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Related Experiment Video

Updated: Aug 9, 2025

Isolation of Adipose Derived Regenerative Cells for the Treatment of Erectile Dysfunction Following Radical Prostatectomy
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Small Effects, Questionable Outcomes: Bremelanotide for Hypoactive Sexual Desire Disorder.

Glen I Spielmans1, Elaine M Ellefson1

  • 1Department of Psychology, Metropolitan State University, Saint Paul, Minnesota, USA.

Journal of Sex Research
|February 22, 2023
PubMed
Summary

Bremelanotide

Area of Science:

  • Pharmacology
  • Clinical Trials
  • Women's Health

Background:

  • Hypoactive sexual desire disorder (HSDD) affects many women.
  • Efficacy measures require validated properties for reliable assessment.
  • Bremelanotide is a treatment for HSDD.

Purpose of the Study:

  • To examine the measurement properties of efficacy measures used in bremelanotide trials for HSDD.
  • To assess the validity of continuous and categorical outcomes from the RECONNECT trials.

Main Methods:

  • Analysis of continuous efficacy outcomes: Female Sexual Function Index (FSFI) and Female Sexual Distress Scale-Desire/Arousal/Orgasm (FSDS-DAO).
  • Evaluation of validity evidence for previously published categorical treatment response outcomes.
  • Review of unpublished efficacy outcomes from the RECONNECT trials.

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Main Results:

  • The validity evidence for FSFI and FSDS-DAO in women with HSDD is questionable.
  • No validity evidence was found for categorical treatment response outcomes.
  • Effect sizes for analyzed outcomes ranged from nil to small, with modest apparent benefits for some measures.
  • Most reported benefits were based on post-hoc analyses or outcomes with limited validity evidence.

Conclusions:

  • The validity of commonly used efficacy measures for HSDD requires further investigation.
  • Bremelanotide's demonstrated benefits in the RECONNECT trials are statistically modest.
  • The clinical significance of bremelanotide's effects is limited by the questionable validity of the outcome measures used.