Clinical trial NCT00652262: BAY38-9456 - Supportive Trial for Spinal Injury
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Erectile Dysfunction
Sexual Dysfunction
Spinal Cord Injury
Keywords: Vardenafil
PDE5 inhibitor
Erectile dysfunction
Spinal cord injury
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2008-04-03
Enrollment: 32
Sex: MALE
Minimum age (years): 20
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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


Eligibility criteria: 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

Primary outcomes:
measure: The Erectile Function (EF) domain score of IIEF calculated as the sum of scores from Questions 1 to 5 and 15
timeFrame: At 12 weeks after start of study drug administration using data at LOCF to account for dropouts
Secondary outcomes:
measure: The Global Assessment Question
timeFrame: At 4, 8, 12 weeks after start of study drug administration and LOCF
measure: The IIEF EF domain score
timeFrame: At 4, 8, 12 weeks after start of study drug administration
measure: 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
measure: Scores of Questions 1 to 15 on the IIEF Questionnaire
timeFrame: At 4, 8, 12 weeks after start of study drug administration and LOCF
measure: 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
timeFrame: At 4, 8, 12 weeks after start of study drug administration and LOCF
measure: Safety data
timeFrame: Throughout the study
Other outcomes:
Locations:
city: Nagoya
country: Japan
state: Aichi
city: Iizuka
country: Japan
state: Fukuoka
city: Beppu
country: Japan
state: Oita
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References: