Research Evaluating an Investigational Medication for Erectile Dysfunction - Post-Prostatectomy

A Phase 3 study testing Avanafil in people with Erectile Dysfunction, run by VIVUS LLC at 51 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

The objectives of this study are to evaluate the safety and efficacy of two doses of avanafil in the treatment of adult males for erectile dysfunction following bilateral nerve-sparing radical prostatectomy. Read more about this study

Who is it for?: Ages 18 to 70 years, men only
Conditions the study is for: Erectile Dysfunction
What is being tested?: Avanafil
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 298 participants
Where: 51 sitesUnited States
Study dates: Apr 2009to Apr 2011
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 70 years
Men only
No healthy volunteers
Adult, Older adult

Who may be able to join

Adult males ≥ 18 years and ≤ 70 years;
Have a history of erectile dysfunction of at least 6 months duration following bilateral nerve-sparing retropubic radical prostatectomy;
Have a PSA level consistent with the absence of prostate cancer;
Have a history of sexual potency prior to radical prostatectomy without requiring medical therapy;
Be in a monogamous, heterosexual relationship with their current partner for at least 3 months;
Provide written informed consent;

Show all 9Show fewer

Agree to make at least 4 attempts at intercourse per month;
Agree not to use any other treatments for erectile dysfunction;
Be willing and able to comply with all study requirements (including scheduled study visits, treatment plans, laboratory tests and other study procedures).

Who cannot join

Allergy or hypersensitivity to PDE5 inhibitors or any of the components of these drug products;
History of dose-limiting AEs during prior treatment with a PDE5 inhibitor or discontinued use of a PDE5 inhibitor due to lack of efficacy at the highest tolerated dose;
Concomitant use of one or more of the following medications:
Any nitrate, trazodone, itraconazole, ketoconazole, erythromycin, or cimetidine;
Other prescription or OTC drugs that are known to interfere with metabolism by the CYP 3A4 enzyme;
If receiving hormone replacement therapy (including thyroid supplementation), dose that has not been stable for at least 3 months;

Show all 39Show fewer

If treated with an alpha blocker, dose that has not been stable for at least 14 days;
Erectile dysfunction as a consequence of advanced neurologic disease, spinal cord injury, or diabetes;
History of severe erectile dysfunction requiring medical therapy prior to bilateral nerve-sparing radical prostatectomy;
History of previous pelvic surgery, brachytherapy, or cryotherapy of the prostate;
Sexual partner who is under 18 years of age, pregnant, intends to become pregnant during the course of the study, is breastfeeding, has dyspareunia or other gynecologic conditions or other major medical conditions that would interfere with sexual activity or would have difficulty complying with study requirements;
Uncontrolled hypertension;
Hypotension;
Orthostatic hypotension;
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;
History or ECG evidence of any high-risk arrhythmia or clinically significant ECG;
Hypertrophic, obstructive, or other clinically significant cardiomyopathy, moderate or severe cardiac valvular disease;
Type 1 or type 2 diabetes, history of use of any antidiabetic medication;
Clinically evident penile lesions, abrasions, anatomical deformities such as penile fibrosis, Peyronie's disease, penile implants, urinary tract or bladder infection, or sexually transmissible disease that the investigator deems to be clinically significant;
Condition(s) predisposing to priapism, such as sickle cell disease , multiple myeloma, or leukemia;
Any malignancy other than carcinoma of the prostate (except basal cell carcinoma or squamous cell carcinoma of the skin);
Prior use of, or likely to require radiotherapy, chemotherapy, androgen deprivation therapy, cryotherapy, non-nerve-sparing surgery, and/or bladder or penile surgery during the study;
Evidence of significant hepatic impairment;
On dialysis, or history of renal transplantation;
Untreated hypogonadism or low serum total testosterone;
Abnormal laboratory value(s) judged to be clinically significant by the investigator;
Positive STD screen (syphilis, gonorrhea, or chlamydia);
Positive for HIV, HCV Ab, or HBsAg at screening;
History or current drug, alcohol, or substance abuse;
Positive urine drug screen;
Positive breath alcohol test;
Retinitis pigmentosa or nonarteritic anterior ischemic optic neuropathy;
Use of any treatment or device for treatment of erectile dysfunction;
Use of any other investigational medication or device for any indication within 30 days prior to enrollment or at any time during this study;
Previous participation in any other investigational study of avanafil;
Any history of bipolar disorder or psychosis, greater than one lifetime episode of major depression, current depression of moderate or greater severity or antidepressant use that has not been stable for at least 3 months;
Involvement in the planning and conduct of the study on the part of subject or partner;
Evidence of any clinically significant medical, psychiatric, social or other condition by history, physical examination or laboratory studies that, in the opinion of the investigator, would contraindicate the administration of study medications, affect compliance, interfere with study evaluations, limit study participation, contraindicate sexual activity or confound the interpretation of study results.

Trial locations and contacts

51 sites in 1 country.

City, postcode or hospital

51 sites in 1 country

United States51 sites

Research Site
Ann Arbor, Michigan, 48109
Research Site
Arlington, Texas, 76017
Research Site
Aurora, Colorado, 80045
Research Site
Bala-Cynwyd, Pennsylvania, 19004
Research Site
Baltimore, Maryland, 21287
Research Site
Brighton, Massachusetts, 02135
Research Site
Brooklyn, New York, 11215
Research Site
Brooklyn, New York, 11235
Research Site
Burlington, Massachusetts, 01805
Research Site
Charlottesville, Virginia, 22908
Research Site
Chicago, Illinois, 60611
Research Site
Chicago, Illinois, 60637
Research Site
Cincinnati, Ohio, 45212
Research Site
Cleveland, Ohio, 44195
Research Site
Durham, North Carolina, 27710
Research Site
Englewood, Colorado, 80113
Research Site
Fairfax, Virginia, 22030
Research Site
Garden City, New York, 11530
Research Site
Great Neck, New York, 11021
Research Site
Greensboro, North Carolina, 27403
Research Site
Hackensack, New Jersey, 07601
Research Site
Houston, Texas, 77030
Research Site
Indianapolis, Indiana, 46202
Research Site
Jacksonville, Florida, 32224
Research Site
Jamaica Plain, Massachusetts, 02130
Research Site
Laguna Hills, California, 92653
Research Site
Lawrenceville, New Jersey, 08648
Research Site
Los Angeles, California, 90073
Research Site
Los Angeles, California, 90095
Research Site
Miami, Florida, 33136
Research Site
Myrtle Beach, South Carolina, 29572
Research Site
Nashville, Tennessee, 37232
Research Site
New Orleans, Louisiana, 70112
Research Site
New York, New York, 10016
Research Site
New York, New York, 10029
Research Site
New York, New York, 10065
Research Site
Parker, Colorado, 80134
Research Site
Philadelphia, Pennsylvania, 19107
Research Site
Philadelphia, Pennsylvania, 19111
Research Site
Phoenix, Arizona, 85050
Research Site
Poughkeepsie, New York, 12601
Research Site
Richmond, Virginia, 23235
Research Site
Rock Hill, South Carolina, 29732
Research Site
Sacramento, California, 95817
Research Site
San Antonio, Texas, 78229
Research Site
Shreveport, Louisiana, 71106
Research Site
Springfield, Illinois, 62703
Research Site
Temple, Texas, 76508
Research Site
Towson, Maryland, 21204
Research Site
Trinity, Florida, 34655
Research Site
Washington D.C., District of Columbia, 20006

Other trials in United States

About this study

Official title: A Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Multicenter Study of the Safety and Efficacy of Avanafil in the Treatment of Erectile Dysfunction Following Bilateral Nerve-Sparing Radical Prostatectomy

Conditions: Erectile Dysfunction
Being tested: Placebo, Avanafil
Keywords: Erectile Dysfunction, E.D.
Medical subject headings: Erectile Dysfunction

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

PlaceboDrug
One dose 30 minutes prior to initiation of sexual activity
AvanafilDrug
Also called TA-1790, Stendra
One dose 30 minutes prior to initiation of sexual activity
AvanafilDrug
Also called TA-1790, Stendra
One dose 30 minutes prior to initiation of sexual activity

Study groups in NCT00895011
Study group	Role	What they receive
Placebo	Placebo comparator	Not described Receives: Drug: Placebo
Avanafil 100 mg	Experimental	Not described Receives: Drug: Avanafil
Avanafil 200 mg	Experimental	Not described Receives: Drug: Avanafil

What is being measured

The primary outcome is the main question the study is designed to answer.

Change in Percentage of Sexual Attempts in Which Subjects Are Able to Maintain an Erection of Sufficient Duration to Have Successful Intercourse
Data presented as mean change from baseline in the percentage of Yes responses to Sexual Encounter Profile (SEP) diary question 3 "Did your erection last long enough for you to have successful intercourse?"
Measured: Baseline, Week 12
The Change in Percentage of Sexual Attempts in Which Subjects Are Able to Insert the Penis Into the Partner's Vagina
Data presented as mean change from baseline in the percentage of Yes responses to Sexual Encounter Profile (SEP) diary question 2 "Were you able to insert your penis into your partner's vagina?"
Measured: Baseline, Week 12
Change in International Index of Erectile Function - Erectile Function Domain (IIEF-EF) Score
Questionnaire assesses subject's evaluation of erectile function over the previous 4-week period. Total scores from questions 1-5 \& 15 range from 1 to 30. A higher score indicates better erectile function.
Measured: Baseline, End of Treatment (up to 12 weeks)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Apr 2009Apr 2011

First posted7 May 2009 (estimated)
Study startApr 2009
Primary completionApr 2011
Study completionApr 2011

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Erectile DysfunctionStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 298 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00895011
Sponsor's protocol ID: TA-303
Status last verified: Sep 2012
First submitted: 5 May 2009
Last updated: 1 Oct 2012
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

Mulhall JP, Burnett AL, Wang R, McVary KT, Moul JW, Bowden CH, DiDonato K, Shih W, Day WW. A phase 3, placebo controlled study of the safety and efficacy of avanafil for the treatment of erectile dysfunction after nerve sparing radical prostatectomy. J Urol. 2013 Jun;189(6):2229-36. doi: 10.1016/j.juro.2012.11.177. Epub 2012 Dec 3.
PubMed 23219537

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingPhase 2
Multimodal Prehabilitation and Rehabilitation for Men Undergoing Robot-Assisted Radical Prostatectomy
Erectile Dysfunction Following Radical Prostatectomy, Prostate Cancer
Active, not recruiting
Treatment With Peripheral Nerve Stimulation of the Pudendal Nerve in Patients With Erectile Dysfunction
Erectile Dysfunction, Electric Stimulation
Active, not recruiting
Efficacy of Low-dose Percutaneous Electrical Stimulation in Patients With Erectile Dysfunction.
Pudendal Nerve Injury, Erectile Dysfunction
Recruiting
Concurrent Low Intensity Shockwave Therapy on Collagenase Clostridium Histolyticum for Peyronie's Disease
Peyronie Disease, Erectile Dysfunction
Recruiting
Embolosclerotherapy Versus Deep Dorsal Vein Revascularization in Venogenic Erectile Dysfunction
Erectile Dysfunction Due to Venous Disorder, Erectile Dysfunction (ED)

All Erectile Dysfunction trials

Study at a glance

From the registry record, last updated by the sponsor on 1 Oct 2012. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Multicenter Study of the Safety and Efficacy of Avanafil in the Treatment of Erectile Dysfunction Following Bilateral Nerve-Sparing Radical Prostatectomy
ClinicalTrials.gov ID: NCT00895011
Acronym / sponsor ID: TA-303
Conditions: Erectile Dysfunction
Keywords: Erectile Dysfunction, E.D.
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 298 participants (actual)
Lead sponsor: VIVUS LLCIndustry (pharma, biotech, devices)
Study start: Apr 2009
Primary completion: Apr 2011 (actual)
Study completion: Apr 2011 (actual)
First posted: 7 May 2009 (estimated)
Results: Posted 28 Jun 2012

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 3

Arm	Type	Receives
Placebo	Placebo comparator	Drug: Placebo
Avanafil 100 mg	Experimental	Drug: Avanafil
Avanafil 200 mg	Experimental	Drug: Avanafil

Who may qualify

Ages: 18 to 70 years
Sex: Male only
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (9 listed)

Adult males ≥ 18 years and ≤ 70 years;
Have a history of erectile dysfunction of at least 6 months duration following bilateral nerve-sparing retropubic radical prostatectomy;
Have a PSA level consistent with the absence of prostate cancer;
Have a history of sexual potency prior to radical prostatectomy without requiring medical therapy;
Be in a monogamous, heterosexual relationship with their current partner for at least 3 months;

Key exclusion criteria (39 listed)

Allergy or hypersensitivity to PDE5 inhibitors or any of the components of these drug products;
History of dose-limiting AEs during prior treatment with a PDE5 inhibitor or discontinued use of a PDE5 inhibitor due to lack of efficacy at the highest tolerated dose;
Concomitant use of one or more of the following medications:
Erectile dysfunction as a consequence of advanced neurologic disease, spinal cord injury, or diabetes;
History of severe erectile dysfunction requiring medical therapy prior to bilateral nerve-sparing radical prostatectomy;

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
PlaceboOne dose 30 minutes prior to initiation of sexual activity	Drug	Placebo
AvanafilAlso: TA-1790, StendraOne dose 30 minutes prior to initiation of sexual activity	Drug	Avanafil 100 mg
AvanafilAlso: TA-1790, StendraOne dose 30 minutes prior to initiation of sexual activity	Drug	Avanafil 200 mg

Primary outcome

Change in Percentage of Sexual Attempts in Which Subjects Are Able to Maintain an Erection of Sufficient Duration to Have Successful Intercourse
Time frame: Baseline, Week 12
Data presented as mean change from baseline in the percentage of Yes responses to Sexual Encounter Profile (SEP) diary question 3 "Did your erection last long enough for you to have successful intercourse?"
The Change in Percentage of Sexual Attempts in Which Subjects Are Able to Insert the Penis Into the Partner's Vagina
Time frame: Baseline, Week 12
Data presented as mean change from baseline in the percentage of Yes responses to Sexual Encounter Profile (SEP) diary question 2 "Were you able to insert your penis into your partner's vagina?"
Change in International Index of Erectile Function - Erectile Function Domain (IIEF-EF) Score
Time frame: Baseline, End of Treatment (up to 12 weeks)
Questionnaire assesses subject's evaluation of erectile function over the previous 4-week period. Total scores from questions 1-5 \& 15 range from 1 to 30. A higher score indicates better erectile function.

Results and safety

Results posted to the registry on 28 Jun 2012, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Placebo	100	76
Avanafil 100 mg	99	85
Avanafil 200 mg	99	91

Primary outcome: Change in Percentage of Sexual Attempts in Which Subjects Are Able to Maintain an Erection of Sufficient Duration to Have Successful Intercourse

Time frame: Baseline, Week 12. Least squares mean (Standard Error). Unit: percentage of sexual attempts

Measure	Placebo n = 96	Avanafil 100 mg n = 94	Avanafil 200 mg n = 96
Value	13.9 (3.42)	28.0 (3.54)	29.4 (3.33)

Population analysed: Number of participants analyzed represents the Intent-to-Treat population.

Primary outcome: The Change in Percentage of Sexual Attempts in Which Subjects Are Able to Insert the Penis Into the Partner's Vagina

Time frame: Baseline, Week 12. Least squares mean (Standard Deviation). Unit: Percentage of Sexual Attempts

Measure	Placebo n = 96	Avanafil 100 mg n = 94	Avanafil 200 mg n = 96
Value	7.5 (3.68)	22.3 (3.66)	27.7 (3.48)

Population analysed: Number of participants analyzed represents the Intent-to-Treat population.

Primary outcome: Change in International Index of Erectile Function - Erectile Function Domain (IIEF-EF) Score

Time frame: Baseline, End of Treatment (up to 12 weeks). Least squares mean (Standard Error). Unit: scores on a scale

Measure	Placebo n = 95	Avanafil 100 mg n = 94	Avanafil 200 mg n = 96
Value	1.2 (1.16)	4.7 (1.18)	6.2 (1.11)

Population analysed: Number of participants analyzed represents the Intent-to-Treat population. For dropouts or missing data, the last observation carried forward convention was used.

Adverse events

Time frame: AE reporting began when the subject provided written informed consent and extended until 28 calendar days after the last dose of the investigational product was administered, or until the subject was discontinued from the study, whichever was later.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Placebo	0 of 100 (0%)	1 of 100 (1%)	Not reported
Avanafil 100 mg	0 of 99 (0%)	16 of 99 (16.2%)	Not reported
Avanafil 200 mg	0 of 99 (0%)	27 of 99 (27.3%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2012.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 23219537Mulhall JP, Burnett AL, Wang R, McVary KT, Moul JW, Bowden CH, DiDonato K, Shih W, Day WW. A phase 3, placebo controlled study of the safety and efficacy of avanafil for the treatment of erectile dysfunction after nerve sparing radical prostatectomy. J Urol. 2013 Jun;189(6):2229-36. doi: 10.1016/j.juro.2012.11.177. Epub 2012 Dec 3.

Related trials for Erectile Dysfunction

RecruitingPhase 2
Multimodal Prehabilitation and Rehabilitation for Men Undergoing Robot-Assisted Radical Prostatectomy
Erectile Dysfunction Following Radical Prostatectomy, Prostate Cancer
Active, not recruiting
Treatment With Peripheral Nerve Stimulation of the Pudendal Nerve in Patients With Erectile Dysfunction
Erectile Dysfunction, Electric Stimulation
Active, not recruiting
Efficacy of Low-dose Percutaneous Electrical Stimulation in Patients With Erectile Dysfunction.
Pudendal Nerve Injury, Erectile Dysfunction
Recruiting
Concurrent Low Intensity Shockwave Therapy on Collagenase Clostridium Histolyticum for Peyronie's Disease
Peyronie Disease, Erectile Dysfunction
Recruiting
Embolosclerotherapy Versus Deep Dorsal Vein Revascularization in Venogenic Erectile Dysfunction
Erectile Dysfunction Due to Venous Disorder, Erectile Dysfunction (ED)

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

John Mulhall, MD study director

Memorial Sloan Kettering Cancer Center

51 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Avanafil in people with Erectile Dysfunction, run by VIVUS LLC at 51 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 39 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 1 Oct 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 51 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 28 Jun 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Percentage of Sexual Attempts in Which Subjects Are Able to Maintain an Erection of Sufficient Duration to Have Successful Intercourse (time frame: Baseline, Week 12). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00895011, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Oct 2012.