JOURNAL ARTICLE

(319) Evaluating the Racial Distribution of Clinical Trial Participants for Drugs Leading to FDA Approval of Novel Biologics for the Treatment of Hypoactive Sexual Desire Disorder (HSDD).

  • Published In: Journal of Sexual Medicine, 2024. P. 1 1 of 3

  • Database: Academic Search Ultimate 2 of 3

  • Authored By: Matthew-Onabanjo, A; Bjurlin, M; Rogers, M 3 of 3

Abstract

This article evaluates the racial and ethnic distribution of participants in clinical trials that led to FDA approval of two novel biologic drugs, Addyi (flibanserin) and Vyleesi (bremelanotide injection), for the treatment of hypoactive sexual desire disorder (HSDD). The study found that the majority of trial participants were white women (89% in Addyi trials and 86% in Vyleesi trials), despite HSDD also affecting minority women. The authors note that the impact of HSDD on minority populations may be underestimated and suggest that involving diverse stakeholders in trial design could improve representation and equity in future research. Limitations include the categorization of unknown race data.

Additional Information

  • Source:Journal of Sexual Medicine. 2024/01, p1
  • Document Type:Article
  • Subject Area:Law
  • Publication Date:2024
  • ISSN:1743-6095
  • DOI:10.1093/jsxmed/qdae001.304
  • Accession Number:175496031
  • Copyright Statement:Copyright of Journal of Sexual Medicine is the property of Oxford University Press / USA and its content may not be copied or emailed to multiple sites without the copyright holder's express written permission. Additionally, content may not be used with any artificial intelligence tools or machine learning technologies. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.)

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