If you’re exploring treatment options for Peyronie’s disease, this page is your starting point. Below, you’ll find clear, simple resources to help you:
We’ve also included detailed information for healthcare providers at the bottom of this page. If you’re ready to begin, or just have questions, we’re here to help.
Int J Impot Res. 2016 Mar-Apr;28(2):41-5. doi: 10.1038/ijir.2015.22. Epub 2015 Dec 24.
Topical treatment for acute phase Peyronie’s disease utilizing a new gel, H-100: a randomized, prospective, placebo-controlled pilot study.
Twidwell J, Levine L.
Abstract
Safety and efficacy of topically applied gel H100™ composed of Nicardipine, superoxide dismutase and emu oil for treatment of acute phase Peyronie’s disease (PD) was evaluated. Twenty-two patients (PD <12 months duration) were studied in a prospective, randomized, double-blind, placebo-controlled study. Eleven patients received H100™ and 11 patients received placebo for 3 months. All 22 patients then received H100™ for the final 3 months. Flaccid-stretched penile length, degree of penile curvature, pain level and side effects were assessed monthly. H100™ showed significant improvement in all PD parameters at 6 months: mean stretched penile length increase (22.6%, P=0.0002), mean curvature reduction (40.8%, P=0.0014), and mean pain level reduction (85.7%, P=0.004). Placebo group showed no significant improvement except for mean stretched penile length increase (6.8%, P=0.009). Crossover patients from placebo to H-100 showed significant improvement in all parameters: mean stretched penile length increase (17.5%, P=0.000007), mean curvature reduction (37.1%, P=0.006), and mean pain level reduction (40%, P=0.17). Treatment was well tolerated. A self-limited rash was the only side effect in three patients. Statistically significant improvements in flaccid-stretched penile length, curvature and pain suggest that H100™ is a safe and possibly effective non-invasive, topically applied treatment for acute phase Peyronie’s Disease.
The study size was relatively small, but its design was done under the guidance of Dr. Larry Levine, a world expert in Peyronie’s Disease. Due to H100™’s mechanism of action, the study only included acute phase patients with developing disease.
Based on our study, maximum benefit was seen after six months of treatment with H100™, though many patients noted improvement after three months of treatment. (1)
A skin rash in the area of application is the only known side effect or adverse reaction in about 10% of patients with H100™ use.
No compounded medication is reviewed by the FDA for safety and efficacy.
Important Note: H100™ gel is only meant to be applied topically as directed for treatment of Peyronie’s disease. It is not intended for any other use. Do NOT take it orally, by injection or through any other method of delivery. For best results, always follow prescribing directions carefully.
TRANSDERMAL APPLICATION OF H100™ GEL TO THE PENILE SHAFT IN PATIENTS WITH PEYRONIE’S DISEASE INFILTRATES THE TUNICA ALBUGINEA
JEFFRY TWIDWELL, Minnesota Urology, Minneapolis , MN USA, JOSEPH MAHON, Minnesota Urology, Minneapolis , MN USA, DEAN TORTORELIS, Minnesota Urology, Minneapolis , MN USA, LAURENCE LEVINE, Rush Medical College, Chicago, IL USA
ABSTRACT
Treatment options for Peyronie’s disease (PD) remain limited. Topical H100™ gel, (Hybrid Medical, Edina, USA), which contains nicardipine, super oxide dismutase and emu oil showed safety and efficacy in a previous small double-blind placebo-controlled pilot study. The present study evaluates if topically applied H100™ gel applied to the penile shaft infiltrates the tunica albuginea. Nicardipine is a key active ingredient in H100™ and serves as a surrogate marker. 3 men already scheduled to undergo a planned surgical procedure for PD applied commercially available H100™ gel twice daily to the penile shaft for up to 30 days prior to the procedure. Tunica albuginea samples were obtained at surgery. Nicardipine evaluation was performed using isotope dilution technique via liquid-chromatograph-mass spectrometry (LCMS).
All 3 patients tolerated H100™ gel application without side effects. All 3 tunica albuginea specimens showed detectable nicardipine in the tunical tissue.
Transdermal application of commercially available H100™ gel is able to penetrate the tunica albuginea tissue and is detectable in men with acute and chronic PD. This finding may support the encouraging results found in the prior H100™ pilot study.
Talking with your health care provider about Peyronie’s disease and H100® is an important step toward finding the right treatment. It’s normal to feel nervous or unsure what to ask—that’s why we’ve created a simple guide to help you start the conversation, share your symptoms, and learn whether H100® might be right for you.
We’ve also prepared a detailed Prescriber Information Sheet you can share with your healthcare provider. It explains how H100® works, its ingredients, dosing recommendations, and how to order it. Download these resources below to feel confident and prepared for your next appointment.
When your health care provider determines H100® is right for you and you’re ready to start your treatment, have your health care provider follow the steps further below for How to Prescribe H100®
If you’re using H100® treatment for Peyronie’s disease, adding a simple stretching routine can help improve your results. Here’s how to do it:
Stretching helps prevent new scar tissue from forming and supports the remodeling of existing plaques, making it an important part of treatment with H100®.
If you have a previous diagnosis from a Urologist, PDLabs offers convenient telemedicine services nationwide for most compounded medications, including H100®. For those without a prior diagnosis, our growing network of licensed prescribers—including some who offer nationwide telemedicine appointments—can help you get started.
You’re Almost There! Once you and your doctor decide that H100® is right for you, your physician will need to submit a prescription to PD Labs to get your medication prepared. You can’t order H100® yourself, but you can help make the process easier by bringing the sample prescription form below to your appointment. This shows your doctor exactly what’s needed to prescribe H100®.
This sample form shows what your doctor needs to submit to PD Labs to order H100®. Bring it to your appointment so your doctor knows how to get started.
Only licensed healthcare providers can submit this prescription.
We’re here to help answer your questions and guide you through the next steps toward treatment
