CommentsCommentsRaymond C. Rosen, Raymond C. Rosen,

Ph.D.Ph.D.

Professor of PsychiatryProfessor of Psychiatry

Robert Wood Johnson Robert Wood Johnson Medical School – Medical School – Piscataway, NJ.Piscataway, NJ.

2 Documents2 Documents CDER Draft Guidance on CDER Draft Guidance on

FSD (2000)FSD (2000)

Princeton Consensus Princeton Consensus Conference: Androgen Conference: Androgen Insufficiency in Women Insufficiency in Women (2001)(2001)

FDA Guidance FDA Guidance DocumentDocument

Female Sexual DysfunctionFemale Sexual Dysfunction

Clinical Development of Drug Products Clinical Development of Drug Products

for Treatmentfor Treatment (2000) (2000)

www.fda.gov/cder/guidance/www.fda.gov/cder/guidance/

FDA Draft GuidelineFDA Draft Guideline

4 Types of Sexual 4 Types of Sexual Dysfunction in Dysfunction in Women:Women:

Inhibited desire (HSDD)Inhibited desire (HSDD)

Lack of arousal (SAD)Lack of arousal (SAD)

AnorgasmiaAnorgasmia

Sexual pain disorderSexual pain disorder

FDA Draft GuidelineFDA Draft Guideline

Clinical Trial Clinical Trial EndpointsEndpoints

Frequency of satisfactory Frequency of satisfactory sexual sexual events (daily diary)events (daily diary)

Symptom scores and PROs Symptom scores and PROs (validated scales) (validated scales)

The Princeton The Princeton ConferenceConferenceJune 2001June 2001

International consensus International consensus conference (June 2001)conference (June 2001)

Definition of androgen Definition of androgen insufficiency in womeninsufficiency in women

Role of androgen in FSDRole of androgen in FSD

Female Androgen Female Androgen InsufficiencyInsufficiency

Female androgen insufficiency (FAI) Female androgen insufficiency (FAI)

consists of a pattern of consists of a pattern of clinical clinical

symptomssymptoms in the presence of: (i) in the presence of: (i)

decreased bioavailable testosterone decreased bioavailable testosterone

and (ii) normal estrogen status. and (ii) normal estrogen status.

Clinical symptoms include impaired Clinical symptoms include impaired

sexual functionsexual function, mood alterations, and , mood alterations, and

diminished energy and well-being. diminished energy and well-being.

Princeton Consensus Statement (Fertility & SterilityPrinceton Consensus Statement (Fertility & Sterility 2002; 77:660-5)2002; 77:660-5)

Etiological Sub-TypesEtiological Sub-Types

Ovarian (oophorectomy, radiation)Ovarian (oophorectomy, radiation) Adrenal (adrenalectomy, AI)Adrenal (adrenalectomy, AI) Hypothalamic-pituitary Hypothalamic-pituitary

(hypopituitarism)(hypopituitarism) Drug-related (OCs, ERT, CSs)Drug-related (OCs, ERT, CSs) Idiopathic Idiopathic

Princeton Consensus StatementPrinceton Consensus Statement (Fertility & Sterility (Fertility & Sterility 2002; 77:660-5)2002; 77:660-5)

Summary of RCTsSummary of RCTs

Androgen replacement via different Androgen replacement via different formulations (patch, oral, topical formulations (patch, oral, topical gel) gel)

Improvements in sexual function in Improvements in sexual function in both pre- and post-menopausal both pre- and post-menopausal womenwomen

Well tolerated at physiologic levels of Well tolerated at physiologic levels of TT

Additional benefits in energy, mood Additional benefits in energy, mood and well-beingand well-being