Trial · NCT00556478
Efficacy, Safety and Tolerability of PSD502 (a Topical Anesthetic) in the Treatment Premature Ejaculation
NCT00556478, Phase 2, Phase 3, Completed, Plethora Solutions Ltd; results first posted 2016-09-26
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Efficacy, Safety and Tolerability of PSD502 (a Topical Anesthetic) in the Treatment Premature Ejaculation. Trials, record NCT00556478. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00556478
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Efficacy, Safety and Tolerability of PSD502 (a Topical Anesthetic) in the Treatment Premature Ejaculation
- NCT number
- NCT00556478
- Status
- Completed
- Phases
- Phase 2, Phase 3
- Enrollment
- 256 participants, actual
- Lead sponsor
- Plethora Solutions Ltd
- Conditions
- Premature Ejaculation
- Interventions
- PSD502, contains a mixture of lidocaine and prilocaine, Placebo
- First posted
- 2007-11-12
- Last updated
- 2016-09-26
- Results first posted
- 2016-09-26
Source ClinicalTrials.gov
Registered outcomes10
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Mean Intravaginal Ejaculatory Latency Time (IELT): Change From Baseline to During 3 Month Double Blind-treatment | Baseline to 3 Months | To evaluate efficacy of treatment with PSD502 compared with placebo in subjects with PE as measured by: • change in mean IELT from baseline to during the 3 month double-blind treatment Results provide are ratio (over the 3 months/baseline). |
| Primary | Index of Premature Ejaculation (IPE): Change From Baseline to End of Month 3 | Baseline to 3 Months | To Evaluate Efficacy of Treatment With PSD502 Compared With Placebo in Subjects With PE as measured by: • changes in all 3 IPE domains from baseline to month 3 Ejaculatory control scores range from 4 to 20 with a higher score indicating greater ejaculatory control Sexual satisfaction scores range from 4 to 20 with a higher score indicating greater sexual satisfaction Distress scores range from 2 to 10 with a higher score indicating less distress |
| Secondary | Percentage of Subjects With Mean Intravaginal Ejaculatory Latency Time (IELT) > 1 Minute and >2 Minutes During the 3 Months of Double-blind Treatment | 3 months | Percentage of subjects with mean IELT \> 1 minute and \>2 minutes during the 3 months of double-blind treatment as measured by the proportion of subjects |
| Secondary | Change in Mean Intravaginal Ejaculatory Latency Time (IELT) From Baseline to Month 3 | 3 months | Summary of mean IELT at Baseline and at month 3 during double-blind treatment |
| Secondary | Change in the Index of Premature Ejaculation (IPE) Domains of Ejaculatory Control, Distress and Sexual Satisfaction From Baseline to Month 1 | 1 month | Change in the IPE domains of ejaculatory control, distress and sexual satisfaction from Baseline to month 1. Ejaculatory control scores range from 4 to 20 with a higher score indicating greater ejaculatory control Sexual satisfaction scores range from 4 to 20 with a higher score indicating greater sexual satisfaction Distress scores range from 2 to 10 with a higher score indicating less distress |
| Secondary | Subject PEP at Month 1 | 1 month | Scores for perceived control over ejaculation, personal distress related to ejaculation, satisfaction with sexual intercourse and interpersonal difficulty related to ejaculation based on the subject PEP at month 1. Percentage of subjects with at least a 1 point category improvement in subject PEP domain scores at month 1. |
| Secondary | Change in the Index of Premature Ejaculation (IPE) Domains of Ejaculatory Control, Distress and Sexual Satisfaction From Baseline to Month 2 | 2 months | Change in the IPE domains of ejaculatory control, distress and sexual satisfaction from Baseline to month 2 Ejaculatory control scores range from 4 to 20 with a higher score indicating greater ejaculatory control Sexual satisfaction scores range from 4 to 20 with a higher score indicating greater sexual satisfaction Distress scores range from 2 to 10 with a higher score indicating less distress |
| Secondary | Subject Premature Ejaculation Profile (PEP) at Month 2 | 2 months | Scores for perceived control over ejaculation, personal distress related to ejaculation, satisfaction with sexual intercourse and interpersonal difficulty related to ejaculation based on the subject PEP at month 2. Proportion of subjects with at least a 1 point category improvement in subject PEP domain scores from baseline to month 2. |
| Secondary | Subject Premature Ejaculation Profile (PEP) at Month 3 | 3 months | Scores for perceived control over ejaculation, personal distress related to ejaculation, satisfaction with sexual intercourse and interpersonal difficulty related to ejaculation based on the subject PEP at month 3. Proportion of subjects with at least a 1 point category improvement in subject PEP domain scores from baseline to month 3. |
| Secondary | Partner Premature Ejaculation Profile (PEP) at Month 3 | 3 months | Scores for perceived control over ejaculation, personal distress related to ejaculation, satisfaction with sexual intercourse and interpersonal difficulty related to ejaculation based on the partner PEP at month 3. Proportion of partners with at least a 1 point category improvement in partner PEP domain scores from baseline to month 3. |
Source ClinicalTrials.gov
Outcomes10
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Mean Intravaginal Ejaculatory Latency Time (IELT): Change From Baseline to During 3 Month Double Blind-treatment | Baseline to 3 Months | ITT | ratio | GEOMETRIC_MEAN |
| PRIMARY | Index of Premature Ejaculation (IPE): Change From Baseline to End of Month 3 | Baseline to 3 Months | ITT | Score | MEAN |
| SECONDARY | Percentage of Subjects With Mean Intravaginal Ejaculatory Latency Time (IELT) > 1 Minute and >2 Minutes During the 3 Months of Double-blind Treatment | 3 months | ITT | percentage of subjects | NUMBER |
| SECONDARY | Change in Mean Intravaginal Ejaculatory Latency Time (IELT) From Baseline to Month 3 | 3 months | ITT | Seconds | GEOMETRIC_MEAN |
| SECONDARY | Change in the Index of Premature Ejaculation (IPE) Domains of Ejaculatory Control, Distress and Sexual Satisfaction From Baseline to Month 1 | 1 month | ITT | Score | MEAN |
| SECONDARY | Subject PEP at Month 1 | 1 month | ITT | percentage of participants | NUMBER |
| SECONDARY | Change in the Index of Premature Ejaculation (IPE) Domains of Ejaculatory Control, Distress and Sexual Satisfaction From Baseline to Month 2 | 2 months | ITT | Score | MEAN |
| SECONDARY | Subject Premature Ejaculation Profile (PEP) at Month 2 | 2 months | ITT | percentage of participants | NUMBER |
| SECONDARY | Subject Premature Ejaculation Profile (PEP) at Month 3 | 3 months | ITT | percentage of participants | NUMBER |
| SECONDARY | Partner Premature Ejaculation Profile (PEP) at Month 3 | 3 months | ITT | percentage of partners | NUMBER |
Source ClinicalTrials.gov
Results by group58
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Mean Intravaginal Ejaculatory Latency Time (IELT): Change From Baseline to During 3 Month Double Blind-treatment | Double-Blind Active / Open-Label Active | 4.607 | Full Range 0.01 to 559.78 | ratio | |
| Mean Intravaginal Ejaculatory Latency Time (IELT): Change From Baseline to During 3 Month Double Blind-treatment | Double-Blind Placebo / Open-Label Active | 1.505 | Full Range 0.27 to 12.58 | ratio | |
| Index of Premature Ejaculation (IPE): Change From Baseline to End of Month 3 | Double-Blind Active / Open-Label Active | Ejaculatory control | 7.2 | Full Range -3 to 16 | Score |
| Index of Premature Ejaculation (IPE): Change From Baseline to End of Month 3 | Double-Blind Placebo / Open-Label Active | Ejaculatory control | 2.2 | Full Range -1 to 14 | Score |
| Index of Premature Ejaculation (IPE): Change From Baseline to End of Month 3 | Double-Blind Active / Open-Label Active | Sexual satisfaction | 6.6 | Full Range -8 to 16 | Score |
| Index of Premature Ejaculation (IPE): Change From Baseline to End of Month 3 | Double-Blind Placebo / Open-Label Active | Sexual satisfaction | 2.1 | Full Range -4 to 14 | Score |
| Index of Premature Ejaculation (IPE): Change From Baseline to End of Month 3 | Double-Blind Active / Open-Label Active | Distress | 3.5 | Full Range -2 to 8 | Score |
| Index of Premature Ejaculation (IPE): Change From Baseline to End of Month 3 | Double-Blind Placebo / Open-Label Active | Distress | 0.9 | Full Range -2 to 6 | Score |
| Percentage of Subjects With Mean Intravaginal Ejaculatory Latency Time (IELT) > 1 Minute and >2 Minutes During the 3 Months of Double-blind Treatment | Double-Blind Active / Open-Label Active | IELT > 1 minute | 80.2 | percentage of subjects | |
| Percentage of Subjects With Mean Intravaginal Ejaculatory Latency Time (IELT) > 1 Minute and >2 Minutes During the 3 Months of Double-blind Treatment | Double-Blind Placebo / Open-Label Active | IELT > 1 minute | 37.8 | percentage of subjects |
1 to 10 of 58Source ClinicalTrials.gov
See all 58 results by groupParticipant flow16
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Double-blind Phase | STARTED | Double-Blind Active / Open-Label Active | 171 | |
| Double-blind Phase | STARTED | Double-Blind Placebo / Open-Label Active | 85 | |
| Double-blind Phase | ITT | Double-Blind Active / Open-Label Active | 167 | |
| Double-blind Phase | ITT | Double-Blind Placebo / Open-Label Active | 82 | |
| Double-blind Phase | COMPLETED | Double-Blind Active / Open-Label Active | 150 | |
| Double-blind Phase | COMPLETED | Double-Blind Placebo / Open-Label Active | 77 | |
| Double-blind Phase | NOT COMPLETED | Double-Blind Active / Open-Label Active | 21 | |
| Double-blind Phase | NOT COMPLETED | Double-Blind Placebo / Open-Label Active | 8 | |
| Open-Label Phase | STARTED | Double-Blind Active / Open-Label Active | 146 | |
| Open-Label Phase | STARTED | Double-Blind Placebo / Open-Label Active | 77 |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 participant flowAdverse events21
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 | Erectile dysfunction | Reproductive system and breast disorders | Double-Blind Active | 9 | 167 | 14 |
| other | Erectile dysfunction | Reproductive system and breast disorders | Double-Blind Placebo | 0 | 82 | 0 |
| other | Erectile dysfunction | Reproductive system and breast disorders | Open Label Phase | 8 | 223 | 20 |
| serious | Burns second degree | Injury, poisoning and procedural complications | Double-Blind Active | 1 | 167 | 1 |
| serious | Burns second degree | Injury, poisoning and procedural complications | Double-Blind Placebo | 0 | 82 | 0 |
| serious | Burns second degree | Injury, poisoning and procedural complications | Open Label Phase | 0 | 223 | 0 |
| serious | Contusion | Injury, poisoning and procedural complications | Double-Blind Active | 0 | 167 | 0 |
| serious | Contusion | Injury, poisoning and procedural complications | Double-Blind Placebo | 1 | 82 | 1 |
| serious | Contusion | Injury, poisoning and procedural complications | Open Label Phase | 0 | 223 | 0 |
| serious | Concussion | Injury, poisoning and procedural complications | Double-Blind Active | 0 | 167 | 0 |
1 to 10 of 21Source ClinicalTrials.gov
See all 21 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Double-Blind Active | ||
| Total, all-cause mortality | Double-Blind Placebo | ||
| Total, all-cause mortality | Open Label Phase | ||
| Total, other adverse events | Double-Blind Active | 9 | 167 |
| Total, other adverse events | Double-Blind Placebo | 0 | 82 |
| Total, other adverse events | Open Label Phase | 8 | 223 |
| Total, serious adverse events | Double-Blind Active | 1 | 167 |
| Total, serious adverse events | Double-Blind Placebo | 1 | 82 |
| Total, serious adverse events | Open Label Phase | 4 | 223 |
Source ClinicalTrials.gov
Papers3
The papers the trial lists on ClinicalTrials.gov.
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
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