean and one-sided p-value of mean difference vs placebo for each active OnabotulinumtoxinA dose level is calculated from the ANCOVA Model with treatment as the fixed effect and baseline average IELT as the covariate.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Least square mean difference
Estimated Value 136.96
Estimation Comments [Not Specified]
Hide Statistical Analysis 15
Statistical Analysis Overview Comparison Group Selection OnabotulinumtoxinA Dose 3, Placebo
Comments OnabotulinumtoxinA Dose 3 vs Placebo at Week 6
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.670
Comments Least square mean and one-sided p-value of mean difference vs placebo for each active OnabotulinumtoxinA dose level is calculated from the ANCOVA Model with treatment as the fixed effect and baseline average IELT as the covariate.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Least square mean difference
Estimated Value -27.62
Estimation Comments [Not Specified]
Hide Statistical Analysis 16
Statistical Analysis Overview Comparison Group Selection OnabotulinumtoxinA Dose 4, Placebo
Comments OnabotulinumtoxinA Dose 4 vs Placebo at Week 6
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.561
Comments Least square mean and one-sided p-value of mean difference vs placebo for each active OnabotulinumtoxinA dose level is calculated from the ANCOVA Model with treatment as the fixed effect and baseline average IELT as the covariate.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Least square mean difference
Estimated Value -10.06
Estimation Comments [Not Specified]
Hide Statistical Analysis 17
Statistical Analysis Overview Comparison Group Selection OnabotulinumtoxinA Dose 5, Placebo
Comments OnabotulinumtoxinA Dose 5 vs Placebo at Week 6
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.604
Comments Least square mean and one-sided p-value of mean difference vs placebo for each active OnabotulinumtoxinA dose level is calculated from the ANCOVA Model with treatment as the fixed effect and baseline average IELT as the covariate.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Least square mean difference
Estimated Value -16.58
Estimation Comments [Not Specified]
Hide Statistical Analysis 18
Statistical Analysis Overview Comparison Group Selection OnabotulinumtoxinA Dose 6, Placebo
Comments OnabotulinumtoxinA Dose 6 vs Placebo at Week 6
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.394
Comments Least square mean and one-sided p-value of mean difference vs placebo for each active OnabotulinumtoxinA dose level is calculated from the ANCOVA Model with treatment as the fixed effect and baseline average IELT as the covariate.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Least square mean difference
Estimated Value 17.76
Estimation Comments [Not Specified]
Hide Statistical Analysis 19
Statistical Analysis Overview Comparison Group Selection OnabotulinumtoxinA Dose 1, Placebo
Comments OnabotulinumtoxinA Dose 1 vs Placebo at Week 8
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.532
Comments Least square mean and one-sided p-value of mean difference vs placebo for each active OnabotulinumtoxinA dose level is calculated from the ANCOVA Model with treatment as the fixed effect and baseline average IELT as the covariate.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Least square mean difference
Estimated Value -5.94
Estimation Comments [Not Specified]
Hide Statistical Analysis 20
Statistical Analysis Overview Comparison Group Selection OnabotulinumtoxinA Dose 2, Placebo
Comments OnabotulinumtoxinA Dose 2 vs Placebo at Week 8
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.058
Comments Least square mean and one-sided p-value of mean difference vs placebo for each active OnabotulinumtoxinA dose level is calculated from the ANCOVA Model with treatment as the fixed effect and baseline average IELT as the covariate.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Least square mean difference
Estimated Value 111.27
Estimation Comments [Not Specified]
Hide Statistical Analysis 21
Statistical Analysis Overview Comparison Group Selection OnabotulinumtoxinA Dose 3, Placebo
Comments OnabotulinumtoxinA Dose 3 vs Placebo at Week 8
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.778
Comments Least square mean and one-sided p-value of mean difference vs placebo for each active OnabotulinumtoxinA dose level is calculated from the ANCOVA Model with treatment as the fixed effect and baseline average IELT as the covariate.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Least square mean difference
Estimated Value -48.65
Estimation Comments [Not Specified]
Hide Statistical Analysis 22
Statistical Analysis Overview Comparison Group Selection OnabotulinumtoxinA Dose 4, Placebo
Comments OnabotulinumtoxinA Dose 4 vs Placebo at Week 8
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.662
Comments Least square mean and one-sided p-value of mean difference vs placebo for each active OnabotulinumtoxinA dose level is calculated from the ANCOVA Model with treatment as the fixed effect and baseline average IELT as the covariate.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Least square mean difference
Estimated Value -27.74
Estimation Comments [Not Specified]
Hide Statistical Analysis 23
Statistical Analysis Overview Comparison Group Selection OnabotulinumtoxinA Dose 5, Placebo
Comments OnabotulinumtoxinA Dose 5 vs Placebo at Week 8
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.712
Comments Least square mean and one-sided p-value of mean difference vs placebo for each active OnabotulinumtoxinA dose level is calculated from the ANCOVA Model with treatment as the fixed effect and baseline average IELT as the covariate.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Least square mean difference
Estimated Value -35.72
Estimation Comments [Not Specified]
Hide Statistical Analysis 24
Statistical Analysis Overview Comparison Group Selection OnabotulinumtoxinA Dose 6, Placebo
Comments OnabotulinumtoxinA Dose 6 vs Placebo at Week 8
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.501
Comments Least square mean and one-sided p-value of mean difference vs placebo for each active OnabotulinumtoxinA dose level is calculated from the ANCOVA Model with treatment as the fixed effect and baseline average IELT as the covariate.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Least square mean difference
Estimated Value -0.18
Estimation Comments [Not Specified]
Hide Statistical Analysis 25
Statistical Analysis Overview Comparison Group Selection OnabotulinumtoxinA Dose 1, Placebo
Comments OnabotulinumtoxinA Dose 1 vs Placebo at Week 10
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.565
Comments Least square mean and one-sided p-value of mean difference vs placebo for each active OnabotulinumtoxinA dose level is calculated from the ANCOVA Model with treatment as the fixed effect and baseline average IELT as the covariate.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Least square mean difference
Estimated Value -12.14
Estimation Comments [Not Specified]
Hide Statistical Analysis 26
Statistical Analysis Overview Comparison Group Selection OnabotulinumtoxinA Dose 2, Placebo
Comments OnabotulinumtoxinA Dose 2 vs Placebo at Week 10
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.071
Comments Least square mean and one-sided p-value of mean difference vs placebo for each active OnabotulinumtoxinA dose level is calculated from the ANCOVA Model with treatment as the fixed effect and baseline average IELT as the covariate.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Least square mean difference
Estimated Value 102.44
Estimation Comments [Not Specified]
Hide Statistical Analysis 27
Statistical Analysis Overview Comparison Group Selection OnabotulinumtoxinA Dose 3, Placebo
Comments OnabotulinumtoxinA Dose 3 vs Placebo at Week 10
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.799
Comments Least square mean and one-sided p-value of mean difference vs placebo for each active OnabotulinumtoxinA dose level is calculated from the ANCOVA Model with treatment as the fixed effect and baseline average IELT as the covariate.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Least square mean difference
Estimated Value -52.81
Estimation Comments [Not Specified]
Hide Statistical Analysis 28
Statistical Analysis Overview Comparison Group Selection OnabotulinumtoxinA Dose 4, Placebo
Comments OnabotulinumtoxinA Dose 4 vs Placebo at Week 10
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.681
Comments Least square mean and one-sided p-value of mean difference vs placebo for each active OnabotulinumtoxinA dose level is calculated from the ANCOVA Model with treatment as the fixed effect and baseline average IELT as the covariate.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Least square mean difference
Estimated Value -30.81
Estimation Comments [Not Specified]
Hide Statistical Analysis 29
Statistical Analysis Overview Comparison Group Selection OnabotulinumtoxinA Dose 5, Placebo
Comments OnabotulinumtoxinA Dose 5 vs Placebo at Week 10
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.741
Comments Least square mean and one-sided p-value of mean difference vs placebo for each active OnabotulinumtoxinA dose level is calculated from the ANCOVA Model with treatment as the fixed effect and baseline average IELT as the covariate.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Least square mean difference
Estimated Value -40.68
Estimation Comments [Not Specified]
Hide Statistical Analysis 30
Statistical Analysis Overview Comparison Group Selection OnabotulinumtoxinA Dose 6, Placebo
Comments OnabotulinumtoxinA Dose 6 vs Placebo at Week 10
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.526
Comments Least square mean and one-sided p-value of mean difference vs placebo for each active OnabotulinumtoxinA dose level is calculated from the ANCOVA Model with treatment as the fixed effect and baseline average IELT as the covariate.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Least square mean difference
Estimated Value -4.33
Estimation Comments [Not Specified]
Hide Statistical Analysis 31
Statistical Analysis Overview Comparison Group Selection OnabotulinumtoxinA Dose 1, Placebo
Comments OnabotulinumtoxinA Dose 1 vs Placebo at Week 12
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.584
Comments Least square mean and one-sided p-value of mean difference vs placebo for each active OnabotulinumtoxinA dose level is calculated from the ANCOVA Model with treatment as the fixed effect and baseline average IELT as the covariate.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Least square mean difference
Estimated Value -14.76
Estimation Comments [Not Specified]
Hide Statistical Analysis 32
Statistical Analysis Overview Comparison Group Selection OnabotulinumtoxinA Dose 2, Placebo
Comments OnabotulinumtoxinA Dose 2 vs Placebo at Week 12
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.101
Comments Least square mean and one-sided p-value of mean difference vs placebo for each active OnabotulinumtoxinA dose level is calculated from the ANCOVA Model with treatment as the fixed effect and baseline average IELT as the covariate.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Least square mean difference
Estimated Value 84.09
Estimation Comments [Not Specified]
Hide Statistical Analysis 33
Statistical Analysis Overview Comparison Group Selection OnabotulinumtoxinA Dose 3, Placebo
Comments OnabotulinumtoxinA Dose 3 vs Placebo at Week 12
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.823
Comments Least square mean and one-sided p-value of mean difference vs placebo for each active OnabotulinumtoxinA dose level is calculated from the ANCOVA Model with treatment as the fixed effect and baseline average IELT as the covariate.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Least square mean difference
Estimated Value -55.14
Estimation Comments [Not Specified]
Hide Statistical Analysis 34
Statistical Analysis Overview Comparison Group Selection OnabotulinumtoxinA Dose 4, Placebo
Comments OnabotulinumtoxinA Dose 4 vs Placebo at Week 12
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.741
Comments Least square mean and one-sided p-value of mean difference vs placebo for each active OnabotulinumtoxinA dose level is calculated from the ANCOVA Model with treatment as the fixed effect and baseline average IELT as the covariate.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Least square mean difference
Estimated Value -40.18
Estimation Comments [Not Specified]
Hide Statistical Analysis 35
Statistical Analysis Overview Comparison Group Selection OnabotulinumtoxinA Dose 5, Placebo
Comments OnabotulinumtoxinA Dose 5 vs Placebo at Week 12
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.756
Comments Least square mean and one-sided p-value of mean difference vs placebo for each active OnabotulinumtoxinA dose level is calculated from the ANCOVA Model with treatment as the fixed effect and baseline average IELT as the covariate.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Least square mean difference
Estimated Value -41.31
Estimation Comments [Not Specified]
Hide Statistical Analysis 36
Statistical Analysis Overview Comparison Group Selection OnabotulinumtoxinA Dose 6, Placebo
Comments OnabotulinumtoxinA Dose 6 vs Placebo at Week 12
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.517
Comments Least square mean and one-sided p-value of mean difference vs placebo for each active OnabotulinumtoxinA dose level is calculated from the ANCOVA Model with treatment as the fixed effect and baseline average IELT as the covariate.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Least square mean difference
Estimated Value -2.57
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Change From Baseline in Geometric Mean IELT
Hide Description IELT, the time from vaginal penetration to ejaculation, was measured by a stopwatch and was recorded in the SID. The Logarithm Value of the Geometric Mean of each individual participant's IELT recorded in the SID up to each time point was calculated. The mean and SD of log-transformed geometric mean IELTs were then calculated for each treatment group. An ANCOVA Model with treatment as the fixed effect and baseline geometric mean IELT as the covariate was used for analyses. A positive change from Baseline indicates improvement.
Time Frame Baseline (Day 1) to Weeks 2, 4, 6, 8, and 10
Hide Outcome Measure Data
Hide Analysis Population Description
The mITT population included all randomized participants who received study treatment and had post-baseline IELT data available based on the dose actually received by the participant. Number analyzed is the number of participants with available data at the given time-point.
Arm/Group Title OnabotulinumtoxinA Dose 1 OnabotulinumtoxinA Dose 2 OnabotulinumtoxinA Dose 3 OnabotulinumtoxinA Dose 4 OnabotulinumtoxinA Dose 5 OnabotulinumtoxinA Dose 6 Placebo
Hide Arm/Group Description:
OnabotulinumtoxinA Dose 1 injected into specified muscle per protocol on Day 1.
OnabotulinumtoxinA Dose 2 injected into specified muscle per protocol on Day 1. Participants were eligible for another treatment after 12 weeks.
OnabotulinumtoxinA Dose 3 injected into specified muscle per protocol on Day 1.
OnabotulinumtoxinA Dose 4 injected into specified muscle per protocol on Day 1.
OnabotulinumtoxinA Dose 5 injected into specified muscle per protocol on Day 1.
OnabotulinumtoxinA Dose 6 injected into specified muscle per protocol on Day 1.
Placebo (normal saline) injected into specified muscle per protocol on Day 1.
Overall Number of Participants Analyzed 5 7 8 7 8 7 15
Mean (Standard Deviation)
Unit of Measure: log(seconds)
Baseline Number Analyzed 5 participants 6 participants 8 participants 7 participants 8 participants 7 participants 15 participants
3.57  (0.283) 3.50  (0.631) 3.46  (0.371) 3.52  (0.531) 3.53  (0.475) 3.54  (0.505) 3.46  (0.610)
Change from Baseline to Week 2 Number Analyzed 5 participants 6 participants 8 participants 7 participants 8 participants 7 participants 14 participants
0.76  (1.014) 0.95  (1.497) 0.26  (0.677) 0.34  (0.690) 0.47  (0.604) 0.62  (0.623) 0.19  (0.486)
Change from Baseline to Week 4 Number Analyzed 5 participants 6 participants 8 participants 7 participants 8 participants 7 participants 14 participants
0.70  (1.000) 0.77  (1.505) 0.18  (0.879) 0.33  (0.616) 0.38  (0.481) 0.61  (0.618) 0.22  (0.627)
Change from Baseline to Week 6 Number Analyzed 5 participants 6 participants 8 participants 7 participants 8 participants 7 participants 14 participants
0.70  (0.999) 0.83  (1.513) 0.08  (0.971) 0.36  (0.629) 0.36  (0.483) 0.59  (0.722) 0.36  (0.524)
Change from Baseline to Week 8 Number Analyzed 5 participants 6 participants 8 participants 7 participants 8 participants 7 participants 14 participants
0.67  (1.007) 0.79  (1.525) 0.05  (0.968) 0.37  (0.627) 0.36  (0.522) 0.61  (0.682) 0.44  (0.567)
Change from Baseline to Week 10 Number Analyzed 5 participants 6 participants 8 participants 7 participants 8 participants 7 participants 15 participants
0.60  (1.009) 0.80  (1.503) 0.07  (0.905) 0.37  (0.624) 0.32  (0.512) 0.56  (0.727) 0.44  (0.603)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection OnabotulinumtoxinA Dose 1, Placebo
Comments OnabotulinumtoxinA Dose 1 vs Placebo at Week 2
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.079
Comments Least square mean and one-sided p-value of mean difference vs placebo for each active OnabotulinumtoxinA dose level is calculated from the ANCOVA Model with treatment as the fixed effect and baseline geometric mean IELT as the covariate.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Least square mean difference
Estimated Value 0.59
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection OnabotulinumtoxinA Dose 2, Placebo
Comments OnabotulinumtoxinA Dose 2 vs Placebo at Week 2
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.025
Comments Least square mean and one-sided p-value of mean difference vs placebo for each active OnabotulinumtoxinA dose level is calculated from the ANCOVA Model with treatment as the fixed effect and baseline geometric mean IELT as the covariate.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Least square mean difference
Estimated Value 0.77
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection OnabotulinumtoxinA Dose 3, Placebo
Comments OnabotulinumtoxinA Dose 3 vs Placebo at Week 2
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.417
Comments Least square mean and one-sided p-value of mean difference vs placebo for each active OnabotulinumtoxinA dose level is calculated from the ANCOVA Model with treatment as the fixed effect and baseline geometric mean IELT as the covariate.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Least square mean difference
Estimated Value 0.07
Estimation Comments [Not Specified]
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection OnabotulinumtoxinA Dose 4, Placebo
Comments OnabotulinumtoxinA Dose 4 vs Placebo at Week 2
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.330
Comments Least square mean and one-sided p-value of mean difference vs placebo for each active OnabotulinumtoxinA dose level is calculated from the ANCOVA Model with treatment as the fixed effect and baseline geometric mean IELT as the covariate.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Least square mean difference
Estimated Value 0.16
Estimation Comments [Not Specified]
Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection OnabotulinumtoxinA Dose 5, Placebo
Comments OnabotulinumtoxinA Dose 5 vs Placebo at Week 2
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.199
Comments Least square mean and one-sided p-value of mean difference vs placebo for each active OnabotulinumtoxinA dose level is calculated from the ANCOVA Model with treatment as the fixed effect and baseline geometric mean IELT as the covariate.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Least square mean difference
Estimated Value 0.30
Estimation Comments [Not Specified]
Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection OnabotulinumtoxinA Dose 6, Placebo
Comments OnabotulinumtoxinA Dose 6 vs Placebo at Week 2
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.113
Comments Least square mean and one-sided p-value of mean difference vs placebo for each active OnabotulinumtoxinA dose level is calculated from the ANCOVA Model with treatment as the fixed effect and baseline geometric mean IELT as the covariate.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Least square mean difference
Estimated Value 0.45
Estimation Comments [Not Specified]
Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection OnabotulinumtoxinA Dose 1, Placebo
Comments OnabotulinumtoxinA Dose 1 vs Placebo at Week 4
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.127
Comments Least square mean and one-sided p-value of mean difference vs placebo for each active OnabotulinumtoxinA dose level is calculated from the ANCOVA Model with treatment as the fixed effect and baseline geometric mean IELT as the covariate.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Least square mean difference
Estimated Value 0.50
Estimation Comments [Not Specified]
Hide Statistical Analysis 8
Statistical Analysis Overview Comparison Group Selection OnabotulinumtoxinA Dose 2, Placebo
Comments OnabotulinumtoxinA Dose 2 vs Placebo at Week 4
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.087
Comments Least square mean and one-sided p-value of mean difference vs placebo for each active OnabotulinumtoxinA dose level is calculated from the ANCOVA Model with treatment as the fixed effect and baseline geometric mean IELT as the covariate.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Least square mean difference
Estimated Value 0.56
Estimation Comments [Not Specified]
Hide Statistical Analysis 9
Statistical Analysis Overview Comparison Group Selection OnabotulinumtoxinA Dose 3, Placebo
Comments OnabotulinumtoxinA Dose 3 vs Placebo at Week 4
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.543
Comments Least square mean and one-sided p-value of mean difference vs placebo for each active OnabotulinumtoxinA dose level is calculated from the ANCOVA Model with treatment as the fixed effect and baseline geometric mean IELT as the covariate.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Least square mean difference
Estimated Value -0.04
Estimation Comments [Not Specified]
Hide Statistical Analysis 10
Statistical Analysis Overview Comparison Group Selection OnabotulinumtoxinA Dose 4, Placebo
Comments OnabotulinumtoxinA Dose 4 vs Placebo at Week 4
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.377
Comments Least square mean and one-sided p-value of mean difference vs placebo for each active OnabotulinumtoxinA dose level is calculated from the ANCOVA Model with treatment as the fixed effect and baseline geometric mean IELT as the covariate.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Least square mean difference
Estimated Value 0.12
Estimation Comments [Not Specified]
Hide Statistical Analysis 11
Statistical Analysis Overview Comparison Group Selection OnabotulinumtoxinA Dose 5, Placebo
Comments OnabotulinumtoxinA Dose 5 vs Placebo at Week 4
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.321
Comments Least square mean and one-sided p-value of mean difference vs placebo for each active OnabotulinumtoxinA dose level is calculated from the ANCOVA Model with treatment as the fixed effect and baseline geometric mean IELT as the covariate.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Least square mean difference
Estimated Value 0.17
Estimation Comments [Not Specified]
Hide Statistical Analysis 12
Statistical Analysis Overview Comparison Group Selection OnabotulinumtoxinA Dose 6, Placebo
Comments OnabotulinumtoxinA Dose 6 vs Placebo at Week 4
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.149
Comments Least square mean and one-sided p-value of mean difference vs placebo for each active OnabotulinumtoxinA dose level is calculated from the ANCOVA Model with treatment as the fixed effect and baseline geometric mean IELT as the covariate.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Least square mean difference
Estimated Value 0.40
Estimation Comments [Not Specified]
Hide Statistical Analysis 13
Statistical Analysis Overview Comparison Group Selection OnabotulinumtoxinA Dose 1, Placebo
Comments OnabotulinumtoxinA Dose 1 vs Placebo at Week 6
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.215
Comments Least square mean and one-sided p-value of mean difference vs placebo for each active OnabotulinumtoxinA dose level is calculated from the ANCOVA Model with treatment as the fixed effect and baseline geometric mean IELT as the covariate.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Least square mean difference
Estimated Value 0.35
Estimation Comments [Not Specified]
Hide Statistical Analysis 14
Statistical Analysis Overview Comparison Group Selection OnabotulinumtoxinA Dose 2, Placebo
Comments OnabotulinumtoxinA Dose 2 vs Placebo at Week 6
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.126
Comments Least square mean and one-sided p-value of mean difference vs placebo for each active OnabotulinumtoxinA dose level is calculated from the ANCOVA Model with treatment as the fixed effect and baseline geometric mean IELT as the covariate.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Least square mean difference
Estimated Value 0.47
Estimation Comments [Not Specified]
Hide Statistical Analysis 15
Statistical Analysis Overview Comparison Group Selection OnabotulinumtoxinA Dose 3, Placebo
Comments OnabotulinumtoxinA Dose 3 vs Placebo at Week 6
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.774
Comments Least square mean and one-sided p-value of mean difference vs placebo for each active OnabotulinumtoxinA dose level is calculated from the ANCOVA Model with treatment as the fixed effect and baseline geometric mean IELT as the covariate.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Least square mean difference
Estimated Value -0.28
Estimation Comments [Not Specified]
Hide Statistical Analysis 16
Statistical Analysis Overview Comparison Group Selection OnabotulinumtoxinA Dose 4, Placebo
Comments OnabotulinumtoxinA Dose 4 vs Placebo at Week 6
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.495
Comments Least square mean and one-sided p-value of mean difference vs placebo for each active OnabotulinumtoxinA dose level is calculated from the ANCOVA Model with treatment as the fixed effect and baseline geometric mean IELT as the covariate.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Least square mean difference
Estimated Value 0.01
Estimation Comments [Not Specified]
Hide Statistical Analysis 17
Statistical Analysis Overview Comparison Group Selection OnabotulinumtoxinA Dose 5, Placebo
Comments OnabotulinumtoxinA Dose 5 vs Placebo at Week 6
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.495
Comments Least square mean and one-sided p-value of mean difference vs placebo for each active OnabotulinumtoxinA dose level is calculated from the ANCOVA Model with treatment as the fixed effect and baseline geometric mean IELT as the covariate.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Least square mean difference
Estimated Value 0.00
Estimation Comments [Not Specified]
Hide Statistical Analysis 18
Statistical Analysis Overview Comparison Group Selection OnabotulinumtoxinA Dose 6, Placebo
Comments OnabotulinumtoxinA Dose 6 vs Placebo at Week 6
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.274
Comments Least square mean and one-sided p-value of mean difference vs placebo for each active OnabotulinumtoxinA dose level is calculated from the ANCOVA Model with treatment as the fixed effect and baseline geometric mean IELT as the covariate.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Least square mean difference
Estimated Value 0.23
Estimation Comments [Not Specified]
Hide Statistical Analysis 19
Statistical Analysis Overview Comparison Group Selection OnabotulinumtoxinA Dose 1, Placebo
Comments OnabotulinumtoxinA Dose 1 vs Placebo at Week 8
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.308
Comments Least square mean and one-sided p-value of mean difference vs placebo for each active OnabotulinumtoxinA dose level is calculated from the ANCOVA Model with treatment as the fixed effect and baseline geometric mean IELT as the covariate.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Least square mean difference
Estimated Value 0.22
Estimation Comments [Not Specified]
Hide Statistical Analysis 20
Statistical Analysis Overview Comparison Group Selection OnabotulinumtoxinA Dose 2, Placebo
Comments OnabotulinumtoxinA Dose 2 vs Placebo at Week 8
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.205
Comments Least square mean and one-sided p-value of mean difference vs placebo for each active OnabotulinumtoxinA dose level is calculated from the ANCOVA Model with treatment as the fixed effect and baseline geometric mean IELT as the covariate.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Least square mean difference
Estimated Value 0.34
Estimation Comments [Not Specified]
Hide Statistical Analysis 21
Statistical Analysis Overview Comparison Group Selection OnabotulinumtoxinA Dose 3, Placebo
Comments OnabotulinumtoxinA Dose 3 vs Placebo at Week 8
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.849
Comments Least square mean and one-sided p-value of mean difference vs placebo for each active OnabotulinumtoxinA dose level is calculated from the ANCOVA Model with treatment as the fixed effect and baseline geometric mean IELT as the covariate.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Least square mean difference
Estimated Value -0.39
Estimation Comments [Not Specified]
Hide Statistical Analysis 22
Statistical Analysis Overview Comparison Group Selection OnabotulinumtoxinA Dose 4, Placebo
Comments OnabotulinumtoxinA Dose 4 vs Placebo at Week 8
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.571
Comments Least square mean and one-sided p-value of mean difference vs placebo for each active OnabotulinumtoxinA dose level is calculated from the ANCOVA Model with treatment as the fixed effect and baseline geometric mean IELT as the covariate.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Least square mean difference
Estimated Value -0.07
Estimation Comments [Not Specified]
Hide Statistical Analysis 23
Statistical Analysis Overview Comparison Group Selection OnabotulinumtoxinA Dose 5, Placebo
Comments OnabotulinumtoxinA Dose 5 vs Placebo at Week 8
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.592
Comments Least square mean and one-sided p-value of mean difference vs placebo for each active OnabotulinumtoxinA dose level is calculated from the ANCOVA Model with treatment as the fixed effect and baseline geometric mean IELT as the covariate.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Least square mean difference
Estimated Value -0.09
Estimation Comments [Not Specified]
Hide Statistical Analysis 24
Statistical Analysis Overview Comparison Group Selection OnabotulinumtoxinA Dose 6, Placebo
Comments OnabotulinumtoxinA Dose 6 vs Placebo at Week 8
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.340
Comments Least square mean and one-sided p-value of mean difference vs placebo for each active OnabotulinumtoxinA dose level is calculated from the ANCOVA Model with treatment as the fixed effect and baseline geometric mean IELT as the covariate.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Least square mean difference
Estimated Value 0.16
Estimation Comments [Not Specified]
Hide Statistical Analysis 25
Statistical Analysis Overview Comparison Group Selection OnabotulinumtoxinA Dose 1, Placebo
Comments OnabotulinumtoxinA Dose 1 vs Placebo at Week 10
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.360
Comments Least square mean and one-sided p-value of mean difference vs placebo for each active OnabotulinumtoxinA dose level is calculated from the ANCOVA Model with treatment as the fixed effect and baseline geometric mean IELT as the covariate.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Least square mean difference
Estimated Value 0.16
Estimation Comments [Not Specified]
Hide Statistical Analysis 26
Statistical Analysis Overview Comparison Group Selection OnabotulinumtoxinA Dose 2, Placebo
Comments OnabotulinumtoxinA Dose 2 vs Placebo at Week 10
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.192
Comments Least square mean and one-sided p-value of mean difference vs placebo for each active OnabotulinumtoxinA dose level is calculated from the ANCOVA Model with treatment as the fixed effect and baseline geometric mean IELT as the covariate.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Least square mean difference
Estimated Value 0.35
Estimation Comments [Not Specified]
Hide Statistical Analysis 27
Statistical Analysis Overview Comparison Group Selection OnabotulinumtoxinA Dose 3, Placebo
Comments OnabotulinumtoxinA Dose 3 vs Placebo at Week 10
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.843
Comments Least square mean and one-sided p-value of mean difference vs placebo for each active OnabotulinumtoxinA dose level is calculated from the ANCOVA Model with treatment as the fixed effect and baseline geometric mean IELT as the covariate.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Least square mean difference
Estimated Value -0.37
Estimation Comments [Not Specified]
Hide Statistical Analysis 28
Statistical Analysis Overview Comparison Group Selection OnabotulinumtoxinA Dose 4, Placebo
Comments OnabotulinumtoxinA Dose 4 vs Placebo at Week 10
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.572
Comments Least square mean and one-sided p-value of mean difference vs placebo for each active OnabotulinumtoxinA dose level is calculated from the ANCOVA Model with treatment as the fixed effect and baseline geometric mean IELT as the covariate.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Least square mean difference
Estimated Value -0.07
Estimation Comments [Not Specified]
Hide Statistical Analysis 29
Statistical Analysis Overview Comparison Group Selection OnabotulinumtoxinA Dose 5, Placebo
Comments OnabotulinumtoxinA Dose 5 vs Placebo at Week 10
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.628
Comments Least square mean and one-sided p-value of mean difference vs placebo for each active OnabotulinumtoxinA dose level is calculated from the ANCOVA Model with treatment as the fixed effect and baseline geometric mean IELT as the covariate.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Least square mean difference
Estimated Value -0.12
Estimation Comments [Not Specified]
Hide Statistical Analysis 30
Statistical Analysis Overview Comparison Group Selection OnabotulinumtoxinA Dose 6, Placebo
Comments OnabotulinumtoxinA Dose 6 vs Placebo at Week 10
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.380
Comments Least square mean and one-sided p-value of mean difference vs placebo for each active OnabotulinumtoxinA dose level is calculated from the ANCOVA Model with treatment as the fixed effect and baseline geometric mean IELT as the covariate.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Least square mean difference
Estimated Value 0.12
Estimation Comments [Not Specified]
Time Frame First dose and for at least 28 days after the last dose of study medication (Up to 26 Weeks in the Randomized-treatment Period and Up to 17 Weeks in the Open-Label Period)
Adverse Event Reporting Description

A treatment-emergent adverse event (TEAE) was an adverse event with onset on or after the initiation of study treatment or an adverse event with onset prior to study treatment that worsened in severity or became serious after the initiation of study treatment.

Safety Population included all treated participants.

 
Arm/Group Title OnabotulinumtoxinA Dose 1 OnabotulinumtoxinA Dose 2 OnabotulinumtoxinA Dose 3 OnabotulinumtoxinA Dose 4 OnabotulinumtoxinA Dose 5 OnabotulinumtoxinA Dose 6 Placebo OnabotulinumtoxinA Dose 2 (Open-label Period)
Hide Arm/Group Description OnabotulinumtoxinA Dose 1 injected into specified muscle per protocol on Day 1. OnabotulinumtoxinA Dose 2 injected into specified muscle per protocol on Day 1. OnabotulinumtoxinA Dose 3 injected into specified muscle per protocol on Day 1. OnabotulinumtoxinA Dose 4 injected into specified muscle per protocol on Day 1. OnabotulinumtoxinA Dose 5 injected into specified muscle per protocol on Day 1. OnabotulinumtoxinA Dose 6 injected into specified muscle per protocol on Day 1. Placebo (normal saline) injected into specified muscle per protocol on Day 1. Participants who completed 12 weeks of randomized period were eligible to receive a second injection with active drug in the Open-label Period.
All-Cause Mortality
OnabotulinumtoxinA Dose 1 OnabotulinumtoxinA Dose 2 OnabotulinumtoxinA Dose 3 OnabotulinumtoxinA Dose 4 OnabotulinumtoxinA Dose 5 OnabotulinumtoxinA Dose 6 Placebo OnabotulinumtoxinA Dose 2 (Open-label Period)
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   0/5 (0.00%)   0/7 (0.00%)   0/8 (0.00%)   0/8 (0.00%)   0/8 (0.00%)   0/8 (0.00%)   0/15 (0.00%)   0/8 (0.00%) 
Hide Serious Adverse Events
OnabotulinumtoxinA Dose 1 OnabotulinumtoxinA Dose 2 OnabotulinumtoxinA Dose 3 OnabotulinumtoxinA Dose 4 OnabotulinumtoxinA Dose 5 OnabotulinumtoxinA Dose 6 Placebo OnabotulinumtoxinA Dose 2 (Open-label Period)
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   0/5 (0.00%)   0/7 (0.00%)   0/8 (0.00%)   0/8 (0.00%)   0/8 (0.00%)   0/8 (0.00%)   0/15 (0.00%)   0/8 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
OnabotulinumtoxinA Dose 1 OnabotulinumtoxinA Dose 2 OnabotulinumtoxinA Dose 3 OnabotulinumtoxinA Dose 4 OnabotulinumtoxinA Dose 5 OnabotulinumtoxinA Dose 6 Placebo OnabotulinumtoxinA Dose 2 (Open-label Period)
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   3/5 (60.00%)   2/7 (28.57%)   1/8 (12.50%)   2/8 (25.00%)   3/8 (37.50%)   4/8 (50.00%)   12/15 (80.00%)   3/8 (37.50%) 
Cardiac disorders                 
Angina pectoris  1  0/5 (0.00%)  0/7 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  1/15 (6.67%)  0/8 (0.00%) 
Endocrine disorders                 
Hypogonadism  1  0/5 (0.00%)  0/7 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/15 (0.00%)  1/8 (12.50%) 
Eye disorders                 
Vision blurred  1  0/5 (0.00%)  0/7 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  1/15 (6.67%)  0/8 (0.00%) 
Gastrointestinal disorders                 
Abdominal pain upper  1  0/5 (0.00%)  0/7 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  1/8 (12.50%)  0/8 (0.00%)  1/15 (6.67%)  0/8 (0.00%) 
Abdominal pain lower  1  0/5 (0.00%)  0/7 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  1/8 (12.50%)  0/8 (0.00%)  0/15 (0.00%)  0/8 (0.00%) 
Constipation  1  0/5 (0.00%)  0/7 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  1/8 (12.50%)  0/8 (0.00%)  0/15 (0.00%)  0/8 (0.00%) 
Abnormal faeces  1  0/5 (0.00%)  0/7 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  1/15 (6.67%)  0/8 (0.00%) 
Diarrhoea  1  0/5 (0.00%)  0/7 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  1/15 (6.67%)  0/8 (0.00%) 
General disorders                 
Injection site pain  1  0/5 (0.00%)  0/7 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  1/8 (12.50%)  1/8 (12.50%)  1/15 (6.67%)  0/8 (0.00%) 
Chills  1  0/5 (0.00%)  0/7 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  1/8 (12.50%)  0/8 (0.00%)  0/15 (0.00%)  0/8 (0.00%) 
Injection site paraesthesia  1  0/5 (0.00%)  0/7 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  1/15 (6.67%)  0/8 (0.00%) 
Injection site pruritus  1  0/5 (0.00%)  0/7 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  1/15 (6.67%)  0/8 (0.00%) 
Infections and infestations                 
Influenza  1  0/5 (0.00%)  1/7 (14.29%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  1/15 (6.67%)  0/8 (0.00%) 
Upper respiratory tract infection  1  0/5 (0.00%)  0/7 (0.00%)  1/8 (12.50%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/15 (0.00%)  0/8 (0.00%) 
Rhinitis  1  0/5 (0.00%)  0/7 (0.00%)  0/8 (0.00%)  1/8 (12.50%)  0/8 (0.00%)  0/8 (0.00%)  0/15 (0.00%)  0/8 (0.00%) 
Viral upper respiratory tract infection  1  0/5 (0.00%)  0/7 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  1/8 (12.50%)  3/15 (20.00%)  0/8 (0.00%) 
Pharyngitis streptococcal  1  0/5 (0.00%)  0/7 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  1/8 (12.50%)  0/15 (0.00%)  0/8 (0.00%) 
Sinusitis  1  0/5 (0.00%)  0/7 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  1/8 (12.50%)  0/15 (0.00%)  0/8 (0.00%) 
Urinary tract infection  1  0/5 (0.00%)  0/7 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  1/8 (12.50%)  0/15 (0.00%)  0/8 (0.00%) 
Conjunctivitis  1  0/5 (0.00%)  0/7 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  1/15 (6.67%)  0/8 (0.00%) 
Ear infection  1  0/5 (0.00%)  0/7 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  1/15 (6.67%)  0/8 (0.00%) 
Gastroenteritis  1  0/5 (0.00%)  0/7 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  1/15 (6.67%)  0/8 (0.00%) 
Gastroenteritis viral  1  0/5 (0.00%)  1/7 (14.29%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/15 (0.00%)  0/8 (0.00%) 
Injury, poisoning and procedural complications                 
Joint injury  1  0/5 (0.00%)  0/7 (0.00%)  0/8 (0.00%)  1/8 (12.50%)  0/8 (0.00%)  0/8 (0.00%)  0/15 (0.00%)  0/8 (0.00%) 
Penis injury  1  0/5 (0.00%)  0/7 (0.00%)  0/8 (0.00%)  1/8 (12.50%)  0/8 (0.00%)  0/8 (0.00%)  0/15 (0.00%)  0/8 (0.00%) 
Concussion  1  0/5 (0.00%)  0/7 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  1/15 (6.67%)  0/8 (0.00%) 
Contusion  1  0/5 (0.00%)  0/7 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  1/15 (6.67%)  0/8 (0.00%) 
Road traffic accident  1  0/5 (0.00%)  0/7 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  1/15 (6.67%)  0/8 (0.00%) 
Investigations                 
Semen volume decreased  1  2/5 (40.00%)  0/7 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/15 (0.00%)  0/8 (0.00%) 
Blood creatine phosphokinase increased  1  0/5 (0.00%)  0/7 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  1/8 (12.50%)  0/8 (0.00%)  2/15 (13.33%)  0/8 (0.00%) 
Heart rate irregular  1  0/5 (0.00%)  0/7 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  1/15 (6.67%)  0/8 (0.00%) 
Musculoskeletal and connective tissue disorders                 
Back pain  1  0/5 (0.00%)  0/7 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  1/8 (12.50%)  1/15 (6.67%)  0/8 (0.00%) 
Muscle spasms  1  0/5 (0.00%)  0/7 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  3/15 (20.00%)  0/8 (0.00%) 
Arthralgia  1  0/5 (0.00%)  0/7 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  1/15 (6.67%)  0/8 (0.00%) 
Nervous system disorders                 
Headache  1  0/5 (0.00%)  0/7 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  1/8 (12.50%)  3/15 (20.00%)  0/8 (0.00%) 
Dizziness  1  0/5 (0.00%)  0/7 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  1/15 (6.67%)  0/8 (0.00%) 
Loss of consciousness  1  0/5 (0.00%)  0/7 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  1/15 (6.67%)  0/8 (0.00%) 
Memory impairment  1  0/5 (0.00%)  0/7 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  1/15 (6.67%)  0/8 (0.00%) 
Psychiatric disorders                 
Enuresis  1  0/5 (0.00%)  0/7 (0.00%)  0/8 (0.00%)  1/8 (12.50%)  0/8 (0.00%)  0/8 (0.00%)  0/15 (0.00%)  0/8 (0.00%) 
Psychogenic erectile dysfunction  1  0/5 (0.00%)  0/7 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  1/15 (6.67%)  0/8 (0.00%) 
Renal and urinary disorders                 
Dysuria  1  0/5 (0.00%)  1/7 (14.29%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/15 (0.00%)  0/8 (0.00%) 
Terminal dribbling  1  0/5 (0.00%)  1/7 (14.29%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/15 (0.00%)  0/8 (0.00%) 
Urine odour abnormal  1  0/5 (0.00%)  0/7 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  1/15 (6.67%)  0/8 (0.00%) 
Reproductive system and breast disorders                 
Ejaculation disorder  1  3/5 (60.00%)  0/7 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  2/15 (13.33%)  0/8 (0.00%) 
Epididymal tenderness  1  0/5 (0.00%)  0/7 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  1/8 (12.50%)  0/8 (0.00%)  0/15 (0.00%)  0/8 (0.00%) 
Perineal pain  1  0/5 (0.00%)  0/7 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  1/8 (12.50%)  0/8 (0.00%)  0/15 (0.00%)  0/8 (0.00%) 
Pruritus genital  1  0/5 (0.00%)  0/7 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  1/8 (12.50%)  0/8 (0.00%)  0/15 (0.00%)  1/8 (12.50%) 
Erectile dysfunction  1  0/5 (0.00%)  0/7 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  1/8 (12.50%)  0/15 (0.00%)  0/8 (0.00%) 
Ejaculation failure  1  0/5 (0.00%)  0/7 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  1/15 (6.67%)  0/8 (0.00%) 
Respiratory, thoracic and mediastinal disorders                 
Sinus congestion  1  0/5 (0.00%)  0/7 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  1/8 (12.50%)  0/15 (0.00%)  0/8 (0.00%) 
Cough  1  0/5 (0.00%)  0/7 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  1/15 (6.67%)  0/8 (0.00%) 
Dyspnoea  1  0/5 (0.00%)  0/7 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  1/15 (6.67%)  0/8 (0.00%) 
Oropharyngeal pain  1  0/5 (0.00%)  0/7 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  1/15 (6.67%)  0/8 (0.00%) 
Skin and subcutaneous tissue disorders                 
Dyshidrotic eczema  1  0/5 (0.00%)  0/7 (0.00%)  0/8 (0.00%)  1/8 (12.50%)  0/8 (0.00%)  0/8 (0.00%)  0/15 (0.00%)  0/8 (0.00%) 
Skin odour abnormal  1  0/5 (0.00%)  0/7 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  1/15 (6.67%)  0/8 (0.00%) 
Rosacea  1  0/5 (0.00%)  0/7 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/15 (0.00%)  1/8 (12.50%) 
Vascular disorders                 
Hypertension  1  0/5 (0.00%)  0/7 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  1/15 (6.67%)  0/8 (0.00%) 
1
Term from vocabulary, MedDRA, Version 20.0
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
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Responsible Party: Allergan
ClinicalTrials.gov Identifier: NCT01917006    
Other Study ID Numbers: 191622-133
2013-001650-94 ( EudraCT Number )
First Submitted: August 2, 2013
First Posted: August 6, 2013
Results First Submitted: August 15, 2018
Results First Posted: October 18, 2018
Last Update Posted: October 18, 2018