Premature Ejaculation
Conditions
Brief summary
This is a safety and efficacy study of OnabotulinumtoxinA for the treatment of premature ejaculation (PE) in male participants.
Detailed description
This is a phase 2, multicenter, randomized, double-blind, placebo-controlled, dose-escalation study to assess a range of doses of OnabotulinumtoxinA for the treatment of male participants with PE. Participants will attend a minimum of 6 or 7 clinic visits and also have 1 or 2 telephone visits. Partners will need to attend a clinic visit during the screening period to provide informed consent and to receive training on measurement and recording of the intravaginal ejaculatory latency time (IELT). Participants will be enrolled in cohorts. Within the first 5 cohorts, 8 participants are to receive OnabotulinumtoxinA and 2 participants to receive placebo. For cohort 6, 12 participants will receive OnabotulinumtoxinA and 12 participants will receive placebo. Participants will receive a single treatment of study medication delivered bilaterally to the bulbospongiosus muscle. The initial OnabotulinumtoxinA total dose in this dose escalation study will be 5 U and the maximum OnabotulinumtoxinA total dose will be 100 U. Upon request and if eligible, participants in cohort 6, will have the option to receive a second injection of OnabotulinumtoxinA (Open-label).
Interventions
DRUGOnabotulinumtoxinA
OnabotulinumtoxinA injected into specified muscle per protocol on Day 1.
DRUGNormal Saline
Placebo (normal saline) injected into specified muscle per protocol on Day 1.
Sponsors
Allergan
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
MALE
Age
18 Years to 50 Years
Healthy volunteers
No
Inclusion criteria
* History of premature ejaculation * Stable monogamous sexual relationship with female partner for at least 6 months, and intends to continue with the same partner for the duration of the study * Participant has ability to follow study instructions and complete study assessment tools
Exclusion criteria
* Premature ejaculation caused by medical or surgical issues, or is related to stress or other issues (eg, relationship problems) * Pain with ejaculation * Planned use of topical penile treatments (eg, anesthetics, herbal treatments) or penile injections during the study * Prior genital, prostatic or lower urinary tract surgery (other than vasectomy or circumcision) * Previous or current usage of botulinum toxin therapy of any serotype for any urological condition * Use of botulinum toxin therapy of any serotype for any nonurological condition (eg, cosmetic, chronic migraine) during the 12 weeks prior to screening, or planned usage during the study * Diagnosis of Myasthenia gravis, Eaton-Lambert Syndrome, Amyotrophic Lateral Sclerosis
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Geometric Mean Intravaginal Ejaculatory Latency Time (IELT) | Baseline (Day 1) to Week 12 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Average IELT | Baseline (Day 1) to Weeks 2, 4, 6, 8, 10, and 12 | 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. |
| Change From Baseline in Geometric Mean IELT | Baseline (Day 1) to Weeks 2, 4, 6, 8, and 10 | 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. |
Countries
United Kingdom, United States
Participant flow
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.
Participants by arm
| Arm | Count |
|---|---|
| OnabotulinumtoxinA Dose 1 OnabotulinumtoxinA Dose 1 injected into specified muscle per protocol on Day 1. | 5 |
| OnabotulinumtoxinA Dose 2 OnabotulinumtoxinA Dose 2 injected into specified muscle per protocol on Day 1. Participants were eligible for another treatment after 12 weeks. | 7 |
| OnabotulinumtoxinA Dose 3 OnabotulinumtoxinA Dose 3 injected into specified muscle per protocol on Day 1. | 8 |
| OnabotulinumtoxinA Dose 4 OnabotulinumtoxinA Dose 4 injected into specified muscle per protocol on Day 1. | 7 |
| OnabotulinumtoxinA Dose 5 OnabotulinumtoxinA Dose 5 injected into specified muscle per protocol on Day 1. | 8 |
| OnabotulinumtoxinA Dose 6 OnabotulinumtoxinA Dose 6 injected into specified muscle per protocol on Day 1. | 7 |
| Placebo Placebo (normal saline) injected into specified muscle per protocol on Day 1. | 15 |
| Total | 57 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 | FG005 | FG006 | FG007 |
|---|---|---|---|---|---|---|---|---|---|
| Open-label Period | Adverse Event | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 |
| Open-label Period | Lost to Follow-up | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 |
| Randomized-treatment Period | Lost to Follow-up | 1 | 0 | 0 | 1 | 0 | 0 | 0 | 0 |
| Randomized-treatment Period | Other Miscellaneous Reasons | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 |
| Randomized-treatment Period | Personal Reasons | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 |
| Randomized-treatment Period | Protocol Violation | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
Baseline characteristics
| Characteristic | Placebo | Total | OnabotulinumtoxinA Dose 1 | OnabotulinumtoxinA Dose 2 | OnabotulinumtoxinA Dose 3 | OnabotulinumtoxinA Dose 4 | OnabotulinumtoxinA Dose 5 | OnabotulinumtoxinA Dose 6 |
|---|---|---|---|---|---|---|---|---|
| Age, Continuous | 41.0 years STANDARD_DEVIATION 6.08 | 40.4 years STANDARD_DEVIATION 7.41 | 41.2 years STANDARD_DEVIATION 10.83 | 41.9 years STANDARD_DEVIATION 11.65 | 39.1 years STANDARD_DEVIATION 5.62 | 39.3 years STANDARD_DEVIATION 9.05 | 40.1 years STANDARD_DEVIATION 6.53 | 39.9 years STANDARD_DEVIATION 5.96 |
| Race/Ethnicity, Customized Asian | 1 participants | 4 participants | 0 participants | 1 participants | 0 participants | 1 participants | 1 participants | 0 participants |
| Race/Ethnicity, Customized Black | 3 participants | 9 participants | 1 participants | 2 participants | 1 participants | 1 participants | 1 participants | 0 participants |
| Race/Ethnicity, Customized Caucasian | 9 participants | 37 participants | 3 participants | 4 participants | 5 participants | 5 participants | 5 participants | 6 participants |
| Race/Ethnicity, Customized Hispanic | 2 participants | 5 participants | 1 participants | 0 participants | 0 participants | 0 participants | 1 participants | 1 participants |
| Race/Ethnicity, Customized Other | 0 participants | 2 participants | 0 participants | 0 participants | 2 participants | 0 participants | 0 participants | 0 participants |
| Sex: Female, Male Female | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Male | 15 Participants | 57 Participants | 5 Participants | 7 Participants | 8 Participants | 7 Participants | 8 Participants | 7 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk | EG006 affected / at risk | EG007 affected / at risk |
|---|---|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 5 | 0 / 7 | 0 / 8 | 0 / 8 | 0 / 8 | 0 / 8 | 0 / 15 | 0 / 8 |
| other Total, other adverse events | 3 / 5 | 2 / 7 | 1 / 8 | 2 / 8 | 3 / 8 | 4 / 8 | 12 / 15 | 3 / 8 |
| serious Total, serious adverse events | 0 / 5 | 0 / 7 | 0 / 8 | 0 / 8 | 0 / 8 | 0 / 8 | 0 / 15 | 0 / 8 |
Outcome results
Primary
Change From Baseline in Geometric Mean Intravaginal Ejaculatory Latency Time (IELT)
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
Population: 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 | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| OnabotulinumtoxinA Dose 1 | Change From Baseline in Geometric Mean Intravaginal Ejaculatory Latency Time (IELT) | Baseline | 3.57 log(seconds) | Standard Deviation 0.283 |
| OnabotulinumtoxinA Dose 1 | Change From Baseline in Geometric Mean Intravaginal Ejaculatory Latency Time (IELT) | Change from Baseline to Week 12 | 0.55 log(seconds) | Standard Deviation 1.037 |
| OnabotulinumtoxinA Dose 2 | Change From Baseline in Geometric Mean Intravaginal Ejaculatory Latency Time (IELT) | Baseline | 3.50 log(seconds) | Standard Deviation 0.631 |
| OnabotulinumtoxinA Dose 2 | Change From Baseline in Geometric Mean Intravaginal Ejaculatory Latency Time (IELT) | Change from Baseline to Week 12 | 0.69 log(seconds) | Standard Deviation 1.426 |
| OnabotulinumtoxinA Dose 3 | Change From Baseline in Geometric Mean Intravaginal Ejaculatory Latency Time (IELT) | Baseline | 3.46 log(seconds) | Standard Deviation 0.371 |
| OnabotulinumtoxinA Dose 3 | Change From Baseline in Geometric Mean Intravaginal Ejaculatory Latency Time (IELT) | Change from Baseline to Week 12 | 0.05 log(seconds) | Standard Deviation 0.856 |
| OnabotulinumtoxinA Dose 4 | Change From Baseline in Geometric Mean Intravaginal Ejaculatory Latency Time (IELT) | Baseline | 3.52 log(seconds) | Standard Deviation 0.531 |
| OnabotulinumtoxinA Dose 4 | Change From Baseline in Geometric Mean Intravaginal Ejaculatory Latency Time (IELT) | Change from Baseline to Week 12 | 0.30 log(seconds) | Standard Deviation 0.472 |
| OnabotulinumtoxinA Dose 5 | Change From Baseline in Geometric Mean Intravaginal Ejaculatory Latency Time (IELT) | Baseline | 3.53 log(seconds) | Standard Deviation 0.475 |
| OnabotulinumtoxinA Dose 5 | Change From Baseline in Geometric Mean Intravaginal Ejaculatory Latency Time (IELT) | Change from Baseline to Week 12 | 0.31 log(seconds) | Standard Deviation 0.525 |
| OnabotulinumtoxinA Dose 6 | Change From Baseline in Geometric Mean Intravaginal Ejaculatory Latency Time (IELT) | Baseline | 3.54 log(seconds) | Standard Deviation 0.505 |
| OnabotulinumtoxinA Dose 6 | Change From Baseline in Geometric Mean Intravaginal Ejaculatory Latency Time (IELT) | Change from Baseline to Week 12 | 0.59 log(seconds) | Standard Deviation 0.719 |
| Placebo | Change From Baseline in Geometric Mean Intravaginal Ejaculatory Latency Time (IELT) | Baseline | 3.46 log(seconds) | Standard Deviation 0.61 |
| Placebo | Change From Baseline in Geometric Mean Intravaginal Ejaculatory Latency Time (IELT) | Change from Baseline to Week 12 | 0.44 log(seconds) | Standard Deviation 0.615 |
p-value: 0.393ANCOVA
p-value: 0.263ANCOVA
p-value: 0.861ANCOVA
p-value: 0.647ANCOVA
p-value: 0.645ANCOVA
p-value: 0.343ANCOVA
Secondary
Change From Baseline in Average IELT
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
Population: 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 | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| OnabotulinumtoxinA Dose 1 | Change From Baseline in Average IELT | Change from Baseline to Week 12 | 53.65 seconds | Standard Deviation 102.527 |
| OnabotulinumtoxinA Dose 1 | Change From Baseline in Average IELT | Change from Baseline to Week 4 | 61.94 seconds | Standard Deviation 100.446 |
| OnabotulinumtoxinA Dose 1 | Change From Baseline in Average IELT | Change from Baseline to Week 10 | 56.13 seconds | Standard Deviation 101.447 |
| OnabotulinumtoxinA Dose 1 | Change From Baseline in Average IELT | Baseline | 37.25 seconds | Standard Deviation 10.518 |
| OnabotulinumtoxinA Dose 1 | Change From Baseline in Average IELT | Change from Baseline to Week 6 | 61.42 seconds | Standard Deviation 100.446 |
| OnabotulinumtoxinA Dose 1 | Change From Baseline in Average IELT | Change from Baseline to Week 2 | 66.25 seconds | Standard Deviation 101.132 |
| OnabotulinumtoxinA Dose 1 | Change From Baseline in Average IELT | Change from Baseline to Week 8 | 59.55 seconds | Standard Deviation 100.896 |
| OnabotulinumtoxinA Dose 2 | Change From Baseline in Average IELT | Change from Baseline to Week 6 | 183.44 seconds | Standard Deviation 374.404 |
| OnabotulinumtoxinA Dose 2 | Change From Baseline in Average IELT | Change from Baseline to Week 12 | 152.74 seconds | Standard Deviation 295.219 |
| OnabotulinumtoxinA Dose 2 | Change From Baseline in Average IELT | Change from Baseline to Week 4 | 176.71 seconds | Standard Deviation 367.665 |
| OnabotulinumtoxinA Dose 2 | Change From Baseline in Average IELT | Change from Baseline to Week 2 | 180.31 seconds | Standard Deviation 317.657 |
| OnabotulinumtoxinA Dose 2 | Change From Baseline in Average IELT | Change from Baseline to Week 8 | 176.59 seconds | Standard Deviation 349.777 |
| OnabotulinumtoxinA Dose 2 | Change From Baseline in Average IELT | Baseline | 39.42 seconds | Standard Deviation 21.504 |
| OnabotulinumtoxinA Dose 2 | Change From Baseline in Average IELT | Change from Baseline to Week 10 | 170.65 seconds | Standard Deviation 331.039 |
| OnabotulinumtoxinA Dose 3 | Change From Baseline in Average IELT | Change from Baseline to Week 10 | 15.55 seconds | Standard Deviation 39.149 |
| OnabotulinumtoxinA Dose 3 | Change From Baseline in Average IELT | Change from Baseline to Week 6 | 20.75 seconds | Standard Deviation 55.85 |
| OnabotulinumtoxinA Dose 3 | Change From Baseline in Average IELT | Baseline | 34.41 seconds | Standard Deviation 10.194 |
| OnabotulinumtoxinA Dose 3 | Change From Baseline in Average IELT | Change from Baseline to Week 12 | 12.95 seconds | Standard Deviation 30.93 |
| OnabotulinumtoxinA Dose 3 | Change From Baseline in Average IELT | Change from Baseline to Week 2 | 24.73 seconds | Standard Deviation 59.725 |
| OnabotulinumtoxinA Dose 3 | Change From Baseline in Average IELT | Change from Baseline to Week 8 | 17.08 seconds | Standard Deviation 44.158 |
| OnabotulinumtoxinA Dose 3 | Change From Baseline in Average IELT | Change from Baseline to Week 4 | 24.06 seconds | Standard Deviation 59.472 |
| OnabotulinumtoxinA Dose 4 | Change From Baseline in Average IELT | Change from Baseline to Week 10 | 37.45 seconds | Standard Deviation 71.782 |
| OnabotulinumtoxinA Dose 4 | Change From Baseline in Average IELT | Baseline | 38.00 seconds | Standard Deviation 16.008 |
| OnabotulinumtoxinA Dose 4 | Change From Baseline in Average IELT | Change from Baseline to Week 12 | 28.32 seconds | Standard Deviation 48.965 |
| OnabotulinumtoxinA Dose 4 | Change From Baseline in Average IELT | Change from Baseline to Week 2 | 34.87 seconds | Standard Deviation 74.842 |
| OnabotulinumtoxinA Dose 4 | Change From Baseline in Average IELT | Change from Baseline to Week 8 | 37.69 seconds | Standard Deviation 71.873 |
| OnabotulinumtoxinA Dose 4 | Change From Baseline in Average IELT | Change from Baseline to Week 4 | 35.00 seconds | Standard Deviation 73.475 |
| OnabotulinumtoxinA Dose 4 | Change From Baseline in Average IELT | Change from Baseline to Week 6 | 36.95 seconds | Standard Deviation 71.996 |
| OnabotulinumtoxinA Dose 5 | Change From Baseline in Average IELT | Change from Baseline to Week 2 | 28.04 seconds | Standard Deviation 31.298 |
| OnabotulinumtoxinA Dose 5 | Change From Baseline in Average IELT | Baseline | 40.88 seconds | Standard Deviation 16.435 |
| OnabotulinumtoxinA Dose 5 | Change From Baseline in Average IELT | Change from Baseline to Week 4 | 28.46 seconds | Standard Deviation 36.881 |
| OnabotulinumtoxinA Dose 5 | Change From Baseline in Average IELT | Change from Baseline to Week 6 | 29.35 seconds | Standard Deviation 39.334 |
| OnabotulinumtoxinA Dose 5 | Change From Baseline in Average IELT | Change from Baseline to Week 8 | 29.48 seconds | Standard Deviation 44.505 |
| OnabotulinumtoxinA Dose 5 | Change From Baseline in Average IELT | Change from Baseline to Week 10 | 27.49 seconds | Standard Deviation 45.365 |
| OnabotulinumtoxinA Dose 5 | Change From Baseline in Average IELT | Change from Baseline to Week 12 | 27.51 seconds | Standard Deviation 48.72 |
| OnabotulinumtoxinA Dose 6 | Change From Baseline in Average IELT | Change from Baseline to Week 4 | 64.97 seconds | Standard Deviation 67.471 |
| OnabotulinumtoxinA Dose 6 | Change From Baseline in Average IELT | Change from Baseline to Week 2 | 55.77 seconds | Standard Deviation 65.549 |
| OnabotulinumtoxinA Dose 6 | Change From Baseline in Average IELT | Change from Baseline to Week 6 | 64.49 seconds | Standard Deviation 66.546 |
| OnabotulinumtoxinA Dose 6 | Change From Baseline in Average IELT | Baseline | 38.75 seconds | Standard Deviation 15.596 |
| OnabotulinumtoxinA Dose 6 | Change From Baseline in Average IELT | Change from Baseline to Week 12 | 66.01 seconds | Standard Deviation 71.489 |
| OnabotulinumtoxinA Dose 6 | Change From Baseline in Average IELT | Change from Baseline to Week 10 | 63.91 seconds | Standard Deviation 67.725 |
| OnabotulinumtoxinA Dose 6 | Change From Baseline in Average IELT | Change from Baseline to Week 8 | 65.19 seconds | Standard Deviation 65.612 |
| Placebo | Change From Baseline in Average IELT | Change from Baseline to Week 10 | 68.26 seconds | Standard Deviation 146.33 |
| Placebo | Change From Baseline in Average IELT | Change from Baseline to Week 4 | 29.30 seconds | Standard Deviation 69.073 |
| Placebo | Change From Baseline in Average IELT | Change from Baseline to Week 2 | 11.25 seconds | Standard Deviation 23.985 |
| Placebo | Change From Baseline in Average IELT | Change from Baseline to Week 8 | 65.57 seconds | Standard Deviation 128.47 |
| Placebo | Change From Baseline in Average IELT | Baseline | 37.92 seconds | Standard Deviation 16.656 |
| Placebo | Change From Baseline in Average IELT | Change from Baseline to Week 6 | 47.62 seconds | Standard Deviation 89.847 |
| Placebo | Change From Baseline in Average IELT | Change from Baseline to Week 12 | 68.49 seconds | Standard Deviation 151.68 |
Comparison: OnabotulinumtoxinA Dose 1 versus (vs) Placebo at Week 2p-value: 0.184ANCOVA
Comparison: OnabotulinumtoxinA Dose 2 vs Placebo at Week 2p-value: 0.002ANCOVA
Comparison: OnabotulinumtoxinA Dose 3 vs Placebo at Week 2p-value: 0.404ANCOVA
Comparison: OnabotulinumtoxinA Dose 4 vs Placebo at Week 2p-value: 0.328ANCOVA
Comparison: OnabotulinumtoxinA Dose 5 vs Placebo at Week 2p-value: 0.362ANCOVA
Comparison: OnabotulinumtoxinA Dose 6 vs Placebo at Week 2p-value: 0.203ANCOVA
Comparison: OnabotulinumtoxinA Dose 1 vs Placebo at Week 4p-value: 0.322ANCOVA
Comparison: OnabotulinumtoxinA Dose 2 vs Placebo at Week 4p-value: 0.015ANCOVA
Comparison: OnabotulinumtoxinA Dose 3 vs Placebo at Week 4p-value: 0.541ANCOVA
Comparison: OnabotulinumtoxinA Dose 4 vs Placebo at Week 4p-value: 0.459ANCOVA
Comparison: OnabotulinumtoxinA Dose 5 vs Placebo at Week 4p-value: 0.491ANCOVA
Comparison: OnabotulinumtoxinA Dose 6 vs Placebo at Week 4p-value: 0.281ANCOVA
Comparison: OnabotulinumtoxinA Dose 1 vs Placebo at Week 6p-value: 0.424ANCOVA
Comparison: OnabotulinumtoxinA Dose 2 vs Placebo at Week 6p-value: 0.026ANCOVA
Comparison: OnabotulinumtoxinA Dose 3 vs Placebo at Week 6p-value: 0.67ANCOVA
Comparison: OnabotulinumtoxinA Dose 4 vs Placebo at Week 6p-value: 0.561ANCOVA
Comparison: OnabotulinumtoxinA Dose 5 vs Placebo at Week 6p-value: 0.604ANCOVA
Comparison: OnabotulinumtoxinA Dose 6 vs Placebo at Week 6p-value: 0.394ANCOVA
Comparison: OnabotulinumtoxinA Dose 1 vs Placebo at Week 8p-value: 0.532ANCOVA
Comparison: OnabotulinumtoxinA Dose 2 vs Placebo at Week 8p-value: 0.058ANCOVA
Comparison: OnabotulinumtoxinA Dose 3 vs Placebo at Week 8p-value: 0.778ANCOVA
Comparison: OnabotulinumtoxinA Dose 4 vs Placebo at Week 8p-value: 0.662ANCOVA
Comparison: OnabotulinumtoxinA Dose 5 vs Placebo at Week 8p-value: 0.712ANCOVA
Comparison: OnabotulinumtoxinA Dose 6 vs Placebo at Week 8p-value: 0.501ANCOVA
Comparison: OnabotulinumtoxinA Dose 1 vs Placebo at Week 10p-value: 0.565ANCOVA
Comparison: OnabotulinumtoxinA Dose 2 vs Placebo at Week 10p-value: 0.071ANCOVA
Comparison: OnabotulinumtoxinA Dose 3 vs Placebo at Week 10p-value: 0.799ANCOVA
Comparison: OnabotulinumtoxinA Dose 4 vs Placebo at Week 10p-value: 0.681ANCOVA
Comparison: OnabotulinumtoxinA Dose 5 vs Placebo at Week 10p-value: 0.741ANCOVA
Comparison: OnabotulinumtoxinA Dose 6 vs Placebo at Week 10p-value: 0.526ANCOVA
Comparison: OnabotulinumtoxinA Dose 1 vs Placebo at Week 12p-value: 0.584ANCOVA
Comparison: OnabotulinumtoxinA Dose 2 vs Placebo at Week 12p-value: 0.101ANCOVA
Comparison: OnabotulinumtoxinA Dose 3 vs Placebo at Week 12p-value: 0.823ANCOVA
Comparison: OnabotulinumtoxinA Dose 4 vs Placebo at Week 12p-value: 0.741ANCOVA
Comparison: OnabotulinumtoxinA Dose 5 vs Placebo at Week 12p-value: 0.756ANCOVA
Comparison: OnabotulinumtoxinA Dose 6 vs Placebo at Week 12p-value: 0.517ANCOVA
Secondary
Change From Baseline in Geometric Mean IELT
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
Population: 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 | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| OnabotulinumtoxinA Dose 1 | Change From Baseline in Geometric Mean IELT | Change from Baseline to Week 10 | 0.60 log(seconds) | Standard Deviation 1.009 |
| OnabotulinumtoxinA Dose 1 | Change From Baseline in Geometric Mean IELT | Baseline | 3.57 log(seconds) | Standard Deviation 0.283 |
| OnabotulinumtoxinA Dose 1 | Change From Baseline in Geometric Mean IELT | Change from Baseline to Week 6 | 0.70 log(seconds) | Standard Deviation 0.999 |
| OnabotulinumtoxinA Dose 1 | Change From Baseline in Geometric Mean IELT | Change from Baseline to Week 8 | 0.67 log(seconds) | Standard Deviation 1.007 |
| OnabotulinumtoxinA Dose 1 | Change From Baseline in Geometric Mean IELT | Change from Baseline to Week 2 | 0.76 log(seconds) | Standard Deviation 1.014 |
| OnabotulinumtoxinA Dose 1 | Change From Baseline in Geometric Mean IELT | Change from Baseline to Week 4 | 0.70 log(seconds) | Standard Deviation 1 |
| OnabotulinumtoxinA Dose 2 | Change From Baseline in Geometric Mean IELT | Change from Baseline to Week 10 | 0.80 log(seconds) | Standard Deviation 1.503 |
| OnabotulinumtoxinA Dose 2 | Change From Baseline in Geometric Mean IELT | Change from Baseline to Week 4 | 0.77 log(seconds) | Standard Deviation 1.505 |
| OnabotulinumtoxinA Dose 2 | Change From Baseline in Geometric Mean IELT | Baseline | 3.50 log(seconds) | Standard Deviation 0.631 |
| OnabotulinumtoxinA Dose 2 | Change From Baseline in Geometric Mean IELT | Change from Baseline to Week 2 | 0.95 log(seconds) | Standard Deviation 1.497 |
| OnabotulinumtoxinA Dose 2 | Change From Baseline in Geometric Mean IELT | Change from Baseline to Week 8 | 0.79 log(seconds) | Standard Deviation 1.525 |
| OnabotulinumtoxinA Dose 2 | Change From Baseline in Geometric Mean IELT | Change from Baseline to Week 6 | 0.83 log(seconds) | Standard Deviation 1.513 |
| OnabotulinumtoxinA Dose 3 | Change From Baseline in Geometric Mean IELT | Change from Baseline to Week 8 | 0.05 log(seconds) | Standard Deviation 0.968 |
| OnabotulinumtoxinA Dose 3 | Change From Baseline in Geometric Mean IELT | Baseline | 3.46 log(seconds) | Standard Deviation 0.371 |
| OnabotulinumtoxinA Dose 3 | Change From Baseline in Geometric Mean IELT | Change from Baseline to Week 2 | 0.26 log(seconds) | Standard Deviation 0.677 |
| OnabotulinumtoxinA Dose 3 | Change From Baseline in Geometric Mean IELT | Change from Baseline to Week 4 | 0.18 log(seconds) | Standard Deviation 0.879 |
| OnabotulinumtoxinA Dose 3 | Change From Baseline in Geometric Mean IELT | Change from Baseline to Week 6 | 0.08 log(seconds) | Standard Deviation 0.971 |
| OnabotulinumtoxinA Dose 3 | Change From Baseline in Geometric Mean IELT | Change from Baseline to Week 10 | 0.07 log(seconds) | Standard Deviation 0.905 |
| OnabotulinumtoxinA Dose 4 | Change From Baseline in Geometric Mean IELT | Baseline | 3.52 log(seconds) | Standard Deviation 0.531 |
| OnabotulinumtoxinA Dose 4 | Change From Baseline in Geometric Mean IELT | Change from Baseline to Week 6 | 0.36 log(seconds) | Standard Deviation 0.629 |
| OnabotulinumtoxinA Dose 4 | Change From Baseline in Geometric Mean IELT | Change from Baseline to Week 10 | 0.37 log(seconds) | Standard Deviation 0.624 |
| OnabotulinumtoxinA Dose 4 | Change From Baseline in Geometric Mean IELT | Change from Baseline to Week 8 | 0.37 log(seconds) | Standard Deviation 0.627 |
| OnabotulinumtoxinA Dose 4 | Change From Baseline in Geometric Mean IELT | Change from Baseline to Week 4 | 0.33 log(seconds) | Standard Deviation 0.616 |
| OnabotulinumtoxinA Dose 4 | Change From Baseline in Geometric Mean IELT | Change from Baseline to Week 2 | 0.34 log(seconds) | Standard Deviation 0.69 |
| OnabotulinumtoxinA Dose 5 | Change From Baseline in Geometric Mean IELT | Change from Baseline to Week 10 | 0.32 log(seconds) | Standard Deviation 0.512 |
| OnabotulinumtoxinA Dose 5 | Change From Baseline in Geometric Mean IELT | Change from Baseline to Week 4 | 0.38 log(seconds) | Standard Deviation 0.481 |
| OnabotulinumtoxinA Dose 5 | Change From Baseline in Geometric Mean IELT | Change from Baseline to Week 2 | 0.47 log(seconds) | Standard Deviation 0.604 |
| OnabotulinumtoxinA Dose 5 | Change From Baseline in Geometric Mean IELT | Change from Baseline to Week 6 | 0.36 log(seconds) | Standard Deviation 0.483 |
| OnabotulinumtoxinA Dose 5 | Change From Baseline in Geometric Mean IELT | Baseline | 3.53 log(seconds) | Standard Deviation 0.475 |
| OnabotulinumtoxinA Dose 5 | Change From Baseline in Geometric Mean IELT | Change from Baseline to Week 8 | 0.36 log(seconds) | Standard Deviation 0.522 |
| OnabotulinumtoxinA Dose 6 | Change From Baseline in Geometric Mean IELT | Baseline | 3.54 log(seconds) | Standard Deviation 0.505 |
| OnabotulinumtoxinA Dose 6 | Change From Baseline in Geometric Mean IELT | Change from Baseline to Week 2 | 0.62 log(seconds) | Standard Deviation 0.623 |
| OnabotulinumtoxinA Dose 6 | Change From Baseline in Geometric Mean IELT | Change from Baseline to Week 6 | 0.59 log(seconds) | Standard Deviation 0.722 |
| OnabotulinumtoxinA Dose 6 | Change From Baseline in Geometric Mean IELT | Change from Baseline to Week 4 | 0.61 log(seconds) | Standard Deviation 0.618 |
| OnabotulinumtoxinA Dose 6 | Change From Baseline in Geometric Mean IELT | Change from Baseline to Week 8 | 0.61 log(seconds) | Standard Deviation 0.682 |
| OnabotulinumtoxinA Dose 6 | Change From Baseline in Geometric Mean IELT | Change from Baseline to Week 10 | 0.56 log(seconds) | Standard Deviation 0.727 |
| Placebo | Change From Baseline in Geometric Mean IELT | Baseline | 3.46 log(seconds) | Standard Deviation 0.61 |
| Placebo | Change From Baseline in Geometric Mean IELT | Change from Baseline to Week 10 | 0.44 log(seconds) | Standard Deviation 0.603 |
| Placebo | Change From Baseline in Geometric Mean IELT | Change from Baseline to Week 4 | 0.22 log(seconds) | Standard Deviation 0.627 |
| Placebo | Change From Baseline in Geometric Mean IELT | Change from Baseline to Week 2 | 0.19 log(seconds) | Standard Deviation 0.486 |
| Placebo | Change From Baseline in Geometric Mean IELT | Change from Baseline to Week 6 | 0.36 log(seconds) | Standard Deviation 0.524 |
| Placebo | Change From Baseline in Geometric Mean IELT | Change from Baseline to Week 8 | 0.44 log(seconds) | Standard Deviation 0.567 |
Comparison: OnabotulinumtoxinA Dose 1 vs Placebo at Week 2p-value: 0.079ANCOVA
Comparison: OnabotulinumtoxinA Dose 2 vs Placebo at Week 2p-value: 0.025ANCOVA
Comparison: OnabotulinumtoxinA Dose 3 vs Placebo at Week 2p-value: 0.417ANCOVA
Comparison: OnabotulinumtoxinA Dose 4 vs Placebo at Week 2p-value: 0.33ANCOVA
Comparison: OnabotulinumtoxinA Dose 5 vs Placebo at Week 2p-value: 0.199ANCOVA
Comparison: OnabotulinumtoxinA Dose 6 vs Placebo at Week 2p-value: 0.113ANCOVA
Comparison: OnabotulinumtoxinA Dose 1 vs Placebo at Week 4p-value: 0.127ANCOVA
Comparison: OnabotulinumtoxinA Dose 2 vs Placebo at Week 4p-value: 0.087ANCOVA
Comparison: OnabotulinumtoxinA Dose 3 vs Placebo at Week 4p-value: 0.543ANCOVA
Comparison: OnabotulinumtoxinA Dose 4 vs Placebo at Week 4p-value: 0.377ANCOVA
Comparison: OnabotulinumtoxinA Dose 5 vs Placebo at Week 4p-value: 0.321ANCOVA
Comparison: OnabotulinumtoxinA Dose 6 vs Placebo at Week 4p-value: 0.149ANCOVA
Comparison: OnabotulinumtoxinA Dose 1 vs Placebo at Week 6p-value: 0.215ANCOVA
Comparison: OnabotulinumtoxinA Dose 2 vs Placebo at Week 6p-value: 0.126ANCOVA
Comparison: OnabotulinumtoxinA Dose 3 vs Placebo at Week 6p-value: 0.774ANCOVA
Comparison: OnabotulinumtoxinA Dose 4 vs Placebo at Week 6p-value: 0.495ANCOVA
Comparison: OnabotulinumtoxinA Dose 5 vs Placebo at Week 6p-value: 0.495ANCOVA
Comparison: OnabotulinumtoxinA Dose 6 vs Placebo at Week 6p-value: 0.274ANCOVA
Comparison: OnabotulinumtoxinA Dose 1 vs Placebo at Week 8p-value: 0.308ANCOVA
Comparison: OnabotulinumtoxinA Dose 2 vs Placebo at Week 8p-value: 0.205ANCOVA
Comparison: OnabotulinumtoxinA Dose 3 vs Placebo at Week 8p-value: 0.849ANCOVA
Comparison: OnabotulinumtoxinA Dose 4 vs Placebo at Week 8p-value: 0.571ANCOVA
Comparison: OnabotulinumtoxinA Dose 5 vs Placebo at Week 8p-value: 0.592ANCOVA
Comparison: OnabotulinumtoxinA Dose 6 vs Placebo at Week 8p-value: 0.34ANCOVA
Comparison: OnabotulinumtoxinA Dose 1 vs Placebo at Week 10p-value: 0.36ANCOVA
Comparison: OnabotulinumtoxinA Dose 2 vs Placebo at Week 10p-value: 0.192ANCOVA
Comparison: OnabotulinumtoxinA Dose 3 vs Placebo at Week 10p-value: 0.843ANCOVA
Comparison: OnabotulinumtoxinA Dose 4 vs Placebo at Week 10p-value: 0.572ANCOVA
Comparison: OnabotulinumtoxinA Dose 5 vs Placebo at Week 10p-value: 0.628ANCOVA
Comparison: OnabotulinumtoxinA Dose 6 vs Placebo at Week 10p-value: 0.38ANCOVA