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Erectile DysfunctionPhase 3ALERTNCT00903981

Therapeutic Confirmatory Study to Evaluate the Efficacy and Safety of Avanafil

A Phase 3 study testing Avanafil in people with Erectile Dysfunction, run by JW Pharmaceutical at 1 site in South Korea.

Completed

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

Official record
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Trial summary

The purpose of this study is to confirm the efficacy and the safety of Avanafil 100mg, 200mg or placebo administered orally for 12 weeks in patients with erectile dysfunction. The efficacy is evaluated by IIEF, SEP Q2 and Q3 and GEAQ and the safety is evaluated by laboratory tests, vital signs, physical examination… Read more about this study

Who is it for?
Ages 19 to 70 years, 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
208 participants
Where
1 siteSouth Korea
Study dates
Mar 2009to Nov 2009
Phase
Phase 3
Are there results?
None posted in the registry

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 19 to 70 years
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • male subjects aged 19 to 70 with history of erectile dysfunction for at least 6 months
  • subjects have stable monogamous relationships
  • their partners are free from pregnancy and lactation and well prevent conception
  • subjects consented to participate in the clinical study in writing
  • subjects attempted sexual intercourse at least 4 times in separate days during 4 weeks' free run-in period, and failure rate is over 50%

Who cannot join

  • history of spinal cord injury or radical prostatectomy
  • subjects whose penises are anatomically deformed
  • erectile dysfunction due to neurogenic or endocrine cause
  • subjects who have uncontrolled major psychiatric disorder and do not accept therapies or have significant neurological abnormalities
  • history of cancer chemotherapy within 1 year
  • subjects who are addicted to alcohol or have continuously misused dependent drugs
Show all 21Show fewer
  • subjects who have hepatic dysfunction(GOP,GPT ≥ 3xUNL) or renal dysfunctions(serum creatinine > 2.0)
  • subjects who have uncontrollable diabetes(FPG>180)
  • subjects sho have proliferative diabetic retinopathy
  • history of stroke, transient ischemic attacks, myocardial infarction, heart failure that needs to be medically treated, unstable angina or fatal arrhythmia or coronary artery bypass graft within 6 months
  • serious hypotension or uncontrollable severe hypertension
  • hematological disorders that is likely to be developed into priapism such as sickle cell disease, multiple myeloma, leukemia
  • subjects who have retinitis pigmentosa
  • subjects who suffered from serious GI bleeding disorder within 1 year
  • subjects who took other PDE5 inhibitors or ED therapies within 2 weeks
  • subjects who use non-concomitant medications(Nitrate/NO donors, Androgens, anti-androgen, trazodone, Anticoagulant,over-the-counter drugs known to inhibit the activity of CYP3A4)
  • history of hypersensitivity to the PDE5 inhibitors or not responded to them
  • subjects who have hypoactive sexual desire
  • subjects who have no intention of having sexual intercourses 4 times in separate days during 4 weeks' free run-in period
  • subjects who took other investigational products within 30 days before this clinical study
  • subjects who are judged to be unsuitable to the clinical study by other reasons

Trial locations and contacts

1 site in 1 country.

South Korea1 site

  • Chonbuk national university hospital

    Jeonju, Cholabukdo, 561-712

Other trials in South Korea

About this study

Official title: A Randomized, Placebo Controlled, Double Blind, Multicenter Therapeutic Confirmatory Clinical Study for the Evaluation of the Efficacy and Safety of Avanafil in the Patients With Erectile Dysfunction

The purpose of this study is to confirm the efficacy and the safety of Avanafil 100mg, 200mg or placebo administered orally for 12 weeks in patients with erectile dysfunction. The efficacy is evaluated by IIEF, SEP Q2 and Q3 and GEAQ and the safety is evaluated by laboratory tests, vital signs, physical examination and adverse events.

Being tested
Avanafil, Placebo
Medical subject headings
Erectile Dysfunction

What participants receive

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

  • AvanafilDrug

    2 tablets(Avanafil 100mg tablet + Placebo 200mg tablet), 30 minutes before sexual intercourse

  • AvanafilDrug

    2 Tablets(Avanafil 200mg tablet + Placebo 100mg tablet), 30 minutes before sexual intercourse

  • PlaceboDrug

    2 Tablets(Placebo 100mg tablet + Placebo 200mg tablet), 30 minutes before sexual intercourse

Study groups in NCT00903981
Study groupRoleWhat they receive
Avanafil 100mgExperimentalNot described
Receives: Drug: Avanafil
Avanafil 200mgExperimentalNot described
Receives: Drug: Avanafil
PlaceboPlacebo comparatorNot described
Receives: Drug: Placebo

What is being measured

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

  1. Change of EF domain score in the IIEF(The International Index of Erectile Function)

    Measured: 12 weeks

Secondary outcomes (1)

  1. Change of successful rate in SEPQ2,Q3,Q4,Q5 Change of score in other domains of IIEF Change of IIEF Q3 and Q4 score GEAQ The rate of normal erectile function

    Measured: 12 weeks

Timeline

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

  1. First posted19 May 2009 (estimated)
  2. Study startMar 2009
  3. Primary completionOct 2009
  4. Study completionNov 2009

Resources

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
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
208 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00903981
Sponsor's protocol ID
CWP-AVA-301
Acronym
ALERT
Status last verified
Feb 2009
First submitted
18 May 2009
Last updated
23 Apr 2010
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Avanafil in people with Erectile Dysfunction, run by JW Pharmaceutical at 1 site in South Korea.

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 21 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 23 Apr 2010. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in South Korea. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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 of EF domain score in the IIEF(The International Index of Erectile Function) (time frame: 12 weeks). 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 NCT00903981.

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 23 Apr 2010.

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