A Study to Investigate the Time to Onset of Action of 10 mg and 20 mg of Vardenafil Compared to Placebo in Males With Erectile Dysfunction
This study has been completed.
Sponsor:
Bayer
Information provided by:
Bayer
ClinicalTrials.gov Identifier:
NCT00665496
First received: April 23, 2008
Last updated: June 12, 2009
Last verified: June 2009
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Purpose
This purpose of the study was to evaluate the earliest time to onset of action in adults with erectile dysfunction (often called impotence). In this study vardenafil has been compared to placebo. Patients were asked to fill in questionnaires and a diary in which they filled in details about attempts at sexual activity during study period. Patients received also a stopwatch to record the time of onset of erection. Stopwatch should be started immediately prior to initiating sexual activity and stopped when an erection perceived to be adequate for penetration was obtained.
| Condition | Intervention | Phase |
|---|---|---|
|
Erectile Dysfunction |
Drug: Levitra (Vardenafil, BAY38-9456) Drug: Placebo |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment |
| Official Title: | A Randomized, Double Blind, Double Dummy, Parallel Group, Multi-Center Study to Investigate the Time to Onset of Action of 10 mg and 20 mg of Vardenafil Compared to Placebo in Males With Erectile Dysfunction. |
Resource links provided by NLM:
MedlinePlus related topics:
Erectile Dysfunction
Drug Information available for:
Vardenafil
Vardenafil hydrochloride
Vardenafil dihydrochloride
Vardenafil hydrochloride trihydrate
U.S. FDA Resources
Further study details as provided by Bayer:
Primary Outcome Measures:
- - Earliest elapsed time from dosing to attainment of an erection perceived to be adequate for penetration leading to completion of successful intercourse as measured by Sexual Encounter Profile Question 3 (SEP 3) [ Time Frame: First four doses with successful intercourse ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- - Earliest elapsed time from dosing to attainment of an erection perceived to be adequate for penetration as measured by Sexual Encounter Profile Question 2 (SEP 2). [ Time Frame: among the first four doses ] [ Designated as safety issue: No ]
- - The erectile function (EF) domain score of the International Index of Erectile Function (IIEF) calculated as the sum of scores from Questions 1-5 and 15 at Week 4 as well as all other IIEF factor subscores. [ Time Frame: among the first four doses ] [ Designated as safety issue: No ]
- - Responder time to onset, where onset is time from dosing to attainment of an erection perceived to be adequate for penetration. [ Time Frame: among the first four doses ] [ Designated as safety issue: No ]
- - Other diary questions [ Time Frame: among the first four doses ] [ Designated as safety issue: No ]
- - Safety and tolerability [ Time Frame: within the study duration ] [ Designated as safety issue: Yes ]
| Enrollment: | 870 |
| Study Start Date: | June 2003 |
| Study Completion Date: | November 2003 |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Arm 1 |
Drug: Levitra (Vardenafil, BAY38-9456)
Vardenafil 10 mg and 20 mg orally once a day as needed
|
| Placebo Comparator: Arm 2 |
Drug: Placebo
Matching Placebo
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Male |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Males with ED for more than 6 months according to the NIH Consensus statement(inability to attain and/or maintain penile erection sufficient for satisfactory sexual performance)
- Heterosexual relationship
- 18 years and older
Exclusion Criteria:
- Primary hypoactive sexual desire
- History of myocardial infarction, stroke or life threatening arrhythmia within the prior 6 months
- Nitrates or nitric oxide donors use
- Other exclusion criteria according to the US Product Information
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00665496
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Hide Study LocationsLocations
| United States, Arizona | |
| Phoenix, Arizona, United States, 85023 | |
| United States, California | |
| Beverly Hills, California, United States, 90212 | |
| San Bernardino, California, United States, 92404 | |
| United States, Colorado | |
| Aurora, Colorado, United States, 80012 | |
| United States, Connecticut | |
| Trumbull, Connecticut, United States, 06611 | |
| United States, Florida | |
| Aventura, Florida, United States, 33180 | |
| Jacksonville, Florida, United States, 32257 | |
| Pembroke Pines, Florida, United States, 33024 | |
| United States, New Jersey | |
| Lawrenceville, New Jersey, United States, 08648 | |
| United States, New York | |
| New York, New York, United States, 10016 | |
| United States, North Carolina | |
| Charlotte, North Carolina, United States, 28209 | |
| Wilmington, North Carolina, United States, 28401 | |
| Canada, Alberta | |
| Calgary, Alberta, Canada, T3G 3J9 | |
| Canada, Manitoba | |
| Winnipeg, Manitoba, Canada, R3T 5J3 | |
| Canada, New Brunswick | |
| St. John, New Brunswick, Canada, E2L 3J8 | |
| Canada, Nova Scotia | |
| Kentville, Nova Scotia, Canada, B4N 4K9 | |
| Canada, Ontario | |
| Barrie, Ontario, Canada, L4M 4S5 | |
| Toronto, Ontario, Canada, M4C 3E7 | |
| Canada, Quebec | |
| Montreal, Quebec, Canada, H1T 2M4 | |
| Sherbrooke, Quebec, Canada, J1H 5N4 | |
| France | |
| Carpentras, France, 84200 | |
| Lille, France, 59000 | |
| Lyon, France, 69000 | |
| Lyon Cedex, France, 69437 | |
| Marseille, France, 13275 | |
| Montpellier, France, 34000 | |
| Nimes, France, 30000 | |
| Paris, France, 75015 | |
| Germany | |
| Garmisch-Partenkirchen, Bayern, Germany, 82467 | |
| München, Bayern, Germany, 80333 | |
| München, Bayern, Germany, 81925 | |
| Marburg, Hessen, Germany, 35039 | |
| Hannover, Niedersachsen, Germany, 30625 | |
| Osnabrück, Niedersachsen, Germany, 49076 | |
| Westerstede, Niedersachsen, Germany, 26655 | |
| Düsseldorf, Nordrhein-Westfalen, Germany, 40210 | |
| Mönchengladbach, Nordrhein-Westfalen, Germany, 41061 | |
| Niederkassel, Nordrhein-Westfalen, Germany, 53859 | |
| Halle, Sachsen-Anhalt, Germany, 06097 | |
| Leipzig, Sachsen, Germany, 04105 | |
| Hamburg, Germany, 20354 | |
| Italy | |
| Milano, Italy, 20132 | |
| Milano, Italy, 20142 | |
| Modena, Italy, 41100 | |
| Napoli, Italy, 80131 | |
| Padova, Italy, 35128 | |
| Netherlands | |
| Amsterdam, Netherlands, 1061 AE | |
| Den Haag, Netherlands, 2512 VA | |
| Nijmegen, Netherlands, 6525 GA | |
| Roermond, Netherlands, 6043 CV | |
| Utrecht, Netherlands, 3514 AB | |
| Norway | |
| Moelv, Norway, 2390 | |
| Oslo, Norway, 0272 | |
| Sarpsborg, Norway, 1700 | |
| Trondheim, Norway, 7006 | |
| Poland | |
| Koscierzyna, Poland, 83-400 | |
| Lodz, Poland, 91-425 | |
| Poznan, Poland, 61-701 | |
| Warszawa, Poland, 04-749 | |
| Warszawa, Poland, 01-059 | |
| Wroclaw, Poland, 54-144 | |
| Spain | |
| Badalona, Barcelona, Spain, 08916 | |
| L'Hospitalet de Llobregat, Barcelona, Spain, 08907 | |
| Galdakao, Bizkaia, Spain, 48960 | |
| Barcelona, Cataluña, Spain, 08025 | |
| Barcelona, Spain, 08003 | |
| Castellón de la Plana, Spain, 12004 | |
| Madrid, Spain, 28040 | |
| Zaragoza, Spain, 50009 | |
| Sweden | |
| Borås, Sweden, 503 32 | |
| Göteborg, Sweden, 412 59 | |
| Skövde, Sweden, 541 30 | |
| Stockholm, Sweden, 171 76 | |
| United Kingdom | |
| Bristol, Avon, United Kingdom, BS2 8HW | |
| Bristol, Avon, United Kingdom, BS10 5NB | |
Sponsors and Collaborators
Bayer
Investigators
| Study Director: | Bayer Study Director | Bayer |
More Information
Additional Information:
No publications provided
| Responsible Party: | Therapeutic Area Head, Bayer Healthcare AG |
| ClinicalTrials.gov Identifier: | NCT00665496 History of Changes |
| Other Study ID Numbers: | 100492, ONTIME |
| Study First Received: | April 23, 2008 |
| Last Updated: | June 12, 2009 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Bayer:
|
Erectile Dysfunction Vardenafil Onset of action |
Additional relevant MeSH terms:
|
Erectile Dysfunction Sexual Dysfunction, Physiological Genital Diseases, Male Sexual Dysfunctions, Psychological Sexual and Gender Disorders Mental Disorders Vardenafil Vasodilator Agents |
Cardiovascular Agents Therapeutic Uses Pharmacologic Actions Phosphodiesterase 5 Inhibitors Phosphodiesterase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |
ClinicalTrials.gov processed this record on May 16, 2013