Sheryl Kingsberg1. 1. Case Western Reserve University School of Medicine, Cleveland, OH, USA. Sheryl.Kingsberg@uhhospital.org
Abstract
INTRODUCTION: The reduced levels of testosterone in postmenopausal women are associated with loss of libido, decreased sexual activity, diminished feelings of physical well-being, and fatigue. A bilateral oophorectomy can lead to decreases in sexual desire in 50% of cases by removing ovarian contribution to the circulating levels of testosterone. Testosterone therapy is an option for the restoration of sexual drive. AIM: Transdermal testosterone administration may bypass the effects of first pass hepatic metabolism. To this end a series of studies have been carried out using a novel transdermal testosterone system. A review of the results from these studies are presented here. MAIN OUTCOME MEASURES: A key feature of these studies was the use of validated study instruments to measure sexual function: Sexual Activity Log (SAL), Profile of Female Sexual Function (PFSF) and Personal Distress Scale. METHODS: The data from the Phase III studies, known as the Investigation of Natural Testosterone in Menopausal women Also Taking Estrogen in Surgically Menopausal women (INTIMATE SM) 1 and 2 were reviewed and the salient information is presented here. RESULTS: Both INTIMATE 1 and 2 showed a significant increase in total satisfying sexual activity, via the SAL in those women receiving testosterone, compared with those women in the placebo group. Total satisfying sexual activity increased by 74% and 51% for INTIMATE 1 and 2, respectively. The PFSF instrument demonstrated significant improvements in INTIMATE 1 and 2 in all domains of sexual function in testosterone-treated women compared with the placebo patients. In both studies, personal distress decreased in those patients receiving testosterone, compared with the placebo group. The most commonly reported adverse events were application site reactions. Eight-five percent of patients said they would probably or definitely continue treatment. Conclusions. The transdermal testosterone patch is an effective treatment for hypoactive sexual desire disorder in surgically postmenopausal women receiving concomitant estrogen therapy. The treatment has a favorable safety profile.
INTRODUCTION: The reduced levels of testosterone in postmenopausal women are associated with loss of libido, decreased sexual activity, diminished feelings of physical well-being, and fatigue. A bilateral oophorectomy can lead to decreases in sexual desire in 50% of cases by removing ovarian contribution to the circulating levels of testosterone. Testosterone therapy is an option for the restoration of sexual drive. AIM: Transdermal testosterone administration may bypass the effects of first pass hepatic metabolism. To this end a series of studies have been carried out using a novel transdermal testosterone system. A review of the results from these studies are presented here. MAIN OUTCOME MEASURES: A key feature of these studies was the use of validated study instruments to measure sexual function: Sexual Activity Log (SAL), Profile of Female Sexual Function (PFSF) and Personal Distress Scale. METHODS: The data from the Phase III studies, known as the Investigation of Natural Testosterone in Menopausal women Also Taking Estrogen in Surgically Menopausal women (INTIMATE SM) 1 and 2 were reviewed and the salient information is presented here. RESULTS: Both INTIMATE 1 and 2 showed a significant increase in total satisfying sexual activity, via the SAL in those women receiving testosterone, compared with those women in the placebo group. Total satisfying sexual activity increased by 74% and 51% for INTIMATE 1 and 2, respectively. The PFSF instrument demonstrated significant improvements in INTIMATE 1 and 2 in all domains of sexual function in testosterone-treated women compared with the placebo patients. In both studies, personal distress decreased in those patients receiving testosterone, compared with the placebo group. The most commonly reported adverse events were application site reactions. Eight-five percent of patients said they would probably or definitely continue treatment. Conclusions. The transdermal testosterone patch is an effective treatment for hypoactive sexual desire disorder in surgically postmenopausal women receiving concomitant estrogen therapy. The treatment has a favorable safety profile.