Trial Outcomes & Findings for Study of Vardenafil in Patients Suffering From Erectile Dysfunction and Metabolic Syndrome (NCT NCT00738400)

NCT ID: NCT00738400

Last Updated: 2015-11-16

Results Overview

The primary variable was the least square (LS)-mean difference between treatment groups in the IIEF-EF domain score (6-30 ordinal points, specifying the severity of erectile dysfunction: 6-10 'severe'; 11-16 'moderate'; 17-21 'mild to moderate'; 22-25 'mild'; 26-30 'no erectile dysfunction \[ED\]'). The target variable is the LS-mean difference between treatment groups at endpoint. The LS-means of both treatment groups are derived from a baseline-adjusted endpoint measure (week 8/last observation carried forward \[LOCF\]) as calculated via an ANCOVA.

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 150 participants
• Primary outcome timeframe: baseline and up to 8 weeks or LOCF
• Results posted on: 2015-11-16

Participant Flow

Participant milestones

Measure	Vardenafil (Levitra, BAY38-9456) Vardenafil 10 mg tablets PRN (pro re nata) for 4 weeks, Vardenafil 5 mg/10 mg/20 mg tablets PRN for consecutive 4 weeks	Placebo Matching placebo tablets PRN (pro re nata) for 4 weeks, placebo tablets PRN for consecutive 4 weeks
Overall Study STARTED	76	74
Overall Study Received Treatment, Safety Population	75	72
Overall Study ITT (Intent To Treatment) Population	75	70
Overall Study COMPLETED	72	67
Overall Study NOT COMPLETED	4	7

Reasons for withdrawal

Measure	Vardenafil (Levitra, BAY38-9456) Vardenafil 10 mg tablets PRN (pro re nata) for 4 weeks, Vardenafil 5 mg/10 mg/20 mg tablets PRN for consecutive 4 weeks	Placebo Matching placebo tablets PRN (pro re nata) for 4 weeks, placebo tablets PRN for consecutive 4 weeks
Overall Study Adverse Event	3	1
Overall Study Withdrawal by Subject	0	1
Overall Study Lack of Efficacy	0	1
Overall Study Lost to Follow-up	0	3
Overall Study Protocol Violation	1	0
Overall Study Non-compliant with study medication	0	1

Baseline Characteristics

Study of Vardenafil in Patients Suffering From Erectile Dysfunction and Metabolic Syndrome

Baseline characteristics by cohort

Measure	Vardenafil (Levitra, BAY38-9456) n=75 Participants Vardenafil 10 mg tablets PRN (pro re nata) for 4 weeks, Vardenafil 5 mg/10 mg/20 mg tablets PRN for consecutive 4 weeks	Placebo n=72 Participants Matching placebo tablets PRN (pro re nata) for 4 weeks, placebo tablets PRN for consecutive 4 weeks	Total n=147 Participants Total of all reporting groups
Age, Continuous	56.3 years STANDARD_DEVIATION 5.9 • n=5 Participants	55.6 years STANDARD_DEVIATION 6.7 • n=7 Participants	56.0 years STANDARD_DEVIATION 6.3 • n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Sex: Female, Male Male	75 Participants n=5 Participants	72 Participants n=7 Participants	147 Participants n=5 Participants
BMI (body mass index)	30.4 kg/m^2 STANDARD_DEVIATION 3.6 • n=5 Participants	30.4 kg/m^2 STANDARD_DEVIATION 3.4 • n=7 Participants	30.4 kg/m^2 STANDARD_DEVIATION 3.5 • n=5 Participants

PRIMARY outcome

Timeframe: baseline and up to 8 weeks or LOCF

Population: Number of participants analyzed differs due to missing data.

The primary variable was the least square (LS)-mean difference between treatment groups in the IIEF-EF domain score (6-30 ordinal points, specifying the severity of erectile dysfunction: 6-10 'severe'; 11-16 'moderate'; 17-21 'mild to moderate'; 22-25 'mild'; 26-30 'no erectile dysfunction [ED]'). The target variable is the LS-mean difference between treatment groups at endpoint. The LS-means of both treatment groups are derived from a baseline-adjusted endpoint measure (week 8/last observation carried forward [LOCF]) as calculated via an ANCOVA.

Outcome measures

Measure	Vardenafil (Levitra, BAY38-9456) n=74 Participants Vardenafil 10 mg tablets PRN (pro re nata) for 4 weeks, Vardenafil 5 mg/10 mg/20 mg tablets PRN for consecutive 4 weeks	Placebo n=70 Participants Matching placebo tablets PRN (pro re nata) for 4 weeks, placebo tablets PRN for consecutive 4 weeks
Change From Baseline in International Index of Erectile Function - Erectile Function Domain (IIEF-EF) Subscore at Week 8 or Last Observation Carried Forward (LOCF)	20.96 Scores on a scale Interval 19.38 to 22.54	14.20 Scores on a scale Interval 12.57 to 15.83

PRIMARY outcome

Timeframe: Baseline and 8 weeks

Population: Number of participants analyzed differs due to missing data.

Percent successful penetrations were calculated per participant as the number of successful sexual attempts (penetrations) divided by the total number of attempts. The mean percent successful penetrations was then calculated across all participants.

Outcome measures

Measure	Vardenafil (Levitra, BAY38-9456) n=73 Participants Vardenafil 10 mg tablets PRN (pro re nata) for 4 weeks, Vardenafil 5 mg/10 mg/20 mg tablets PRN for consecutive 4 weeks	Placebo n=64 Participants Matching placebo tablets PRN (pro re nata) for 4 weeks, placebo tablets PRN for consecutive 4 weeks
Change in Percentage From Baseline in Success of Penetration (SEP2: Sexual Encounter Profile Question 2) at Week 8	73.50 Percent successful penetrations Interval 66.71 to 80.3	52.79 Percent successful penetrations Interval 45.51 to 60.08

PRIMARY outcome

Timeframe: Baseline and 8 weeks

Population: Number of participants analyzed differs due to missing data.

Percent successful maintenance of erection were calculated per participant as the number of successful attempts (maintenance of erection) divided by the total number of attempts. The mean percent successful maintenance of erection was then calculated across all participants.

Outcome measures

Measure	Vardenafil (Levitra, BAY38-9456) n=73 Participants Vardenafil 10 mg tablets PRN (pro re nata) for 4 weeks, Vardenafil 5 mg/10 mg/20 mg tablets PRN for consecutive 4 weeks	Placebo n=64 Participants Matching placebo tablets PRN (pro re nata) for 4 weeks, placebo tablets PRN for consecutive 4 weeks
Change in Percentage From Baseline in Success of Erection Maintenance (SEP3: Sexual Encounter Profile Question 3) at Week 8	53.15 Percent erection maintenance Interval 45.42 to 60.89	27.00 Percent erection maintenance Interval 18.7 to 35.29

SECONDARY outcome

Timeframe: up to 8 weeks or LOCF

Population: Number of participants analyzed differs due to missing data.

Responders: percentage of participants achieving an IIEF-EF score >25.(IIEF-EF domain score: 6-30 ordinal points, specifying the severity of erectile dysfunction: 6-10 'severe'; 11-16 'moderate'; 17-21 'mild to moderate'; 22-25 'mild'; 26-30 'no ED')

Outcome measures

Measure	Vardenafil (Levitra, BAY38-9456) n=74 Participants Vardenafil 10 mg tablets PRN (pro re nata) for 4 weeks, Vardenafil 5 mg/10 mg/20 mg tablets PRN for consecutive 4 weeks	Placebo n=70 Participants Matching placebo tablets PRN (pro re nata) for 4 weeks, placebo tablets PRN for consecutive 4 weeks
Percentage of Participants Achieving "Back to Normal" Erectile Function at Week 8 or Last Observation Carried Forward (LOCF)	35 Percentage of participants	10 Percentage of participants

SECONDARY outcome

Timeframe: Baseline and 8 weeks

Population: Number of participants analyzed differs due to missing data.

Percent successful erections were calculated per participant as the number of successful attempts (achievement of erection) divided by the total number of attempts. The mean percent successful erections was then calculated across all participants.

Outcome measures

Measure	Vardenafil (Levitra, BAY38-9456) n=73 Participants Vardenafil 10 mg tablets PRN (pro re nata) for 4 weeks, Vardenafil 5 mg/10 mg/20 mg tablets PRN for consecutive 4 weeks	Placebo n=64 Participants Matching placebo tablets PRN (pro re nata) for 4 weeks, placebo tablets PRN for consecutive 4 weeks
Change in Percentage From Baseline in Ability to Obtain an Erection (SEP1) at Week 8	91.36 Percent successful erections Interval 85.74 to 96.97	75.79 Percent successful erections Interval 69.76 to 81.81

SECONDARY outcome

Timeframe: Baseline and 8 weeks

Population: Number of participants analyzed differs due to missing data.

Percent successful ejaculations were calculated per participant as the number of successful attempts (achievement of ejaculation) divided by the total number of attempts. The mean percent successful ejaculations was then calculated across all participants.

Outcome measures

Measure	Vardenafil (Levitra, BAY38-9456) n=73 Participants Vardenafil 10 mg tablets PRN (pro re nata) for 4 weeks, Vardenafil 5 mg/10 mg/20 mg tablets PRN for consecutive 4 weeks	Placebo n=64 Participants Matching placebo tablets PRN (pro re nata) for 4 weeks, placebo tablets PRN for consecutive 4 weeks
Change in Percentage From Baseline in Ability to Ejaculate (SEP6) at Week 8	71.29 Percent successful ejaculations Interval 64.53 to 78.06	43.96 Percent successful ejaculations Interval 36.71 to 51.21

SECONDARY outcome

Timeframe: week 4 and week 8

Number of participants with no recorded titration of Vardenafil after visit 3.

Outcome measures

Measure	Vardenafil (Levitra, BAY38-9456) n=75 Participants Vardenafil 10 mg tablets PRN (pro re nata) for 4 weeks, Vardenafil 5 mg/10 mg/20 mg tablets PRN for consecutive 4 weeks	Placebo n=70 Participants Matching placebo tablets PRN (pro re nata) for 4 weeks, placebo tablets PRN for consecutive 4 weeks
Number of Participants Who Can Stay on the Initially Provided Dosage of Vardenafil (10 mg PRN (Pro re Nata))	28 Participants	13 Participants

Adverse Events

Vardenafil (Levitra, BAY38-9456)

Serious events: 0 serious events

Other events: 16 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 8 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Vardenafil (Levitra, BAY38-9456) n=75 participants at risk Vardenafil 10 mg tablets PRN (pro re nata) for 4 weeks, Vardenafil 5 mg/10 mg/20 mg tablets PRN for consecutive 4 weeks	Placebo n=72 participants at risk Matching placebo tablets PRN (pro re nata) for 4 weeks, placebo tablets PRN for consecutive 4 weeks
Infections and infestations Abscess	1.3% 1/75 • Number of events 1	0.00% 0/72
Infections and infestations Balanitis candida	0.00% 0/75	1.4% 1/72 • Number of events 1
Infections and infestations Nasopharyngitis	4.0% 3/75 • Number of events 3	1.4% 1/72 • Number of events 1
Metabolism and nutrition disorders Diabetes mellitus	0.00% 0/75	1.4% 1/72 • Number of events 1
Musculoskeletal and connective tissue disorders Back pain	2.7% 2/75 • Number of events 2	0.00% 0/72
Musculoskeletal and connective tissue disorders Pain in extremity	1.3% 1/75 • Number of events 1	0.00% 0/72
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Bladder cancer	0.00% 0/75	1.4% 1/72 • Number of events 1
Nervous system disorders Headache	9.3% 7/75 • Number of events 13	1.4% 1/72 • Number of events 1
Psychiatric disorders Depression	0.00% 0/75	1.4% 1/72 • Number of events 1
Psychiatric disorders Premature ejaculation	1.3% 1/75 • Number of events 1	0.00% 0/72
Reproductive system and breast disorders Balanitis	1.3% 1/75 • Number of events 1	0.00% 0/72
Vascular disorders Flushing	1.3% 1/75 • Number of events 4	0.00% 0/72
Cardiac disorders Arrhythmia	1.3% 1/75 • Number of events 1	0.00% 0/72
Ear and labyrinth disorders Tinnitus	0.00% 0/75	1.4% 1/72 • Number of events 1
Gastrointestinal disorders Diarrhoea	0.00% 0/75	1.4% 1/72 • Number of events 1
Gastrointestinal disorders Nausea	0.00% 0/75	2.8% 2/72 • Number of events 2
Gastrointestinal disorders Reflux oesophagitis	1.3% 1/75 • Number of events 1	0.00% 0/72

Additional Information

Therapeutic Area Head

BAYER

Email: clinical-trials-contact@bayerhealthcare.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place

Restriction type: LTE60