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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00377793
Recruitment Status : Completed
First Posted : September 18, 2006
Last Update Posted : December 24, 2014
Sponsor:
Information provided by:
Bayer

Study Description
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Brief Summary:
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 or disease Intervention/treatment Phase
Sexual Dysfunction Male Erectile Dysfunction Drug: Levitra (Vardenafil, BAY38-9456) Drug: Placebo Phase 4

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 352 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
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
Study Start Date : July 2006
Actual Study Completion Date : August 2007

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Arms and Interventions
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Arm Intervention/treatment
Experimental: Arm 1 Drug: Levitra (Vardenafil, BAY38-9456)
Placebo Comparator: Arm 2 Drug: Placebo


Outcome Measures
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Primary Outcome Measures :
  1. Maintenance of erection in men with ED, Improvement of their female partners sexual quality of life [ Time Frame: 12 weeks ]

Secondary Outcome Measures :
  1. SEP3 at weeks 4, 12, 18, and 24 of treatment compared to placebo [ Time Frame: 24 weeks ]
  2. Additional Subject Diary questions at weeks 4, 12, 18, and 24, LOCF, and over entire treatment period compared to placebo [ Time Frame: 24 weeks ]
  3. 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 ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 64 Years   (Adult)
Sexes 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
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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00377793


Locations
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Belgium
Bruxelles - Brussel, Belgium, 1000
Genk, Belgium, 3600
Leuven, Belgium, 3000
Liege, Belgium, 4000
Roeselare, Belgium, 8800
France
La Rochelle, France, 17000
Lille, France, 59000
Lyon, France, 69000
Marseille, France, 13009
Marseille, France, 13275
Mont-de-marsan, France, 40000
Paris, France, 75009
Toulouse, France, 31000
Germany
Hamburg, Hamburg / 287, Germany, 20251
Hamburg, Hamburg / 287, Germany, 20354
Hamburg, Hamburg / 287, Germany, 22177
Hannover, Niedersachsen / 291, Germany, 30625
Brühl, Nordrhein-Westfalen / 325, Germany, 50321
Mülheim, Nordrhein-Westfalen / 481, Germany, 45468
Wuppertal, Nordrhein-Westfalen / 616, Germany, 42103
Bautzen, Sachsen / 313, Germany, 02625
Dresden, Sachsen / 313, Germany, 01129
Leipzig, Sachsen / 313, Germany, 04105
Leisnig, Sachsen / 313, Germany, 04703
Meißen, Sachsen / 313, Germany, 01662
Wahlstedt, Schleswig-Holstein / 306, Germany, 23812
Italy
Bergamo, Italy, 24128
Firenze, Italy, 50139
Milano, Italy, 20132
Napoli, Italy, 80131
Roma, Italy, 00155
Netherlands
Arnhem, Netherlands, 6836 BH
Deventer, Netherlands, 7415 EH
Enschede, Netherlands, 7511 JX
Nijverdal, Netherlands, 7442 LS
South Africa
Bloemfontein, Free State, South Africa, 9324
Johannesburg, Gauteng, South Africa, 2090
Newcastle, Kwa Zulu-Natal, South Africa, 2940
Durban, KwaZulu Natal, South Africa, 4037
Durban, KwaZulu Natal, South Africa, 4091
Spain
La Roca del Vallès, Barcelona, Spain, 08430
Barcelona, Cataluña, Spain, 08025
Vigo, Pontevedra, Spain, 36211
La Laguna, Tenerife, Spain, 38320
Alicante, Spain, 03010
Barcelona, Spain, 08034
Valencia, Spain, 46010
Sponsors and Collaborators
Bayer
Investigators
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Study Director: Bayer Study Director Bayer
More Information
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Additional Information:

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Responsible Party: Medical Affairs Therapeutic Area Head, Bayer Schering Pharma AG
ClinicalTrials.gov Identifier: NCT00377793    
Other Study ID Numbers: 12146
EudraCT 2006-001228-37
First Posted: September 18, 2006    Key Record Dates
Last Update Posted: December 24, 2014
Last Verified: December 2014
Additional relevant MeSH terms:
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Erectile Dysfunction
Sexual Dysfunction, Physiological
Genital Diseases, Male
Sexual Dysfunctions, Psychological
Mental Disorders
Vardenafil Dihydrochloride
 Vasodilator Agents
Phosphodiesterase 5 Inhibitors
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Urological Agents