Study Evaluating the Effects of Avanafil on Semen Parameters

Erectile Dysfunction Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01768676
• Other study ID #: TA-401
• Status: Completed
• Phase: Phase 4
• First received: January 11, 2013
• Last updated: November 5, 2015
• Start date: December 2012
• Est. completion date: August 2014

Study information

• Verified date: November 2015
• Source: VIVUS, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 181
• Est. completion date: August 2014
• Est. primary completion date: August 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 45 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Erectile Dysfunction

Intervention

Drug:
• avanafil
100 mg
• Placebo

Locations

Country	Name	City	State
United States	Research Facility	Albany	New York
United States	Research Facility	Aventura	Florida
United States	Research Facility	Bala Cynwyd	Pennsylvania
United States	Research Facility	Carmel	Indiana
United States	Research Facility	Cincinnati	Ohio
United States	Research Facility	Huntsville	Alabama
United States	Research Facility	Kansas City	Missouri
United States	Research Facility	Knoxville	Tennessee
United States	Research Facility	LA	California
United States	Research Facility	New Orleans	Louisiana
United States	Research Facility	New York	New York
United States	Research Facility	Parker	Colorado
United States	Research Facility	San Antonio	Texas
United States	Research Facility	San Diego	California
United States	Research Facility	Shreveport	Louisiana

Sponsors (1)

Lead Sponsor	Collaborator
VIVUS, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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.	Baseline to Week 26	Yes
Secondary	Percentage of Subjects With Greater Than or Equal to 50% Reduction in Sperm Count From Baseline to Week 26		baseline to week 26	Yes
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.	baseline to week 26	Yes
Secondary	Percentage of Subjects With Greater Than or Equal to 50% Reduction in Semen Volume From Baseline to Week 26		baseline to week 26	Yes
Secondary	Percentage of Subjects With Greater Than or Equal to 50% Reduction in Normal Sperm Morphology From Baseline to Week 26		baseline to week 26	Yes