Study Evaluating the Effects of Avanafil on Semen Parameters

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

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

Study Overview

• Status: Completed
• Conditions: Erectile Dysfunction
• Intervention / Treatment: Drug: Placebo; Drug: avanafil

• Study Type: Interventional
• Enrollment (Actual): 181
• Phase: Phase 4

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: TRIPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
PLACEBO_COMPARATOR: Placebo; placebo	Drug: Placebo
EXPERIMENTAL: avanafil; 100 mg	Drug: avanafil; 100 mg; Other Names: TA-1790; Stendra

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: VIVUS LLC

Study record dates

Study Major Dates

• Study Start: December 1, 2012
• Primary Completion (ACTUAL): August 1, 2014
• Study Completion (ACTUAL): August 1, 2014

Study Registration Dates

• First Submitted: January 11, 2013
• First Submitted That Met QC Criteria: January 11, 2013
• First Posted (ESTIMATE): January 15, 2013

Study Record Updates

• Last Update Posted (ESTIMATE): December 14, 2015
• Last Update Submitted That Met QC Criteria: November 5, 2015
• Last Verified: November 1, 2015

More Information

Terms related to this study

• Keywords: healthy male
• Additional Relevant MeSH Terms: Mental Disorders; Sexual Dysfunctions, Psychological; Sexual Dysfunction, Physiological; Erectile Dysfunction
• Other Study ID Numbers: TA-401