NCT06703840

Phase 2a Trial to Investigate the Efficacy of LIB-01 in Treatment of Erectile Dysfunction

A Phase 2a, Randomised, Double-blind, Parallel and Placebo-controlled Trial Investigating Safety and Efficacy of LIB-01 in Treatment of Erectile Dysfunction

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 156 (actual)
• Sponsor: Dicot AB · Industry
• Sex: Male
• Age: 25 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

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

Conditions

• Erectile Dysfunction

Interventions

Type	Name	Description
DRUG	LIB-01	LIB-01 oral suspension
DRUG	LIB-01 Placebo	LIB-01 Placebo oral suspension

Timeline

• Start date: 2024-11-08
• Primary completion: 2025-07-19
• Completion: 2025-08-19
• First posted: 2024-11-25
• Last updated: 2025-08-24

Locations

6 sites across 3 countries: Denmark, Netherlands, Sweden