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Var3.6
Vardenafil (Levitra) Research
Too few graded studies
25 peer-reviewed studies
What the evidence says
Too few graded studies
Vardenafil (Levitra) doesn't have enough studies with structured effect-size data yet to pool a verdict. Browse the studies below for individual findings.
Most evidence is from high-quality meta-analyses and randomised trials published 2001–2026.
Based on 25 studies · 3 meta-analyses · 12 RCTs
Confidence
High confidence
By outcome
Erectile functionRobust RCT and meta-analytic evidence for dose-dependent, clinically meaningful improvement in erectile function versus placebo, including in men with diabetes and after prostatectomy · ~30-60 minutes (on-demand)
Too few graded studies15 studies
Safety profile
Too few graded studies7 studies
Cardiovascular & vascular
Too few graded studies6 studies
Active research area
12 studies in the last 5 years · Latest meta-analysis: 2025
200120132026
1Meta-Analysis2021
In plain English: Vardenafil demonstrated significant efficacy in the treatment of ED, but the optimal dose and course of vardenafil remain to be established.
Wang H et al. · Advances in therapy (2021)
Vardenafil demonstrated significant efficacy in the treatment of ED, but the optimal dose and course of vardenafil remain to be established.
In plain English: PDE5i-induced priapism is a rare event.
Rezaee ME et al. · The journal of sexual medicine (2020)
PDE5i-induced priapism accounted for only 2.9% (n = 7) of drug-induced priapism cases.
Second-generation antipsychotics (33.8%), a group of "other" medications (11.3%), and alpha-adrenergic antagonists (8.8%) accounted for the greatest percentage of published drug-induced priapism cases.
In plain English: Based on low-certainty evidence, PDE5i may reduce the frequency of attacks of Raynaud's phenomenon by a small amount per week, result in a small reduction in the duration of attack, improve patients' global assessment of their disease, and result in little to no difference in pain.
Maltez N et al. · The Cochrane database of systematic reviews (2023)
The frequency of attacks per week was 24 with placebo and PDE5i reduced the frequency of attacks by an average of three attacks per week (mean difference (MD) -3.07, 95% confidence interval (CI) -5.15 to -1.00; 8 studies; low-certainty evidence).
The duration of attacks per day was 55 minutes with placebo and PDE5i reduced the duration of attacks by an average of five minutes (MD -5.31, 95% CI -8.90 to -1.71; 8 studies; low-certainty evidence).
Low-certainty evidence showed that the use of PDE5i may result in little to no difference compared to placebo in reducing the average pain of Raynaud's attacks (3 to 2.9; MD -0.10, 95% CI -0.78 to 0.57; 4 studies).
In plain English: In summary, this review helps doctors and researchers by providing clear information about PDE5 inhibitor drugs for ED and pointing out areas where more research can improve treatment and quality of life for men with this condition.
Rajasekhar AT, Un-Nabi SS, Kaliyamoorthy S, Anusha D, S N. · The Journal of pharmacy and pharmacology (2026)
Key findings PDE5 inhibitors significantly improve erectile function compared with placebo across diverse patient populations.
Adverse events are generally mild, transient, and dose-related, with a favourable benefit-risk profile when prescribed in accordance with contraindications and cardiovascular risk assessment.
Alternative therapies are effective in PDE5 inhibitor non-responders.
In plain English: The phosphodiesterase type 5 inhibitors sildenafil, tadalafil, and vardenafil were proved to be effective and safe in first-line therapy of erectile dysfunction caused by neurogenic disorders.
Del Popolo G et al. · European urology focus (2020)
The phosphodiesterase type 5 inhibitors sildenafil, tadalafil, and vardenafil were proved to be effective and safe in first-line therapy of erectile dysfunction caused by neurogenic disorders.
In addition, intracavernous injections of prostaglandin E1, papaverine, or phentolamine and vacuum systems have been a mainstay of second-line treatment for NSD, extremely successful in the spinal cord injury population.
Surgical therapy via penile prosthesis implantation remains a viable alternative as a third-line approach and may also be utilised to assist men with bladder management, despite higher complication rates of infections.
In plain English: Within the grading of comparison network, tadalafil appeared to be the best PDE5i in the treatment of SCI-related ED.
Tienforti D, Felzani G, Di Pasquale AB, Barbonetti A. · Andrology (2025)
Overall, at the pairwise meta-analysis, PDE5i were four times more effective than placebo in improving erectile function (risk ratio: 4.13, 95% CI: 2.76, 6.19).
The comparative analysis from NMA revealed that tadalafil was associated with the highest SUCRA value (81%), followed by vardenafil (68%) and sildenafil (49%).
Discussion and conclusion Within the grading of comparison network, tadalafil appeared to be the best PDE5i in the treatment of SCI-related ED.
In plain English: However, there are limitations to the evidence that should be considered.
· Unknown Journal (2025)
What did we find? • We identified 3 relevant clinical studies.
What does this mean? • Initial combination therapy with 2 oral medications, an ERA and a PDE5 inhibitor, may provide better treatment outcomes in patients with PAH compared to monotherapy.
However, there are limitations to the evidence that should be considered.
15Review2025
In plain English: This review synthesizes clinical, preclinical, and mechanistic studies on PDE5-Is in the context of learning, memory, and Alzheimer's disease, highlighting their potential as therapeutic agents for cognitive impairment.
Ricciarelli R · Cells (2025)
Erectile dysfunction (ED) and cognitive decline share overlapping vascular, metabolic, and neurodegenerative mechanisms, particularly in aging populations.
Phosphodiesterase type 5 inhibitors (PDE5-Is), such as sildenafil and vardenafil, are widely used to treat ED by elevating cyclic guanosine monophosphate (cGMP) levels and enhancing vascular function.
Emerging evidence suggests that PDE5-Is may also benefit cognitive function by promoting neurovascular coupling, synaptic plasticity, and neuroprotection.
In plain English: Our study indicated that the present VDF formulation, when administered intranasally, can achieve a more rapid but similar plasma concentration with only about one-third dose when compared with the oral administration.
Wang J et al. · The journal of sexual medicine (2023)
Intranasal VDF caused transient but tolerable local nasal reactions in 50% of subjects.
Our study indicated that the present VDF formulation, when administered intranasally, can achieve a more rapid but similar plasma concentration with only about one-third dose when compared with the oral administration.
In plain English: Vardenafil represents a valuable treatment option within multidisciplinary management strategies for ED, particularly when its pharmacokinetic profile aligns with patient needs and preferences.
Zhou J, Hu S, Ouyang Y, Kong Y, Liu M. · World journal of urology (2026)
Vardenafil represents a valuable treatment option within multidisciplinary management strategies for ED, particularly when its pharmacokinetic profile aligns with patient needs and preferences.
High‑quality, long‑term randomized trials are necessary to determine optimal combination protocols, treatment duration, and long‑term safety, with particular emphasis on precision dosing and biomarker‑guided interventions.
In plain English: Further, other PDE inhibitors such as tadalafil and vardenafil have been briefly discussed in parts of this review.
Ala M et al. · Fundamental & clinical pharmacology (2021)
Furthermore, it has significantly improved the prognosis of organ ischemia in various animal models.
Clinical trials in several diseases, such as recurrent spontaneous miscarriage, fatty liver disease, bronchopulmonary dysplasia (BPD), heart failure, and premature ejaculation (PE) brought promising results.
Although some clinical trials are available on the effects of sildenafil on various diseases, further studies on humans are needed to consolidate the ultimate effects of sildenafil.