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

Sponsor

Bayer (Industry)

Overall Status

Completed

CT.gov ID

NCT00665496

Collaborator

(none)

732

Enrollment

Locations

Arms

Duration (Months)

9.8

Patients Per Site

1.9

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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 or Disease	Intervention/Treatment	Phase
Erectile Dysfunction	Drug: Levitra (Vardenafil, BAY38-9456) Drug: Placebo	Phase 3

Study Design

Study Type:

Interventional

Actual Enrollment :

732 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, 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.

Study Start Date :

Jun 1, 2003

Actual Study Completion Date :

Nov 1, 2003

Arms and Interventions

Arm	Intervention/Treatment
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

Arm

Intervention/Treatment

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

Outcome Measures

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) [First four doses with successful intercourse]

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). [among the first four doses]
- 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. [among the first four doses]
- Responder time to onset, where onset is time from dosing to attainment of an erection perceived to be adequate for penetration. [among the first four doses]
- Other diary questions [among the first four doses]
- Safety and tolerability [within the study duration]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Male

Accepts Healthy Volunteers:

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

Locations

	City	State	Country	Postal Code
1	Phoenix	Arizona	United States	85023
2	Beverly Hills	California	United States	90212
3	San Bernardino	California	United States	92404
4	Aurora	Colorado	United States	80012
5	Trumbull	Connecticut	United States	06611
6	Aventura	Florida	United States	33180
7	Jacksonville	Florida	United States	32257
8	Pembroke Pines	Florida	United States	33024
9	Lawrenceville	New Jersey	United States	08648
10	New York	New York	United States	10016
11	Charlotte	North Carolina	United States	28209
12	Wilmington	North Carolina	United States	28401
13	Calgary	Alberta	Canada	T3G 3J9
14	Winnipeg	Manitoba	Canada	R3T 5J3
15	St. John	New Brunswick	Canada	E2L 3J8
16	Kentville	Nova Scotia	Canada	B4N 4K9
17	Barrie	Ontario	Canada	L4M 4S5
18	Toronto	Ontario	Canada	M4C 3E7
19	Montreal	Quebec	Canada	H1T 2M4
20	Sherbrooke	Quebec	Canada	J1H 5N4
21	Carpentras		France	84200
22	Lille		France	59000
23	Lyon Cedex		France	69437
24	Lyon		France	69000
25	Marseille		France	13275
26	Montpellier		France	34000
27	Nimes		France	30000
28	Paris		France	75015
29	Garmisch-Partenkirchen	Bayern	Germany	82467
30	München	Bayern	Germany	80333
31	München	Bayern	Germany	81925
32	Marburg	Hessen	Germany	35039
33	Hannover	Niedersachsen	Germany	30625
34	Osnabrück	Niedersachsen	Germany	49076
35	Westerstede	Niedersachsen	Germany	26655
36	Düsseldorf	Nordrhein-Westfalen	Germany	40210
37	Mönchengladbach	Nordrhein-Westfalen	Germany	41061
38	Niederkassel	Nordrhein-Westfalen	Germany	53859
39	Halle	Sachsen-Anhalt	Germany	06097
40	Leipzig	Sachsen	Germany	04105
41	Hamburg		Germany	20354
42	Milano		Italy	20132
43	Milano		Italy	20142
44	Modena		Italy	41100
45	Napoli		Italy	80131
46	Padova		Italy	35128
47	Amsterdam		Netherlands	1061 AE
48	Den Haag		Netherlands	2512 VA
49	Nijmegen		Netherlands	6525 GA
50	Roermond		Netherlands	6043 CV
51	Utrecht		Netherlands	3514 AB
52	Moelv		Norway	2390
53	Oslo		Norway	0272
54	Sarpsborg		Norway	1700
55	Trondheim		Norway	7006
56	Koscierzyna		Poland	83-400
57	Lodz		Poland	91-425
58	Poznan		Poland	61-701
59	Warszawa		Poland	01-059
60	Warszawa		Poland	04-749
61	Wroclaw		Poland	54-144
62	Badalona	Barcelona	Spain	08916
63	L'Hospitalet de Llobregat	Barcelona	Spain	08907
64	Galdakao	Bizkaia	Spain	48960
65	Barcelona	Cataluña	Spain	08025
66	Barcelona		Spain	08003
67	Castellón de la Plana		Spain	12004
68	Madrid		Spain	28040
69	Zaragoza		Spain	50009
70	Borås		Sweden	503 32
71	Göteborg		Sweden	412 59
72	Skövde		Sweden	541 30
73	Stockholm		Sweden	171 76
74	Bristol	Avon	United Kingdom	BS10 5NB
75	Bristol	Avon	United Kingdom	BS2 8HW