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NCT Number: NCT00678704

BAY38-9456 - Pivotal Trial for Diabetes Patient

The superiority of BAY 38-9456 10 mg and 20 mg regimens to placebo, and of 20 mg to 10 mg was confirmed in patients with diabetes mellitus suffering from erectile dysfunction. There was no large difference in incidence rate of drug-related adverse events between 10 mg and 20 mg regimens. Overall the tolerability was considered good with both regimens.

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Key information

Conditions

Erectile Dysfunction Diabetes Mellitus Endocrine System Diseases Genital Diseases Genital Diseases, Male Glucose Metabolism Disorders Male Urogenital Diseases Mental Disorders Metabolic Diseases Nutritional and Metabolic Diseases Sexual Dysfunction, Physiological Sexual Dysfunctions, Psychological Urogenital Diseases

Age range

20 year–64 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 3

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Male with erectile dysfunction for more than 3 years according to the National Institutes of Health (NIH) Consensus Statement (inability to attain and/or maintain penile erection sufficient for satisfactory sexual performance)
  • Diabetes for more than 3 years

Exclusion criteria

  • Following to the labeling of Japanese package insert for vardenafil 5/10 mg, except for the highest dose
  • Spinal cord injury
  • History of surgical prostatectomy (excluding TURP)
  • Patients with an HbA1c > 12% at Visit 1
  • Use of nitrates
  • Use of potent CYP3a4 inhibitors
  • Severe liver disease
  • Presence of Peyronie's Disease

Treatment and study plan

Levitra (Vardenafil, BAY38-9456)

Drug

BAY 38-9456 10 mg tablet prior to intercourse on demand

Placebo

Drug

Placebo tablet prior to intercourse on demand

Primary outcomes

  1. The Erectile Function (EF) domain score of IIEF calculated as the sum of scores from Questions 1 to 5 and 15

    Time frame: At 12 weeks after start of study drug administration using data at LOCF to account for dropouts

Secondary outcomes

  1. The Global Assessment Question

    Time frame: At 4, 8, 12 weeks after start of study drug administration and LOCF

  2. The IIEF EF domain score

    Time frame: At 4, 8, 12 weeks after start of study drug administration

  3. IIEF domain scores other than the EF domain score[intercourse satisfaction (Q6 to Q8), overall satisfaction (Q13, Q14), orgasmic function (Q9, Q10), sexual desire (Q11, Q12)]

    Time frame: At 4, 8, 12 weeks after start of study drug administration and LOCF

  4. Scores of Questions 1 to 15 on the IIEF Questionnaire

    Time frame: At 4, 8, 12 weeks after start of study drug administration and LOCF

  5. Patient's diary response concerning hardness of erection, maintenance of erection, satisfaction with overall hardness of erection, ability of insertion, overall satisfaction with sexual experience and ejaculation

    Time frame: At 4, 8, 12 weeks after start of study drug administration and LOCF

  6. Safety data

    Time frame: Throughout the study

Sponsors and collaborators

Lead sponsor

Bayer

Industry

Registry information

Official study title

A Randomized, Placebo-controlled, Double-blind, Multi-centre, Parallel Group Study to Investigate the Efficacy and Safety of BAY 38-9456 in Males With Diabetes Suffering From Erectile Dysfunction

Important dates

Study start
2004
Study completion
2004
First posted
May 15, 2008
Registry last updated
Dec 19, 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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