Clinical studies and efficacy
Vitaros has been investigated in two Phase II and two Phase III clinical studies in order to confirm its efficacy and safety profile.
Explore the clinical data below.
Overview of clinical trials
Phase II [1]
•Two multicenter, randomised, double-blind studies
• Study 1 (n=161): Patients with mild-to moderate erectile dysfunction (ED), defined as having an IIEF-EF domain score 14–21. Patients treated with placebo or Vitaros 50, 100 or 200 mcg/100g
•Study 2 (n=142): Severe ED (IIEF-EF domain score <14). Treatment administered as placebo or Vitaros 100, 200 or 300 mcg/100g
•Primary endpoint of both studies was to assess change from baseline in erectile function (EF) domain score of the IIEF
Phase III [2]
•Two multicenter, randomised, double-blind studies
• Data have been described in an integrated analysis
•Patients (n=1732) with mild-to-severe ED, defined as a mean baseline IIEF-EF 13.7, received Vitaros 100, 200 or 300 mcg/100g or placebo
• Primary endpoints: - Changes from baseline in IIEF-EF domain score - Vaginal penetration success (Sexual Encounter Profile question 2) - Erection maintenance to ejaculation (Sexual Encounter Profile question 3
Onset of erection typically within 5 to 30 minutes from application of Vitaros leading to successful sexual intercourse [2-3]
Onset of action with Vitaros 300 μg vs placebo shown from time from application[2]
Vitaros offers statistically significant improvements in erectile function [1]
n=434
Adapted from Moncada et al. 2015.[2]
Onset of erection has been demonstrated from 5 minutes with most patients achieving an erection within 30 minutes. Efficacy of duration is approximately 1-2 hours.[2] Some patients had moderate to severe erectile dysfunction with comorbid conditions.[2]
Vitaros has a tolerable safety profile and a lack of interaction with other drugs due to its local absorption and metabolism.[2]
Changes from baseline in the EF domain score and the total IIEF score demonstrate improved function versus placebo [1]
Diagram adapted from Padma-Nathan,H. et al.[1]
In both phase II studies, changes from baseline in the EF domain score and the total IIEF score (primary and secondary endpoints, respectively) were significantly increased in the patients with severe ED receiving the highest dose of treatment (300 mcg/mg) (p<0.01).[1]
Over 80% of men using Vitaros 300g/mg reported improved erections versus 26% with placebo, with these changes being clinically meaningful.[4]
Vitaros demonstrates significant improvements in all primary efficacy outcome parameters[1]
Diagram adapted from Padma-Nathan,H. et al.[1]
Treatment produced statistically and clinically significant improvements in erectile function scores (IIEF-EF), together with penetration/attempts (SEP Q2) and ejaculation (SEP Q3) rates.[1]
Vitaros also provided significant (p<0.001) dose-dependent improvement in the secondary outcome measure of patient satisfaction, as measured by the GAQ.[1]
Vitaros offers statistically significant improvements vs placebo for patients with comorbid conditions[2]
Vitaros 300 g/mg produced statistically significant and clinically significant improvements in IIEF-EF scores (≥4 points), and positive GAQ responses, in patients with comorbidities such as cardiac disease, hypertension and diabetes.[2]
Adapted from Moncada et al. 2015.[2]
Review the well-established safety profile of Vitaros
Improvements in all instances as compared to placebo.
EF: Erectile function domain score
IIEF: International index of erectile functionA 15-question investigation used in the clinical assessment of ED and treatment outcomes in clinical trials. A score of 0-5 is awarded to each question that examines the 4 main domains of male sexual function: erectile function (EF), orgasmic function, sexual desire and intercourse satisfaction. Severe ED (score = 6–10), moderate ED (score = 11–16), mild-to-moderate ED (score = 17–21), or mild ED (score = 22–25).
GAQ: Global Assessment Questionnaire (GAQ), “When using the study medication, did you feel your erections improved? (Yes or No).”
SEP2: Sexual encounter profile question 2, “Were you able to insert your penis into your partner’s vagina? (Yes or No).”
SEP3: Sexual encounter profile question 3, “Did your erection last long enough for you to complete intercourse with ejaculation? (Yes or No).”
References
1. Padma-Nathan H, Steidle C, Salem S, et al. The efficacy and safety of a topical alprostadil cream, Alprox-TD®, for the treatment of erectile dysfunction: two phase 2 studies in mild-to-moderate and severe ED. Int J Impot Res 2003;15(1):10–7.
2. Moncada I, Cuzin B. Clinical efficacy and safety of Vitaros©/Virirec© (alprostadil cream) for the treatment of erectile dysfunction. Urologia 2015;82(2):84–92.
3. Vitaros Summary of Product Characteristics. Last accessed May 2022.
4. Steidle C, Padma-Nathan H, Salem S, et al. Topical alprostadil cream for the treatment of erectile dysfunction: a combined analysis of the phase II program. Urology 2002;60(6):1077–82.