Trial · NCT02495467
Clinical Trial of Topically-applied Glyceryl Trinitrate (GTN) for the Treatment of Erectile Dysfunction (ED)
NCT02495467, Phase 2, Completed, Futura Medical Developments Ltd.; results first posted 2020-01-29
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Clinical Trial of Topically-applied Glyceryl Trinitrate (GTN) for the Treatment of Erectile Dysfunction (ED). Trials, record NCT02495467. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02495467
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Clinical Trial of Topically-applied Glyceryl Trinitrate (GTN) for the Treatment of Erectile Dysfunction (ED)
- NCT number
- NCT02495467
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 232 participants, actual
- Lead sponsor
- Futura Medical Developments Ltd.
- Conditions
- Erectile Dysfunction
- Interventions
- Glyceryl trinitrate, MED Placebo
- First posted
- 2015-07-13
- Last updated
- 2020-02-12
- Results first posted
- 2020-01-29
Source ClinicalTrials.gov
Registered outcomes12
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Erectile Function (EF) Domain Score of the International Index of Erectile Function (IIEF) | 4 Weeks | Erectile Function (EF) domain of the International Index of Erectile Function (IIEF) questionnaire. This will be measured at the end of the treatment periods of 4 weeks (+/- 1 week). The minimum and maximum values are 1-30, a lower score is regarded as more severe. |
| Secondary | Orgasmic Function Domain Score of the International Index of Erectile (IIEF) | 4 Weeks | Orgasmic function domain of the International Index of Erectile Function (IIEF) questionnaire. This will be measured at the end of treatment periods of 4 weeks (+/- 1 week). The minimum and maximum values are 1-10, a lower score is regarded as having a worse outcome. |
| Secondary | Sexual Desire Domain Score of the International Index of Erectile Function (IIEF) | 4 Weeks | Sexual desire domain of the International Index of Erectile Function (IIEF) questionnaire. This will be measured at the end of treatment periods of 4 weeks (+/- 1 week). The minimum and maximum values are 2-10, a lower score is regarded as having a worse outcome. |
| Secondary | Intercourse Satisfaction Domain Score of the International Index of Erectile Function (IIEF) | 4 Weeks | Intercourse satisfaction domain of the International Index of Erectile Function (IIEF) questionnaire. This will be measured at the end of treatment periods of 4 weeks (+/- 1 week). The minimum and maximum values are 0-15, a lower score is regarded as having a worse outcome. |
| Secondary | Overall Satisfaction Domain Score of the International Index of Erectile Function (IIEF) | 4 weeks | Overall satisfaction domain of the International Index of Erectile Function (IIEF) questionnaire. This will be measured at the end of treatment periods of 4 weeks (+/- 1 week). The minimum and maximum values are 2-10, a lower score is regarded as having a worse outcome. |
| Secondary | Percentage of Affirmative Responses to Sexual Encounter Profile (SEP) Question 1 | 4 Weeks | SEP Question 1: "Were you able to achieve at least some erection (some enlargement of the penis)?". Answered yes/no after each intercourse event during treatment periods of 4 weeks (+/- 1 week). Assessed as a percentage of yes responses in each period. |
| Secondary | Percentage of Affirmative Responses to Sexual Encounter Profile (SEP) Question 2 | 4 Weeks | SEP Question 2: "Were you able to insert your penis into your partner's vagina?". Answered yes/no after each intercourse event during treatment periods of 4 weeks (+/- 1 week). Assessed as a percentage of yes responses in each period. |
| Secondary | Percentage of Affirmative Responses to Sexual Encounter Profile (SEP) Question 3 | 4 Weeks | SEP Question 3: "Did your erection last long enough for you to have successful intercourse?". Answered yes/no after each intercourse event during treatment periods of 4 weeks (+/- 1 week). Assessed as a percentage of yes responses in each period. |
| Secondary | Percentage of Affirmative Responses to Sexual Encounter Profile (SEP) Question 4 | 4 Weeks | SEP Question 4: "Were you satisfied with the hardness of your erection?". Answered yes/no after each intercourse event during treatment periods of 4 weeks (+/- 1 week). Assessed as a percentage of yes responses in each period. |
| Secondary | Percentage of Affirmative Responses to Sexual Encounter Profile (SEP) Question 5 | 4 Weeks | SEP Question 5: "Were you satisfied overall with this sexual experience?". Answered yes/no after each intercourse event during treatment periods of 4 weeks (+/- 1 week). Assessed as a percentage of yes responses in each period. |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 registered outcomesOutcomes12
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Erectile Function (EF) Domain Score of the International Index of Erectile Function (IIEF) | 4 Weeks | Full Analysis Set. A total of 230 subjects reported at least one intercourse attempt and had at least one IIEF assessment in a period for which at least one intercourse attempt was reported. Observed cases only. | score on a scale | MEAN |
| SECONDARY | Orgasmic Function Domain Score of the International Index of Erectile (IIEF) | 4 Weeks | Full Analysis Set. A total of 230 subjects reported at least one intercourse attempt and had at least one IIEF assessment in a period for which at least one intercourse attempt was reported. Observed cases only. | score on a scale | MEAN |
| SECONDARY | Sexual Desire Domain Score of the International Index of Erectile Function (IIEF) | 4 Weeks | Full Analysis Set. A total of 230 subjects reported at least one intercourse attempt and had at least one IIEF assessment in a period for which at least one intercourse attempt was reported. Observed cases only. | score on a scale | MEAN |
| SECONDARY | Intercourse Satisfaction Domain Score of the International Index of Erectile Function (IIEF) | 4 Weeks | Full Analysis Set. A total of 230 subjects reported at least one intercourse attempt and had at least one IIEF assessment in a period for which at least one intercourse attempt was reported. Observed cases only. | score on a scale | MEAN |
| SECONDARY | Overall Satisfaction Domain Score of the International Index of Erectile Function (IIEF) | 4 weeks | Full Analysis Set. A total of 230 subjects reported at least one intercourse attempt and had at least one IIEF assessment in a period for which at least one intercourse attempt was reported. Observed cases only. | score on a scale | MEAN |
| SECONDARY | Percentage of Affirmative Responses to Sexual Encounter Profile (SEP) Question 1 | 4 Weeks | Full Analysis Set. A total of 230 subjects reported at least one intercourse attempt and had at least one IIEF assessment in a period for which at least one intercourse attempt was reported. Observed cases only. | percentage of yes responses | MEAN |
| SECONDARY | Percentage of Affirmative Responses to Sexual Encounter Profile (SEP) Question 2 | 4 Weeks | Full Analysis Set. A total of 230 subjects reported at least one intercourse attempt and had at least one IIEF assessment in a period for which at least one intercourse attempt was reported. Observed cases only. | percentage of yes responses | MEAN |
| SECONDARY | Percentage of Affirmative Responses to Sexual Encounter Profile (SEP) Question 3 | 4 Weeks | Full Analysis Set. A total of 230 subjects reported at least one intercourse attempt and had at least one IIEF assessment in a period for which at least one intercourse attempt was reported. Observed cases only. | percentage of yes responses | MEAN |
| SECONDARY | Percentage of Affirmative Responses to Sexual Encounter Profile (SEP) Question 4 | 4 Weeks | Full Analysis Set. A total of 230 subjects reported at least one intercourse attempt and had at least one IIEF assessment in a period for which at least one intercourse attempt was reported. Observed cases only. | percentage of yes responses | MEAN |
| SECONDARY | Percentage of Affirmative Responses to Sexual Encounter Profile (SEP) Question 5 | 4 Weeks | Full Analysis Set. A total of 230 subjects reported at least one intercourse attempt and had at least one IIEF assessment in a period for which at least one intercourse attempt was reported. Observed cases only. | percentage of yes responses | MEAN |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 outcomesResults by group24
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Erectile Function (EF) Domain Score of the International Index of Erectile Function (IIEF) | MED Placebo | 18.5 | Standard Deviation 6.7 | score on a scale | |
| Erectile Function (EF) Domain Score of the International Index of Erectile Function (IIEF) | MED2005 | 19.6 | Standard Deviation 7.5 | score on a scale | |
| Orgasmic Function Domain Score of the International Index of Erectile (IIEF) | MED Placebo | 6.6 | Standard Deviation 2.6 | score on a scale | |
| Orgasmic Function Domain Score of the International Index of Erectile (IIEF) | MED2005 | 7.0 | Standard Deviation 2.8 | score on a scale | |
| Sexual Desire Domain Score of the International Index of Erectile Function (IIEF) | MED Placebo | 7.1 | Standard Deviation 1.8 | score on a scale | |
| Sexual Desire Domain Score of the International Index of Erectile Function (IIEF) | MED2005 | 7.5 | Standard Deviation 1.8 | score on a scale | |
| Intercourse Satisfaction Domain Score of the International Index of Erectile Function (IIEF) | MED Placebo | 8.6 | Standard Deviation 2.8 | score on a scale | |
| Intercourse Satisfaction Domain Score of the International Index of Erectile Function (IIEF) | MED2005 | 9.0 | Standard Deviation 2.8 | score on a scale | |
| Overall Satisfaction Domain Score of the International Index of Erectile Function (IIEF) | MED Placebo | 6.6 | Standard Deviation 2.2 | score on a scale | |
| Overall Satisfaction Domain Score of the International Index of Erectile Function (IIEF) | MED2005 | 7.1 | Standard Deviation 2.3 | score on a scale |
1 to 10 of 24Source ClinicalTrials.gov
See all 24 results by groupParticipant flow18
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| First Intervention (4 Weeks) | STARTED | MED Placebo Then MED2005 | 114 | |
| First Intervention (4 Weeks) | STARTED | MED2005 Then MED Placebo | 118 | |
| First Intervention (4 Weeks) | COMPLETED | MED Placebo Then MED2005 | 114 | |
| First Intervention (4 Weeks) | COMPLETED | MED2005 Then MED Placebo | 118 | |
| First Intervention (4 Weeks) | NOT COMPLETED | MED Placebo Then MED2005 | 0 | |
| First Intervention (4 Weeks) | NOT COMPLETED | MED2005 Then MED Placebo | 0 | |
| Washout (1 Week) | STARTED | MED Placebo Then MED2005 | 114 | |
| Washout (1 Week) | STARTED | MED2005 Then MED Placebo | 118 | |
| Washout (1 Week) | COMPLETED | MED Placebo Then MED2005 | 112 | |
| Washout (1 Week) | COMPLETED | MED2005 Then MED Placebo | 116 |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 participant flowAdverse events4
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 | Nasopharyngitis | Infections and infestations | MED Placebo | 11 | 227 | |
| other | Nasopharyngitis | Infections and infestations | MED2005 | 13 | 229 | |
| other | Headache | Nervous system disorders | MED Placebo | 7 | 227 | |
| other | Headache | Nervous system disorders | MED2005 | 18 | 229 |
Source ClinicalTrials.gov
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | MED Placebo | 0 | 227 |
| Total, all-cause mortality | MED2005 | 0 | 229 |
| Total, other adverse events | MED Placebo | 15 | 227 |
| Total, other adverse events | MED2005 | 28 | 229 |
| Total, serious adverse events | MED Placebo | 0 | 227 |
| Total, serious adverse events | MED2005 | 0 | 229 |
Source ClinicalTrials.gov
Papers0
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 comparisons4
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| MED2005 vs MED Placebo: Number of Participants With Affirmative Response to Global Assessment Questionnaire (GAQ) Question 1 | Trial comparisons |
| MED2005 vs MED Placebo: deaths from any cause | Trial comparisons |
| MED2005 vs MED Placebo: Number of Participants With Affirmative Response to Global Assessment Questionnaire (GAQ) Question 2 | Trial comparisons |
| MED2005 vs MED Placebo: serious adverse events | Trial comparisons |
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/NCT02495467
GET https://conductscience.org/api/trials/v1/NCT02495467/results?page=2