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

Erectile Dysfunction Clinical Trial

— LUTECIA  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00668109
• Other study ID #: 10893
• Status: Completed
• Phase: Phase 3
• First received: April 24, 2008
• Last updated: December 18, 2014
• Start date: December 2003
• Est. completion date: June 2004

Study information

• Verified date: December 2014
• Source: Bayer
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical DevicesSouth Africa: Medicines Control CouncilItaly: The Italian Medicines AgencySpain: Spanish Agency of MedicinesColombia: INVIMA Instituto Nacional de Vigilancia de Medicamentos y AlimentosNetherlands: Medicines Evaluation Board (MEB)Israel: Ministry of HealthNorway: Norwegian Medicines AgencyPeru: General Directorate of Pharmaceuticals, Devices, and DrugsMexico: Federal Commission for Protection Against Health RisksBelgium: Federal Agency for Medicinal Products and Health Products
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 614
• Est. completion date: June 2004
• Est. primary completion date: June 2004
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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 exclusion criteria apply according to Summary of Product Characteristics

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Erectile Dysfunction
• Hyperlipidemias
• Hypertension

Intervention

Drug:
• Levitra (Vardenafil, BAY38-9456)
10 mg one hour prior to sexual intercourse
• Tadalafil
10 mg taken approximately 24 hours prior to sexual intercourse

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Bayer

Countries where clinical trial is conducted

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Sexual encounter profile question 2		4 weeks	No
Secondary	Hardness of erection		4 weeks	No
Secondary	Other diary based variables		4 weeks	No
Secondary	Safety and tolerability		4 weeks	Yes

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