Erectile dysfunction (ED)
Conditions
Brief summary
Change from baseline in total score on the erectile function (EF) domain of the patient questionnaire International Index of Erectile Function (IIEF-EF) at week 4. Safety endpoint: Frequency, seriousness and intensity of adverse events (AEs), Clinically significant changes in safety laboratory measurements, vital signs and electrocardiogram (ECG).
Detailed description
Percentage of successful attempts by the Sexual Encounter Profile (SEP) question 2 throughout the trial period., Percentage of successful attempts by the SEP question 3 throughout the trial period., Percentage of improved erections by the Global Assessment Question (GAQ) at week 4 and week 8., IIEF-EF domain responder rate by minimally clinically important difference (MCID) at week 4 and week 8., Change from baseline in sub-domain scores (orgasmic function, sexual desire, intercourse satisfaction, overall satisfaction) of the patient questionnaire IIEF at week 4 and week 8., PK parameters of LIB-01 in plasma.
Interventions
DRUGLIB-01 MONOHYDRATE
DRUGLIB-01-placebo powder for suspension
Vehicle: SyrSpend® SF PH4
Sponsors
Dicot AB
Eligibility
Sex/Gender
Male
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change from baseline in total score on the erectile function (EF) domain of the patient questionnaire International Index of Erectile Function (IIEF-EF) at week 4. Safety endpoint: Frequency, seriousness and intensity of adverse events (AEs), Clinically significant changes in safety laboratory measurements, vital signs and electrocardiogram (ECG). | — |
Secondary
| Measure | Time frame |
|---|---|
| Percentage of successful attempts by the Sexual Encounter Profile (SEP) question 2 throughout the trial period., Percentage of successful attempts by the SEP question 3 throughout the trial period., Percentage of improved erections by the Global Assessment Question (GAQ) at week 4 and week 8., IIEF-EF domain responder rate by minimally clinically important difference (MCID) at week 4 and week 8., Change from baseline in sub-domain scores (orgasmic function, sexual desire, intercourse satisfaction, overall satisfaction) of the patient questionnaire IIEF at week 4 and week 8., PK parameters of LIB-01 in plasma. | — |
Countries
Denmark, Netherlands, Sweden
Outcome results
None listed