Phase 4
N=181
Study Evaluating the Effects of Avanafil on Semen Parameters
Erectile Dysfunction
Bottom Line
View on ClinicalTrials.gov: NCT01768676 ↗Enrolled (actual)
181
Serious AEs
0.5%
Results posted
Dec 2015
Primary outcome: Primary: Percentage of Subjects With a Greater Than or Equal to 50% Decrease in Sperm Concentration From Baseline to Week 26 — 1.5; 14.5 percentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- avanafil (Drug); Placebo (Drug)
- Age
- Adult · 18+ yrs
- Sex
- Male
- Sponsor
- VIVUS LLC
- Primary completion
- Aug 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Subjects With a Greater Than or Equal to 50% Decrease in Sperm Concentration From Baseline to Week 26 |
1.5; 14.5 | — |
| SECONDARY Percentage of Subjects With Greater Than or Equal to 50% Reduction in Sperm Count From Baseline to Week 26 |
10.3; 21.7 | — |
| SECONDARY Percentage of Subjects With Greater Than or Equal to 50% Reduction in Sperm Motility From Baseline to Week 26 |
0; 1.4 | — |
| SECONDARY Percentage of Subjects With Greater Than or Equal to 50% Reduction in Semen Volume From Baseline to Week 26 |
0; 2.9 | — |
| SECONDARY Percentage of Subjects With Greater Than or Equal to 50% Reduction in Normal Sperm Morphology From Baseline to Week 26 |
0; 0 | — |
Summary
The purpose of this study is to determine whether avanafil will affect different aspects of sperm production.
Eligibility Criteria
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 90 beats per minute at screening (3 rechecks permitted);
- Screening systolic blood pressure 140 mmHg and/or diastolic blood pressure 90 mmHg (3 rechecks permitted);
- High serum FSH (>18.0 mIU/mL), high serum LH (>18 mIU/mL), or low serum testosterone ( 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.
Data sourced from ClinicalTrials.gov (NCT01768676). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.