NCT00652262

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
32

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Mar 2004

Shorter than P25 for phase_3

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2004

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2004

Completed
3.4 years until next milestone

First Submitted

Initial submission to the registry

April 1, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 3, 2008

Completed
Last Updated

December 23, 2014

Status Verified

December 1, 2014

First QC Date

April 1, 2008

Last Update Submit

December 18, 2014

Conditions

Erectile DysfunctionSexual DysfunctionSpinal Cord Injury

Keywords

VardenafilPDE5 inhibitorErectile dysfunctionSpinal cord injury

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (6)

  • The Global Assessment Question

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

  • The IIEF EF domain score

    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)]

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

  • Scores of Questions 1 to 15 on the IIEF Questionnaire

    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

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

  • +1 more secondary outcomes

Study Arms (1)

Arm 1

EXPERIMENTAL
Drug: Levitra (Vardenafil, BAY38-9456)

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.

Arm 1

Eligibility Criteria

Age20 Years - 64 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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 \[At home over the past 6 months, have you experienced at least some enlargement of your penis in response to: (1) mechanical stimulation by yourself or your partner, or (2) visual stimulation?\]

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Unknown Facility

Nagoya, Aichi-ken, 455-8530, Japan

Location

Unknown Facility

Iizuka, Fukuoka, 820-0053, Japan

Location

Unknown Facility

Beppu, Oita Prefecture, 874-0937, Japan

Location

MeSH Terms

Conditions

Erectile DysfunctionSexual Dysfunction, PhysiologicalSpinal Cord Injuries

Interventions

Vardenafil Dihydrochloride

Condition Hierarchy (Ancestors)

Genital Diseases, MaleGenital DiseasesUrogenital DiseasesMale Urogenital DiseasesSexual Dysfunctions, PsychologicalMental DisordersSpinal Cord DiseasesCentral Nervous System DiseasesNervous System DiseasesTrauma, Nervous SystemWounds and Injuries

Intervention Hierarchy (Ancestors)

ImidazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsPiperazines

Study Officials

  • Bayer Study Director

    Bayer

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 1, 2008

First Posted

April 3, 2008

Study Start

March 1, 2004

Study Completion

November 1, 2004

Last Updated

December 23, 2014

Record last verified: 2014-12

Locations

JP(3)