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Levitra (Vardenafil, BAY38-9456) Partner Satisfaction Study II
This study has been completed.
First Received: September 8, 2006   Last Updated: November 7, 2008   History of Changes
Sponsor: Bayer
Information provided by: Bayer
ClinicalTrials.gov Identifier: NCT00377793
  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.


Condition Intervention Phase
Sexual Dysfunction
Male Erectile Dysfunction
Drug: Levitra (Vardenafil, BAY38-9456)
Drug: Placebo
Phase IV

Study Type: Interventional
Study Design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Bayer:

Primary Outcome Measures:
  • Maintenance of erection in men with ED, Improvement of their female partners sexual quality of life [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • SEP3 at weeks 4, 12, 18, and 24 of treatment compared to placebo [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • Additional Subject Diary questions at weeks 4, 12, 18, and 24, LOCF, and over entire treatment period compared to placebo [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • Global confidence question (GCQ) at weeks 12, and 24 of treatment compared to placebo. IIEF, TSS, mSLQQ-QOL, Partnership questionnaire (PFB20) [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]

Enrollment: 353
Study Start Date: July 2006
Study Completion Date: August 2007
Arms Assigned Interventions
Arm 1: Experimental Drug: Levitra (Vardenafil, BAY38-9456)
Arm 2: Placebo Comparator Drug: Placebo

  Eligibility

Ages Eligible for Study:   18 Years to 64 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00377793

  Hide Study Locations
Locations
Belgium
LIEGE, Belgium, 4000
BRUXELLES - BRUSSEL, Belgium, 1000
GENK, Belgium, 3600
ROESELARE, Belgium, 8800
LEUVEN, Belgium, 3000
France
TOULOUSE, France, 31000
MARSEILLE, France, 13009
LILLE, France, 59000
PARIS, France, 75009
LA ROCHELLE, France, 17000
MARSEILLE, France, 13275
MONT-DE-MARSAN, France, 40000
LYON, France, 69000
Germany, Hamburg / 287
Hamburg, Hamburg / 287, Germany, 20354
Hamburg, Hamburg / 287, Germany, 22177
Hamburg, Hamburg / 287, Germany, 20251
Germany, Niedersachsen / 291
Hannover, Niedersachsen / 291, Germany, 30625
Germany, Nordrhein-Westfalen / 325
Brühl, Nordrhein-Westfalen / 325, Germany, 50321
Germany, Nordrhein-Westfalen / 481
Mülheim, Nordrhein-Westfalen / 481, Germany, 45468
Germany, Nordrhein-Westfalen / 616
Wuppertal, Nordrhein-Westfalen / 616, Germany, 42103
Germany, Sachsen / 313
Leisnig, Sachsen / 313, Germany, 04703
Dresden, Sachsen / 313, Germany, 01129
Leipzig, Sachsen / 313, Germany, 04105
Bautzen, Sachsen / 313, Germany, 02625
Meißen, Sachsen / 313, Germany, 01662
Germany, Schleswig-Holstein / 306
Wahlstedt, Schleswig-Holstein / 306, Germany, 23812
Italy
Milano, Italy, 20132
Roma, Italy, 00155
Bergamo, Italy, 24128
Napoli, Italy, 80131
Firenze, Italy, 50139
Netherlands
NIJVERDAL, Netherlands, 7442 LS
ARNHEM, Netherlands, 6836 BH
ENSCHEDE, Netherlands, 7511 JX
DEVENTER, Netherlands, 7415 EH
South Africa, Free State
Bloemfontein, Free State, South Africa, 9324
South Africa, Gauteng
Johannesburg, Gauteng, South Africa, 2090
South Africa, Kwa Zulu-Natal
Newcastle, Kwa Zulu-Natal, South Africa, 2940
South Africa, KwaZulu Natal
Durban, KwaZulu Natal, South Africa, 4091
Durban, KwaZulu Natal, South Africa, 4037
Spain
Alicante, Spain, 03010
Barcelona, Spain, 08034
Valencia, Spain, 46010
Spain, Barcelona
La Roca del Vallès, Barcelona, Spain, 08430
Spain, Cataluña
Barcelona, Cataluña, Spain, 08025
Spain, Pontevedra
Vigo, Pontevedra, Spain, 36211
Spain, Tenerife
La Laguna, Tenerife, Spain, 38320
Sponsors and Collaborators
Bayer
Investigators
Study Director: Bayer Study Director Bayer
  More Information

Additional Information:
No publications provided

Responsible Party: Bayer Schering Pharma AG ( Medical Affairs Therapeutic Area Head )
Study ID Numbers: 12146, EudraCT 2006-001228-37
Study First Received: September 8, 2006
Last Updated: November 7, 2008
ClinicalTrials.gov Identifier: NCT00377793     History of Changes
Health Authority: Spain: Spanish Agency of Medicines;   Germany: Federal Institute for Drugs and Medical Devices

Additional relevant MeSH terms:
Sexual Dysfunctions, Psychological
Phosphodiesterase Inhibitors
Vardenafil
Sexual Dysfunction, Physiological
Molecular Mechanisms of Pharmacological Action
Mental Disorders
Enzyme Inhibitors
Genital Diseases, Male
Sexual and Gender Disorders
Erectile Dysfunction
Pharmacologic Actions

ClinicalTrials.gov processed this record on November 27, 2009