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Completed

NCT Number: NCT00652262

BAY38-9456 - Supportive Trial for Spinal Injury

BAY 38-9456 10 mg and 20 mg can be given as safe and efficacious medications to patients with spinal cord injury suffering from erectile dysfunction, and that erectile dysfunction can be improved by uptitration to BAY 38-9456 20 mg when the treatment with 10 mg is not sufficiently effective

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Key information

Conditions

Erectile Dysfunction Central Nervous System Diseases Genital Diseases Genital Diseases, Male Male Urogenital Diseases Mental Disorders Nervous System Diseases Sexual Dysfunction Sexual Dysfunction, Physiological Sexual Dysfunctions, Psychological Spinal Cord Diseases Spinal Cord Injuries Spinal Cord Injury Trauma, Nervous System Urogenital Diseases Wounds and Injuries

Age range

20 year–64 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 3

Primary location

Nagoya, Aichi-ken, Japan

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Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Male with erectile dysfunction according to the NIH Consensus Statement (inability to attain and/or maintain penile erection sufficient for satisfactory sexual performance), solely as a result of a traumatic injury to the spinal cord (suffering more than 6 months ago)
  • Patients answering "yes" to the question regarding the presence of residual erectile function over the past 6 months [At home over the past 6 months, have you experienced at least some enlargement of your penis in response to: (1) mechanical stimulation by yourself or your partner, or (2) visual stimulation?]

Exclusion criteria

  • History of diabetes mellitus
  • Patients who are taking nitrates or nitric oxide donors
  • Patients who have experienced no enlargement of penis with PDE5 inhibitor and/or who have withdrew the use of PDE5 inhibitor due to ADRs

Treatment and study plan

Levitra (Vardenafil, BAY38-9456)

Drug

Patients received BAY 38-9456 10 mg for the first 4 weeks of the treatment period, and then went on to receive 10 mg or 20 mg for the following 8 weeks.

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

An Open, Multi-centre, Flexible Dose Uptitration Study to Investigate the Efficacy and Safety of Vardenafil 10 mg and 20 mg in Males With Spinal Cord Injury Suffering From Erectile Dysfunction

Important dates

Study start
2004
Study completion
2004
First posted
Apr 3, 2008
Registry last updated
Dec 23, 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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