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A Randomized, Double-Blind, Parallel-Design, Placebo-Controlled Study to Evluate the Efficacy and Safety of Tadalafil (2.5 mg e 5 mg) administered once daily to men with diabetes mellitus and erectile dysfunction

A Randomized, Double-Blind, Parallel-Design, Placebo-Controlled Study to Evluate the Efficacy and Safety of Tadalafil (2.5 mg e 5 mg) administered once daily to men with diabetes mellitus and erectile dysfunction

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2004-001033-41-IT
Enrollment
Unknown
Registered
2004-09-14
Start date
2004-09-22
Completion date
Unknown
Last updated
2012-03-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Therapy of erectile disfunction to subjects with diabetes mellitus and erectile disfunction with a 2.5 mg or 5 mg daily dosing. MedDRA version: 6.1 Level: PT Classification code 10061461

Interventions

Trade Name: Tadanafil Product Name: tadalafil Product Code: IC351 Pharmaceutical Form: Tablet INN or Proposed INN: Tadalafil Current Sponsor code: H6D-MC-LVFZ Concentration unit: mg milligram(s) Conc

Sponsors

ELI LILLY
Lead Sponsor

Eligibility

Sex/Gender
Male

Inclusion criteria

Inclusion criteria: Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

MeasureTime frame
Main Objective: ;Secondary Objective: ;Primary end point(s):

Countries

Italy

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026