Study to Investigate the Efficacy and Safety of Vardenafil Flexible Dose Versus Placebo in Males With Erectile Dysfunction

Completed · Phase 3 · Has a placebo group

Conditions studied: Erectile Dysfunction

In brief

Study to investigate the efficacy and safety of vardenafil flexible dose versus placebo in males with erectile dysfunction, and their female partners' sexual quality of life.

Key facts

Study ID

NCT00657033

Run by

Bayer

People needed

229

Starts

2003-10-01

Expected to finish

2004-08-01

Last updated by the study team

2013-10-14

Who can join

Age: 18 and older. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• Males who have had ED for at least six months according to the National Institutes of Health (NIH) Consensus Conference December 7-9, 1992 (inability to attain and/or maintain penile erection sufficient for satisfactory sexual performance).
• Stable, heterosexual relationship for more than 6 months.
• Males 18 years, and older.
• Written informed consent obtained.
• The subject and his female partner must make at least four attempts at sexual intercourse on four separate days during the untreated baseline period (according to the answer to the following question in the Patient Diary: "Was sexual activity initiated with the intention of intercourse?").
• At least 50% of attempts at sexual intercourse during the untreated baseline 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 some erection (some enlargement of the penis)?"; "Were you able to insert your penis in your partner's vagina?"; "Did your erection last long enough for you to have successful intercourse?".

You may not qualify if…

• A) Previous or current medical conditions:
• 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) which, in the Investigator's opinion, would significantly impair erectile function.
• Primary hypoactive sexual desire.
• Spinal cord injury.
• History of surgical prostatectomy (excluding TURP).
• Retinitis pigmentosa.
• 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).
• Severe chronic or acute liver disease, history of moderate or severe hepatic impairment.
• Clinically significant chronic haematological disease which may lead to priapism such as sickle cell anemia and leukemia.
• Bleeding disorder.
• Significant active peptic ulcer disease.
• 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).
• History of malignancy within the past 5 years (other than squamous or basal cell skin cancer).
• NYHA Class III and IV heart failure.
• History of positive test for Hepatitis B surface antigen (HBsAg) or Hepatitis C.
• Symptomatic postural hypotension within 6 months of visit 1.
• B) Concomitant medication:
• Subjects who are taking nitrates or nitric oxide donors.
• Subjects who take anticoagulants, except for antiplatelet agents.
• Subjects who are taking androgens.
• Subjects who are taking anti-androgens.
• Subjects who are taking the following inhibitors of cytochrome P450 3A4: very potent HIV protease inhibitors (ritonavir, indinavir), the anti-mycotic agents itraconazole and ketoconazole (topical forms are allowed) or erythromycin.

Where it is running

• Study site — Phoenix, Arizona, United States
• Study site — Beverly Hills, California, United States
• Study site — Irvine, California, United States
• Study site — Newport Beach, California, United States
• Study site — San Bernardino, California, United States
• Study site — San Diego, California, United States
• Study site — San Diego, California, United States
• Study site — Trumbull, Connecticut, United States
• Study site — Jacksonville, Florida, United States
• Study site — Riverdale, Georgia, United States
• Study site — Greenbelt, Maryland, United States
• Study site — Lutherville, Maryland, United States
• Study site — Lawrenceville, New Jersey, United States
• Study site — New Brunswick, New Jersey, United States
• Study site — New York, New York, United States
• Study site — Charlotte, North Carolina, United States
• Study site — Statesville, North Carolina, United States
• Study site — Wilmington, North Carolina, United States
• Study site — Calgary, Alberta, Canada
• Study site — Barrie, Ontario, Canada
• Study site — Burlington, Ontario, Canada
• Study site — Kitchener, Ontario, Canada
• Study site — London, Ontario, Canada
• Study site — Oakville, Ontario, Canada
• Study site — Saskatoon, Saskatchewan, Canada

Full record on ClinicalTrials.gov

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