NCT00661115

Brief Summary

To investigate the efficacy and safety of vardenafil in men with erectile dysfunction.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
173

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started May 2003

Shorter than P25 for phase_3

Geographic Reach
1 country

6 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2003

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2004

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2004

Completed
4.2 years until next milestone

First Submitted

Initial submission to the registry

April 15, 2008

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 18, 2008

Completed
Last Updated

December 16, 2014

Status Verified

December 1, 2014

Enrollment Period

9 months

First QC Date

April 15, 2008

Last Update Submit

December 15, 2014

Conditions

Erectile Dysfunction

Keywords

Erectile dysfunctionSexual Dysfunction

Outcome Measures

Primary Outcomes (1)

  • Erectile function (EF) domain score of the International Index of Erectile Function (IIEF)calculated as the sum of scores from Questions 1 to 5 and 15

    At Week 12 using the Last Observation Carried Forward (LOCF) method to account for dropouts.

Secondary Outcomes (5)

  • Success in penetration and maintenance as recorded in subject diaries

    At Weeks 4, 8 and 12 (as observed and at LOCF)

  • Scores for questions 3 and 4 of the IIEF

    At Weeks 4, 8 and 12 (as observed and at LOCF)

  • Other IIEF domain scores

    At Week 12 (observed and at LOCF)

  • Global Assessment Question (GAQ) responses

    At Weeks 4, 8 and 12 (as observed and at LOCF)

  • Rates of premature termination, adverse events, laboratory abnormalities, ECG abnormalities, and concomitant medication use.

    At Weeks 4, 8 and 12 (as observed and at LOCF)

Study Arms (2)

Arm 1

EXPERIMENTAL
Drug: Levitra (Vardenafil, BAY38-9456)

Arm 2

PLACEBO COMPARATOR
Drug: Placebo

Interventions

Levitra (Vardenafil, BAY38-9456)DRUG

Vardenafil 10 mg. After a 4 week run-in period, subjects were randomized in order to enroll 3 times more subjects in the vardenafil group than in the placebo group. The duration of the active treatment phase was 12 weeks

Arm 1
PlaceboDRUG

Placebo. After a 4 week run-in period, subjects were randomized in order to enroll 3 times more subjects in the vardenafil group than in the placebo group. The duration of the active treatment phase was 12 weeks

Arm 2

Eligibility Criteria

Age21 Years+
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Men 21 years or above with ED for more than 6 months with normal libido and stable heterosexual relationship of at least 6 months
  • having at least a 50% failure rate of sexual intercourse attempts during the run-in phase

You may not qualify if:

  • Subjects with penile abnormalities, hypogonadism, history of unstable angina pectoris for 6 months or less, myocardial infarction, life threatening arrhythmia and history of unresponsiveness to sildenafil were excluded.
  • Diabetic subjects with hemoglobin A1c (HbA1c) more than 12% were also excluded.
  • Subjects could not be on androgens/anti-androgens or alpha blockers.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

Unknown Facility

Bangalore, Karnataka, 560010, India

Location

Unknown Facility

Bangalore, Karnataka, 560054, India

Location

Unknown Facility

Belagum, Karnataka, 590010, India

Location

Unknown Facility

Mumbai, Maharashtra, 400007, India

Location

Unknown Facility

Mumbai, Maharashtra, 400022, India

Location

Unknown Facility

Madurai, Tamil Nadu, 625107, India

Location

MeSH Terms

Conditions

Erectile DysfunctionSexual Dysfunction, Physiological

Interventions

Vardenafil Dihydrochloride

Condition Hierarchy (Ancestors)

Genital Diseases, MaleGenital DiseasesUrogenital DiseasesMale Urogenital DiseasesSexual Dysfunctions, PsychologicalMental Disorders

Intervention Hierarchy (Ancestors)

ImidazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsPiperazines

Study Officials

  • Bayer Study Director

    Bayer

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 15, 2008

First Posted

April 18, 2008

Study Start

May 1, 2003

Primary Completion

February 1, 2004

Study Completion

February 1, 2004

Last Updated

December 16, 2014

Record last verified: 2014-12

Locations

IN(6)