Study Evaluating the Effects of Avanafil on Semen Parameters

Phase 4

Completed

• Conditions: Erectile Dysfunction
• Interventions: Drug: Placebo; Drug: avanafil

• Registration Number: NCT01768676
• Lead Sponsor: VIVUS LLC

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2012-12
• Study First Submitted: 2013-01-11
• Study First Submitted QC: 2013-01-11
• Study First Posted: 2013-01-15
• Primary Completion: 2014-08
• Study Completion: 2014-08
• Results First Submitted: 2015-10-07
• Status Verified: 2015-11
• Results First Submitted QC: 2015-11-05
• Last Update Submitted: 2015-11-05
• Results First Posted: 2015-12-14
• Last Update Posted: 2015-12-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 181

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	placebo
avanafil	avanafil	100 mg

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Percentage of Subjects With Greater Than or Equal to 50% Reduction in Normal Sperm Morphology 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 Sperm Count From Baseline to Week 26	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

Trial Locations

Locations (1)

Research Facility; 🇺🇸 San Antonio, Texas, United States