Comments

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• CDER Draft Guidance on FSD (2000)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
  Sterility 2002 77660-5)

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 77660-5)

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