Study Completed

Erectile Dysfunction

Bayer Identifier:

10781

ClinicalTrials.gov Identifier:

NCT00654914

EudraCT Number:

Not Available

EU CT Number:

Not Available

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

Inclusion Criteria
- 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.
Exclusion Criteria
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

Products

Levitra (Vardenafil, BAY38-9456)

Accepts Healthy Volunteer

Where to participate

Status	Institution	Location
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.
Time Frame:
At baseline, after 12 weeks
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.
Time Frame:
Baseline, after 4 weeks, after 12 weeks
Safety Issue:
no
Global Assessment Question
Time Frame:
Baseline, after 4 weeks, after 12 weeks
Safety Issue:
no
Italian validated Version of SF-12 Health Survey
Time Frame:
Baseline, after 12 weeks
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

Additional Information

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