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

This study has been completed.
Information provided by:
Bayer Identifier:
First received: September 8, 2006
Last updated: December 23, 2014
Last verified: December 2014
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 4

Study Type: Interventional
Study Design: 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

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 ]

Secondary Outcome Measures:
  • SEP3 at weeks 4, 12, 18, and 24 of treatment compared to placebo [ Time Frame: 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 ]
  • 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 ]

Enrollment: 352
Study Start Date: July 2006
Study Completion Date: August 2007
Arms Assigned Interventions
Experimental: Arm 1 Drug: Levitra (Vardenafil, BAY38-9456)
Placebo Comparator: Arm 2 Drug: Placebo


Ages Eligible for Study:   18 Years to 64 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00377793

  Show 47 Study Locations
Sponsors and Collaborators
Study Director: Bayer Study Director Bayer
  More Information

Additional Information:
Responsible Party: Medical Affairs Therapeutic Area Head, Bayer Schering Pharma AG Identifier: NCT00377793     History of Changes
Other Study ID Numbers: 12146
EudraCT 2006-001228-37
Study First Received: September 8, 2006
Last Updated: December 23, 2014

Additional relevant MeSH terms:
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 processed this record on August 17, 2017