drugset / Trial / NCT04686916

Clinical Trial Studying the Efficacy and Safety of IP2018 in Depressed, Erectile Dysfunction (ED) Patients

NCT04686916 ↗

Phase 2 Unknown 24 enrolled Initiator Pharma
RandomizedCrossoverDouble-blindTreatment

Summary

This is a Phase IIa, randomised, double-blind, placebo-controlled, 3-period, crossover study to assess two single oral dose levels of IP2018. It is planned to enrol 24 patients. Patients will take part in three treatment periods, in which they will be randomised to receive either a single dose of IP2018 or a single dose of placebo in each treatment period.

Timeline

Start
2020-12-30
Primary completion
2023-07-30
Completion
2023-08-30

Outcome

Met primary endpoint

release “The high dose of IP2018 in single oral administration increased penile tumescence (p=0.04) and duration of rigidity (p=0.025) in a statistically significant way” initiatorpharma.com ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject IP2018 Small molecule — Oral

Indications