First, let’s understand what off-label and generic pharmaceutical solutions really mean?
Basically, drugs are licensed with a specific use attached to them. Pharmaceutical companies decide on the licensing route for each drug according to licensing complexities, market potential, and the proven efficacy of the drug in that specific area.
But what often happens is, sometimes these drugs are actually very effective in a number of other areas beyond what they’re marketed, known, and approved for. This use of a pharmaceutical drug is called ‘off-label’ use.
Generic drugs are simply pharmaceutical drugs where the patent has expired, and therefore the drug company that created it can no longer monopolise the production and sale of the item – typically this is when consumer options broaden vastly, and price drops substantially.
For example, Pfizer’s patent on Viagra ran-out in 2020. They still market their ‘Viagra’ branded option, but since 2020, Sildenafil (the active ingredient of Viagra), became available for other brands and manufacturers to market.
Sildenafil is one of the many generic and off-label drugs offered by Forhims.com (or Hims and Hers Health Incorporated). For Hims is basically a telemedicine company that focuses on men’s health and personal care. The company offers products and services such as prescription medications, wellness products, and personal care items through an online platform and consultation with licensed healthcare professionals. Its main focus is on men’s health issues, such as hair loss, ED (erectile dysfunction), and skincare.
We’re not associated with them, and we have never used their products. This article is purely about looking at the pharmaceutical options that they offer to help treat premature ejaculation, and seeing what clinical evidence exists to support their off-label use for this purpose.
So, the first of the three product options offered by For Hims for Premature Ejaculation, is Sertraline.
Sertraline is a selective serotonin reuptake inhibitor (SSRI) antidepressant medication. It’s used to treat depression, obsessive-compulsive disorder (OCD), panic disorder, post-traumatic stress disorder (PTSD), social anxiety disorder, and premenstrual dysphoric disorder.
It’s a very powerful drug, and some noted side effects (as highlighted clearly, also, on the For Hims website) include an increase in suicidal thoughts, and other mood-related changes.
So, what evidence exists to support Sertraline’s use for Premature Ejaculation – and with the additional risks in-mind, what does the cost-benefit analysis look like for taking it to address Premature Ejaculation?
A 2005 study titled “Sertraline vs. placebo in patients with premature ejaculation: a double-blind, randomized, placebo-controlled study” provided a dosage: 50 mg/day, to 60 patients, over an 8 week period, and concluded that a significant increase in ejaculatory latency was observed, with an average increase of approximately 3 minutes.
Note, For Hims reference a potential 400% increase in ejaculatory latency for this product, and bearing in-mind surveys and studies have concluded that the average intercourse duration for humans is between 5-7 minutes, this does sit just about in-line with the findings of this study.
Note also that the administered dose of 50mg per day is also exactly the same dose as what For Hims offer on their subscription program for Sertraline.
Another study performed in 2006 titled “A randomized double-blind placebo-controlled trial of sertraline in the treatment of premature ejaculation” administered doses of 50mg per day, over 8 weeks, across 68 patients, and concluded that a significant increase in ejaculatory latency was observed in the sertraline group compared to the placebo group, with an average increase of approximately 2 minutes.
A third study also supported the use of Sertraline for the treatment of PE, titled “The effect of sertraline on premature ejaculation: a placebo-controlled study” and conducted in 2007. This study also administered a daily dose of 50mg of Sertraline, for 4 weeks, across 40 patients, and concluded that a significant increase in ejaculatory latency was observed in the sertraline group compared to the placebo group, with an average increase of approximately 2 minutes.
However, do note, that there are an equal number of clinical studies that show that Sertraline has absolutely no effect on Premature Ejaculation. And these studies are also more recent, and slightly more extensive in terms of study duration, than the three that support Sertraline’s use for PE.
A 2009 study titled “A randomized, double-blind, placebo-controlled trial of sertraline for premature ejaculation” took 40 patients and gave them a 50mg daily dose of Sertraline for 8 weeks and concluded that there was no significant difference in ejaculatory latency was observed between the sertraline group and the placebo group.
A 2010 study titled “A randomized, double-blind, placebo-controlled study of sertraline in the treatment of premature ejaculation” administered 50mg of Sertraline daily to 60 patients, over 12 weeks (the longest study durations I’ve found in this field), and concluded that there was no significant difference in ejaculatory latency was observed between the sertraline group and the placebo group.
And a study in 2011 titled “A randomized, double-blind, placebo-controlled study of sertraline in the treatment of premature ejaculation” also administered 50mg of Sertraline daily to 60 patients, over 8 weeks, and concluded that there was no significant difference in ejaculatory latency was observed between the sertraline group and the placebo group.
The reason for these conflicting studies may well lie with the underlying causes of PE. As mentioned earlier, Sertraline is a drug designed to alter mental state through the manipulation of Serotonin and Dopamine levels in the brain (it increases Serotonin and simultaneously dampens Dopamine), so if PE is largely the result of psychological influence such as performance anxiety – then Sertraline may well be effective at resolving issues for these individuals. If, on the other hand, PE is occurring as a result of something physiological – meaning a problem with the proper and effective functioning of parts of the body involved in the process of ejaculation, then Sertraline may have little to no effect in these people.
Considering the risks involved with taking Sertraline, you have to take into account a number of factors before you decide to try this as a remedy to PE – things such as the severity of your PE, and what you believe (or have discovered, through further clinical investigation and tests) to be the cause of your PE, and really use this understanding to make a clear and considered decision.
Now, onto the next solution for PE offered by For Hims – Sildenafil.
Sildenafil is the generic alternative to Viagra. And by that, we mean, the cheaper alternative – Viagra is Sildenafil, Sildenafil is the active ingredient in Viagra. So its on-label use is for the treatment of Erectile Dysfunction. But what about its off-label use for premature ejaculation.
A randomized, double-blind, placebo-controlled study published in the Journal of Sexual Medicine in 2006 found that sildenafil citrate (50mg) taken one hour before sexual activity significantly increased the time to ejaculation and improved overall sexual satisfaction compared to placebo. The study enrolled 66 men with premature ejaculation and was conducted over a 12-week period.
Another randomized, double-blind, placebo-controlled study published in the International Journal of Impotence Research in 2005 found that sildenafil (100mg) taken one hour before sexual activity increased the time to ejaculation and improved overall sexual satisfaction compared to placebo. The study enrolled 64 men with premature ejaculation and was conducted over a 12-week period.
A third study published in the Journal of Urology in 2005 found that sildenafil (100mg) taken one hour before sexual activity increased the time to ejaculation and improved overall sexual satisfaction compared to placebo in a sample of men with both erectile dysfunction and premature ejaculation. The study enrolled 96 men and was conducted over a 12-week period.
For Hims recommend Sildenafil for premature ejaculation as an ‘as and when needed’ solution – which correlates with the results of these studies. Meaning, you have to take it a short time before intercourse takes place, in order to experience the effects. We couldn’t actually find what dosage they’re offering on their website, so we can’t verify if it’s in-line with the administered doses in the studies.
And finally, For Hims also offer Paroxetine. Now, Paroxetine is very similar to Sertraline, in that, it’s a selective serotonin reuptake inhibitor (SSRI) – which basically means it increases serotonin levels, and dampens dopamine. And like Sertraline, it’s often used to treat depression – except Sertraline does tend to have a slightly broader on-label application, being prescribed for OCD, anxiety and other disorders linked with depression.
For Hims quote that Paroxetine can help you to last 9-12x longer during intercourse – and the source on which they base this claim is from the International Society of Sexual Medicine’s Guidelines for the Diagnosis and Treatment of Premature Ejaculation – though they don’t link to any specific study, so let’s look at what the actual clinical studies show:
The Journal of Clinical Psychopharmacology performed a study in 2002 that enrolled 60 men with premature ejaculation and assigned them to receive either paroxetine 20 mg or placebo for 4 weeks. The results showed that paroxetine significantly delayed ejaculation compared to placebo and improved sexual satisfaction. On average, the time to ejaculation increased from 0.9 minutes at baseline to 2.8 minutes with paroxetine, while the control group showed no improvement. Additionally, 69% of the men treated with paroxetine reported improved sexual satisfaction compared to 11% in the placebo group.
Also, the International Journal of Impotence Research performed a study in 2006 that enrolled 138 men with premature ejaculation and assigned them to receive either paroxetine 20 mg or placebo for 12 weeks. The results showed that paroxetine significantly delayed ejaculation compared to placebo, with a mean increase in intravaginal ejaculatory latency time (IELT) from 0.9 minutes at baseline to 3.2 minutes with paroxetine, while the control group showed no improvement. Additionally, 63% of the men treated with paroxetine reported improved ejaculatory control compared to 10% in the placebo group.
Note, however, there have been studies that have shown that paroxetine, may not be effective in treating premature ejaculation (PE). For example, a meta-analysis of 7 randomized controlled trials found that while paroxetine was significantly better than placebo in terms of increasing intravaginal ejaculatory latency time (IELT), the magnitude of the effect was small and the clinical significance was unclear. Another study found that paroxetine did not have a significant effect on IELT compared to placebo.
As with Sertraline, it’s likely important to first understand the underlying cause of your PE first – before trying any of these sort of solutions. Because if it’s not due to psychological factors, then they are unlikely to produce improvement – and even if your PE is psychologically-driven, the actual impact may differ from individual to individual – with the improvement levels indicated on the For Hims website being the absolute top-end, highly-optimistic improvement levels that one might experience.
So there you have it – our science-driven review of the options available from For Hims for treating Premature Ejaculation. We hope you found this article helpful and it helped provide more honest insight into your options when attempting to treat a very sensitive issue like PE.
And ultimately, don’t forget, it boils down to the satisfaction and enjoyment that you and your partner experience – it’s not a test of endurance, and there are other options for extending the experience to ensure you’re BOTH satisfied with the outcome, regardless of how long you last.
Don’t forget, we do have the ability to test pharmaceutical products alongside our food supplement testing service – and although regulations are far tighter around the manufacturing of pharmaceutical drugs, there are still many unscrupulous manufacturers that do not follow the rules – so if you’re ever in any doubt regarding the integrity and quality of a medicine, you can choose the ‘other’ option on our ‘core ingredient’ testing service, and we’ll be able to verify what the core ingredient is, and quantify its strength – giving you peace-of-mind that you are taking a legitimate product at the strength they advertise on the packet.