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Study Evaluating the Effects of Avanafil on Semen Parameters

Primary Purpose

Erectile Dysfunction

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
avanafil
Placebo
Sponsored by
VIVUS LLC
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Erectile Dysfunction focused on measuring healthy male

Eligibility Criteria

18 Years - 45 Years (Adult)MaleAccepts Healthy Volunteers

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.

Sites / Locations

  • Research Facility
  • Research Facility
  • Research Facility
  • Research Facility
  • Research Facility
  • Research Facility
  • Research Facility
  • Research Facility
  • Research Facility
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  • Research Facility
  • Research Facility
  • Research Facility
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  • Research Facility

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

avanafil

Placebo

Arm Description

100 mg

placebo

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Percentage of Subjects With Greater Than or Equal to 50% Reduction in Sperm Count From 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.
Percentage of Subjects With Greater Than or Equal to 50% Reduction in Semen Volume From Baseline to Week 26
Percentage of Subjects With Greater Than or Equal to 50% Reduction in Normal Sperm Morphology From Baseline to Week 26

Full Information

First Posted
January 11, 2013
Last Updated
November 5, 2015
Sponsor
VIVUS LLC
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1. Study Identification

Unique Protocol Identification Number
NCT01768676
Brief Title
Study Evaluating the Effects of Avanafil on Semen Parameters
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
Study Type
Interventional

2. Study Status

Record Verification Date
November 2015
Overall Recruitment Status
Completed
Study Start Date
December 2012 (undefined)
Primary Completion Date
August 2014 (Actual)
Study Completion Date
August 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
VIVUS LLC

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Erectile Dysfunction
Keywords
healthy male

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
181 (Actual)

8. Arms, Groups, and Interventions

Arm Title
avanafil
Arm Type
Experimental
Arm Description
100 mg
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
placebo
Intervention Type
Drug
Intervention Name(s)
avanafil
Other Intervention Name(s)
TA-1790, Stendra
Intervention Description
100 mg
Intervention Type
Drug
Intervention Name(s)
Placebo
Primary Outcome Measure Information:
Title
Percentage of Subjects With a Greater Than or Equal to 50% Decrease in Sperm Concentration From Baseline to Week 26
Description
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
Secondary Outcome Measure Information:
Title
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
Title
Percentage of Subjects With Greater Than or Equal to 50% Reduction in Sperm Motility From Baseline to Week 26
Description
Sperm motility was based upon the WHO grading scale: grade A, B, or C.
Time Frame
baseline to week 26
Title
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
Title
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

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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 <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.
Facility Information:
Facility Name
Research Facility
City
Huntsville
State/Province
Alabama
Country
United States
Facility Name
Research Facility
City
LA
State/Province
California
Country
United States
Facility Name
Research Facility
City
San Diego
State/Province
California
Country
United States
Facility Name
Research Facility
City
Parker
State/Province
Colorado
Country
United States
Facility Name
Research Facility
City
Aventura
State/Province
Florida
Country
United States
Facility Name
Research Facility
City
Carmel
State/Province
Indiana
Country
United States
Facility Name
Research Facility
City
New Orleans
State/Province
Louisiana
Country
United States
Facility Name
Research Facility
City
Shreveport
State/Province
Louisiana
Country
United States
Facility Name
Research Facility
City
Kansas City
State/Province
Missouri
Country
United States
Facility Name
Research Facility
City
Albany
State/Province
New York
Country
United States
Facility Name
Research Facility
City
New York
State/Province
New York
Country
United States
Facility Name
Research Facility
City
Cincinnati
State/Province
Ohio
Country
United States
Facility Name
Research Facility
City
Bala Cynwyd
State/Province
Pennsylvania
Country
United States
Facility Name
Research Facility
City
Knoxville
State/Province
Tennessee
Country
United States
Facility Name
Research Facility
City
San Antonio
State/Province
Texas
Country
United States

12. IPD Sharing Statement

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Study Evaluating the Effects of Avanafil on Semen Parameters

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