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OpenTrials
Completed

NCT Number: NCT00668135

Assessment of Vardenafil in Patients With Erectile Dysfunction in Asia

To demonstrate the efficacy, safety and tolerability of 10 mg oral vardenafil (BAY 38-9456) compared to placebo for a period of 12 weeks in men with erectile dysfunction (ED)

Completed

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Key information

Conditions

Erectile Dysfunction Genital Diseases Genital Diseases, Male Male Urogenital Diseases Mental Disorders Sexual Dysfunction, Physiological Sexual Dysfunctions, Psychological Urogenital Diseases

Age range

20 year–65 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 4

Primary location

Hong Kong

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age: 20 years and older- Males with erectile dysfunction
  • Stable heterosexual relationship 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 the Summary of Product Characteristics

Treatment and study plan

Vardenafil (Levitra, BAY38-9456)

Drug

Vardenafil 10 mg orally on demand prior to intercourse

Placebo

Drug

Matching placebo

Primary outcomes

  1. International Index of Erectile Function (IIEF) Questionnaire and Sexual Encounter Profile question 2 (SEP 2) and Sexual Encounter Profile question 3 (SEP 3)

    Time frame: 12 weeks

Secondary outcomes

  1. Global Assessment Question

    Time frame: 12 weeks

  2. Other diary responses

    Time frame: 12 weeks

  3. Safety and tolerability

    Time frame: 12 weeks

Sponsors and collaborators

Lead sponsor

Bayer

Industry

Registry information

Official study title

Randomised, Double Blind, Placebo Controlled, Parallel Group, Multi-centre, Multinational Study to Evaluate the Efficacy and Tolerability of Vardenafil (BAY 38-9456) in Treatment of Male Erectile Dysfunction in Asia

Important dates

Study start
2003
Primary completion
2004
Study completion
2004
First posted
Apr 29, 2008
Registry last updated
Dec 17, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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