Ignite Creation Date:
2025-12-25 @ 1:25 AM
Ignite Modification Date:
2025-12-27 @ 11:07 PM
Study NCT ID:
NCT04984993
Status:
COMPLETED
Last Update Posted:
2023-09-21
First Post:
2021-07-26
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Clinical Investigation Using MED3000 Gel or Tadalafil Tablets in the Treatment of Erectile Dysfunction
Sponsor:
Futura Medical Developments Ltd.
Organization:
Study Overview
Official Title:
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
Status Verified Date:
2021-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
True
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: