At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 116 enrolled
Drug / intervention
Tadalafil 5mg (Male) +3 moredrug
Likely dose
Tadalafil 5mg (Male)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 Multi-centre, Randomised, Open-label, Home Use, Parallel Group, Clinical Investigation of Topically-applied MED3000 Gel and Oral Tadalafil (5 mg) Tablets for the Treatment of Erectile Dysfunction (ED) Over a 24 Week Period
In Brief
A Phase 3 clinical trial evaluating MED3000 (Male), Tadalafil 5mg (Male), and 2 other interventions for Erectile Dysfunction. Completed, enrolled 116 participants across 18 sites in 4 countries.
Detailed Summary
An open-label investigation using MED3000 gel or tadalafil (5 mg) tablets in the treatment of erectile dysfunction in patients from 22 to 70 years of age. Each patients will be expected to participate for up to 30 weeks. Eligible patients will be randomised to receive either MED3000 gel or tadalafil (5 mg) tablets in a 1:1 ratio.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsErectile Dysfunction
CountriesBulgaria, Georgia, Poland, United States
Collaborators--
Timeline
Phase 3CompletedFinished
20222023202420252026
First PostedAug 2021
Enrollment StartSep 2021
Primary CompletionJul 2022
TodayJul 2026
First PostedAug 2, 2021
Enrollment StartSep 14, 2021
Primary CompletionJul 13, 2022
TodayJul 2, 2026
Enrollment to primary: 10 monthsPosted 4.9 years ago
Interventions
MED3000 (Male)device
Gel formulation
Tadalafil 5mg (Male)drug
Tablets
MED3000 (Female)device
Gel formulation
Tadalafil 5mg (Female)drug
Tablets