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Clinical Efficacy Issues

Efficacy of Testosterone Transdermal System (TTS) for Treatment of HSDD in Surgically Menopausal Women on Concomitant Estrogen Daniel Davis, MD, MPH Division of Reproductive and Urologic Drug Products December 2, 2004. Clinical Efficacy Issues. First application for this indication

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Clinical Efficacy Issues

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  1. Efficacy of Testosterone Transdermal System (TTS) for Treatment of HSDD in Surgically Menopausal Women on Concomitant EstrogenDaniel Davis, MD, MPHDivision of Reproductive and Urologic Drug ProductsDecember 2, 2004

  2. Clinical Efficacy Issues • First application for this indication • Clinical significance of small treatment effects • Small  in satisfactory sexual events (SSEs) • Small changes in secondary endpoints • Strong placebo effect relative to TTS effect • Methodology for determining a clinically meaningful treatment effect

  3. Clinical Development Program • FDA Draft Guidance and advice followed • 3 Instruments developed to assess efficacy • Two placebo-controlled Phase 3 trials that evaluated efficacy over 6 months • Study to determine the magnitude of change that is clinically meaningful

  4. Key Inclusion-Exclusion Criteria • Surgically menopausal, on stable estrogen • Acquired HSDD diagnosed by answer to5 questions • Generally good health, without history of diabetes, cardiovascular disease • No specific entry testosterone level • Stable partner relationship

  5. Diagnosis of Acquired HSDD • Was your sex life satisfying before the surgery? • Have you had a meaningful decrease in sexual desire since surgery? • Have you had a significant  in sexual activity? • Are you distressed by the changes? • Would you like to see an  in desire for sex and sexual activity?

  6. Primary and Secondary Endpoints • Primary endpoint • Change from baseline in satisfactory sexual events (SSEs) per 4 weeks • Secondary endpoints • Change in personal distressscore on the Personal Distress Scale • Change in sexual desiredomain in the Profile of Female Sexual Function

  7. Satisfactory Sexual Events(Mean Change from Baseline per 4 Weeks)

  8. Personal Distress Score(Mean Change from Baseline)

  9. Sexual Desire Score(Mean Change from Baseline)

  10. Summary of Efficacy Findings(Change from Baseline)

  11. TTS Treatment Effects Compared to “Normal” Values

  12. Determination of Minimal Meaningful Treatment Effects • Blinded exit interview of subset (n =132) “Considering everything that we have talked about today, would you say that you experienced a meaningful benefit from the study patches?” • On TTS: 52% yes; On Placebo: 31% yes • Analysis: Receiver Operating Characteristic (ROC) • Results • SSE: ≥1.1 event per 4 weeks • Desire: ≥ 8.9 change in score • Distress: decrease of 20 or more in score

  13. SSEs - Percent Responders (Phase 3 Studies Combined) Differences in percent of responders (TTS minus placebo) ranged from 12 to 14%

  14. Clinical Efficacy Summary • Small, statistically significant increase in mean number of SSEs • TTS - Placebo = 1 event per 4 weeks • Small changes in secondary endpoints • Distress Score: • TTS - Placebo = - 6.7 units • Desire Score • TTS - Placebo = 5.1 units • Small increase in SSEs responders • TTS -Placebo = 14% (>1 event/4 wks)

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