1DEPARTMENT OF HEALTH AND HUMAN SERVICESFOOD AND DRUG ADMINISTRATIONCENTER FOR DRUG EVALUATION AND RESEARCHADVISORY COMMITTEE FORREPRODUCTIVE HEALTH DRUGSThursday, December 2, 20048:00 a.m.Hilton HotelThe BallroomsGaithersburg, Maryland

2P A R T I C I P A N T SAVISORY COMMITTEE REPRODUCTIVE HEALTH DRUGSLinda C. Giudice, M.D. - CHAIRArthur L Burnett, M.D.Scott S. Emerson, M.D.W. David Hager, M.D.Vivian Lewis, M.D.Larry Lipshultz, M.D.Charles L. Lockwood, M.D.George A. Macones, M.D.Valerie Montgomery-Rice, M.D.Joseph B. Stanford, M.D.Jonathan Tobert, M.B. [Industry Representative]Lorraine J. Tulman, R.N.. D.N.Sc.[Consumer Representative]Teresa A. Watkins, R.Ph., Executive SecretaryCONSULTANTS AND GUESTSSGE Consultants (voting)Joanne F. Dorgan, Ph.D., M.P.H.Diane F. Merritt, M.D.Steven Nissen, M.D.Donald L. Patrick, Ph.D.Martha Solonche [Patient Representative]SGE Consultants (non-voting)Adrian S. Dobs, M.D.Julia r. Heiman, Ph.D.FDA PARTICIPANTSJulie Beitz, M.D.Donna Griebel, M.D.Scott Monroe, M.D.Daniel Davis, M.D.Lisa Soule, M.D.

3C O N T E N T SPAGECall to Order and Introductions 5Linda Giudice, M.D., ChairConflict of Interest Statement 8LCDR Teresa Watkins, R.Ph.,Executive SecretaryWelcome and Comments 10Donna Griebel, M.D., Deputy Director,Division of Reproductive and Urologic DrugsAssessing Risks of Hormonal Interventions 19Judith Hsia, M.D.,Professor of Medicine,George Washington UniversitySponsor PresentationIntroduction 36Joan M. Meyer, Ph.D., Senior Director,New Drug Development, Procter & GamblePharmaceuticalsPhase III Clinical Efficacy Data 43Johna D. Lucas, M.D., Medical Director,Procter & Gamble PharmaceuticalsClinical Relevance of Treatment Effects 57Leonard R. DeRogatis, Ph.D.,Director,Johns Hopkins Center for Sexual Healthand MedicinePhase III Clinical Safety Data 68Johna D. Lucas, M.D.Phase III Hormone Data 86Glenn D. Braunstein, M.D., ProfessorGeffen School of Medicine, UCLA;Chairman, Department of Medicine,Cedars-Sinai Medical CenterHypoactive Sexual Desire Disorder 100Jan L. Shifren, M.D., Faculty,Harvard Medical School; Director,Menopause Program, Vincent OB/GYNService, Massachusetts General Hospital