Trial Condition(s):
Sexual Dysfunction, Male Erectile Dysfunction
Levitra (Vardenafil, BAY38-9456) Partner Satisfaction Study II
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 | Status | ||
|---|---|---|---|
Locations Praxis Hr. Dr. M. Orlowski Wahlstedt, Germany, 23812 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Universitäts-Krankenhaus Eppendorf Hamburg, Germany, 20251 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Praxis Hr. Dr. G. Korda Brühl, Germany, 50321 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Cabinet Médical - Morgiou - Marseille MARSEILLE, France, 13009 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Cabinet Médical - 45 Maubeuge - Paris PARIS, France, 75009 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Cabinet Médical - Martinon - Mont de Marsan MONT-DE-MARSAN, France, 40000 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations IRCCS Fondazione San Raffaele Milano, Italy, 20132 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations A.O.U. Policlinico Umberto I Roma, Italy, 00155 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations A.O. Ospedali Riuniti Bergamo Bergamo, Italy, 24128 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations A.O.U. Federico II Napoli, Italy, 80131 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Hospital Clínico Universitario de Valencia Valencia, Spain, 46010 | Status Completed | 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 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Clinique Saint-Jean/Kliniek Sint Jan BRUXELLES - BRUSSEL, Belgium, 1000 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations H.-Hartziekenhuis Roeselare-Menen ROESELARE, Belgium, 8800 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Dr Van Der Mullen LEUVEN, Belgium, 3000 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Kliniken der Medizinischen Hochschule Hannover Hannover, Germany, 30625 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Praxis Hr. Prof. Dr. H. Porst Hamburg, Germany, 20354 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Praxis Hr. Dr. E. U. Krohn Hamburg, Germany, 22177 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Praxis Hr. Dr. F. Matthes Leisnig, Germany, 04703 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Praxis Fr. Dr. W. Pohl Dresden, Germany, 01129 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Praxis Drs. T. Schneider /B. Schneider Mülheim, Germany, 45468 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Praxis Dr. S. Szymula Leipzig, Germany, 04105 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Praxis Hr. Dr. J. Gleißner Wuppertal, Germany, 42103 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Urologische Praxis Dr. D. Müller Bautzen, Germany, 02625 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Praxis Hr. Dr. D. Hennig Meißen, Germany, 01662 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Hôpital Sainte Marguerite - Marseille MARSEILLE, France, 13275 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations CETPARP - Carolus - Lille LILLE, France, 59000 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Cabinet Médical - 32 Leclerc - La Rochelle LA ROCHELLE, France, 17000 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Cabinet Médical - Romiguières - Toulouse TOULOUSE, France, 31000 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Cabinet Médical - Gambetta - Lyon LYON, France, 69000 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Huisartsenmaatschap L.S.V. NIJVERDAL, Netherlands, 7442 LS | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Andros Mannenkliniek Arnhem ARNHEM, Netherlands, 6836 BH | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Josha Research Bloemfontein, South Africa, 9324 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Disa Clinic Johannesburg, South Africa, 2090 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations A.O.U. Careggi Firenze, Italy, 50139 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Hospital Policlínico de Vigo - Clínica Povisa Vigo, Spain, 36211 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Hospital Universitario de Canarias La Laguna, Spain, 38320 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Hospital General Universitario de Alicante Alicante, Spain, 03010 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Hospital Fundació Puigvert Barcelona, Spain, 08025 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations CAP Sarrià Barcelona, Spain, 08034 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations CHU de Liège LIEGE, Belgium, 4000 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Dr Bongaerts - Dr Denier GENK, Belgium, 3600 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Medisch Spectrum Twente, Locatie Ariensplein ENSCHEDE, Netherlands, 7511 JX | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Deventer Ziekenhuis DEVENTER, Netherlands, 7415 EH | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Private Practice Dr MK Dhanjee Newcastle, South Africa, 2940 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Randles Road Medical Centre Durban, South Africa, 4091 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Newkwa Medical Centre Durban, South Africa, 4037 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Parklands Medical Centre - Durban Durban, South Africa, 4091 | Status Completed | 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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