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Trial · NCT02495467

Registered outcomes12

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

ListOutcomeTime frameDescription
PrimaryErectile 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.
SecondaryOrgasmic 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.
SecondarySexual 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.
SecondaryIntercourse 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.
SecondaryOverall 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.
SecondaryPercentage of Affirmative Responses to Sexual Encounter Profile (SEP) Question 14 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.
SecondaryPercentage of Affirmative Responses to Sexual Encounter Profile (SEP) Question 24 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.
SecondaryPercentage of Affirmative Responses to Sexual Encounter Profile (SEP) Question 34 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.
SecondaryPercentage of Affirmative Responses to Sexual Encounter Profile (SEP) Question 44 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.
SecondaryPercentage of Affirmative Responses to Sexual Encounter Profile (SEP) Question 54 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.
SecondaryNumber of Participants With Affirmative Response to Global Assessment Questionnaire (GAQ) Question 14 WeeksGAQ Question 1: "Has the treatment you have been taking improved your erectile function?". Answered yes/no after each treatment period of 4 weeks (+/- 1 week).
SecondaryNumber of Participants With Affirmative Response to Global Assessment Questionnaire (GAQ) Question 24 WeeksGAQ Question 2: "Has the treatment improved your ability to engage in sexual activity?". Answered yes/no after each treatment period of 4 weeks (+/- 1 week).

Source ClinicalTrials.govtrials-2026-11-12-0.5.0

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.

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