The Most Effective Treatment for ED
The most effective non-surgical treatment for ED is penile injection.[i] This is where a combination of vasodilators is injected with a needle directly into the penis just before sexual activity. Its most common form is a liquid called trimix for injection.
TriMix Gel is a compound of vasodilators when combined for use at the same time, as “trimix for injection”, has not been reviewed by the FDA for the specific indication of erectile dysfunction. But these vasodilators have been reviewed individually and have been in medical use for decades.
The compound needs to be kept refrigerated until use, at which time it is injected into the side of the penis before sexual activity.
This triple mix compound known as trimix for injection contains the vasodilators prostaglandin, papaverine, and phentolamine. Trimix has been widely prescribed by physicians for the treatment of ED for many years.[ii]
Physicians and patients agree, trimix for injection is the “Gold Standard” for non-surgical treatment of ED. In fact, the American Urological Association (AUA) recommends trimix for injection in their official protocol for urologists who treat ED. https://www.auanet.org/guidelines/erectile-dysfunction#x2650
Self-Injection
A drawback to injection therapy is the patient must always be aware the medicine could cause priapism or prolonged erection. Any erection lasting more than four hours is a medical emergency and must be detumesced immediately.
Many Men Cannot Self-Inject
Most primary care physicians are not equipped or comfortable enough to encourage or train patients on injection therapy. In addition, even though a patient may have success with injections, there remains a high drop-out rate of 70–80% due to lingering dissatisfaction with self-injection. Even though trimix for injection delivers significant results, many men object to injecting their own penis with a hypodermic needle.[iii]
TriMix-gel is a good example of the value found in compounding pharmacy.
Failure on Viagra-Type Tablets Is Not a Straight Road to Injections
Patients who have failed on Viagra-type tablets have been informed of the superior results of penile injection therapy, but most men object to self-injection. TriMix-gel® (prostaglandin, papaverine, phentolamine) contains the same active vasodilators as trimix for injection. These ingredients have not been reviewed by the FDA for ED but have been individually tested and accepted by physicians for decades.
The TriMix-gel Difference – NO NEEDLES
The difference between trimix for injection and TriMix-gel is “NO NEEDLE.” The active ingredients have been lyophilized into powder form, then mixed with a medicated gel at the time of use and applied at the tip of the penis.
This is accomplished with a novel patented methodology (US patent number 9,005,183). Before sexual activity, the patient uses the “Easy Applicator System™,” which stores, mixes, and applies the medicine—no needle required.
- TriMix-gel does not have to be refrigerated; it can be carried at room temperature.
- Uses a gel carrier, not a hard pellet placed into the urethra.
- Does not require semi-self-catheterization.
- All-in-one application device stores, mixes, and applies the medicine.
- No hypodermic needle is needed before sexual activity.
Clinical Evidence Supporting TriMix-gel®
A recent pilot study evaluated a new Trimix gel formulation administered at the urethral meatus in men who had not responded to oral PDE5 inhibitors. In 42 patients with mixed comorbidities, 40% achieved erections sufficient for penetration, with measurable improvements in Erection Hardness Score (EHS) compared to prior oral therapy. The study highlighted advantages including room-temperature storage, longer shelf life, painless administration, and enhanced absorption with simple glans massage.[vi]
This evidence supports the concept behind TriMix-gel®: a non-invasive, needle-free delivery system using the same active vasodilators as injectable trimix, while offering improved convenience and patient acceptability.
No Injections – No Needles
Doctors often prescribe FDA-approved drugs for off-label purposes. The FDA has not yet reviewed TriMix-gel for ED, but individual components are FDA-approved[iv]. Physicians can prescribe these components safely for ED, supported by decades of clinical use[v].
TriMix-gel is composed of formulated drugs, novel components, and a patented system requiring a prescription.
TriMix-gel is a good example of the value found in compounding pharmacy.
[i] Duff, E, McCullough A. Current Sexual Health Reports, Volume 3, Number 3 / September, 2006. Found at: http://www.springerlink.com/content/d98120983v31v2gj/.
[ii] Nehra, A, Curr Urol Rep, 2001 Dec;2(6):468-72. Available at: http://www.ncbi.nlm.nih.gov/pubmed/12084233.
[iii] Ibid.
[iv] Food and Drug Administration. Obtained at: http://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm?fuseaction=Search.DrugDetails.
[v] Nehra, A, Curr Urol Rep, 2001 Dec;2(6):468-72. Available at: http://www.ncbi.nlm.nih.gov/pubmed/12084233.
[vi] Bennett NE, Guhring P, Narus J, Mulhall JP. Trimix Gel for Erectile Dysfunction: Pilot Study of Urethral Meatus Administration. New York, NY. Available at: https://pdlabsrx.com/wp-content/uploads/2026/02/trimix_gel_study.pdf.