Frequently asked questions

For prescribing clinicians

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1. What is Vitaros indicated for?

Vitaros is indicated for the treatment of men ≥18 years of age with erectile dysfunction, defined the inability to achieve or maintain a penile erection sufficient for satisfactory sexual performance.[1]

2. Is Vitaros available over the counter?

No, Vitaros is available for prescription only. [1]

3. Which patients are likely to benefit from Vitaros?

Given its pharmacodynamic profile, Vitaros is suitable for a broad range of patients.[2-4]

A review of published data indicated that Vitaros can provide benefits for men with mild, moderate and severe erectile dysfunction and those who experience limitations with PDE5inhibitors or for whom PDE5 inhibitors are not appropriate.[3]

Vitaros also provides a therapeutic option for patients who prefer topical therapy and those who are concerned about systemic effects of drugs since Vitaros is applied locally, such as interactions with food or alcohol.[4]
"Learn more about which patients could benefit from Vitaros"

1. How is Vitaros different from other treatments for erectile dysfunction?

Vitaros is the only topical alprostadil cream for the treatment of erectile dysfunction. It is applied locally to the tip of the penis (see Application guidance for further information) and combines alprostadil with dodecyl-2-N,N-dimethylamino propionate hydrochloride(DDAIP-HCl), a drug permeation enhancer to facilitate fast absorption. and rapid onset of erection.[1,3]In contrast to some phosphodiesterase type 5 (PDE5)inhibitors, Vitaros has minimal systemic diffusion, low risk of drug interactions and is not affected by food or alcohol consumption. [1, 3-4] 

2. How long do patients treated with Vitaros maintain an erection?

On-set of erection is from 5 minutes from application with most patients achieving an erection within 30 minutes. The duration of effect is approximately 1-2 hours; however this may vary from patient to patient.[1]

3. How was efficacy assessed in the phase II and phase III clinical trials?

Clinical efficacy of Vitaros was assessed based on changes in several questionnaires, which are standard tools used in the assessment and treatment of erectile dysfunction[3,5] 

- International Index of Erectile Function, Erectile Function domain (IIEF-EF) score,  which is a self-administered questionnaire giving a measure of erectile function. It contains 15 questions used to assess sexual function.
-Sexual Encounter Profile Question 2 (SEP Q2), which asks “Were you able to insert your penis into your partner’s vagina?”- Sexual Encounter Profile Question 3 (SEP Q3), which asks “Did your erection last long enough for you to complete intercourse with ejaculation?”
- Global Assessment Questionnaire (GAQ), which evaluates patient satisfaction through improved erections.

4. How does Vitaros compare with other available treatments for erectile dysfunction?

Direct comparisons between Vitaros and other available treatments have not been performed.[1] However, Vitaros has been investigated in two phase II and two phase III clinical trials to validate and confirm its efficacy and safety profiles and are available for you to review the results [3,5] .

1. What are the most common adverse events reported in trials?

In the phase III trial, the most common adverse events were localised to the application site. 23% reported penile burning, 17.5% reported genital pain and 11.3% reported penile erythema (11.3%).

However, the majority of adverse events were mild to moderate in intensity, and resolved within 2 hours. [1,5]

2. How many patients discontinued Vitaros in trials?

In the long-term study, most adverse events were mild to moderate in nature and the main reasons for discontinuation were patient or partner withdrawals (16%) or inadequate response to treatment (12%, hyper- or hypo- responsiveness).

Overall, 4.3% of patients (n=1161) had discontinued. [6]

3. What are the main contraindications for use?

The main contraindications for Vitaros are listed below: [1]

● Hypersensitivity to the active ingredient or any of the excipients
● Presence of underlying disorders such as orthostatic hypotension, myocardial infarction and syncope
● Presence of conditions that may predispose to priapism● Abnormal penile anatomy including anatomical deformation of the penis
● Inflammation or infection of the glans
● Detected susceptibility to venous thrombosis
● In patients for whom sexual activity is not advisable including those with unstable cardiovascular or unstable cerebrovascular conditions.

A condom should be used during sexual intercourse with a woman with child-bearing potential. [1]

4. Are there any recorded side effects experienced by the users sexual partner?

Yes, some side effects have been reported. The most commonly reported partner adverse events were transient, local vaginal reactions occurring in 3% in the placebo group versus 6.5% in the Vitaros group. [1]

Use of Vitaros has not been investigated with a pregnant partner, and as such a condom should be used during sexual intercourse with a woman with child-bearing potential. [1]

1. How should Vitaros be stored?

Vitaros has a shelf-life of 14 months and should be stored in a fridge (2-8⁰C) in its original packaging and should not be frozen. [1]

The medication can be kept out of the fridge for up to 3 days before use if kept in a place which is under 25⁰C; this stability provides users the option to take the medication on holiday with them. At the end of this period, the product should be discarded if not used [1]

Once the packing is opened, the medication should be used immediately.[1]

2. How should used applicators of Vitaros be discarded?

Each applicator is intended for single-use. After application, the user should replace the cap, place the applicator in the open sachet and discard in accordance with local requirements.


1. Vitaros Summary of Product Characteristics. Last accessed: June 2022.
2. Becher E. Topical alprostadil cream for the treatment of erectile dysfunction. ExpOpin Phamacother. 2004;5(3):623-632.
3. Moncada I and Cuzin B. Clinical efficacy and safety of Vitaros©/Virirec©(Alprostadil cream) for the treatment of erectile dysfunction. Urologia 2015;82(2):84-92.
4. Yeager J, Beihn RM. Retention and migration of alprostadil cream applied topically to the glans meatus for erectile dysfunction. Int J Impot Res 2005;17(1):91–5
5. Padma-Nathan H, Yeager JL. An integrated analysis of alprostadil topical cream for the treatment of erectile dysfunction in 1732 patients. Urology 2006;68(2):386–91
6. Rooney M, Pfister W, Mahoney M, et al. Long-term, multicentre study of the safety and efficacy of topical alprostadil cream in male patients with erectile dysfunction. J Sex Med 2009;6:520–34