check_circleStudy Completed

Erectile Dysfunction

A study to assess the efficacy and safety of Vardenafil in the treatment of male patients with erectile dysfunction

Trial purpose

The primary objective of this study is to assess the efficacy together with safety of a flexible regimen, for a period of twelve weeks, of three doses (5 mg, 10mg and 20mg) of Bay 38-9456, a phosphodiesterase type V inhibitor, in males with erectile dysfunction treated with sildenafil in the previous <6 months .At entry, once the Inclusion and Exclusion criteria are confirmed, the study medication will be administered for twelve weeks in an open label design. Vardenafil will be administered, as needed, at a fix dose of 10 mg once daily for the first four weeks of treatment. At the Investigators' discretion, on the basis of efficacy and safety evaluations, the patients may, then, receive the same dose strength of their assigned study medication or, at the subsequent clinic visit(s), the next lower dose (5 mg vardenafil) or the next higher dose (20 mg vardenafil) for the subsequent four weeks of treatment. Previous dose level of vardenafil is either maintained, increased or decreased by one step according to the three applicable dose strengths (5 mg, 10 mg, 20 mg ). The highest dosage of vardenafil (20 mg) per day will not be exceeded. After twelve weeks of treatment, the patient will be contacted twenty four hours following the last visit in order to collect data concerning serious adverse events.

Key Participants Requirements

Sex

Male

Age

18 Years
  • - Males with erectile dysfunction for more than 6 months and no more than three years according to the NIH Consensus definition (the inability to achieve and maintain penile erection sufficient for satisfactory sexual intercourse)
    - Stable, heterosexual relationship for more than 6 months
    - Age range: 18 years and older
    - Documented, written Informed Consent.
  • A) Previous or current Medical Conditions
    - Any unstable medical or psychiatric condition or substance abuse disorder that, in the opinion of the Investigator, is likely to affect the patient's ability to complete the study or precludes the patient's participation in the study
    - Presence of penile anatomical abnormalities (e.g. penile fibrosis or Peyronie disease) that would significantly impair erectile function.
    - Primary hypoactive sexual desire
    - Erectile dysfunction after spinal cord injury
    - Retinitis pigmentosa.
    - History of positive test for Hepatitis B surface antigen (HbsAg) or Hepatitis C.
    - Unstable angina pectoris
    - History of myocardial infarction, stroke, electrocardiographic ischaemia (except stable angina), or life-threatening arrhythmia, within the prior 6 months.
    - Atrial tachyarrhythmia (e.g. atrial fibrillation/flutter) with a heart rate of > 100 beats per minute at screening
    - Severe chronic liver disease or liver function abnormalities
    - Clinically significant chronic haematological disease or bleeding disorder
    - History of significant peptic ulcer disease within one year of Visit 1.
    - 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)
    - Symptomatic postural hypotension within the six months of Visit 1.
    - Uncontrolled diabetes mellitus (Haemoglobin A1c > 12%)
    - History of malignancy within the past 5 years (other than squamous or basal cell skin cancer and K prostatic).
    B) Concomitant Medication
    1. Patients who are taking nitrates or nitric oxide donors (e.g. molsidomine)
    .2. Patients who are taking anticoagulants, with the exception of anti-platelet agents.
    3. Patients who are taking androgens (e.g. testosterone), trazodone or anti-androgens.
    4. Patients who are taking the following potent inhibitors of cytochrome P 450 3A4: the HIV protease inhibitors ritonavir and indinavir, or the anti-mycotic agents itraconazole and ketoconazole (topical forms are allowed).
    5. Patients who have received any investigational drug (including placebo) within 30 days of Visit 1.
    6. Use of vardenafil (BAY 38-9456) at any time prior to the study.
    C) Abnormal Laboratory Values
    1. Patients who have a serum total testosterone level >10% below the lower limit of normal (according to the range specified by the responsible laboratory).
    2. Patients with serum creatinine > 2.5 mg/dL.D) Other

Trial summary

Enrollment Goal
527
Trial Dates
May 2003 - February 2004
Phase
Phase 3
Could I Receive a placebo
No
Products
Levitra (Vardenafil, BAY38-9456)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Completed
Napoli, 80131, Italy
Completed
Ancona, 60126, Italy
Completed
Arenzano, 16011, Italy
Completed
Avellino, 83100, Italy
Completed
Bari, 70124, Italy
Completed
Bari, 70124, Italy
Completed
Bergamo, 24128, Italy
Completed
Bergamo, 24128, Italy
Completed
Bologna, 40138, Italy
Completed
Brescia, 25123, Italy
Completed
Cagliari, 09121, Italy
Completed
Cagliari, 09134, Italy
Withdrawn
Lucca, 55043, Italy
Completed
Carpi, 41012, Italy
Completed
Caserta, 81100, Italy
Completed
Catania, 95100, Italy
Completed
Catania, 95124, Italy
Completed
Catania, 95124, Italy
Completed
Catanzaro, 88100, Italy
Completed
Chieti, 66013, Italy
Completed
Como, 22020, Italy
Completed
Brescia, 25015, Italy
Completed
Fermo, 63023, Italy
Completed
Firenze, 50139, Italy
Completed
Firenze, 50141, Italy
Withdrawn
Gallarate, 21013, Italy
Completed
Gela, 93012, Italy
Completed
Lucca, 55100, Italy
Withdrawn
Magenta, 20013, Italy
Completed
Matera, 75100, Italy
Completed
Milano, 20162, Italy
Completed
Milano, 20122, Italy
Completed
Milano, 20089, Italy
Completed
Milano, 20142, Italy
Completed
Milano, 20122, Italy
Completed
Modena, 41124, Italy
Withdrawn
Monza-Brianza, 20900, Italy
Completed
Napoli, 80131, Italy
Completed
Napoli, 80131, Italy
Completed
Novara, 28100, Italy
Completed
Novi Ligure, 15067, Italy
Withdrawn
Padova, 35100, Italy
Completed
Palermo, 90146, Italy
Completed
Parma, 43126, Italy
Completed
Pavia, 27100, Italy
Completed
Perugia, 06132, Italy
Completed
Perugia, 06132, Italy
Completed
Pisa, 56126, Italy
Withdrawn
Venezia, 30026, Italy
Completed
Ragusa, 97100, Italy
Completed
Reggio Calabria, 89100, Italy
Withdrawn
Reggio Emilia, 42123, Italy
Withdrawn
Rimini, 47900, Italy
Completed
Roma, 00145, Italy
Withdrawn
Roma, 00149, Italy
Completed
Roma, 00184, Italy
Completed
Roma, 00169, Italy
Withdrawn
Roma, 00189, Italy
Completed
Roma, 00161, Italy
Completed
Roma, 00161, Italy
Withdrawn
Roma, 00168, Italy
Completed
Roma, 00161, Italy
Withdrawn
Rovigo, 45100, Italy
Withdrawn
Salerno, 84131, Italy
Withdrawn
Sassari, 07100, Italy
Withdrawn
Reggio Emilia, 42019, Italy
Completed
Genova, 16039, Italy
Completed
Siena, 53100, Italy
Withdrawn
Taranto, 74100, Italy
Completed
Teramo, 64110, Italy
Completed
Terni, 05100, Italy
Completed
Torino, 10126, Italy
Completed
Torino, 10149, Italy
Completed
Bergamo, 24058, Italy
Completed
Treviso, 31100, Italy
Completed
Udine, 33100, Italy
Completed
Varese, 21100, Italy
Completed
Vicenza, 36100, Italy
Completed
Voghera, 27058, Italy

Primary Outcome

  • Percentage of success rate at the end of treatment period versus baseline.
    date_rangeTime Frame:
    At baseline, after 12 weeks
    enhanced_encryption
    Safety Issue:
    no

Secondary Outcome

  • The Erectile Function (EF) domain score of the International Index of Erectile Function (IIEF-Appendix 10.3) calculated as the sum of scores from Questions 1-5 and 15 at Visit 5 using the last Visit vs baseline.
    date_rangeTime Frame:
    Baseline, after 4 weeks, after 12 weeks
    enhanced_encryption
    Safety Issue:
    no
  • Global Assessment Question
    date_rangeTime Frame:
    Baseline, after 4 weeks, after 12 weeks
    enhanced_encryption
    Safety Issue:
    no
  • Italian validated Version of SF-12 Health Survey
    date_rangeTime Frame:
    Baseline, after 12 weeks
    enhanced_encryption
    Safety Issue:
    no

Trial design

A National, multicentre, open label, flexible dose, twelve week treatment to assess the efficacy and safety of 5mg, 10mg and 20mg Bay 38-9456, a Phosphodiesterase Type V inhibitor, in the treatment of male patients with erectile dysfunction
Trial Type
Interventional
Intervention Type
Drug
Trial Purpose
Treatment
Allocation
Non-randomized
Blinding
Open Label
Assignment
Single Group Assignment
Trial Arms
1