Trial Condition(s):

Sexual Dysfunction, Male Erectile Dysfunction

Levitra (Vardenafil, BAY38-9456) Partner Satisfaction Study II

Bayer Identifier:

12146

ClinicalTrials.gov Identifier:

NCT00377793

EudraCT Number:

Not Available

Study Completed

Trial Purpose

This trial is to provide additional important information on the impact of the treatment of the man its ED with vardenafil on partnership. This study is being run at up to 50 study centers in Europe and South Africa to evaluate the use of vardenafil in adult men with erectile dysfunction (often called impotence), and their female partner's sexual quality of life. Many men experience occasional erectile problems during their lives. However, when this becomes a continued problem, it can affect both the man and his female partner. The causes of erectile dysfunction are varied and may be due to physiological or emotional reasons. This study is designed to 1) study the effectiveness and safety of vardenafil, and 2) show whether treating a man its erectile dysfunction with vardenafil will improve his female partner its sexual quality of life. The second part (week 12) of the study (Educational program) a subgroup of subjects/couples, approximately 50% of the randomized subjects, will receive an educational program concerning ED in the from of a DVD.

Inclusion Criteria
- Males 18 to 64 years
 - Males with ED for more than six months, according to the NIH Consensus Statement (inability to attain and/or maintain penile erection sufficient for satisfactory sexual performance)
 - Stable heterosexual relationship for more than 6 months
 - The subject must make at least four attempts at sexual intercourse 
 - Documented, dated, written Informed Consent
Inclusion Criteria Partner
 - Females 18 years, and older
 - Stable, heterosexual relationship for more than 6 months with male ED subject
 - Documented, dated, written Informed Consent
 - Motivated to support treatment for male partner's ED
 - Absence of significant sexual dysfunction as assessed by the total score on the FSFI16 > 23.55
Exclusion Criteria
- Any unstable medical 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
 - Subjects who are taking nitrates or nitric oxide donors
 - Subjects who are taking the following inhibitors of cytochrome P 450 CYP 3A4: very potent HIV protease inhibitors (ritonavir, indinavir), the anti-mycotic agents traconazole and ketoconazole (topical forms are allowed) or erythromycin
 - Known hypersensitivity to vardenafil
 - Presence of significant penile anatomical abnormalities (e.g. penile fibrosis or Peyronie's disease)
 - History of retinitis pigmentosa
 - Unstable angina pectoris
 - Severe chronic or acute liver disease
 - Premature ejaculator (defined as IELT < 2 minutes)
 - Subjects who were taking alpha blockers
 - Lost of vision of one eye because of  NAION 
Exclusion Criteria Partner
 - Presence of sexual dysfunction as assessed by the FSFI16 < 23.55
 - Any unstable medical condition or substance abuse disorder that, in the opinion of the Investigator, is likely to affect the partner's ability to complete the study or precludes the partner's participation in the study

Trial Summary

Enrollment Goal
352
Trial Dates
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Phase
4
Could I receive a placebo?
Yes
Products
Levitra (Vardenafil, BAY38-9456)
Accepts Healthy Volunteers
No

Where to Participate

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Locations
Status
LocationsStatus
Locations

Praxis Hr. Dr. M. Orlowski

Wahlstedt, Germany, 23812

Status
Completed
 
Locations

Universitäts-Krankenhaus Eppendorf

Hamburg, Germany, 20251

Status
Completed
 
Locations

Praxis Hr. Dr. G. Korda

Brühl, Germany, 50321

Status
Completed
 
Locations

Cabinet Médical - Morgiou - Marseille

MARSEILLE, France, 13009

Status
Completed
 
Locations

Cabinet Médical - 45 Maubeuge - Paris

PARIS, France, 75009

Status
Completed
 
Locations

Cabinet Médical - Martinon - Mont de Marsan

MONT-DE-MARSAN, France, 40000

Status
Completed
 
Locations

IRCCS Fondazione San Raffaele

Milano, Italy, 20132

Status
Not yet recruiting
 
Locations

A.O.U. Policlinico Umberto I

Roma, Italy, 00155

Status
Not yet recruiting
 
Locations

A.O. Ospedali Riuniti Bergamo

Bergamo, Italy, 24128

Status
Not yet recruiting
 
Locations

A.O.U. Federico II

Napoli, Italy, 80131

Status
Not yet recruiting
 
Locations

Hospital Clínico Universitario de Valencia

Valencia, Spain, 46010

Status
Completed
 
Locations

CAP Dr. Vicenç Papaceit - ABS La Roca del Vallès

La Roca del Vallès, Spain, 08430

Status
Completed
 
Locations

Clinique Saint-Jean/Kliniek Sint Jan

BRUXELLES - BRUSSEL, Belgium, 1000

Status
Completed
 
Locations

H.-Hartziekenhuis Roeselare-Menen

ROESELARE, Belgium, 8800

Status
Completed
 
Locations

Dr Van Der Mullen

LEUVEN, Belgium, 3000

Status
Completed
 
Locations

Kliniken der Medizinischen Hochschule Hannover

Hannover, Germany, 30625

Status
Completed
 
Locations

Praxis Hr. Prof. Dr. H. Porst

Hamburg, Germany, 20354

Status
Completed
 
Locations

Praxis Hr. Dr. E. U. Krohn

Hamburg, Germany, 22177

Status
Completed
 
Locations

Praxis Hr. Dr. F. Matthes

Leisnig, Germany, 04703

Status
Completed
 
Locations

Praxis Fr. Dr. W. Pohl

Dresden, Germany, 01129

Status
Completed
 
Locations

Praxis Drs. T. Schneider /B. Schneider

Mülheim, Germany, 45468

Status
Completed
 
Locations

Praxis Dr. S. Szymula

Leipzig, Germany, 04105

Status
Completed
 
Locations

Praxis Hr. Dr. J. Gleißner

Wuppertal, Germany, 42103

Status
Completed
 
Locations

Urologische Praxis Dr. D. Müller

Bautzen, Germany, 02625

Status
Completed
 
Locations

Praxis Hr. Dr. D. Hennig

Meißen, Germany, 01662

Status
Completed
 
Locations

Hôpital Sainte Marguerite - Marseille

MARSEILLE, France, 13275

Status
Completed
 
Locations

CETPARP - Carolus - Lille

LILLE, France, 59000

Status
Completed
 
Locations

Cabinet Médical - 32 Leclerc - La Rochelle

LA ROCHELLE, France, 17000

Status
Completed
 
Locations

Cabinet Médical - Romiguières - Toulouse

TOULOUSE, France, 31000

Status
Completed
 
Locations

Cabinet Médical - Gambetta - Lyon

LYON, France, 69000

Status
Completed
 
Locations

Huisartsenmaatschap L.S.V.

NIJVERDAL, Netherlands, 7442 LS

Status
Completed
 
Locations

Andros Mannenkliniek Arnhem

ARNHEM, Netherlands, 6836 BH

Status
Completed
 
Locations

Josha Research

Bloemfontein, South Africa, 9324

Status
Completed
 
Locations

Disa Clinic

Johannesburg, South Africa, 2090

Status
Completed
 
Locations

A.O.U. Careggi

Firenze, Italy, 50139

Status
Not yet recruiting
 
Locations

Hospital Policlínico de Vigo - Clínica Povisa

Vigo, Spain, 36211

Status
Completed
 
Locations

Hospital Universitario de Canarias

La Laguna, Spain, 38320

Status
Completed
 
Locations

Hospital General Universitario de Alicante

Alicante, Spain, 03010

Status
Completed
 
Locations

Hospital Fundació Puigvert

Barcelona, Spain, 08025

Status
Completed
 
Locations

CAP Sarrià

Barcelona, Spain, 08034

Status
Completed
 
Locations

CHU de Liège

LIEGE, Belgium, 4000

Status
Completed
 
Locations

Dr Bongaerts - Dr Denier

GENK, Belgium, 3600

Status
Completed
 
Locations

Medisch Spectrum Twente, Locatie Ariensplein

ENSCHEDE, Netherlands, 7511 JX

Status
Completed
 
Locations

Deventer Ziekenhuis

DEVENTER, Netherlands, 7415 EH

Status
Completed
 
Locations

Private Practice Dr MK Dhanjee

Newcastle, South Africa, 2940

Status
Completed
 
Locations

Randles Road Medical Centre

Durban, South Africa, 4091

Status
Completed
 
Locations

Newkwa Medical Centre

Durban, South Africa, 4037

Status
Completed
 
Locations

Parklands Medical Centre - Durban

Durban, South Africa, 4091

Status
Completed
 

Trial Design