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A pilot, randomized, double-blind, placebo-controlled, crossover study evaluating the efficacy and safety of Vardenafil versus placebo administered 12, 18 and 24 hours prior to initiation of sexual intercourse in subjects with ED.

A pilot, randomized, double-blind, placebo-controlled, crossover study evaluating the efficacy and safety of Vardenafil versus placebo administered 12, 18 and 24 hours prior to initiation of sexual intercourse in subjects with ED.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2004-001549-13-IT
Enrollment
314
Registered
2005-03-07
Start date
2004-09-14
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

ERECTILE DISFUNCTION MedDRA version: 6.1 Level: PT Classification code 10061461

Interventions

Trade Name: VIVANZA*20 MG 2 CPR RIV. Product Name: NA Product Code: NA Pharmaceutical Form: Film-coated tablet INN or Proposed INN: Vardenafil Concentration unit: mg milligram(s) Concentration type: e

Sponsors

GLAXO SMITHKLINE
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) no 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