Efficacy and Safety of Vardenafil in Men With Erectile Dysfunction
Open-label Multi-centre Non Randomised Study of Efficacy and Safety of Vardenafil (BAY 38-9456; SB-782528) Administered in Flexible-dose Regimen in Males With Erectile Dysfunction of Broad Aetiology.
1 other identifier
interventional
130
1 country
8
Brief Summary
To find out more information on how effective and safe vardenafil is at treating impotence in men living in Russia.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Aug 2003
Shorter than P25 for phase_3
8 active sites
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
August 1, 2003
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2004
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2004
CompletedFirst Submitted
Initial submission to the registry
April 8, 2008
CompletedFirst Posted
Study publicly available on registry
April 14, 2008
CompletedDecember 25, 2014
December 1, 2014
7 months
April 8, 2008
December 23, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Erectile Function (EF) domain score
Week 12
Secondary Outcomes (8)
Erectile Function (EF) domain score
Week 4, 8 and 12 Last Observation Carried Forward (LOCF)
Change from baseline of Erectile Function domain score
Week 4, 8 and 12 Last Observation Carried Forward (LOCF)
IIEF domain scores
Week 4, 8, 12 and 12 Last Observation Carried Forward (LOCF)
Patient Diary Questions
Week 4, 8, 12 and 12 Last Observation Carried Forward (LOCF)
Global Assessment Question (GAQ)
Week 4, 8, 12 and 12 Last Observation Carried Forward (LOCF)
- +3 more secondary outcomes
Study Arms (1)
Arm 1
EXPERIMENTALInterventions
4 weeks treatment with 10 mg vardenafil followed by a flexible titration phase for 8 weeks
Eligibility Criteria
You may qualify if:
- Males with ED according to the NIH definition (the inability to achieve or maintain penile erection sufficient for satisfactory sexual performance) for at least 3 months.
- Heterosexual relationship
- Age range: 18 years and older
- Documented written Informed Consent
- The subject must make at least four attempts at sexual intercourse (according to the question in the subject diary "Was sexual activity initiated with the intention of intercourse?") on four separate days during the untreated baseline period. At least 50% of attempts during this period must be unsuccessful, according to the following questions from the subject diary \[at least one question should be answered "No"\] "Were you able to achieve at least partial erection (some enlargement of the penis)?", "Were you able to insert your penis in your partner's vagina?" and "Did your erection last long enough for you to have successful intercourse?".
You may not qualify if:
- Any unstable medical, psychiatric, or substance abuse disorder that in the opinion of the Investigator is likely to affect the subject's ability to complete the study or precludes the subject's participation in the study
- Presence of penile anatomical abnormalities (e.g. penile fibrosis or Peyronie's disease) that in the opinion of the Investigator would significantly impair erectile function
- Primary hypoactive sexual desire
- Spinal cord injury
- History of surgical prostatectomy (excluding TURP).
- Retinitis pigmentosa
- History of positive test for Hepatitis B surface antigen (HBsAg) or Hepatitis C.
- History of positive test for HIV.9. Severe chronic or acute liver disease, history of moderate or severe hepatic impairment.
- Clinically significant chronic hematological disease, which may lead to priapism such as sickle cell anemia and leukemia.
- Bleeding disorder.
- Significant active peptic ulceration.
- Unstable angina pectoris
- History of myocardial infarction, stroke or life-threatening arrhythmia within the prior 6 months
- Uncontrolled atrial fibrillation/flutter at screening (ventricular response rate \> 100 bpm).
- Resting hypotension (a resting systolic blood pressure of \< 90 mm Hg) or hypertension (a resting systolic blood pressure \> 170 mm Hg or a resting diastolic blood pressure \> 110 mm Hg)
- +16 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (8)
Unknown Facility
Moscow, 105425, Russia
Unknown Facility
Moscow, 117198, Russia
Unknown Facility
Moscow, 117837, Russia
Unknown Facility
Moscow, 117997, Russia
Unknown Facility
Moscow, 123367, Russia
Unknown Facility
Moscow, 125101, Russia
Unknown Facility
Moscow, 127206, Russia
Unknown Facility
Saint Petersburg, 198013, Russia
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Bayer Study Director
Bayer
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 8, 2008
First Posted
April 14, 2008
Study Start
August 1, 2003
Primary Completion
March 1, 2004
Study Completion
March 1, 2004
Last Updated
December 25, 2014
Record last verified: 2014-12