Study Evaluating the Effects of Avanafil on Semen Parameters

Study Overview
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Brief Summary
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The purpose of this study is to determine whether avanafil will affect different aspects of sperm production.

Official Title
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A Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Multicenter Clinical Trial of the Effect of Avanafil (STENDRA™) on Spermatogenesis in Healthy Adult Males and Adult Males With Mild Erectile Dysfunction

Conditions
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Erectile Dysfunction

Intervention / Treatment
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* Drug: avanafil
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: avanafil<br>100 mg | Drug: avanafil<br>* 100 mg<br>* Other names: Stendra;|
| Placebo Comparator: Placebo<br>placebo | Drug: Placebo<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Baseline to Week 26 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | Sperm motility was based upon the WHO grading scale: grade A, B, or C. | baseline to week 26 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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healthy male