Trial Outcomes & Findings for Study Evaluating the Effects of Avanafil on Semen Parameters (NCT NCT01768676)
NCT ID: NCT01768676
Last Updated: 2015-12-14
Results Overview
Subjects provided 2 semen samples at each visit 2 to 12 days apart. The average value is used as the visit result.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
181 participants
Primary outcome timeframe
Baseline to Week 26
Results posted on
2015-12-14
Participant Flow
Participant milestones
| Measure |
Avanafil
100 mg once daily in the evening
|
Placebo
placebo taken once daily in the evening
|
|---|---|---|
|
Overall Study
STARTED
|
90
|
91
|
|
Overall Study
COMPLETED
|
66
|
60
|
|
Overall Study
NOT COMPLETED
|
24
|
31
|
Reasons for withdrawal
| Measure |
Avanafil
100 mg once daily in the evening
|
Placebo
placebo taken once daily in the evening
|
|---|---|---|
|
Overall Study
Adverse Event
|
3
|
3
|
|
Overall Study
Lost to Follow-up
|
13
|
16
|
|
Overall Study
Protocol Violation
|
1
|
1
|
|
Overall Study
Physician Decision
|
4
|
1
|
|
Overall Study
Withdrawal by Subject
|
3
|
10
|
Baseline Characteristics
Study Evaluating the Effects of Avanafil on Semen Parameters
Baseline characteristics by cohort
| Measure |
Avanafil
n=90 Participants
100 mg once daily in the evening
|
Placebo
n=91 Participants
placebo taken once daily in the evening
|
Total
n=181 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
34.8 years
STANDARD_DEVIATION 7.23 • n=5 Participants
|
32.9 years
STANDARD_DEVIATION 7.11 • n=7 Participants
|
33.8 years
STANDARD_DEVIATION 7.21 • 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
|
90 Participants
n=5 Participants
|
91 Participants
n=7 Participants
|
181 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
24 Participants
n=5 Participants
|
29 Participants
n=7 Participants
|
53 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
66 Participants
n=5 Participants
|
62 Participants
n=7 Participants
|
128 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
28 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
44 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
59 Participants
n=5 Participants
|
71 Participants
n=7 Participants
|
130 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
90 participants
n=5 Participants
|
91 participants
n=7 Participants
|
181 participants
n=5 Participants
|
|
Baseline sperm concentration
|
76.1 million sperm/mL
STANDARD_DEVIATION 43.05 • n=5 Participants
|
76.3 million sperm/mL
STANDARD_DEVIATION 40.65 • n=7 Participants
|
76.2 million sperm/mL
STANDARD_DEVIATION 41.75 • n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline to Week 26Population: Completer population is defined as those who completed the study through week 26 and had semen analysis at both baseline and week 26. This may differ from the definition of completers for the study flow.
Subjects provided 2 semen samples at each visit 2 to 12 days apart. The average value is used as the visit result.
Outcome measures
| Measure |
Avanafil
n=68 Participants
100 mg once daily in the evening
|
Placebo
n=69 Participants
placebo taken once daily in the evening
|
|---|---|---|
|
Percentage of Subjects With a Greater Than or Equal to 50% Decrease in Sperm Concentration From Baseline to Week 26
|
1.5 percentage of participants
|
14.5 percentage of participants
|
SECONDARY outcome
Timeframe: baseline to week 26Population: completers population
Outcome measures
| Measure |
Avanafil
n=68 Participants
100 mg once daily in the evening
|
Placebo
n=69 Participants
placebo taken once daily in the evening
|
|---|---|---|
|
Percentage of Subjects With Greater Than or Equal to 50% Reduction in Sperm Count From Baseline to Week 26
|
10.3 percentage of participants
|
21.7 percentage of participants
|
SECONDARY outcome
Timeframe: baseline to week 26Population: completers population
Sperm motility was based upon the WHO grading scale: grade A, B, or C.
Outcome measures
| Measure |
Avanafil
n=68 Participants
100 mg once daily in the evening
|
Placebo
n=69 Participants
placebo taken once daily in the evening
|
|---|---|---|
|
Percentage of Subjects With Greater Than or Equal to 50% Reduction in Sperm Motility From Baseline to Week 26
|
0 percentage of participants
|
1.4 percentage of participants
|
SECONDARY outcome
Timeframe: baseline to week 26Population: completers population
Outcome measures
| Measure |
Avanafil
n=68 Participants
100 mg once daily in the evening
|
Placebo
n=69 Participants
placebo taken once daily in the evening
|
|---|---|---|
|
Percentage of Subjects With Greater Than or Equal to 50% Reduction in Semen Volume From Baseline to Week 26
|
0 percentage of participants
|
2.9 percentage of participants
|
SECONDARY outcome
Timeframe: baseline to week 26Population: completers population
Outcome measures
| Measure |
Avanafil
n=68 Participants
100 mg once daily in the evening
|
Placebo
n=69 Participants
placebo taken once daily in the evening
|
|---|---|---|
|
Percentage of Subjects With Greater Than or Equal to 50% Reduction in Normal Sperm Morphology From Baseline to Week 26
|
0 percentage of participants
|
0 percentage of participants
|
Adverse Events
Avanafil
Serious events: 0 serious events
Other events: 14 other events
Deaths: 0 deaths
Placebo
Serious events: 1 serious events
Other events: 20 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Avanafil
n=90 participants at risk
100 mg once daily in the evening
|
Placebo
n=91 participants at risk
placebo taken once daily in the evening
|
|---|---|---|
|
Renal and urinary disorders
Nephrolithiasis
|
0.00%
0/90
|
1.1%
1/91 • Number of events 1
|
Other adverse events
| Measure |
Avanafil
n=90 participants at risk
100 mg once daily in the evening
|
Placebo
n=91 participants at risk
placebo taken once daily in the evening
|
|---|---|---|
|
Infections and infestations
Nasopharyngitis
|
2.2%
2/90 • Number of events 2
|
2.2%
2/91 • Number of events 2
|
|
Infections and infestations
Tooth abscess
|
0.00%
0/90
|
2.2%
2/91 • Number of events 3
|
|
Gastrointestinal disorders
abdominal discomfort
|
0.00%
0/90
|
2.2%
2/91 • Number of events 2
|
|
Nervous system disorders
Headache
|
3.3%
3/90 • Number of events 3
|
3.3%
3/91 • Number of events 7
|
|
Infections and infestations
Bronchititis
|
1.1%
1/90 • Number of events 1
|
0.00%
0/91
|
|
Infections and infestations
rhinitis
|
1.1%
1/90 • Number of events 1
|
0.00%
0/91
|
|
Infections and infestations
upper respiratory tract infection
|
1.1%
1/90 • Number of events 1
|
0.00%
0/91
|
|
Infections and infestations
influenza
|
0.00%
0/90
|
1.1%
1/91 • Number of events 1
|
|
Infections and infestations
periodontitis
|
0.00%
0/90
|
1.1%
1/91 • Number of events 1
|
|
Infections and infestations
pilonidal cyst
|
0.00%
0/90
|
1.1%
1/91 • Number of events 1
|
|
Infections and infestations
urinary tract infection
|
0.00%
0/90
|
1.1%
1/91 • Number of events 1
|
|
Gastrointestinal disorders
abdominal distension
|
1.1%
1/90 • Number of events 1
|
0.00%
0/91
|
|
Gastrointestinal disorders
dental caries
|
1.1%
1/90 • Number of events 1
|
0.00%
0/91
|
|
Gastrointestinal disorders
inguinal hernia
|
1.1%
1/90 • Number of events 1
|
0.00%
0/91
|
|
Gastrointestinal disorders
nausea
|
1.1%
1/90 • Number of events 1
|
1.1%
1/91 • Number of events 1
|
|
Gastrointestinal disorders
abdominal pain
|
0.00%
0/90
|
1.1%
1/91 • Number of events 1
|
|
Gastrointestinal disorders
diarrhoea
|
0.00%
0/90
|
1.1%
1/91 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
back pain
|
1.1%
1/90 • Number of events 1
|
1.1%
1/91 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
musculoskeletal discomfort
|
1.1%
1/90 • Number of events 1
|
0.00%
0/91
|
|
Musculoskeletal and connective tissue disorders
myalgia
|
1.1%
1/90 • Number of events 1
|
0.00%
0/91
|
|
Musculoskeletal and connective tissue disorders
pain in extremity
|
0.00%
0/90
|
1.1%
1/91 • Number of events 1
|
|
Nervous system disorders
hyperaesthesia
|
0.00%
0/90
|
1.1%
1/91 • Number of events 1
|
|
Vascular disorders
flushing
|
1.1%
1/90 • Number of events 1
|
0.00%
0/91
|
|
Vascular disorders
hot flush
|
1.1%
1/90 • Number of events 1
|
0.00%
0/91
|
|
Vascular disorders
hypertension
|
1.1%
1/90 • Number of events 1
|
0.00%
0/91
|
|
General disorders
pain
|
1.1%
1/90 • Number of events 1
|
0.00%
0/91
|
|
Metabolism and nutrition disorders
decreased appetite
|
1.1%
1/90 • Number of events 1
|
0.00%
0/91
|
|
Psychiatric disorders
insomnia
|
1.1%
1/90 • Number of events 1
|
0.00%
0/91
|
|
Psychiatric disorders
anxiety
|
1.1%
1/90 • Number of events 1
|
0.00%
0/91
|
|
Psychiatric disorders
premature ejaculation
|
1.1%
1/90 • Number of events 1
|
0.00%
0/91
|
|
Respiratory, thoracic and mediastinal disorders
nasal congestion
|
1.1%
1/90 • Number of events 1
|
2.2%
2/91 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
upper-airway cough syndrome
|
1.1%
1/90 • Number of events 1
|
0.00%
0/91
|
|
Respiratory, thoracic and mediastinal disorders
oropharyngeal pain
|
0.00%
0/90
|
1.1%
1/91 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
paranasal sinus hypersecretion
|
0.00%
0/90
|
1.1%
1/91 • Number of events 1
|
|
Cardiac disorders
palpitations
|
0.00%
0/90
|
1.1%
1/91 • Number of events 1
|
|
Renal and urinary disorders
nephrolithiasis
|
0.00%
0/90
|
1.1%
1/91 • Number of events 1
|
|
Renal and urinary disorders
semenuria
|
0.00%
0/90
|
1.1%
1/91 • Number of events 1
|
|
Renal and urinary disorders
urethral meatus stenosis
|
0.00%
0/90
|
1.1%
1/91 • Number of events 1
|
|
Renal and urinary disorders
urinary retention
|
0.00%
0/90
|
1.1%
1/91 • Number of events 1
|
|
Renal and urinary disorders
urinary straining
|
0.00%
0/90
|
1.1%
1/91 • Number of events 1
|
|
Renal and urinary disorders
urine flow decreased
|
0.00%
0/90
|
1.1%
1/91 • Number of events 1
|
|
Reproductive system and breast disorders
penis disorder
|
0.00%
0/90
|
1.1%
1/91 • Number of events 1
|
|
Reproductive system and breast disorders
testicular disorder
|
0.00%
0/90
|
1.1%
1/91 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
acne
|
0.00%
0/90
|
1.1%
1/91 • Number of events 1
|
Additional Information
Wesley D Day, PhD
Vivus
Phone: 650-934-5200
Results disclosure agreements
- Principal investigator is a sponsor employee After Sponsor's written notification that publication of results is no longer planned or 12 months after termination of the study at all sites, Institution \& PI may publish, upon written approval from Sponsor, results of the Study. Sponsor will be given the opportunity to review any proposed publication at least 60 days prior to submission for publication or disclosure. Upon Sponsor's written request, Institution and PI shall not publish or disclose information related to the Study.
- Publication restrictions are in place
Restriction type: OTHER