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

December 23, 2014 updated by: Bayer

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

352

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • 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 / 287
      • Hamburg, Hamburg / 287, Germany, 20251
      • Hamburg, Hamburg / 287, Germany, 20354
      • Hamburg, Hamburg / 287, Germany, 22177
    • Niedersachsen / 291
      • Hannover, Niedersachsen / 291, Germany, 30625
    • Nordrhein-Westfalen / 325
      • Brühl, Nordrhein-Westfalen / 325, Germany, 50321
    • Nordrhein-Westfalen / 481
      • Mülheim, Nordrhein-Westfalen / 481, Germany, 45468
    • Nordrhein-Westfalen / 616
      • Wuppertal, Nordrhein-Westfalen / 616, Germany, 42103
    • Sachsen / 313
      • 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
    • Schleswig-Holstein / 306
      • 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
    • Free State
      • Bloemfontein, Free State, South Africa, 9324
    • Gauteng
      • Johannesburg, Gauteng, South Africa, 2090
    • Kwa Zulu-Natal
      • Newcastle, Kwa Zulu-Natal, South Africa, 2940
    • KwaZulu Natal
      • Durban, KwaZulu Natal, South Africa, 4091
      • Durban, KwaZulu Natal, South Africa, 4037
  • Spain
      • Alicante, Spain, 03010
      • Barcelona, Spain, 08034
      • Valencia, Spain, 46010
    • Barcelona
      • La Roca del Vallès, Barcelona, Spain, 08430
    • Cataluña
      • Barcelona, Cataluña, Spain, 08025
    • Pontevedra
      • Vigo, Pontevedra, Spain, 36211
    • Tenerife
      • La Laguna, Tenerife, Spain, 38320

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 64 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Arm 1
Drug: Levitra (Vardenafil, BAY38-9456)
Placebo Comparator: Arm 2
Drug: Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Maintenance of erection in men with ED, Improvement of their female partners sexual quality of life
Time Frame: 12 weeks
12 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
SEP3 at weeks 4, 12, 18, and 24 of treatment compared to placebo
Time Frame: 24 weeks
24 weeks
Additional Subject Diary questions at weeks 4, 12, 18, and 24, LOCF, and over entire treatment period compared to placebo
Time Frame: 24 weeks
24 weeks
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
24 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bayer

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2006

Study Completion (Actual)

August 1, 2007

Study Registration Dates

First Submitted

September 8, 2006

First Submitted That Met QC Criteria

September 15, 2006

First Posted (Estimate)

September 18, 2006

Study Record Updates

Last Update Posted (Estimate)

December 24, 2014

Last Update Submitted That Met QC Criteria

December 23, 2014

Last Verified

December 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 12146
  • EudraCT 2006-001228-37

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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