Is it safe to use PT (peptide therapy) 141, also known as bremelanotide, prior to sex?

PT 141 (Bremelanotide) Prior to Sex: Safety and Efficacy

Bremelanotide (PT 141) is not recommended for use prior to sexual activity in men as it is only FDA-approved for hypoactive sexual desire disorder in premenopausal women and has no established safety or efficacy profile for male sexual dysfunction.

Understanding Bremelanotide (PT 141)

Bremelanotide is a melanocortin receptor agonist that has been FDA-approved specifically for the treatment of acquired, generalized hypoactive sexual desire disorder (HSDD) in premenopausal women 1. It is administered as a subcutaneous injection approximately 45 minutes before anticipated sexual activity, with specific dosing limitations:

• 1.75 mg subcutaneous injection
• No more than one dose within a 24-hour period
• No more than twelve doses per month 1

Safety Concerns

The safety profile of bremelanotide includes several notable adverse effects:

• Nausea (40% vs 1.3% placebo)
• Flushing (20.3% vs 1.3% placebo)
• Headache (11.3% vs 1.9% placebo)
• Injection site reactions (5.4% vs 0.5% placebo) 2
• Small but statistically significant transient blood pressure increases 2

Additionally, focal hyperpigmentation can occur with repeated use, particularly when used more frequently than recommended 2.

Approved Uses vs. Off-Label Use

It's important to emphasize that bremelanotide is:

1. Only FDA-approved for HSDD in premenopausal women
2. Not approved for use in men
3. Not approved for treatment of erectile dysfunction or premature ejaculation

Evidence-Based Alternatives for Male Sexual Dysfunction

For men experiencing sexual dysfunction, there are several evidence-based treatments available:

For Erectile Dysfunction:

• PDE5 inhibitors (sildenafil, tadalafil, vardenafil, avanafil)
• Testosterone therapy (if hypogonadism is present)
• Lifestyle modifications (increased physical activity, smoking cessation, weight loss, reduced alcohol consumption) 3

For Premature Ejaculation:

• SSRIs with established efficacy:
  • Paroxetine (10-40 mg/day or 20 mg 3-4 hours pre-intercourse)
  • Sertraline (25-200 mg/day or 50 mg 4-8 hours pre-intercourse)
  • Fluoxetine (5-20 mg/day) 3, 4
• Clomipramine (25-50 mg/day or 25 mg 4-24 hours pre-intercourse) 3
• Topical anesthetics (lidocaine/prilocaine cream applied 20-30 minutes before intercourse) 3

Clinical Recommendations

If experiencing sexual dysfunction:

1. Seek proper medical evaluation to determine the specific type of sexual dysfunction (erectile dysfunction, premature ejaculation, or other)

2. Consider FDA-approved treatments appropriate for your specific condition:

   • For ED: PDE5 inhibitors are first-line therapy
   • For PE: SSRIs or topical anesthetics have established efficacy

3. Avoid unapproved peptides like PT 141 for male sexual dysfunction due to:

   • Lack of safety data in men
   • Unknown efficacy for male sexual conditions
   • Potential for serious adverse effects
   • Lack of standardization in non-prescription formulations

Important Cautions

• The Sexual Medicine Society of North America recommends against using "restorative or regenerative" therapies that are not FDA-approved for sexual dysfunction 3
• Treatments without established safety profiles may pose significant health risks
• Medications for sexual dysfunction should be prescribed by healthcare providers familiar with their proper use and potential side effects

In conclusion, bremelanotide (PT 141) should not be used off-label for male sexual dysfunction when there are established, safer, and more effective FDA-approved alternatives available.