Trial · NCT01917006
A Safety and Efficacy Study of OnabotulinumtoxinA in Premature Ejaculation
NCT01917006, Phase 2, Terminated, Allergan; results first posted 2018-10-18
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. A Safety and Efficacy Study of OnabotulinumtoxinA in Premature Ejaculation. Trials, record NCT01917006. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01917006
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Safety and Efficacy Study of OnabotulinumtoxinA in Premature Ejaculation
- NCT number
- NCT01917006
- Status
- Terminated
- Phases
- Phase 2
- Enrollment
- 59 participants, actual
- Lead sponsor
- Allergan
- Conditions
- Premature Ejaculation
- Interventions
- OnabotulinumtoxinA, Normal Saline
- First posted
- 2013-08-06
- Last updated
- 2018-10-18
- Other registries' IDs
- eudract:2013-001650-94
- Results first posted
- 2018-10-18
Source ClinicalTrials.gov
Registered outcomes3
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | 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 | 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. |
| Secondary | 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. |
Source ClinicalTrials.gov
Outcomes3
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change From Baseline in Geometric Mean Intravaginal Ejaculatory Latency Time (IELT) | Baseline (Day 1) to Week 12 | 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. | log(seconds) | MEAN |
| SECONDARY | Change From Baseline in Average IELT | Baseline (Day 1) to Weeks 2, 4, 6, 8, 10, and 12 | 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. | seconds | MEAN |
| SECONDARY | Change From Baseline in Geometric Mean IELT | Baseline (Day 1) to Weeks 2, 4, 6, 8, and 10 | 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. | log(seconds) | MEAN |
Source ClinicalTrials.gov
Results by group105
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change From Baseline in Geometric Mean Intravaginal Ejaculatory Latency Time (IELT) | OnabotulinumtoxinA Dose 1 | Baseline | 3.57 | Standard Deviation 0.283 | log(seconds) |
| Change From Baseline in Geometric Mean Intravaginal Ejaculatory Latency Time (IELT) | OnabotulinumtoxinA Dose 2 | Baseline | 3.50 | Standard Deviation 0.631 | log(seconds) |
| Change From Baseline in Geometric Mean Intravaginal Ejaculatory Latency Time (IELT) | OnabotulinumtoxinA Dose 3 | Baseline | 3.46 | Standard Deviation 0.371 | log(seconds) |
| Change From Baseline in Geometric Mean Intravaginal Ejaculatory Latency Time (IELT) | OnabotulinumtoxinA Dose 4 | Baseline | 3.52 | Standard Deviation 0.531 | log(seconds) |
| Change From Baseline in Geometric Mean Intravaginal Ejaculatory Latency Time (IELT) | OnabotulinumtoxinA Dose 5 | Baseline | 3.53 | Standard Deviation 0.475 | log(seconds) |
| Change From Baseline in Geometric Mean Intravaginal Ejaculatory Latency Time (IELT) | OnabotulinumtoxinA Dose 6 | Baseline | 3.54 | Standard Deviation 0.505 | log(seconds) |
| Change From Baseline in Geometric Mean Intravaginal Ejaculatory Latency Time (IELT) | Placebo | Baseline | 3.46 | Standard Deviation 0.610 | log(seconds) |
| Change From Baseline in Geometric Mean Intravaginal Ejaculatory Latency Time (IELT) | OnabotulinumtoxinA Dose 1 | Change from Baseline to Week 12 | 0.55 | Standard Deviation 1.037 | log(seconds) |
| Change From Baseline in Geometric Mean Intravaginal Ejaculatory Latency Time (IELT) | OnabotulinumtoxinA Dose 2 | Change from Baseline to Week 12 | 0.69 | Standard Deviation 1.426 | log(seconds) |
| Change From Baseline in Geometric Mean Intravaginal Ejaculatory Latency Time (IELT) | OnabotulinumtoxinA Dose 3 | Change from Baseline to Week 12 | 0.05 | Standard Deviation 0.856 | log(seconds) |
1 to 10 of 105Source ClinicalTrials.gov
See all 105 results by groupParticipant flow48
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Randomized-treatment Period | STARTED | OnabotulinumtoxinA Dose 1 | 5 | |
| Randomized-treatment Period | STARTED | OnabotulinumtoxinA Dose 2 | 7 | |
| Randomized-treatment Period | STARTED | OnabotulinumtoxinA Dose 3 | 8 | |
| Randomized-treatment Period | STARTED | OnabotulinumtoxinA Dose 4 | 8 | |
| Randomized-treatment Period | STARTED | OnabotulinumtoxinA Dose 5 | 8 | |
| Randomized-treatment Period | STARTED | OnabotulinumtoxinA Dose 6 | 8 | |
| Randomized-treatment Period | STARTED | Placebo | 15 | |
| Randomized-treatment Period | STARTED | OnabotulinumtoxinA Dose 2 (Open-label Period) | 0 | |
| Randomized-treatment Period | COMPLETED | OnabotulinumtoxinA Dose 1 | 3 | |
| Randomized-treatment Period | COMPLETED | OnabotulinumtoxinA Dose 2 | 7 |
1 to 10 of 48Source ClinicalTrials.gov
See all 48 participant flowAdverse events456
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Angina pectoris | Cardiac disorders | OnabotulinumtoxinA Dose 1 | 0 | 5 | |
| other | Angina pectoris | Cardiac disorders | OnabotulinumtoxinA Dose 2 | 0 | 7 | |
| other | Angina pectoris | Cardiac disorders | OnabotulinumtoxinA Dose 3 | 0 | 8 | |
| other | Angina pectoris | Cardiac disorders | OnabotulinumtoxinA Dose 4 | 0 | 8 | |
| other | Angina pectoris | Cardiac disorders | OnabotulinumtoxinA Dose 5 | 0 | 8 | |
| other | Angina pectoris | Cardiac disorders | OnabotulinumtoxinA Dose 6 | 0 | 8 | |
| other | Angina pectoris | Cardiac disorders | Placebo | 1 | 15 | |
| other | Angina pectoris | Cardiac disorders | OnabotulinumtoxinA Dose 2 (Open-label Period) | 0 | 8 | |
| other | Vision blurred | Eye disorders | OnabotulinumtoxinA Dose 1 | 0 | 5 | |
| other | Vision blurred | Eye disorders | OnabotulinumtoxinA Dose 2 | 0 | 7 |
1 to 10 of 456Source ClinicalTrials.gov
See all 456 adverse eventsAdverse event totals24
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | OnabotulinumtoxinA Dose 1 | 0 | 5 |
| Total, all-cause mortality | OnabotulinumtoxinA Dose 2 | 0 | 7 |
| Total, all-cause mortality | OnabotulinumtoxinA Dose 3 | 0 | 8 |
| Total, all-cause mortality | OnabotulinumtoxinA Dose 4 | 0 | 8 |
| Total, all-cause mortality | OnabotulinumtoxinA Dose 5 | 0 | 8 |
| Total, all-cause mortality | OnabotulinumtoxinA Dose 6 | 0 | 8 |
| Total, all-cause mortality | Placebo | 0 | 15 |
| Total, all-cause mortality | OnabotulinumtoxinA Dose 2 (Open-label Period) | 0 | 8 |
| Total, other adverse events | OnabotulinumtoxinA Dose 1 | 3 | 5 |
| Total, other adverse events | OnabotulinumtoxinA Dose 2 | 2 | 7 |
1 to 10 of 24Source ClinicalTrials.gov
See all 24 adverse event totalsPapers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT01917006
GET https://conductscience.org/api/trials/v1/NCT01917006/results?page=2