Erectile DysfunctionPhase 3REVIVENCT00790751

Research Evaluating an Investigational Medication for Erectile Dysfunction - General ED

A Phase 3 study testing avanafil in people with Erectile Dysfunction, run by VIVUS LLC at 41 sites in United States.

Completed

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

Trial summary

This study is being conducted to compare the safety and efficacy of 3 doses of avanafil to placebo in men with mild to severe erectile dysfunction. Read more about this study

Who is it for?: Ages 18 years and older, men only
Conditions the study is for: Erectile Dysfunction
What is being tested?: avanafil
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 646 participants
Where: 41 sitesUnited States
Study dates: Nov 2008to Aug 2009
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 years and older
Men only
No healthy volunteers
Adult, Older adult

Who may be able to join

Male subjects, age ≥ 18 years;
Minimum 6 month history of mild to severe erectile dysfunction;
Subject is in a monogamous, heterosexual relationship for at least 3 months;
Subject agrees to make at least 4 attempts at intercourse per month;
Subject is willing and able to provide informed consent.

Who cannot join

Allergy or hypersensitivity to PDE5 inhibitors;
History of dose-limiting AEs during therapy with a PDE5 inhibitor or hx of consistent treatment failure with other PDE5 inhibitors for therapy of ED;
Current or expected use of organic nitrates at any time during the study;
Previous or current antiandrogen therapy;
Use of prescription or over-the-counter drugs known to inhibit the activity of CYP3A4 at any time during the study;
Androgen replacement therapy that has not been stable for at least 3 month;

Show all 30Show fewer

Initiation or change in dose of any alpha-blocker within 14 days prior to randomization;
ED as a result of spinal cord injury or radical prostatectomy;
Untreated hypogonadism or low serum total testosterone
History of or predisposition to priapism;
Any penile implant;
Elevated PSA, other evidence of prostate cancer, or previous radical prostatectomy;
History of any malignancy (except basal cell carcinoma or squamous cell carcinoma of the skin successfully treated by curative excision);
History of type 1 or type 2 diabetes;
Uncontrolled hypertension;
Hypotension;
Orthostatic hypotension;
Significant cardiovascular disease;
Abnormal ECG;
Hepatic or renal impairment;
Positive STD screen;
Clinically evident penile lesions, abrasions, or anatomical deformities;
Urinary tract or bladder infection;
Use of any treatment for erectile dysfunction other than study drug at any time during the study;
Participation in another investigational study within 30 days of screening or at any time during this study;
Previous participation in any other investigational study of avanafil;
History or current drug, alcohol, or substance abuse;
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;
Partners who are < 18 years of age, who are nursing, who are known to be pregnant at screening, who wish to become pregnant during the study period, who have any gynecologic problems or major medical conditions that would limit participation in sexual intercourse;
Evidence of any other condition by history, physical examination, or laboratory studies that, in the opinion of the investigator, would contraindicate the administration of study medication, affect compliance, interfere with study evaluations, limit study participation, contraindicate sexual activity, or confound the interpretation of study results.

Trial locations and contacts

41 sites in 1 country.

City, postcode or hospital

41 sites in 1 country

United States41 sites

Research Site
Albany, New York, 12206
Research Site
Atlanta, Georgia, 30308
Research Site
Atlanta, Georgia, 30328
Research Site
Bala-Cynwyd, Pennsylvania, 19004
Research Site
Beachwood, Ohio, 44122
Research Site
Birmingham, Alabama, 35209
Research Site
Cary, North Carolina, 27518
Research Site
Charlotte, North Carolina, 28207
Research Site
Charlotte, North Carolina, 28209
Research Site
Clearwater, Florida, 33756
Research Site
Clearwater, Florida, 33761
Research Site
Coral Gables, Florida, 33134
Research Site
El Paso, Texas, 79925
Research Site
Harrisburg, North Carolina, 28075
Research Site
Hialeah, Florida, 33012
Research Site
Hickory, North Carolina, 28601
Research Site
Homewood, Alabama, 35209
Research Site
Houston, Texas, 77074
Research Site
Jacksonville, Florida, 32205
Research Site
Jacksonville, Florida, 32259
Research Site
Jupiter, Florida, 33458
Research Site
Kansas City, Missouri, 64114
Research Site
Lancaster, Pennsylvania, 17601
Research Site
Lawrenceville, New Jersey, 08648
Research Site
Madisonville, Kentucky, 42431
Research Site
New York, New York, 10016
Research Site
Ocala, Florida, 34471
Research Site
Pembroke Pines, Florida, 33024
Research Site
Raleigh, North Carolina, 27609
Research Site
Sacramento, California, 95821
Research Site
Salisbury, North Carolina, 28144
Research Site
San Diego, California, 92120
Research Site
San Diego, California, 92123
Research Site
Shreveport, Louisiana, 71106
Research Site
Spring, Texas, 77386
Research Site
Tampa, Florida, 33624
Research Site
Tucson, Arizona, 85712
Research Site
Waterbury, Connecticut, 06708
Research Site
Wichita, Kansas, 67205
Research Site
Wilmington, North Carolina, 28401
Research Site
Winston-Salem, North Carolina, 27103

Other trials in United States

About this study

Official title: A Randomized, Double-Blind, Placebo-Controlled Evaluation of the Safety and Efficacy of Avanafil (TA-1790) in Subjects With Generalized Erectile Dysfunction

This study is being conducted to compare the safety and efficacy of 3 doses of avanafil to placebo in men with mild to severe erectile dysfunction.

Conditions: Erectile Dysfunction
Being tested: placebo, avanafil
Keywords: ED, Erectile Dysfunction, Dysfunction, Erectile
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
30 minutes orally prior to initiation of sexual activity
avanafilDrug
Also called TA-1790, Stendra
30 minutes orally prior to initiation of sexual activity
avanafilDrug
Also called TA-1790, Stendra
30 minutes orally prior to initiation of sexual activity
avanafilDrug
Also called TA-1790, Stendra
30 minutes orally prior to initiation of sexual activity

Study groups in NCT00790751
Study group	Role	What they receive
placebo	Placebo comparator	Not described Receives: Drug: placebo
avanafil 50 mg	Experimental	Not described Receives: Drug: avanafil
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 Were 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, 12 weeks
Change in Percentage of Sexual Attempts in Which Subjects Were 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, 12 weeks
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 score from questions 1-5 \& 15 ranges 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.

Nov 2008Aug 2009

First posted13 Nov 2008 (estimated)
Study startNov 2008
Primary completionAug 2009
Study completionAug 2009

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: 646 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00790751
Sponsor's protocol ID: TA-301
Acronym: REVIVE
Status last verified: Jun 2012
First submitted: 10 Nov 2008
Last updated: 11 Jul 2012
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

Goldstein I, McCullough AR, Jones LA, Hellstrom WJ, Bowden CH, Didonato K, Trask B, Day WW. A randomized, double-blind, placebo-controlled evaluation of the safety and efficacy of avanafil in subjects with erectile dysfunction. J Sex Med. 2012 Apr;9(4):1122-33. doi: 10.1111/j.1743-6109.2011.02629.x. Epub 2012 Jan 16.
PubMed 22248153

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 4
Assessment of the Value of FAPI and FDG-PET-CT in Diagnosis of Acute Phase Peyronie's Disease
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RecruitingPhase 3
A Study to Evaluate Efficacy and Safety of HIP2602 in Erectile Dysfunction Patients
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RecruitingPhase 2
Multimodal Prehabilitation and Rehabilitation for Men Undergoing Robot-Assisted Radical Prostatectomy
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Active, not recruiting
Efficacy of Low-dose Percutaneous Electrical Stimulation in Patients With Erectile Dysfunction.
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Active, not recruiting
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All Erectile Dysfunction trials

Study at a glance

From the registry record, last updated by the sponsor on 11 Jul 2012. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomized, Double-Blind, Placebo-Controlled Evaluation of the Safety and Efficacy of Avanafil (TA-1790) in Subjects With Generalized Erectile Dysfunction
ClinicalTrials.gov ID: NCT00790751
Acronym / sponsor ID: REVIVE / TA-301
Conditions: Erectile Dysfunction
Keywords: ED, Erectile Dysfunction, Dysfunction, Erectile
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 646 participants (actual)
Lead sponsor: VIVUS LLCIndustry (pharma, biotech, devices)
Study start: Nov 2008
Primary completion: Aug 2009 (actual)
Study completion: Aug 2009 (actual)
First posted: 13 Nov 2008 (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.

This study is being conducted to compare the safety and efficacy of 3 doses of avanafil to placebo in men with mild to severe erectile dysfunction.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 4

Arm	Type	Receives
placebo	Placebo comparator	Drug: placebo
avanafil 50 mg	Experimental	Drug: avanafil
avanafil 100 mg	Experimental	Drug: avanafil
avanafil 200 mg	Experimental	Drug: avanafil

Who may qualify

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

Key inclusion criteria (5 listed)

Male subjects, age ≥ 18 years;
Minimum 6 month history of mild to severe erectile dysfunction;
Subject is in a monogamous, heterosexual relationship for at least 3 months;
Subject agrees to make at least 4 attempts at intercourse per month;
Subject is willing and able to provide informed consent.

Key exclusion criteria (30 listed)

Allergy or hypersensitivity to PDE5 inhibitors;
History of dose-limiting AEs during therapy with a PDE5 inhibitor or hx of consistent treatment failure with other PDE5 inhibitors for therapy of ED;
Current or expected use of organic nitrates at any time during the study;
Previous or current antiandrogen therapy;
Use of prescription or over-the-counter drugs known to inhibit the activity of CYP3A4 at any time during the study;

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
placebo30 minutes orally prior to initiation of sexual activity	Drug	placebo
avanafilAlso: TA-1790, Stendra30 minutes orally prior to initiation of sexual activity	Drug	avanafil 50 mg
avanafilAlso: TA-1790, Stendra30 minutes orally prior to initiation of sexual activity	Drug	avanafil 100 mg
avanafilAlso: TA-1790, Stendra30 minutes orally prior to initiation of sexual activity	Drug	avanafil 200 mg

Primary outcome

Change in Percentage of Sexual Attempts in Which Subjects Were Able to Maintain an Erection of Sufficient Duration to Have Successful Intercourse
Time frame: Baseline, 12 weeks
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?"
Change in Percentage of Sexual Attempts in Which Subjects Were Able to Insert the Penis Into the Partner's Vagina
Time frame: Baseline, 12 weeks
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 score from questions 1-5 \& 15 ranges 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	162	137
Avanafil 50 mg	161	131
Avanafil 100 mg	161	141
Avanafil 200 mg	162	141

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

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

Measure	Placebo n = 155	Avanafil 50 mg n = 154	Avanafil 100 mg n = 157	Avanafil 200 mg n = 156
Value	14.1 (2.57)	27.8 (2.58)	43.4 (2.56)	44.2 (2.57)

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

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

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

Measure	Placebo n = 155	Avanafil 50 mg n = 154	Avanafil 100 mg n = 157	Avanafil 200 mg n = 156
Value	7.1 (2.33)	18.2 (2.34)	27.2 (2.32)	29.8 (2.33)

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 = 152	Avanafil 50 mg n = 152	Avanafil 100 mg n = 156	Avanafil 200 mg n = 155
Value	2.9 (0.57)	5.4 (0.57)	8.3 (0.56)	9.5 (0.56)

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 2% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Placebo	2 of 161 (1.2%)	7 of 161 (4.3%)	Not reported
Avanafil 50 mg	1 of 160 (0.6%)	16 of 160 (10%)	Not reported
Avanafil 100 mg	3 of 161 (1.9%)	28 of 161 (17.4%)	Not reported
Avanafil 200 mg	3 of 162 (1.9%)	31 of 162 (19.1%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 11 Jul 2012.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publication: PubMed 22248153Goldstein I, McCullough AR, Jones LA, Hellstrom WJ, Bowden CH, Didonato K, Trask B, Day WW. A randomized, double-blind, placebo-controlled evaluation of the safety and efficacy of avanafil in subjects with erectile dysfunction. J Sex Med. 2012 Apr;9(4):1122-33. doi: 10.1111/j.1743-6109.2011.02629.x. Epub 2012 Jan 16.

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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.

Irwin Goldstein, MD principal investigator

San Diego Sexual Medicine

41 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 41 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 5 inclusion and 30 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 11 Jul 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 41 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 Were Able to Maintain an Erection of Sufficient Duration to Have Successful Intercourse (time frame: Baseline, 12 weeks). 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 NCT00790751, 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 11 Jul 2012.