The goal of this clinical trial is to learn if the drug LIB-01 works to treat erectile dysfunction in male adults. It will also learn about the safety of the drug LIB-01. The main questions it aims to answer are: * Does the drug LIB-01 improve erectile function in males with erectile dysfunction? * What medical problems do participants have when taking the drug LIB-01? Researchers will compare the drug LIB-01 to a placebo (a look-alike substance that contains no drug) to see if the drug LIB-01 works to treat erectile dysfunction. Participants will: * Take the drug LIB-01 or a placebo every day for 3 days * Visit the clinic every week for 4 weeks, and at 8 weeks, for checkups and tests
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
156
LIB-01 oral suspension
LIB-01 Placebo oral suspension
Herlev Hospital
Herlev, Herlev, Denmark
Clinical Trial Consultants
Groningen, Provincie Groningen, Netherlands
Clinical Trial Consultants
Mölndal, Göteborg, Sweden
Clinical Trial Consultants
Linköping, Linköping, Sweden
Clinical Trial Consultants
Solna, Stockholm County, Sweden
Clinical Trial Consultants
Uppsala, Uppsala County, Sweden
To evaluate the efficacy of LIB-01 in the treatment of erectile dysfunction (ED).
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.
Time frame: 4 weeks
To evaluate the efficacy of LIB-01 in improving erectile function (ability to penetrate) during sexual intercourse.
Percentage of successful attempts by the Sexual Encounter Profile (SEP) question 2 throughout the trial period.
Time frame: 8 weeks
To evaluate the efficacy of LIB-01 in improving erectile function (maintained for completion) during sexual intercourse.
Percentage of successful attempts by the Sexual Encounter Profile (SEP) question 3 throughout the trial period.
Time frame: 8 weeks
To evaluate the efficacy of LIB-01 in improving erections.
Percentage of improved erections by the Global Assessment Question (GAQ) at week 4 and week 8.
Time frame: 8 weeks
To evaluate the incidence of treatment-emergent adverse events as assessed by Common Terminology Criteria for Adverse Events (CTCAE) following oral dosing of LIB-01
Frequency, seriousness and intensity of adverse events (AEs). Adverse events will be graded from 1-5 by the Common Terminology Criteria for Adverse Events (CTCAE): Grade 1, Mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated. Grade 2, Moderate; minimal, local or non-invasive intervention indicated; limiting age-appropriate instrumental activities of daily living (ADL). Grade 3, Severe or medically significant but not immediately life-threatening; hospitalisation or prolongation of hospitalisation indicated; disabling; limiting self- care ADL. Grade 4, Life-threatening consequences: urgent intervention indicated. Grade 5, Death related to AE.
Time frame: 8 weeks
To evaluate changes in vital signs (blood pressure), following oral dosing of LIB-01.
Clinically significant changes in blood pressure.
Time frame: 8 weeks
To evaluate changes in vital signs (pulse), following oral dosing of LIB-01.
Clinically significant changes in pulse.
Time frame: 8 weeks
To evaluate changes in vital signs (respiratory rate), following oral dosing of LIB-01.
Clinically significant changes in respiratory rate.
Time frame: 8 weeks
To evaluate changes in vital signs (body temperature), following oral dosing of LIB-01.
Clinically significant changes in vital body temperature.
Time frame: 8 weeks
To evaluate changes in ECG parameters (resting heart rate [HR]), following oral dosing of LIB-01.
Clinically significant changes in resting heart rate (HR).
Time frame: 8 weeks
To evaluate changes in ECG parameters (PQ/PR), following oral dosing of LIB-01.
Clinically significant changes in PQ/PR interval.
Time frame: 8 weeks
To evaluate changes in ECG parameters (QRS), following oral dosing of LIB-01.
Clinically significant changes in QRS interval.
Time frame: 8 weeks
To evaluate changes in ECG parameters (QT), following oral dosing of LIB-01.
Clinically significant changes in QT interval.
Time frame: 8 weeks
To evaluate changes in ECG parameters (QTcF [corrected QT interval by Fredericia]), following oral dosing of LIB-01.
Clinically significant changes in QTcF interval.
Time frame: 8 weeks
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