Bremelanotide for Hypoactive Sexual Desire Disorder: A Randomized Clinical Trial (RECONNECT) — VialBase Research

Summary

RECONNECT was the pivotal phase 3 clinical trial that led to FDA approval of bremelanotide (PT-141, brand name Vyleesi) for hypoactive sexual desire disorder (HSDD) in premenopausal women. Two replicate studies demonstrated significant improvements in sexual desire and reductions in distress related to low sexual desire.

Key Findings

• Bremelanotide significantly increased Female Sexual Function Index (FSFI) desire domain score
• Increased number of satisfying sexual events (SSEs) vs placebo
• Reduced distress related to low sexual desire (FSDS-DAO score)
• Approximately 25% of patients achieved clinically meaningful improvement in desire
• Most common side effect: nausea (40%), mostly mild and decreasing over time
• Transient increases in blood pressure noted — contraindicated in uncontrolled hypertension

Methodology

Two replicate randomized, double-blind, placebo-controlled, phase 3 trials (RECONNECT Study 1 and 2). 1,267 premenopausal women with HSDD randomized to bremelanotide 1.75 mg or placebo, self-administered subcutaneously as needed before anticipated sexual activity. 24-week treatment period.

Limitations

• Premenopausal women only — efficacy in postmenopausal women studied separately
• High nausea rate (40%) may limit adoption
• Blood pressure increases require screening
• On-demand dosing (not daily) — different from continuous peptide therapy models
• Modest effect sizes — NNT approximately 4-5 for meaningful response
• Sexual dysfunction has strong psychosocial components difficult to isolate

Relevance to Content

The FDA-approved indication makes PT-141 one of the few peptides with regulatory validation. Essential reference for all PT-141/bremelanotide content. The female sexual dysfunction indication distinguishes it from PDE5 inhibitors (Viagra). Content should note the nausea issue and blood pressure concerns for balanced coverage.

See Also

• Parent compound: PT-141