FDA Phase IV - Commitment - Retinal Function Study

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

63 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-02-28

Study Completion Date

2006-10-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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).

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

A Double-blind "Preferred" Vardenafil Dose Study of QoL and Functional Outcomes in Males With Erectile Dysfunction

NCT00661700

Erectile Dysfunction

COMPLETED PHASE3

To Investigate the Efficacy and Safety of Vardenafil in Men With Erectile Dysfunction.

NCT00661115

Erectile Dysfunction

COMPLETED PHASE3

Study Evaluating the Efficacy and Safety of Flexible-dose Vardenafil in Subjects With Erectile Dysfunction

NCT00658177

Erectile Dysfunction

COMPLETED PHASE3

Fundus Oculi and Erectile Dysfunction

NCT02845765

Erectile Dysfunction

UNKNOWN

A Study to Assess the Efficacy and Safety of Vardenafil in the Treatment of Male Patients With Erectile Dysfunction

NCT00654914

Erectile Dysfunction

COMPLETED PHASE3

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Safety

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Part A1

Group Type ACTIVE_COMPARATOR

Sildenafil

Intervention Type DRUG

A1) Two dosis of 200 mg Sildenafil orally. Patients receive either A1) or A2) in cross over design with either B1) or B2).

Part A2

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

A2) Matching Placebo orally. Patients receive either A1) or A2) in cross over design with either B1) or B2).

Part B1

Group Type EXPERIMENTAL

Vardenafil (Levitra, BAY38-9456)

Intervention Type DRUG

B1) At least 15 dosis of 20 mg Levitra orally. Patients receive either A1) or A2) in cross over design with either B1) or B2).

Part B2

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

B2) Matching Placebo orally. Patients receive either A1) or A2) in cross over design with either B1) or B2).

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Sildenafil

A1) Two dosis of 200 mg Sildenafil orally. Patients receive either A1) or A2) in cross over design with either B1) or B2).

Intervention Type DRUG

Placebo

A2) Matching Placebo orally. Patients receive either A1) or A2) in cross over design with either B1) or B2).

Intervention Type DRUG

Vardenafil (Levitra, BAY38-9456)

B1) At least 15 dosis of 20 mg Levitra orally. Patients receive either A1) or A2) in cross over design with either B1) or B2).

Intervention Type DRUG

Placebo

B2) Matching Placebo orally. Patients receive either A1) or A2) in cross over design with either B1) or B2).

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

Inclusion Criteria:- 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 Exclusion Criteria:- 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

Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes