Trial Condition(s):
Sexual Dysfunction, Male Erectile Dysfunction
Levitra (Vardenafil, BAY38-9456) Partner Satisfaction Study II
Bayer Identifier:
12146
ClinicalTrials.gov Identifier:
EudraCT Number:
Not Available
EU CT Number:
Not Available
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
Trial Dates
Phase
Could I receive a placebo?
Products
Accepts Healthy Volunteers
Where to Participate
| Locations | |
|---|---|
Locations Praxis Hr. Dr. M. Orlowski Wahlstedt, Germany, 23812 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Universitäts-Krankenhaus Eppendorf Hamburg, Germany, 20251 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Praxis Hr. Dr. G. Korda Brühl, Germany, 50321 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Cabinet Médical - Morgiou - Marseille MARSEILLE, France, 13009 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Cabinet Médical - 45 Maubeuge - Paris PARIS, France, 75009 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Cabinet Médical - Martinon - Mont de Marsan MONT-DE-MARSAN, France, 40000 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations IRCCS Fondazione San Raffaele Milano, Italy, 20132 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations A.O.U. Policlinico Umberto I Roma, Italy, 00155 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations A.O. Ospedali Riuniti Bergamo Bergamo, Italy, 24128 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations A.O.U. Federico II Napoli, Italy, 80131 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Hospital Clínico Universitario de Valencia Valencia, Spain, 46010 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations CAP Dr. Vicenç Papaceit - ABS La Roca del Vallès La Roca del Vallès, Spain, 08430 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Clinique Saint-Jean/Kliniek Sint Jan BRUXELLES - BRUSSEL, Belgium, 1000 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations H.-Hartziekenhuis Roeselare-Menen ROESELARE, Belgium, 8800 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Dr Van Der Mullen LEUVEN, Belgium, 3000 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Kliniken der Medizinischen Hochschule Hannover Hannover, Germany, 30625 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Praxis Hr. Prof. Dr. H. Porst Hamburg, Germany, 20354 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Praxis Hr. Dr. E. U. Krohn Hamburg, Germany, 22177 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Praxis Hr. Dr. F. Matthes Leisnig, Germany, 04703 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Praxis Fr. Dr. W. Pohl Dresden, Germany, 01129 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Praxis Drs. T. Schneider /B. Schneider Mülheim, Germany, 45468 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Praxis Dr. S. Szymula Leipzig, Germany, 04105 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Praxis Hr. Dr. J. Gleißner Wuppertal, Germany, 42103 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Urologische Praxis Dr. D. Müller Bautzen, Germany, 02625 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Praxis Hr. Dr. D. Hennig Meißen, Germany, 01662 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Hôpital Sainte Marguerite - Marseille MARSEILLE, France, 13275 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations CETPARP - Carolus - Lille LILLE, France, 59000 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Cabinet Médical - 32 Leclerc - La Rochelle LA ROCHELLE, France, 17000 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Cabinet Médical - Romiguières - Toulouse TOULOUSE, France, 31000 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Cabinet Médical - Gambetta - Lyon LYON, France, 69000 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Huisartsenmaatschap L.S.V. NIJVERDAL, Netherlands, 7442 LS | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Andros Mannenkliniek Arnhem ARNHEM, Netherlands, 6836 BH | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Josha Research Bloemfontein, South Africa, 9324 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Disa Clinic Johannesburg, South Africa, 2090 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations A.O.U. Careggi Firenze, Italy, 50139 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Hospital Policlínico de Vigo - Clínica Povisa Vigo, Spain, 36211 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Hospital Universitario de Canarias La Laguna, Spain, 38320 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Hospital General Universitario de Alicante Alicante, Spain, 03010 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Hospital Fundació Puigvert Barcelona, Spain, 08025 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations CAP Sarrià Barcelona, Spain, 08034 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations CHU de Liège LIEGE, Belgium, 4000 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Dr Bongaerts - Dr Denier GENK, Belgium, 3600 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Medisch Spectrum Twente, Locatie Ariensplein ENSCHEDE, Netherlands, 7511 JX | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Deventer Ziekenhuis DEVENTER, Netherlands, 7415 EH | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Private Practice Dr MK Dhanjee Newcastle, South Africa, 2940 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Randles Road Medical Centre Durban, South Africa, 4091 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Newkwa Medical Centre Durban, South Africa, 4037 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Parklands Medical Centre - Durban Durban, South Africa, 4091 | Contact Us: E-mail: [email protected] Phone: Not Available |
Trial Design
A randomized, double blind, parallel group study of vardenafil flexible dose versus placebo in males with erectile dysfunction and their female partners sexual quality of life. PARTNER II
Trial Type:
Interventional
Intervention Type:
Drug
Trial Purpose:
Treatment
Allocation:
Randomized
Blinding:
Double Blind
Assignment:
Parallel Assignment
Trial Arms:
2
Primary Outcome
- Maintenance of erection in men with ED, Improvement of their female partners sexual quality of lifeTimeframe: 12 weeks
Secondary Outcome
- SEP3 at weeks 4, 12, 18, and 24 of treatment compared to placeboTimeframe: 24 weeks
- Additional Subject Diary questions at weeks 4, 12, 18, and 24, LOCF, and over entire treatment period compared to placeboTimeframe: 24 weeks
- Global confidence question (GCQ) at weeks 12, and 24 of treatment compared to placebo. IIEF, TSS, mSLQQ-QOL, Partnership questionnaire (PFB20)Timeframe: 24 weeks
Additional Information
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