NCT04984993

Clinical Investigation Using MED3000 Gel or Tadalafil Tablets in the Treatment of Erectile Dysfunction

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 116 (actual)
• Sponsor: Futura Medical Developments Ltd. · Industry
• Sex: Male
• Age: 22 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Erectile Dysfunction

Interventions

Type	Name	Description
DEVICE	MED3000 (Male)	Gel formulation
DRUG	Tadalafil 5mg (Male)	Tablets
DEVICE	MED3000 (Female)	Gel formulation
DRUG	Tadalafil 5mg (Female)	Tablets

Timeline

• Start date: 2021-09-14
• Primary completion: 2022-07-13
• Completion: 2022-07-13
• First posted: 2021-08-02
• Last updated: 2023-09-21
• Results posted: 2023-09-21

Locations

18 sites across 4 countries: United States, Bulgaria, Georgia, Poland

Regulatory

• FDA-regulated device study