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Regulatory perspective on clinical trials and end points for female sexual dysfunction, in particular, hypoactive sexual desire disorder: formulating recommendations in an environment of evolving clinical science

Abstract

This article examines the history, current status, and potential future challenges in the development of drugs for female sexual dysfunction (FSD) from the perspective of the United States Food and Drug Administration. In particular, the article focuses on testosterone therapy for hypoactive sexual desire disorder (a component of FSD), and the role of the Division of Reproductive and Urologic Products in facilitating the development of safe and effective therapies for this indication.

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References

  1. Federal Food, Drug, and Cosmetic Act. Section 505(d), 21 U.S.C. 351 1962.

  2. US Food and Drug Administration. Innovation or Stagnation: Challenge and Opportunity on the Critical Path to New Medical Products. March 2004 Available from: http://www.fda.gov/oc/initiatives/criticalpath/whitepaper.html.

  3. US Food and Drug Administration. Good Review Management Principles and Practices for PDUFA Products. April 2005 Available from: http://www.fda.gov/cder/guidance/5812fnl.pdf.

  4. Allen SS . Regulatory and drug development issues related to female sexual dysfunction. J Sex Marital Ther 2002; 28(Suppl 1): 11–16.

    Article  Google Scholar 

  5. US Food and Drug Administration. Female Sexual Dysfunction: Clinical Development of Drug Products for Treatment. May 2000 Available from: http://www.fda.gov/cder/guidance/3312dft.pdf.

  6. Temple RJ . Are surrogate markers adequate to assess cardiovascular disease drugs? JAMA 1999; 282: 790–795.

    Article  CAS  Google Scholar 

  7. Rossouw JE, Anderson GL, Prentice RL, LaCroix AZ, Kooperberg C, Stefanick ML et al. Risks and benefits of estrogen plus progestin in healthy postmenopausal women: principal results From the Women's Health Initiative randomized controlled trial. JAMA 2002; 288: 321–333.

    Article  CAS  Google Scholar 

  8. Althof SE, Rosen RC, DeRogatis L, Corty E, Quirk F, Symonds T . Outcome measurement in female sexual dysfunction clinical trials: Review and Recommendations. J Sex Marital Ther 2005; 31: 153.

    Article  Google Scholar 

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Shames, D., Monroe, S., Davis, D. et al. Regulatory perspective on clinical trials and end points for female sexual dysfunction, in particular, hypoactive sexual desire disorder: formulating recommendations in an environment of evolving clinical science. Int J Impot Res 19, 30–36 (2007). https://doi.org/10.1038/sj.ijir.3901481

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