Painful Sex Associated with Menopause: Interpreting FDA Warnings when Choosing a Treatment for Dyspareunia

Michael W. DeGregorio, Timothy B. Cadman and Gregory T. Wurz, Ph.D.
University of California, Davis Department of Internal Medicine, Division of Hematology and Oncology, CA, US

Series: Sexology Research and Issues
BISAC: MED036000

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Dyspareunia, or painful sexual intercourse, associated with menopause has been a taboo subject for decades. During the past year, postmenopausal women have been saturated with print and television advertisements regarding two prescription treatments for painful sex associated with menopause. This book is intended to elucidate in understandable terms the two prescription options currently available for the treatment of dyspareunia, Premarin® (conjugated equine estrogens) Vaginal Cream and Osphena™ (ospemifene) oral tablets. Premarin® is a cocktail of hormones isolated from the urine of pregnant horses that was originally approved by the U.S. Food and Drug Administration (FDA) for the treatment of menopausal symptoms in 1942. Today, Premarin® remains the most commonly prescribed hormone replacement therapy (HRT). Osphena™ is a synthetic non-estrogen drug approved in 2013 that is classified as a selective estrogen receptor modulator (SERM). Other SERMs approved by the FDA include tamoxifen for breast cancer treatment and prevention, and Evista® (raloxifene) for the prevention of postmenopausal osteoporosis and reducing the risk of breast cancer. The FDA is required to educate the public about the benefits and risks of prescription drugs. Unfortunately, these messages are not always clear. We discuss, in understandable terms, the benefits and risks of Premarin® Vaginal Cream and Osphena™ oral tablets as seen in media advertisements, boxed warnings and package inserts. Throughout this book, we discuss the history of these two treatment options for dyspareunia and the future research intended to improve upon hormone replacement therapy for postmenopausal women. (Imprint: Nova Biomedical)

About the Authors

Preface

Chapter 1 - Quality of Life Impacts of Vulvar and Vaginal Atrophy (VVA) and Other Menopausal Symptoms (pp. 1-26)

Chapter 2 - Interpreting Television Commercials (pp. 27-38)

Chapter 3 - Premarin®: History and Development of Hormone Replacement Therapy (HRT) (pp. 39-68)

Chapter 4 - Osphena™ (ospemifene): History, Development and FDA Approval of a Non-estrogen (pp. 69-108)

Chapter 5 - Understanding Side Effects: Boxed Warnings and Package Inserts (pp. 109-128)

Chapter 6 - What Are the Effects of Osphena™ on Bone? (pp. 129-146)

Chapter 7 - What Are the Effects of Osphena™ in the Breast? (pp. 147-166)

Glossary of Terms

Index

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