LUTECIA: Assessment of Efficacy of Vardenafil in Subjects With Erectile Dysfunction and Diabetes, Hypertension or Hyperlipidemia

Sponsor

Bayer (Industry)

Overall Status

Completed

CT.gov ID

NCT00668109

Collaborator

(none)

614

Enrollment

Locations

Arms

Duration (Months)

8.2

Patients Per Site

1.4

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Assessment of efficacy of vardenafil in subjects with erectile dysfunction and diabetes, hypertension or hyperlipidemia

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

Study Design

Study Type:

Interventional

Actual Enrollment :

614 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

A Randomized, Open-label, Multi-center, Parallel Group Study to Investigate the Efficacy and Safety of Vardenafil in Comparison to Tadalafil in Males With Erectile Dysfunction and a Diagnosis of Diabetes, Hypertension or Hyperlipidemia

Study Start Date :

Dec 1, 2003

Actual Primary Completion Date :

Jun 1, 2004

Actual Study Completion Date :

Jun 1, 2004

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Arm 1	Drug: Levitra (Vardenafil, BAY38-9456) 10 mg one hour prior to sexual intercourse
Active Comparator: Arm 2	Drug: Tadalafil 10 mg taken approximately 24 hours prior to sexual intercourse

Arm

Intervention/Treatment

Experimental: Arm 1

Drug: Levitra (Vardenafil, BAY38-9456)

10 mg one hour prior to sexual intercourse

Active Comparator: Arm 2

Drug: Tadalafil

10 mg taken approximately 24 hours prior to sexual intercourse

Outcome Measures

Primary Outcome Measures

Sexual encounter profile question 3 observed within 15 minutes to 4 hours for vardenafil and 22 to 26 hours for the tadalafil group [4 weeks]

Secondary Outcome Measures

Sexual encounter profile question 2 [4 weeks]
Hardness of erection [4 weeks]
Other diary based variables [4 weeks]
Safety and tolerability [4 weeks]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Male

Accepts Healthy Volunteers:

Inclusion Criteria:- Age: 18 years and older- Males with erectile dysfunction- Stable heterosexual relationship- Medical history / diagnosis of diabetes mellitus and/or hypertension and/or hyperlipidemia Exclusion Criteria:- Primary hypoactive sexual desire- History of myocardial infarction, stroke or life-threatening arrhythmia within the prior 6 months- Nitrate use- Other exclusion criteria apply according to Summary of Product Characteristics

Contacts and Locations

Locations

	City	State	Country	Postal Code
1	Bruxelles - Brussel		Belgium	1070
2	Bruxelles - Brussel		Belgium	1200
3	Edegem		Belgium	2650
4	Roeselare		Belgium	8800
5	Barranquilla		Colombia
6	Bogotá		Colombia
7	Medellín		Colombia
8	Santa Fé de Bogotá		Colombia
9	Santafe de Bogotá		Colombia
10	Helsinki		Finland	00100
11	Helsinki		Finland	00180
12	Oulu		Finland	90100
13	Freiburg	Baden-Württemberg	Germany	79106
14	Stuttgart	Baden-Württemberg	Germany	70372
15	Königsbrunn	Bayern	Germany	86343
16	München	Bayern	Germany	80333
17	München	Bayern	Germany	81925
18	Weiden	Bayern	Germany	92637
19	Marburg	Hessen	Germany	35039
20	Hannover	Niedersachsen	Germany	30625
21	Osnabrück	Niedersachsen	Germany	49076
22	Westerstede	Niedersachsen	Germany	26655
23	Mönchengladbach	Nordrhein-Westfalen	Germany	41061
24	Berlin		Germany	13125
25	Berlin		Germany	13347
26	Berlin		Germany	13465
27	Hamburg		Germany	20354
28	Haifa		Israel	31096
29	Jerusalem		Israel	91120
30	Tel Aviv		Israel	64239
31	Tel Hashomer		Israel	52621
32	Catania		Italy	95124
33	Milano		Italy	20123
34	Milano		Italy	20132
35	Milano		Italy	20142
36	Padova		Italy	35128
37	Pavia		Italy	27100
38	Perugia		Italy	06126
39	Pisa		Italy	56126
40	Iguala	Guerrero	Mexico	40000
41	Monterrey	Nuevo León	Mexico	66260
42	Durango		Mexico	34000
43	México, D. F.		Mexico	06700
44	México, D.F.		Mexico	14050
45	México, D.F.		Mexico	14080
46	Nijverdal		Netherlands	7442 LS
47	Utrecht		Netherlands	3514 AB
48	Moelv		Norway	2390
49	Oslo		Norway	0272
50	Sarpsborg		Norway	1700
51	Trondheim		Norway	7006
52	Callao		Peru	CALLAO 2
53	Lima		Peru	33
54	Lima		Peru	LIMA 27
55	George	Eastern Cape	South Africa	6530
56	Johannesburg	Gauteng	South Africa	2193
57	Pretoria	Gauteng	South Africa	0083
58	Pietermaritzburg	Kwa Zulu Natal	South Africa	3200
59	Newcastle	Kwa Zulu-Natal	South Africa	2940
60	Durban	KwaZulu Natal	South Africa	4091
61	Durban	KwaZulu- Natal	South Africa	4000
62	Durban	KwaZulu-Natal	South Africa	3630
63	Cape Town	Western Cape	South Africa	7505
64	Cape Town	Western Cape	South Africa	7800
65	San Juan de Alicante	Alicante	Spain	03550
66	L'Hospitalet de Llobregat	Barcelona	Spain	08907
67	Vigo	Pontevedra	Spain	36211
68	A Coruña		Spain	15006
69	Castellón de la Plana		Spain	12004
70	Málaga		Spain	29010
71	Palma de Mallorca		Spain	07014
72	Zaragoza		Spain	50009
73	Borås		Sweden	503 32
74	Skövde		Sweden	541 30
75	Stockholm		Sweden	171 76