check_circleStudy Completed

Sexual Dysfunction, Male Erectile Dysfunction

Bayer Identifier:
12146
ClinicalTrials.gov Identifier:
NCT00377793
EudraCT Number:
Not Available
EU CT Number:
Not Available
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.

Key Participants Requirements

Sex

Male

Age

18 - 64 Years
  • - 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
    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
  • - 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

Trial summary

Enrollment Goal
352
Trial Dates
July 2006 - August 2007
Phase
Phase 4
Could I Receive a placebo
Yes
Products
Levitra (Vardenafil, BAY38-9456)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Completed
Praxis Hr. Dr. M. OrlowskiWahlstedt, 23812, Germany
Completed
Universitäts-Krankenhaus EppendorfHamburg, 20251, Germany
Completed
Praxis Hr. Dr. G. KordaBrühl, 50321, Germany
Completed
Cabinet Médical - Morgiou - MarseilleMARSEILLE, 13009, France
Completed
Cabinet Médical - 45 Maubeuge - ParisPARIS, 75009, France
Completed
Cabinet Médical - Martinon - Mont de MarsanMONT-DE-MARSAN, 40000, France
Not yet recruiting
IRCCS Fondazione San RaffaeleMilano, 20132, Italy
Not yet recruiting
A.O.U. Policlinico Umberto IRoma, 00155, Italy
Not yet recruiting
A.O. Ospedali Riuniti BergamoBergamo, 24128, Italy
Not yet recruiting
A.O.U. Federico IINapoli, 80131, Italy
Completed
Hospital Clínico Universitario de ValenciaValencia, 46010, Spain
Completed
CAP Dr. Vicenç Papaceit - ABS La Roca del VallèsLa Roca del Vallès, 08430, Spain
Completed
Clinique Saint-Jean/Kliniek Sint JanBRUXELLES - BRUSSEL, 1000, Belgium
Completed
H.-Hartziekenhuis Roeselare-MenenROESELARE, 8800, Belgium
Completed
Dr Van Der MullenLEUVEN, 3000, Belgium
Completed
Kliniken der Medizinischen Hochschule HannoverHannover, 30625, Germany
Completed
Praxis Hr. Prof. Dr. H. PorstHamburg, 20354, Germany
Completed
Praxis Hr. Dr. E. U. KrohnHamburg, 22177, Germany
Completed
Praxis Hr. Dr. F. MatthesLeisnig, 04703, Germany
Completed
Praxis Fr. Dr. W. PohlDresden, 01129, Germany
Completed
Praxis Drs. T. Schneider /B. SchneiderMülheim, 45468, Germany
Completed
Praxis Dr. S. SzymulaLeipzig, 04105, Germany
Completed
Praxis Hr. Dr. J. GleißnerWuppertal, 42103, Germany
Completed
Urologische Praxis Dr. D. MüllerBautzen, 02625, Germany
Completed
Praxis Hr. Dr. D. HennigMeißen, 01662, Germany
Completed
Hôpital Sainte Marguerite - MarseilleMARSEILLE, 13275, France
Completed
CETPARP - Carolus - LilleLILLE, 59000, France
Completed
Cabinet Médical - 32 Leclerc - La RochelleLA ROCHELLE, 17000, France
Completed
Cabinet Médical - Romiguières - ToulouseTOULOUSE, 31000, France
Completed
Cabinet Médical - Gambetta - LyonLYON, 69000, France
Completed
Huisartsenmaatschap L.S.V.NIJVERDAL, 7442 LS, Netherlands
Completed
Andros Mannenkliniek ArnhemARNHEM, 6836 BH, Netherlands
Completed
Josha ResearchBloemfontein, 9324, South Africa
Completed
Disa ClinicJohannesburg, 2090, South Africa
Not yet recruiting
IRCCS Fondazione San RaffaeleMilano, 20132, Italy
Not yet recruiting
A.O.U. CareggiFirenze, 50139, Italy
Completed
Hospital Policlínico de Vigo - Clínica PovisaVigo, 36211, Spain
Completed
Hospital Universitario de CanariasLa Laguna, 38320, Spain
Completed
Hospital General Universitario de AlicanteAlicante, 03010, Spain
Completed
Hospital Fundació PuigvertBarcelona, 08025, Spain
Completed
CAP SarriàBarcelona, 08034, Spain
Completed
CHU de LiègeLIEGE, 4000, Belgium
Completed
Dr Bongaerts - Dr DenierGENK, 3600, Belgium
Completed
Medisch Spectrum Twente, Locatie ArienspleinENSCHEDE, 7511 JX, Netherlands
Completed
Deventer ZiekenhuisDEVENTER, 7415 EH, Netherlands
Completed
Private Practice Dr MK DhanjeeNewcastle, 2940, South Africa
Completed
Randles Road Medical CentreDurban, 4091, South Africa
Completed
Newkwa Medical CentreDurban, 4037, South Africa
Completed
Parklands Medical Centre - DurbanDurban, 4091, South Africa

Primary Outcome

  • Maintenance of erection in men with ED, Improvement of their female partners sexual quality of life
    date_rangeTime Frame:
    12 weeks
    enhanced_encryption
    Safety Issue:
    no

Secondary Outcome

  • SEP3 at weeks 4, 12, 18, and 24 of treatment compared to placebo
    date_rangeTime Frame:
    24 weeks
    enhanced_encryption
    Safety Issue:
    no
  • Additional Subject Diary questions at weeks 4, 12, 18, and 24, LOCF, and over entire treatment period compared to placebo
    date_rangeTime Frame:
    24 weeks
    enhanced_encryption
    Safety Issue:
    no
  • Global confidence question (GCQ) at weeks 12, and 24 of treatment compared to placebo. IIEF, TSS, mSLQQ-QOL, Partnership questionnaire (PFB20)
    date_rangeTime Frame:
    24 weeks
    enhanced_encryption
    Safety Issue:
    no

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

Additional Information

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