Bremelanotide and Male Fertility
Bremelanotide is FDA-approved exclusively for treating hypoactive sexual desire disorder in premenopausal women and is not indicated for use in men; therefore, there are no data on its effects on sperm quality or male fertility. 1
Current Evidence and Regulatory Status
Bremelanotide (Vyleesi) is a melanocortin receptor agonist that works by activating MC4 receptors in the medial preoptic area of the hypothalamus, increasing dopamine release to enhance sexual desire. 2, 3 However, all clinical development and approval has been limited to female patients with HSDD. 4, 5, 6
Key Points About Bremelanotide Use
- Approved indication: Treatment of acquired, generalized HSDD in premenopausal women only 1, 4
- Dosing: 1.75 mg subcutaneous injection administered at least 45 minutes before sexual activity 4, 6
- Mechanism: Melanocortin receptor agonist that increases dopamine in brain regions controlling sexual desire 2, 3
Why This Question Cannot Be Answered
No studies have evaluated bremelanotide's effects on male reproductive function, sperm parameters, or fertility outcomes. The drug has never been studied in men for any indication, and all preclinical and clinical research focused exclusively on female sexual function. 4, 5, 3, 6
Important Clinical Considerations
If a male patient is asking about fertility concerns:
- Bremelanotide is not prescribed to men in clinical practice, as it lacks FDA approval and evidence for male use 1, 4
- For male sexual dysfunction: Guidelines recommend established therapies with known safety profiles rather than off-label use of medications without male fertility data 1
- If inadvertent exposure occurs: There are no data to guide counseling, but the drug's mechanism (melanocortin receptor activation) does not have a known direct pathway affecting spermatogenesis
Common Pitfall to Avoid
Do not extrapolate female sexual function data to make assumptions about male fertility effects—the hormonal and neurobiological pathways differ substantially between sexes, and bremelanotide's dopaminergic effects in the female hypothalamus do not predict testicular or reproductive tract effects in males. 2, 3