Assessment of Efficacy of Vardenafil in Subjects With Erectile Dysfunction and Diabetes, Hypertension or Hyperlipidemia

A Randomized, Open-label, Multi-center, Parallel Group Study to Investigate the Efficacy and Safety of Vardenafil in Comparison to Tadalafil in Males With Erectile Dysfunction and a Diagnosis of Diabetes, Hypertension or Hyperlipidemia

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00668109

Acronym

LUTECIA

Enrollment

614

Registered

2008-04-28

Start date

2003-12-31

Completion date

2004-06-30

Last updated

2014-12-23

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

Conditions

Erectile Dysfunction

Keywords

Erectile Dysfunction, Diabetes mellitus, Hypertension, Hyperlipidemia, Vardenafil

Brief summary

Assessment of efficacy of vardenafil in subjects with erectile dysfunction and diabetes, hypertension or hyperlipidemia

Interventions

DRUGLevitra (Vardenafil, BAY38-9456)

10 mg one hour prior to sexual intercourse

DRUGTadalafil

10 mg taken approximately 24 hours prior to sexual intercourse

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

MALE

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

- Age: 18 years and older- Males with erectile dysfunction- Stable heterosexual relationship- Medical history / diagnosis of diabetes mellitus and/or hypertension and/or hyperlipidemia

Exclusion criteria

- Primary hypoactive sexual desire- History of myocardial infarction, stroke or life-threatening arrhythmia within the prior 6 months- Nitrate use- Other

Design outcomes

Primary

Measure	Time frame
Sexual encounter profile question 3 observed within 15 minutes to 4 hours for vardenafil and 22 to 26 hours for the tadalafil group	4 weeks

Secondary

Measure	Time frame
Sexual encounter profile question 2	4 weeks
Hardness of erection	4 weeks
Other diary based variables	4 weeks
Safety and tolerability	4 weeks

Countries

Belgium, Colombia, Finland, Germany, Israel, Italy, Mexico, Netherlands, Norway, Peru, South Africa, Spain, Sweden

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026