Safety of Vitaros (Topical Alprostadil) for Men Planning Conception
Based on the most recent and highest-quality guideline evidence, topical alprostadil cream (Vitaros) can be safely used when trying to conceive, as the 2025 European Association of Urology guidelines explicitly state that alprostadil requires no fertility-related restrictions or discontinuation period for men attempting conception. 1
Guideline-Based Fertility Safety
The 2025 EAU guidelines provide clear reassurance on this specific concern:
Alprostadil cream is listed among recommended erectile dysfunction therapies that can be used without any fertility-related restrictions for men actively trying to conceive. 1
No discontinuation period is required before attempting conception with alprostadil, in stark contrast to truly gonadotoxic medications like cyclophosphamide (requires 3+ months discontinuation), methotrexate (1-3 months), and mycophenolate (1.5 months). 1
The absence of any fertility warnings or required discontinuation in the 2025 EAU male infertility guidelines indicates that alprostadil is considered safe in this context. 1
Understanding the Animal Data Concern
The rabbit study findings you referenced require important context:
The testicular atrophy observed in male rabbits occurred after "repeated dosing" of systemic alprostadil, not topical application. 2
Topical alprostadil cream has minimal systemic absorption, with systemic adverse events reported in only 3% of treated patients, making it fundamentally different from the high-dose systemic exposure used in animal toxicology studies. 3, 4
No human fertility impairment has been documented despite widespread clinical use of alprostadil in various formulations (intracavernosal, intraurethral, and topical) for decades. 5, 6, 3
Recommended Approach When Planning Pregnancy
While alprostadil itself requires no special precautions, the EAU guidelines recommend a comprehensive fertility evaluation for men with erectile dysfunction who are planning pregnancy:
Obtain a semen analysis and hormonal profile (morning testosterone and FSH levels) to identify and treat any underlying causes of infertility, regardless of alprostadil use. 1
Address modifiable risk factors first, as smoking, excess body weight, and physical inactivity have greater impact on both erectile function and fertility outcomes than any adjustments to erectile dysfunction medication. 1
Clinical Efficacy and Safety Profile
Vitaros demonstrates strong clinical performance that supports its use during conception attempts:
Clinical efficacy reaches up to 83% with the 300 μg dose in patients with severe ED, significantly better than placebo. 3, 4
Fast onset of action and lack of drug interactions make it particularly suitable for men who cannot use PDE5 inhibitors (such as those on nitrates) or who have failed oral therapy. 3, 4
Most adverse events are limited to the application site (burning, erythema in 12.2% of patients), with priapism occurring in only 0.4% of patients. 6
Partner vaginal burning or itching occurs in only 2.1% of cases, which is relevant when actively trying to conceive. 6
Common Pitfalls to Avoid
Do not confuse systemic alprostadil toxicology data with topical cream safety. The rabbit studies used repeated systemic dosing at levels far exceeding human topical exposure. 2
Do not delay conception attempts unnecessarily. Unlike truly gonadotoxic medications, alprostadil requires no washout period. 1
Do not overlook underlying fertility issues. Erectile dysfunction and male infertility can coexist, so obtain a baseline semen analysis regardless of alprostadil use. 1