BAY38-9456 - Supportive Trial for Spinal Injury

Bayer32 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Erectile Dysfunction Sexual Dysfunction Spinal Cord Injury

Interventions

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.

Eligibility

Sex: MALEMin age: 20 YearsMax age: 64 Years

Medical Language ↔ Plain English

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

Locations (3)

Unnamed facility

Nagoya, Aichi-ken, Japan

Unnamed facility

Iizuka, Fukuoka, Japan

Unnamed facility

Beppu, Oita Prefecture, Japan

Outcomes

Primary Outcomes

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

The Global Assessment Question

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

The IIEF EF domain score

Time frame: 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)]

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

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

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

Safety data

Time frame: Throughout the study

Data from ClinicalTrials.gov

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