check_circleStudy Completed
Erectile Dysfunction, Sexual Dysfunction, Spinal Cord Injury
Bayer Identifier:
100608
ClinicalTrials.gov Identifier:
EudraCT Number:
Not Available
EU CT Number:
Not Available
BAY38-9456 - Supportive trial for spinal injury
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
Key Participants Requirements
Sex
MaleAge
20 - 64 YearsTrial summary
Enrollment Goal
32Trial Dates
March 2004 - November 2004Phase
Phase 3Could I Receive a placebo
NoProducts
Levitra (Vardenafil, BAY38-9456)Accepts Healthy Volunteer
NoWhere to participate
Status | Institution | Location |
---|---|---|
Completed | Beppu, 874-0937, Japan | |
Completed | Iizuka, 820-0053, Japan | |
Completed | Nagoya, 455-8530, Japan |
Primary Outcome
- The Erectile Function (EF) domain score of IIEF calculated as the sum of scores from Questions 1 to 5 and 15date_rangeTime Frame:At 12 weeks after start of study drug administration using data at LOCF to account for dropoutsenhanced_encryptionnoSafety Issue:
Secondary Outcome
- The Global Assessment Questiondate_rangeTime Frame:At 4, 8, 12 weeks after start of study drug administration and LOCFenhanced_encryptionnoSafety Issue:
- The IIEF EF domain scoredate_rangeTime Frame:At 4, 8, 12 weeks after start of study drug administrationenhanced_encryptionnoSafety Issue:
- 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)]date_rangeTime Frame:At 4, 8, 12 weeks after start of study drug administration and LOCFenhanced_encryptionnoSafety Issue:
- Scores of Questions 1 to 15 on the IIEF Questionnairedate_rangeTime Frame:At 4, 8, 12 weeks after start of study drug administration and LOCFenhanced_encryptionnoSafety Issue:
- 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 ejaculationdate_rangeTime Frame:At 4, 8, 12 weeks after start of study drug administration and LOCFenhanced_encryptionnoSafety Issue:
- Safety datadate_rangeTime Frame:Throughout the studyenhanced_encryptionyesSafety Issue:
Trial design
Trial Type
InterventionalIntervention Type
DrugTrial Purpose
TreatmentAllocation
Non-randomizedBlinding
Open LabelAssignment
Single Group AssignmentTrial Arms
1