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Comments. Raymond C. Rosen, Ph.D. Professor of Psychiatry Robert Wood Johnson Medical School – Piscataway, NJ. 2 Documents. CDER Draft Guidance on FSD (2000) Princeton Consensus Conference: Androgen Insufficiency in Women (2001). FDA Guidance Document. Female Sexual Dysfunction

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  1. Comments Raymond C. Rosen, Ph.D. Professor of Psychiatry Robert Wood Johnson Medical School – Piscataway, NJ.

  2. 2 Documents • CDER Draft Guidance on FSD (2000) • Princeton Consensus Conference: Androgen Insufficiency in Women (2001)

  3. FDA Guidance Document Female Sexual Dysfunction Clinical Development of Drug Products for Treatment (2000) www.fda.gov/cder/guidance/

  4. FDA Draft Guideline 4 Types of Sexual Dysfunction in Women: • Inhibited desire (HSDD) • Lack of arousal (SAD) • Anorgasmia • Sexual pain disorder

  5. FDA Draft Guideline Clinical Trial Endpoints • Frequency of satisfactory sexual events (daily diary) • Symptom scores and PROs (validated scales)

  6. The Princeton ConferenceJune 2001 • International consensus conference (June 2001) • Definition of androgen insufficiency in women • Role of androgen in FSD

  7. Female Androgen Insufficiency Female androgen insufficiency (FAI) consists of a pattern of clinical symptoms in the presence of: (i) decreased bioavailable testosterone and (ii) normal estrogen status. Clinical symptoms include impaired sexual function, mood alterations, and diminished energy and well-being. Princeton Consensus Statement (Fertility & Sterility2002; 77:660-5)

  8. Etiological Sub-Types • Ovarian (oophorectomy, radiation) • Adrenal (adrenalectomy, AI) • Hypothalamic-pituitary (hypopituitarism) • Drug-related (OCs, ERT, CSs) • Idiopathic Princeton Consensus Statement(Fertility & Sterility 2002; 77:660-5)

  9. Summary of RCTs • Androgen replacement via different formulations (patch, oral, topical gel) • Improvements in sexual function in both pre- and post-menopausal women • Well tolerated at physiologic levels of T • Additional benefits in energy, mood and well-being

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