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Phase 2A Clinical Trial Evaluating the Potential Activity and Safety of hMaxi-K Gene for ED

NCT02713789 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 26

Last updated 2019-08-08

Study results available
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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.

Conditions

Interventions

DRUG

hMaxi-K Single Treatment/ 2 escalating dose levels (8000 µg and 16000 µg injection)

DRUG

Placebo (PBS-20% sucrose)

Sponsors & Collaborators

  • Dasman Diabetes Institute

    collaborator OTHER

  • Ion Channel Innovations

    collaborator INDUSTRY

  • Urovant Sciences GmbH

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-04-30
Primary Completion
2017-08-24
Completion
2017-08-24

Countries

  • Kuwait

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02713789 on ClinicalTrials.gov