Trial Condition(s):
Erectile Dysfunction, Sexual Dysfunction, Spinal Cord Injury
BAY38-9456 - Supportive trial for spinal injury
Bayer Identifier:
100608
ClinicalTrials.gov Identifier:
EudraCT Number:
Not Available
EU CT Number:
Not Available
Trial Purpose
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
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
Trial Summary
Enrollment Goal
Trial Dates
Phase
Could I receive a placebo?
Products
Accepts Healthy Volunteers
Where to Participate
| Locations | |
|---|---|
Locations Investigative Site Beppu, Japan, 874-0937 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Iizuka, Japan, 820-0053 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Nagoya, Japan, 455-8530 | Contact Us: E-mail: [email protected] Phone: Not Available |
Trial Design
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
Trial Type:
Interventional
Intervention Type:
Drug
Trial Purpose:
Treatment
Allocation:
Non-randomized
Blinding:
Open Label
Assignment:
Single Group Assignment
Trial Arms:
1
Primary Outcome
- The Erectile Function (EF) domain score of IIEF calculated as the sum of scores from Questions 1 to 5 and 15Timeframe: At 12 weeks after start of study drug administration using data at LOCF to account for dropouts
Secondary Outcome
- The Global Assessment QuestionTimeframe: At 4, 8, 12 weeks after start of study drug administration and LOCF
- The IIEF EF domain scoreTimeframe: At 4, 8, 12 weeks after start of study drug administration
- 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)]Timeframe: At 4, 8, 12 weeks after start of study drug administration and LOCF
- Scores of Questions 1 to 15 on the IIEF QuestionnaireTimeframe: At 4, 8, 12 weeks after start of study drug administration and LOCF
- 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 ejaculationTimeframe: At 4, 8, 12 weeks after start of study drug administration and LOCF
- Safety dataTimeframe: Throughout the study
Additional Information
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