NCT01698684

Brief Summary

The objectives of this study are to examine the therapeutic effects of two doses of avanafil after dosing in men with erectile dysfunction

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
440

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Sep 2012

Shorter than P25 for phase_4

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2012

Completed
24 days until next milestone

First Submitted

Initial submission to the registry

September 25, 2012

Completed
8 days until next milestone

First Posted

Study publicly available on registry

October 3, 2012

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2013

Completed
1.6 years until next milestone

Results Posted

Study results publicly available

October 27, 2014

Completed
Last Updated

October 27, 2014

Status Verified

October 1, 2014

Enrollment Period

7 months

First QC Date

September 25, 2012

Results QC Date

October 15, 2014

Last Update Submit

October 21, 2014

Conditions

Erectile Dysfunction

Keywords

ED

Outcome Measures

Primary Outcomes (1)

  • Per-subject Proportion of Sexual Attempts That Had an Erectogenic Effect Within Approximately 15 Minutes Following Dosing

    Week 0 (Baseline) up to Week 8 (End of Study)

Study Arms (3)

Placebo

PLACEBO COMPARATOR
Drug: Placebo

Avanafil 100 mg

EXPERIMENTAL
Drug: Avanafil 100 mg

Avanafil 200 mg

EXPERIMENTAL
Drug: Avanafil 200 mg

Interventions

PlaceboDRUG

One dose 15 minutes before attempting intercourse

Placebo
Avanafil 100 mgDRUG

One dose 15 minutes before attempting intercourse

Avanafil 100 mg
Avanafil 200 mgDRUG

One dose 15 minutes before attempting intercourse

Avanafil 200 mg

Eligibility Criteria

Age18 Years+
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Males ≥ 18 years of age;
  • Minimum 6 months of erectile dysfunction;
  • In a monogamous, heterosexual relationship for at least 3 months;
  • Agree to make at least 4 attempts at intercourse per month;
  • Provide written informed consent;
  • Agree not to use any other ED treatments for erectile dysfunction;
  • Willing and able to comply with all study requirements.

You may not qualify if:

  • Allergy or hypersensitivity to PDE5 inhibitors;
  • History of dose-limiting AEs with a PDE5 inhibitor or discontinued use of a PDE5 inhibitor;
  • Concomitant use of one or more of the following medications:
  • Other prescription or OTC drugs known to interfere with metabolism by the CYP 3A4 enzyme;
  • Dose of an alpha blocker that has not been stable for at least 14 days;
  • Any nitrate;
  • ED as a consequence of advanced neurologic disease, spinal cord injury,or radical prostatectomy;
  • Myocardial infarction, stroke, life-threatening arrhythmia or coronary revascularization within the past 6 months;
  • Unstable angina, angina with sexual intercourse, or congestive heart failure \> NYHA Class II;
  • Poorly controlled type 1 or type 2 diabetes;
  • Evidence of prostate cancer or previous radical prostatectomy;
  • Untreated hypogonadism or total testosterone levels outside normal reference range;
  • Abnormal laboratory value(s) judged to be clinically significant by the investigator;
  • Positive urine drug screen;
  • History of retinitis pigmentosa, nonarteritic anterior ischemic optic neuropathy or glaucoma;
  • +3 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Unknown Facility

Jupiter, Florida, United States

Location

Unknown Facility

Raleigh, North Carolina, United States

Location

Unknown Facility

Wilmington, North Carolina, United States

Location

MeSH Terms

Conditions

Erectile Dysfunction

Interventions

avanafil

Condition Hierarchy (Ancestors)

Genital Diseases, MaleGenital DiseasesUrogenital DiseasesSexual Dysfunction, PhysiologicalMale Urogenital DiseasesSexual Dysfunctions, PsychologicalMental Disorders

Results Point of Contact

Title
Wesley W Day, PhD
Organization
Vivus, Inc.
650-934-5200

Study Officials

  • Chuck Bowden, M.D.

    VIVUS LLC

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
GT60
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 25, 2012

First Posted

October 3, 2012

Study Start

September 1, 2012

Primary Completion

April 1, 2013

Study Completion

April 1, 2013

Last Updated

October 27, 2014

Results First Posted

October 27, 2014

Record last verified: 2014-10

Locations

US(3)