At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 26 enrolled
Drug / intervention
hMaxi-K Single Treatment/ 2 escalating dose levels (8000 µg and 16000 µg injection) +1 moredrug
Likely dose
hMaxi-K Single Treatment/ 2 escalating dose levels (8000 µg and 16000 µg injection)from record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Double-blind, Placebo-controlled, Parallel Design, Randomized, Phase 2A Clinical Trial Evaluating the Potential Activity and Safety of hMaxi-K Gene Transfer in Males With Erectile Dysfunction
In Brief
A Phase 2 clinical trial evaluating hMaxi-K Single Treatment/ 2 escalating dose levels (8000 µg and 16000 µg injection) and Placebo (PBS-20% sucrose) for Erectile Dysfunction. Completed, enrolled 26 participants across 1 site.
Detailed Summary
To evaluate the safety and efficacy of a single intracavernous injection of hMaxi K (8000 µg and 16000 µg) or placebo upon penile rigidity or erection in males with erectile dysfunction longer than six months that is attributable to an underlying, stable medical condition.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsErectile Dysfunction
CountriesKuwait
CollaboratorsDasman Diabetes Institute, Ion Channel Innovations
Timeline
Phase 2CompletedFinished
201520162017201820192020202120222023202420252026
Enrollment StartApr 2015
First PostedMar 2016
Primary CompletionAug 2017
TodayJul 2026
First PostedMar 21, 2016
Enrollment StartApr 1, 2015
Primary CompletionAug 24, 2017
TodayJul 2, 2026
Enrollment to primary: 2.4 yearsPosted 10.3 years ago
Interventions
hMaxi-K Single Treatment/ 2 escalating dose levels (8000 µg and 16000 µg injection)drug
Placebo (PBS-20% sucrose)drug