check_circleStudy Completed

Safety

Bayer Identifier:

11337

ClinicalTrials.gov Identifier:

NCT00461565

EudraCT Number:

Not Available

EU CT Number:

Not Available
FDA Phase IV - Commitment - Retinal Function Study

Trial purpose

Vardenafil (Levitra) and Sildenafil (Viagra) are drugs that are marketed for use in patients with erectile dysfunction. The purpose of this study is to find out if there are any changes in the eye after taking at least 15 doses of Vardenafil and after two doses of Sildenafil. This is a double-blind study, which means that neither you nor the study doctor will know which treatment you are receiving. If you qualify for the study, you will receive:- Vardenafil 20 mg twice per week (Monday and Thursday) for a maximum of 8 weeks. There will be two times when this occurs during the study.- Sildenafil 200 mg/day for two days. There will be two times when this occurs during the study. - Placebo (a pill that looks like vardenafil or sildenafil but has no active ingredient).

Key Participants Requirements

Sex

Male

Age

18 - 55 Years
  • - Healthy adult male subjects between 18 and 55 years of age, inclusive, at screening- Body mass index (BMI) 19 to 34 kg/m2- Negative for HIV, Hepatitis B and Hepatitis C at screening
  • - Any unstable medical, psychiatric, or substance abuse disorder- History of moderate or severe hepatic impairment- Creatinine clearance- A resting systolic blood pressure of < 100 mm Hg or > 170 mm Hg or a resting diastolic blood pressure > 110 mm Hg- Blindness, color blindness or vision in either eye judged as abnormal by the investigator- History of trauma or surgery to either eye, of retinitis pigmentosa, of diabetes or current diabetes, of epilepsy or of seizure disorders- Symptomatic hypotension within 6 months of start of study- History of sickle cell anemia or sickle cell trait or bleeding disorder- Significant active peptic ulceration or other gastrointestinal disorder such as colitis or Crohn's Disease- Use of alpha blockers, nitrates, ritonavir, indinavir, ketoconazole, itraconazole, or erythromycin, ciprofloxacin, tadalafil, isotretinoin, ibuprofen, unoprostone isopropyl, Lily-of-the-Valley, Strophanthus, ranitidine and sildenafil

Trial summary

Enrollment Goal
63
Trial Dates
February 2005 - October 2006
Phase
Phase 4
Could I Receive a placebo
Yes
Products
Levitra (Vardenafil, BAY38-9456)
Accepts Healthy Volunteer
Yes

Primary Outcome

  • The change from baseline in Fansworth Munsell (FM) 100 test total error score (TES) in both the left and right eyes for vardenafil treated subjects as compared to placebo
    date_rangeTime Frame:
    8 weeks
    enhanced_encryption
    Safety Issue:
    None

Secondary Outcome

  • The change from baseline in Electroretinogram (ERG) as measured by amplitude and implicit time of b wave in both the left and right eyes for vardenafil treated subjects as compared to placebo
    date_rangeTime Frame:
    8 weeks
    enhanced_encryption
    Safety Issue:
    None
  • Change in the FM-100 total error score from baseline at approximately 6 hours and 24 hours post dose
    date_rangeTime Frame:
    8 weeks
    enhanced_encryption
    Safety Issue:
    None
  • Safety and tolerability of 20 mg vardenafil after at least 15 oral doses of 20 mg vardenafil or placebo (dosed over approximately 8 weeks)
    date_rangeTime Frame:
    8 weeks
    enhanced_encryption
    Safety Issue:
    None
  • ERG and FM-100 total error score from baseline at approximately 2 hours following one dose of sildenafil 200 mg
    date_rangeTime Frame:
    8 weeks
    enhanced_encryption
    Safety Issue:
    None

Trial design

A Double Blind, Randomized, Placebo Controlled, two Part, two Session Balanced, Crossover Study to Evaluate Visual Changes in Healthy Male Subjects Aged 18 - 55 Years After Receiving: 1. at Least 15 Doses of 20 mg Vardenafil, Compared to Placebo and 2. two Doses of Sildenafil, 200 mg Compared to Placebo
Trial Type
Interventional
Intervention Type
Drug
Trial Purpose
Treatment
Allocation
Randomized
Blinding
Double Blind
Assignment
Crossover Assignment
Trial Arms
4

Additional Information

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