Erectile Dysfunction
Conditions
Keywords
healthy male
Brief summary
The purpose of this study is to determine whether avanafil will affect different aspects of sperm production.
Interventions
DRUGavanafil
100 mg
DRUGPlacebo
Sponsors
VIVUS LLC
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
MALE
Age
18 Years to 45 Years
Healthy volunteers
Yes
Inclusion criteria
* Provide written informed consent * Able to produce semen samples without requiring therapy (PDE5 inhibitors, over-the-counter (OTC) medication, and/or herbal supplements) for erectile dysfunction * Be medically healthy (no clinically significant screening results for medical history, electrocardiogram (ECG), laboratory studies, physical examination, etc.) in the opinion of the investigator * Be willing and able to comply with all study requirements
Exclusion criteria
* An International Index of Erectile Function (IIEF) erectile function domain score of less than 17; * History of infertility, vasectomy, testicular mass, testicular trauma, testicular abnormality (including size), radiation to the testis, previous pelvic surgery, cryotherapy of the prostate, known sperm defect, or retrograde ejaculation, or cryptorchidism; * Resting heart rate \<45 or \>90 beats per minute at screening (3 rechecks permitted); * Screening systolic blood pressure \<90 or \>140 mmHg and/or diastolic blood pressure \<50 or \>90 mmHg (3 rechecks permitted); * High serum FSH (\>18.0 mIU/mL), high serum LH (\>18 mIU/mL), or low serum testosterone (\< 270 ng/dL, early morning collection) on screening; * AST or ALT \>2.0 x ULN or other evidence of significant hepatic impairment; * Prostate specific antigen (PSA) level ≥4 ng/mL at screening; * Individuals who perform rotating shift work during the course of the study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Subjects With a Greater Than or Equal to 50% Decrease in Sperm Concentration From Baseline to Week 26 | Baseline to Week 26 | Subjects provided 2 semen samples at each visit 2 to 12 days apart. The average value is used as the visit result. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Subjects With Greater Than or Equal to 50% Reduction in Sperm Count From Baseline to Week 26 | baseline to week 26 | — |
| Percentage of Subjects With Greater Than or Equal to 50% Reduction in Sperm Motility From Baseline to Week 26 | baseline to week 26 | Sperm motility was based upon the WHO grading scale: grade A, B, or C. |
| Percentage of Subjects With Greater Than or Equal to 50% Reduction in Semen Volume From Baseline to Week 26 | baseline to week 26 | — |
| Percentage of Subjects With Greater Than or Equal to 50% Reduction in Normal Sperm Morphology From Baseline to Week 26 | baseline to week 26 | — |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Avanafil 100 mg once daily in the evening | 90 |
| Placebo placebo taken once daily in the evening | 91 |
| Total | 181 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 3 | 3 |
| Overall Study | Lost to Follow-up | 13 | 16 |
| Overall Study | Physician Decision | 4 | 1 |
| Overall Study | Protocol Violation | 1 | 1 |
| Overall Study | Withdrawal by Subject | 3 | 10 |
Baseline characteristics
| Characteristic | Avanafil | Placebo | Total |
|---|---|---|---|
| Age, Continuous | 34.8 years STANDARD_DEVIATION 7.23 | 32.9 years STANDARD_DEVIATION 7.11 | 33.8 years STANDARD_DEVIATION 7.21 |
| Baseline sperm concentration | 76.1 million sperm/mL STANDARD_DEVIATION 43.05 | 76.3 million sperm/mL STANDARD_DEVIATION 40.65 | 76.2 million sperm/mL STANDARD_DEVIATION 41.75 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 24 Participants | 29 Participants | 53 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 66 Participants | 62 Participants | 128 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 3 Participants | 3 Participants | 6 Participants |
| Race (NIH/OMB) Black or African American | 28 Participants | 16 Participants | 44 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 59 Participants | 71 Participants | 130 Participants |
| Region of Enrollment United States | 90 participants | 91 participants | 181 participants |
| Sex: Female, Male Female | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Male | 90 Participants | 91 Participants | 181 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 14 / 90 | 20 / 91 |
| serious Total, serious adverse events | 0 / 90 | 1 / 91 |
Outcome results
Primary
Percentage of Subjects With a Greater Than or Equal to 50% Decrease in Sperm Concentration From Baseline to Week 26
Subjects provided 2 semen samples at each visit 2 to 12 days apart. The average value is used as the visit result.
Time frame: Baseline to Week 26
Population: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Avanafil | 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 |
| Placebo | Percentage of Subjects With a Greater Than or Equal to 50% Decrease in Sperm Concentration From Baseline to Week 26 | 14.5 percentage of participants |
95% CI: [-21.56, -4.29]
Secondary
Percentage of Subjects With Greater Than or Equal to 50% Reduction in Normal Sperm Morphology From Baseline to Week 26
Time frame: baseline to week 26
Population: completers population
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Avanafil | Percentage of Subjects With Greater Than or Equal to 50% Reduction in Normal Sperm Morphology From Baseline to Week 26 | 0 percentage of participants |
| Placebo | Percentage of Subjects With Greater Than or Equal to 50% Reduction in Normal Sperm Morphology From Baseline to Week 26 | 0 percentage of participants |
95% CI: [0, 0]
Secondary
Percentage of Subjects With Greater Than or Equal to 50% Reduction in Semen Volume From Baseline to Week 26
Time frame: baseline to week 26
Population: completers population
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Avanafil | Percentage of Subjects With Greater Than or Equal to 50% Reduction in Semen Volume From Baseline to Week 26 | 0 percentage of participants |
| Placebo | Percentage of Subjects With Greater Than or Equal to 50% Reduction in Semen Volume From Baseline to Week 26 | 2.9 percentage of participants |
95% CI: [-6.8, 1.1]
Secondary
Percentage of Subjects With Greater Than or Equal to 50% Reduction in Sperm Count From Baseline to Week 26
Time frame: baseline to week 26
Population: completers population
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Avanafil | Percentage of Subjects With Greater Than or Equal to 50% Reduction in Sperm Count From Baseline to Week 26 | 10.3 percentage of participants |
| Placebo | Percentage of Subjects With Greater Than or Equal to 50% Reduction in Sperm Count From Baseline to Week 26 | 21.7 percentage of participants |
95% CI: [-23.5, 0.7]
Secondary
Percentage of Subjects With Greater Than or Equal to 50% Reduction in Sperm Motility From Baseline to Week 26
Sperm motility was based upon the WHO grading scale: grade A, B, or C.
Time frame: baseline to week 26
Population: completers population
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Avanafil | Percentage of Subjects With Greater Than or Equal to 50% Reduction in Sperm Motility From Baseline to Week 26 | 0 percentage of participants |
| Placebo | Percentage of Subjects With Greater Than or Equal to 50% Reduction in Sperm Motility From Baseline to Week 26 | 1.4 percentage of participants |
95% CI: [-4.2, 1.3]