BAY38-9456 - Supportive Trial for Spinal Injury

Spinal Cord Injury Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00652262
• Other study ID #: 100608
• Status: Completed
• Phase: Phase 3
• First received: April 1, 2008
• Last updated: December 18, 2014
• Start date: March 2004
• Est. completion date: November 2004

Study information

• Verified date: December 2014
• Source: Bayer
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Pharmaceuticals and Medical Devices AgencyUnited States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: November 2004
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 20 Years to 64 Years

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Erectile Dysfunction
• Sexual Dysfunction
• Spinal Cord Injuries
• Spinal Cord Injury

Intervention

Drug:
• Levitra (Vardenafil, BAY38-9456)
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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Bayer

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The Erectile Function (EF) domain score of IIEF calculated as the sum of scores from Questions 1 to 5 and 15		At 12 weeks after start of study drug administration using data at LOCF to account for dropouts	No
Secondary	The Global Assessment Question		At 4, 8, 12 weeks after start of study drug administration and LOCF	No
Secondary	The IIEF EF domain score		At 4, 8, 12 weeks after start of study drug administration	No
Secondary	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)]		At 4, 8, 12 weeks after start of study drug administration and LOCF	No
Secondary	Scores of Questions 1 to 15 on the IIEF Questionnaire		At 4, 8, 12 weeks after start of study drug administration and LOCF	No
Secondary	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		At 4, 8, 12 weeks after start of study drug administration and LOCF	No
Secondary	Safety data		Throughout the study	Yes

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