CHAMGAP
APPROVEDReviewed and approved by the Chamgap Editorial Team (2026-07-21). The draft was written by AI, the existence of all 3 cited sources was verified at the original page, and the verdict passed blind grading and adversarial audit. Methodology v0.6.
Verdict No. 1015 · Search date 2026-07-21 · Methodology v0.6

Avanafil,
does it really help with Improvement in IIEF erectile function, penetration success on SEP2, and intercourse success on SEP3 in men with erectile dysfunction?

30-Second Summary
C
Evidence Grade C · 59 · Safety caution
Avanafil improves erectile function, penetration, and intercourse success, while nitrate contraindication and vision and priapism warnings remain essential
What the
research shows
Avanafil improves IIEF erectile-function scores, penetration success, and intercourse success in men with erectile dysfunction, but its evidence grade is C. A 646-person phase 3 trial, a separate 200-person trial in Korea, and a meta-analysis of eight randomized trials involving 3,709 participants were positive. However, positive placebo-controlled evidence is concentrated in the VIVUS phase 3 program, while the comparative trial was funded by Zydus, and no large independent placebo-controlled confirmation exists. IIEF and SEP are direct functional outcomes but do not qualify for the hard-outcome exception, so the manufacturer-evidence ceiling applies. Strong sample size and international breadth place it at the top of C, aligned with mirodenafil verdict 745 and udenafil verdict 803, with 59 points.
What the
ads claim
Simplified messaging can promise natural erections for everyone within 15 minutes, prolonged performance, and almost no adverse effects. Sexual stimulation is required, some men do not respond, onset is affected by food, alcohol, disease, and concomitant drugs, and treatment does not replace evaluation of the underlying cause.
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Useful facts when choosing a product

  • Avanafil is an as-needed prescription drug that facilitates an erectile response in the presence of sexual stimulation. A common starting dose is 100 mg approximately 15 to 30 minutes before sexual activity, but the Korean product label and prescription determine exact dose, timing, and a maximum of once daily.
  • Combining avanafil with a nitrate or nitric oxide donor can cause life-threatening hypotension and is contraindicated. Alpha blockers, other blood-pressure medicines, and strong CYP3A4 inhibitors require medical review.
  • Headache, flushing, nasal congestion, and dizziness can occur. Sudden loss of vision or hearing requires stopping the drug and urgent medical care, and people for whom sexual activity is unsafe because of cardiovascular disease need prior assessment.
  • An erection lasting four hours or longer is an emergency. Other phosphodiesterase type 5 inhibitors or erectile-dysfunction treatments should not be combined without direction, and emergency clinicians treating chest pain must be told when the last avanafil dose was taken.
Gap Measurement · Verdict 1015 · C 59
What advertising claims
What independent, higher-quality research supports
△ GAP
01

What the research actually shows

Goldstein 2012 randomized 646 men with mild to severe erectile dysfunction for twelve weeks to placebo or avanafil 50, 100, or 200 mg. Changes in SEP2 and SEP3 success and IIEF-EF favored every dose over placebo. Zhao 2012 randomized 200 Korean men with erectile dysfunction to placebo, 100 mg, or 200 mg and reproduced the primary IIEF-EF outcome and SEP2 and SEP3 benefits. Li 2019 synthesized eight randomized trials with 3,709 participants and estimated risk ratios of 3.20 for successful vaginal penetration and 2.53 for successful intercourse and a 4.57-point mean IIEF-EF advantage. Both 100 and 200 mg were generally effective, but the incremental high-dose benefit varied by outcome, and short duration and concentrated industry funding limit long-term durability and independent replication.

02

Why this is classified as C (59)

Multiple trials, including a phase 3 study in Korea, and an eight-trial meta-analysis consistently improve direct IIEF-EF, SEP2, and SEP3 functional outcomes. Positive placebo-controlled evidence is concentrated in the VIVUS phase 3 program, a comparative trial was funded by Zydus, and large independent placebo-controlled confirmation is absent. Because functional outcomes do not qualify for the hard-outcome exception, boundary rule ②-b imposes the manufacturer-evidence ceiling; strong sample size and international breadth justify the top of C, aligned with mirodenafil verdict 745 and udenafil verdict 803, at 59 points. Safety issues remain separate.

Counterpoint. For an appropriately prescribed man with erectile dysfunction and no contraindication, avanafil offers a relatively rapid as-needed option. Repeated failure should prompt review of administration, underlying disease, and alternatives rather than unsupervised dose stacking.

Rejudgment record. Cross-check incorporated — Accepted repeated IIEF-EF, SEP2, and SEP3 improvement and strong sample size and international breadth, but applied the boundary rule ②-b manufacturer ceiling because positive placebo-controlled evidence is concentrated in the VIVUS phase 3 program, the comparative trial was funded by Zydus, no large independent placebo-controlled confirmation exists, and functional outcomes do not qualify for the hard-outcome exception; aligned the upper-C rating with mirodenafil verdict 745 and udenafil verdict 803

Sub-claim grades by effect

This ingredient is marketed for several effects. A single overall grade blends strong and weak claims together, so each effect is graded separately here. The overall grade reflects the strongest disconfirming or core claim.

Effect (sub-claim)GradeBasis
Improvement in the IIEF erectile-function domainCAn approximately 4.6-point mean benefit recurs, but large independent placebo-controlled confirmation is absent and the manufacturer-evidence ceiling applies.
Improvement in penetration success on SEP2CThis direct functional outcome is positive, but evidence centers on VIVUS development trials without large independent placebo-controlled confirmation.
Improvement in intercourse success on SEP3CThis direct functional outcome is positive, but the manufacturer ceiling applies and the on-dose symptomatic benefit lacks independent confirmation.

Cross-check — Codex and Claude

This verdict was drafted by Codex through literature review and source-existence checks, cross-checked through blind grading and adversarial audit, and settled by reapplying the methodology boundary rules. Cases with split grades were resolved through rejudgment.
03

Evidence Table

StudyDesignSampleFundingEndpointResultWeight
Goldstein I et al. 2012Twelve-week multicenter randomized double-blind placebo-controlled phase 3 trial646VIVUS product-development study with employee coauthorshipIIEF-EF, penetration success on SEP2, and intercourse success on SEP3All avanafil doses of 50, 100, and 200 mg significantly improved all three outcomes versus placebo.Large direct product trial with functional outcomes
Zhao C et al. 2012 Korean phase 3 trialTwelve-week multicenter randomized double-blind placebo-controlled fixed-dose phase 3 trial200Industry product-development trialChange in IIEF-EF as the primary outcome; SEP2 and SEP3 as secondary outcomesBoth 100 mg and 200 mg significantly improved IIEF-EF, SEP2, and SEP3 versus placebo.Direct replication trial in Korean participants
Li J et al. 2019Systematic review and meta-analysis of randomized trials3,709Academic meta-analysis; included trials were predominantly industry fundedSuccessful vaginal penetration, successful intercourse, IIEF-EF, and treatment adverse eventsVersus placebo, the risk ratio was 3.20 for penetration and 2.53 for successful intercourse, with a 4.57-point mean IIEF-EF advantage.Synthesis of repeated direct functional outcomes
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Receipt — 3 References

All 3 cited sources were verified for existence at the original page (as of 2026-07-21).

Goldstein I, McCullough AR, Jones LA, et al. A randomized, double-blind, placebo-controlled evaluation of the safety and efficacy of avanafil in subjects with erectile dysfunction. J Sex Med. 2012;9(4):1122-1133. PMID: 22248153. DOI: 10.1111/j.1743-6109.2011.02629.x.
checked
Zhao C, Kim SW, Yang DY, et al. Efficacy and safety of avanafil for treating erectile dysfunction: results of a multicentre, randomized, double-blind, placebo-controlled trial. BJU Int. 2012;110(11):1801-1806. PMID: 22448738. DOI: 10.1111/j.1464-410X.2012.11095.x.
checked
Li J, Peng L, Cao D, He L, Li Y, Wei Q. Avanafil for the Treatment of Men With Erectile Dysfunction: A Systematic Review and Meta-analysis of Randomized Controlled Trials. Am J Mens Health. 2019;13(5):1557988319880764. PMID: 31672076. PMCID: PMC6826932. DOI: 10.1177/1557988319880764.
checked
Draft and rewrite: Codex (AI) · Verification: Codex blind grading and adversarial audit · Final adjudication: Claude
Reviewed and approved: Chamgap Editorial Team · Approval date: 2026-07-21 · Corrections: none

Cite this verdict

Avanafil x improved IIEF, penetration, and intercourse success in erectile dysfunction Evidence Grade C card
[Chamgap] Avanafil x improved IIEF, penetration, and intercourse success in erectile dysfunction — Evidence Grade C·59. 3 cited sources checked. Source: https://chamgap.com/en/verdicts/mens/avanafil-men-erectile-dysfunction-iief-sep2-sep3/ · CC BY 4.0

CC BY 4.0 — free to use with attribution; do not distort grades, numbers, or verdict meaning.

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What this document does and does not do

Chamgap is an information source. It reports what research has and has not confirmed; it does not tell readers what to take or buy. That decision belongs to readers and, when needed, medical or legal professionals. This verdict reflects literature available up to the search date and may change as new research appears. Nothing here is medical advice.