MED2005, a topical gel, could be a viable on-demand treatment for erectile dysfunction (ED), according to a recent phase II trial.
The gel contains 0.2% glyceryl trinitrate and uses DermaSys technology for quick absorption into the skin of the penis with minimal effects on a partner.
Glyceryl trinitrate is a nitric oxide donor. Scientists believe it could help men with ED by relaxing smooth muscle tissue and improving blood flow to the penis. Adequate blood flow is essential for a firm erection.
Current ED treatments, such as oral medications, injections, and vacuum devices, are effective, but have some limitations. For example, phosphodiesterase type 5 (PDE5) inhibitors, a class of drugs that includes name brands like Viagra, Cialis, Levitra, and Stendra, may need to be taken 30 to 60 minutes before intercourse, which limits spontaneity. Also, men who take nitrates for heart problems cannot take these drugs.
MED2005 can be applied minutes before intercourse and could become part of a couple’s foreplay, the researchers explained.
The trial involved 232 heterosexual men (average age 43 years) and their partners in the United Kingdom and Poland. All of the men had had ED for at least three months.
The men were randomly assigned to one of two treatment arms:
- 4 weeks of MED2005 treatment, 1-week break, 4 weeks placebo treatment
- 4 weeks of placebo treatment, 1-week break, 4 weeks of MED2005 treatment
Men and their partners were required to attempt intercourse at least four times during each treatment period.
The researchers used the International Index of Erectile Function’s erectile function domain (IIEF-EF) as their primary tool for measuring progress.
For this study, IIEF-EF scores of 17-25 indicated mild ED, scores of 11-16 indicated moderate ED, and scores of 10 or below indicated severe ED. At baseline, the men’s mean IIEF-EF score was 17.1.
Overall, mean IIEF-EF scores increased to 19.6 after MED2005 treatment and 18.5 after placebo treatment. Improvements were more likely to occur in men with mild ED.
About 23% of the men saw their IIEF-EF scores improve by at least 4 points after using MED2005.
With both treatments, erections took about the same amount of time. Seventy percent of all men achieved erections within 10 minutes.
For both patients and partners, the most common side effects of MED2005 were headache and common cold symptoms. No partners reported pain or burning sensations as a result of MED2005 exposure.
The researchers suggested that this trial used a minimally effective dose and that trials with larger doses might show greater effects for men with moderate and severe ED. More research is needed, they said.
The study was published online in January 2018 in the Journal of Sexual Medicine.
The Journal of Sexual Medicine
Ralph, David J., MBBS, BSc, MS, FRCS, et al.
“Efficacy and Safety of MED2005, a Topical Glyceryl Trinitrate Formulation, in the Treatment of Erectile Dysfunction: A Randomized Crossover Study”
(Full-text. Published online: January 3, 2018)