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Trial · NCT01037244

Outcomes13

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

TypeOutcomeTime framePopulationUnitsMeasured as
PRIMARY
Change in Erectile Function Domain Assessed by International Index of Erectile Function (IIEF), Baseline to Final Visit/Week 12, mITT (Modified Intent-to-Treat), LOCF (Last Observation Carried Forward)
Baseline and Week 12Last Observation Carried Forward (LOCF), Modified Intent-to-Treat (mITT)units on a scaleLEAST_SQUARES_MEAN
PRIMARYChange in Sexual Encounter Profile (SEP), Question 2, Change From Baseline to Overall Study/Weeks 1-12, mITTBaseline and Weeks 1 - 12Modified Intent-to-Treat (mITT)Percentage Yes RespondersLEAST_SQUARES_MEAN
SECONDARYGlobal Assessment Questionnaire (GAQ), While Using the Study Medication, Did You Feel That Your Erections Improved? (Yes Responders), Week 12/Final Visit, mITT PopulationWeek 12mITT PopulationparticipantsNUMBER
SECONDARYChange From Baseline to Week 12/Final Visit in Mean Patient Self-Assessment of Erection (PSAE), mITT PopulationBaseline to Week 12mITT Populationunits on a scaleLEAST_SQUARES_MEAN
SECONDARYErectile Dysfunction Inventory of Treatment Satisfaction (EDITS) Derived Score, Subject Version, Week 12/ Final Visit, LOCF, mITT PopulationBaseline to Week 12mITT Populationunits on a scaleLEAST_SQUARES_MEAN
SECONDARYChange in Satisfaction of Intercourse Domain Score Assessed by IIEF, Baseline to Week 12/Final Visit, mITT, LOCFBaseline and Week 12Last Observation Carried Forward (LOCF), Modified Intent-to-Treat (mITT)units on a scaleLEAST_SQUARES_MEAN
SECONDARYChange in Orgasmic Function Domain Score Assessed by IIEF, Baseline to Week 12/Final Visit, mITT, LOCFBaseline and Week 12Last Observation Carried Forward (LOCF), Modified Intent-to-Treat (mITT)units on a scaleLEAST_SQUARES_MEAN
SECONDARYChange in Sexual Desire Domain Score Assessed by IIEF, Baseline to Week 12/Final Visit, mITT, LOCFBaseline and Week 12Last Observation Carried Forward (LOCF), Modified Intent-to-Treat (mITT)units on a scaleLEAST_SQUARES_MEAN
SECONDARYChange in Overall Satisfaction Domain Score Assessed by IIEF, Baseline to Week 12/Final Visit, mITT, LOCFBaseline and Week 12Last Observation Carried Forward (LOCF), Modified Intent-to-Treat (mITT)units on a scaleLEAST_SQUARES_MEAN
SECONDARYChange in SEP Question 1, Change From Baseline to Overall/Weeks 1-12, mITTBaseline and Weeks 1 - 12Modified Intent-to-Treat (mITT)Percentage of Yes RespondersLEAST_SQUARES_MEAN
SECONDARYChange in SEP Question 4, Change From Baseline to Overall Study/Weeks 1-12, mITTBaseline and Weeks 1 - 12Modified Intent-to-Treat (mITT)Percentage of Yes RespondersLEAST_SQUARES_MEAN
SECONDARYChange in SEP Question 5, Change From Baseline to Overall/Weeks 1-12, mITTBaseline and Weeks 1 - 12Modified Intent-to-Treat (mITT)Percentage of Yes RespondersLEAST_SQUARES_MEAN
PRIMARYChange in SEP Question 3, Change From Baseline to Overall Study/Weeks 1-12, mITTBaseline and Weeks 1 - 12Modified Intent-to-Treat (mITT)Percentage Yes RespondersLEAST_SQUARES_MEAN

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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