Trial reportMayo Clinic proceedings2012
Avanafil for the treatment of erectile dysfunction: a multicenter, randomized, double-blind study in men with diabetes mellitus.
Trial report in Mayo Clinic proceedings, 2012. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00809471 (A Randomized, Double-Blind, Placebo-Controlled Evaluation of the Safety and Efficacy of Avanafil), which is not on this map. Cited by 24 papers, 2 of them syntheses that pooled it.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
A Randomized, Double-Blind, Placebo-Controlled Evaluation of the Safety and Efficacy of Avanafil (TA-1790) in the Treatment of Erectile Dysfunction in Diabetic Men
Who cites it
24 citing papers in PubMed, 2 syntheses or guidelines pooled it.
- Avanafil for male erectile dysfunction: a systematic review and meta-analysis.Asian journal of andrologyPooled it
- Avanafil for the Treatment of men With Erectile Dysfunction: A Systematic Review and Meta-analysis of Randomized Controlled Trials.American journal of men's healthPooled it
- Efficacy and safety of avanafil as compared with sildenafil in the treatment of erectile dysfunction: A randomized, double blind, multicenter clinical trial.International journal of urology : official journal of the Japanese Urological Association · 2022Trial
- Article
- Avanafil use in patients with erectile dysfunction and co-morbidities: Clinical insights from multiple aetiologies - A case series.Malaysian family physician : the official journal of the Academy of Family Physicians of Malaysia · 2025Article
- A real-world pilot study assessing treatment satisfaction with avanafil in patients with erectile dysfunction.Sexual medicine · 2024Article
- Rethinking of phosphodiesterase 5 inhibition: the old, the new and the perspective in human health.Frontiers in endocrinology · 2024Review
- The Efficacy and Safety of Avanafil During a Treatment of Male Erectile Dysfunction: A Systematic Review and Meta-Analysis of Randomized Controlled Trials.Therapeutics and clinical risk management · 2023Review
- Erectile dysfunction and diabetes: A melting pot of circumstances and treatments.Diabetes/metabolism research and reviews · 2022Review
- Bibliometric and visualization analysis of literature relating to diabetic erectile dysfunction.Frontiers in endocrinology · 2022Article
- From the PnTx2-6 Toxin to the PnPP-19 Engineered Peptide: Therapeutic Potential in Erectile Dysfunction, Nociception, and Glaucoma.Frontiers in molecular biosciences · 2022Review
- Efficacy and Safety of Avanafil in Chinese Subjects With Erectile Dysfunction: A Multi-Center, Randomized, Double-Blinded, Placebo-Controlled Phase III Clinical Trial.Sexual medicine · 2021Article
- Article
- Article
- Comparative efficacy and safety of phosphodiesterase type 5 inhibitors for erectile dysfunction in diabetic men: a Bayesian network meta-analysis of randomized controlled trials.World journal of urology · 2019Article
- Efficacy and safety of PDE5 inhibitors in the treatment of diabetes mellitus erectile dysfunction: Protocol for a systematic review.Medicine · 2018Article
- Phosphodiesterase type 5 inhibitors: back and forward from cardiac indications.Journal of endocrinological investigation · 2016Review
- Erectile dysfunction and its management in patients with diabetes mellitus.Reviews in endocrine & metabolic disorders · 2015Article
- Avanafil for erectile dysfunction in elderly and younger adults: differential pharmacology and clinical utility.Therapeutics and clinical risk management · 2014Review
- How to treat erectile dysfunction in men with diabetes: from pathophysiology to treatment.Current diabetes reports · 2014Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
8 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
objectiveTo prospectively assess the safety and effectiveness of the investigational phosphodiesterase 5 inhibitor avanafil to treat erectile dysfunction in men with diabetes mellitus. PATIENTS AND
methodsThis 12-week, multicenter, double-blind, placebo-controlled study conducted between December 15, 2008, and February 11, 2010, randomized 390 men with diabetes and erectile dysfunction 1:1:1 to receive avanafil, 100 mg (n=129), avanafil, 200 mg (n=131), or placebo (n=130). Coprimary end points assessed changes in the percentage of sexual attempts in which men were able to maintain an erection of sufficient duration to have successful intercourse (Sexual Encounter Profile [SEP] 3), percentage of sexual attempts in which men were able to insert the penis into the partner's vagina (SEP 2), and International Index of Erectile Function erectile function domain score.
resultsCompared with placebo, least-squares mean change from baseline to study end in SEP 3, SEP 2, and International Index of Erectile Function erectile function domain score were significantly improved with both avanafil, 100 mg (P≤.002), and avanafil, 200 mg (P<.001). Additional analyses indicated that successful intercourse could be initiated in 15 minutes or less through more than 6 hours after avanafil dosing. Adverse events most commonly reported with avanafil treatment were headache, nasopharyngitis, flushing, and sinus congestion.
conclusionAvanafil was safe and effective for treating erectile dysfunction in men with diabetes and was effective as early as 15 minutes and more than 6 hours after dosing. The adverse events seen with avanafil were similar to those seen with other phosphodiesterase 5 inhibitors.
trial registrationclinicaltrials.gov Identifier NCT00809471.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.