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

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ClinicalTrials.gov Identifier: NCT00377793
Recruitment Status : Completed
First Posted : September 18, 2006
Last Update Posted : December 24, 2014
Sponsor:
Information provided by:
Bayer

Tracking Information
First Submitted Date  ICMJE September 8, 2006
First Posted Date  ICMJE September 18, 2006
Last Update Posted Date December 24, 2014
Study Start Date  ICMJE July 2006
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE
 (submitted: November 7, 2008)
Maintenance of erection in men with ED, Improvement of their female partners sexual quality of life [ Time Frame: 12 weeks ]
Original Primary Outcome Measures  ICMJE Not Provided
Change History Complete list of historical versions of study NCT00377793 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: November 7, 2008)
  • 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 ]
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Levitra (Vardenafil, BAY38-9456) Partner Satisfaction Study II
Official Title  ICMJE 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
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Condition  ICMJE
  • Sexual Dysfunction
  • Male Erectile Dysfunction
Intervention  ICMJE
  • Drug: Levitra (Vardenafil, BAY38-9456)
  • Drug: Placebo
Study Arms  ICMJE
  • Experimental: Arm 1
    Intervention: Drug: Levitra (Vardenafil, BAY38-9456)
  • Placebo Comparator: Arm 2
    Intervention: Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: December 23, 2014)
352
Original Enrollment  ICMJE Not Provided
Actual Study Completion Date  ICMJE August 2007
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 18 Years to 64 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Belgium,   France,   Germany,   Italy,   Netherlands,   South Africa,   Spain
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00377793
Other Study ID Numbers  ICMJE 12146
EudraCT 2006-001228-37
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Medical Affairs Therapeutic Area Head, Bayer Schering Pharma AG
Study Sponsor  ICMJE Bayer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Bayer Study Director Bayer
PRS Account Bayer
Verification Date December 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP