check_circleStudy Completed
Erectile Dysfunction
Bayer Identifier:
10781
ClinicalTrials.gov Identifier:
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
MaleAge
18 YearsTrial summary
Enrollment Goal
527Trial Dates
May 2003 - February 2004Phase
Phase 3Could I Receive a placebo
NoProducts
Levitra (Vardenafil, BAY38-9456)Accepts Healthy Volunteer
NoWhere 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Withdrawn | Lucca, 55043, Italy | |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.date_rangeTime Frame:At baseline, after 12 weeksenhanced_encryptionnoSafety Issue:
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 weeksenhanced_encryptionnoSafety Issue:
- Global Assessment Questiondate_rangeTime Frame:Baseline, after 4 weeks, after 12 weeksenhanced_encryptionnoSafety Issue:
- Italian validated Version of SF-12 Health Surveydate_rangeTime Frame:Baseline, after 12 weeksenhanced_encryptionnoSafety Issue:
Trial design
Trial Type
InterventionalIntervention Type
DrugTrial Purpose
TreatmentAllocation
Non-randomizedBlinding
Open LabelAssignment
Single Group AssignmentTrial Arms
1