A Study Evaluating Vardenafil Compared to Placebo in Subjects With Erectile Dysfunction (ED) and Dyslipidemia

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00379756
First received: September 21, 2006
Last updated: June 7, 2012
Last verified: March 2011

September 21, 2006
June 7, 2012
May 2006
May 2007   (final data collection date for primary outcome measure)
EF domain score of the International Index of Erectile Function (IIEF) at randomization and every 4 weeks during therapyDiary response: success of insertion and maintenance recorded at every attempt from randomization through end of treatment [ Time Frame: 12 week study ] [ Designated as safety issue: No ]
  • IIEF-EF domain score
  • Subject diary questions regarding ability to insert penis into partner's vagina and ability to maintain erection to completion of sexual intercourse and duration of erection.
Complete list of historical versions of study NCT00379756 on ClinicalTrials.gov Archive Site
Duration of erection and specific diary responses concerning satisfaction: every attemptResponse to diary questions and scores for Keep It Simple (KIS): randomization and every 4 weeksResponse to Global Assessment Question (GAQ): every 4 weeks [ Time Frame: 12 week study ] [ Designated as safety issue: No ]
Global assessment question, KIS scale, Proportion of subjects with normal erectile function, subject's diary response, concerning: overall satisfaction with hardness of erection,satisfaction with sexual experience, and success of ejaculation (Y/N).
Not Provided
Not Provided
 
A Study Evaluating Vardenafil Compared to Placebo in Subjects With Erectile Dysfunction (ED) and Dyslipidemia
A Randomized, Double-blind, Placebo-controlled, Parallel-group, Study Evaluating the Efficacy, Safety, and Duration of Erection of Flexible-dose Vardenafil Administered for 12 Weeks Compared to Placebo in Subjects With Erectile Dysfunction and Dyslipidemia

This is a study consisting of four periods (screening, run-in, treatment, follow-up). A four-week treatment-free, run-in period where the subject will make at least four attempts at intercourse on four separate days with at least 50% of the attempts must be unsuccessful. During run-in the subjects will be using a stopwatch to measure the time from erection perceived hard enough for penetration until withdrawal from the partner's vagina. Next there are 12 weeks of treatment with either placebo or LEVITRA. Each subject will be required to visit the clinic on 5 occasions over a period of 4 months.

Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
  • Erectile Dysfunction (ED)
  • Erectile Dysfunction
  • Drug: LEVITRA (vardenafil)
    active comparator
    Other Name: LEVITRA (vardenafil)
  • Drug: placebo
    placebo comparator
  • Active Comparator: Levitra
    10mg x 4 weeks, with option to increase to 20mg aat that time if desired
    Intervention: Drug: LEVITRA (vardenafil)
  • Placebo Comparator: placebo
    Intervention: Drug: placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
510
May 2007
May 2007   (final data collection date for primary outcome measure)

Inclusion criteria:

  • 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 (according to the question in the subject diary: Was sexual activity initiated with the intention of intercourse?) on four separate days during the untreated baseline period. At least 50% of attempts during this period must be unsuccessful, according to the following questions from the subject diary [at least one question should be answered "No"]: Were you able to achieve at least some erection (some enlargement of the penis)? Were you able to insert your penis into your partner's vagina? Did your erection last long enough for you to have successful intercourse?
  • Diagnosis of dyslipidemia treated with a stable dose of a statin for 6 months at Visit 1.
  • IIEF-EF domain score of 25 denoting mild to severe ED at Visit 2.
  • Documented, dated, written Informed Consent.

Exclusion criteria:

  • Premature ejaculator <2 minutes
  • Any unstable medical, psychiatric, spinal cord injury, penile anatomical abnormalities, or substance abuse disorder that MD feels subject will not be able to complete the study.
  • Low sexual desire.
  • Prior prostatectomy surgery
  • Severe chronic or acute liver disease, history of moderate or severe liver impairment
  • Clinically significant chronic hematological disease
  • Bleeding disorder or significant active peptic ulceration.
  • Cardiovascular conditions that prevent sexual activity.
  • History of heart attack, stroke, or life-threatening arrhythmia within the prior 6 months.
  • hypotension or hypertension at rest.
  • cancer within the past 5 years. Use of these medications: nitrates or nitric oxide donors, anti-androgens, oral or injectable androgens, received any investigational drug (including placebo) within 30 days of screening (Visit 1).
  • Use of any treatment for ED within 7 days of screening including oral medications, vacuum devices, constrictive devices, injections or urethral suppositories.
  • Subjects who are taking the following potent inhibitors of cytochrome P-450 3A4.
  • Abnormal Laboratory Values:

    1. serum total testosterone level >25% below the lower limit of normal
    2. serum creatinine >3.0 mg/dl.
    3. AST and/or ALT >3x the upper limit of normal.
Male
18 Years to 64 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00379756
106718
No
GlaxoSmithKline
GlaxoSmithKline
Not Provided
Study Director: GSK Clinical Trials GlaxoSmithKline
GlaxoSmithKline
March 2011

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