AIMS: To compare the effects of 3 months' tibolone treatment with the effects of placebo on sexual function (in particular, vaginal blood flow, and sexual desire and arousability) and climacteric symptoms in postmenopausal women. METHODS: A randomized, double-blind, cross-over study was conducted in 38 postmenopausal women who receivedtibolone 2.5 mg/day and placebo. Vaginal blood flow during erotic stimulation by fantasy and film was measured using a vaginal photoplethysmograph and subjects completed sexual function questionnaires and daily diaries. RESULTS:Tibolone significantly increased baseline vaginal pulse amplitude (VPA) levels compared with placebo. There were significant treatment differences in VPA in favor of tibolone during fantasy periods but not during erotic film stimulation. Tibolone was associated with significant increases in sexual desire, and the frequency of arousability and of sexual fantasies compared with those with placebo. Vaginal lubrication was significantly improved on tibolone. Twenty-five of 38 (66%) subjects correctly guessed when they were on active treatment. Tibolone was well tolerated. CONCLUSIONS:Tibolone was associated with significant improvements in sexual function in postmenopausal women, reflecting both its estrogenic and androgenic properties. There were significantly greater increases in vaginal blood flow with tibolone in response to erotic fantasy but not film, suggesting two possible pathways of female sexual response.
RCT Entities:
AIMS: To compare the effects of 3 months' tibolone treatment with the effects of placebo on sexual function (in particular, vaginal blood flow, and sexual desire and arousability) and climacteric symptoms in postmenopausal women. METHODS: A randomized, double-blind, cross-over study was conducted in 38 postmenopausal women who received tibolone 2.5 mg/day and placebo. Vaginal blood flow during erotic stimulation by fantasy and film was measured using a vaginal photoplethysmograph and subjects completed sexual function questionnaires and daily diaries. RESULTS:Tibolone significantly increased baseline vaginal pulse amplitude (VPA) levels compared with placebo. There were significant treatment differences in VPA in favor of tibolone during fantasy periods but not during erotic film stimulation. Tibolone was associated with significant increases in sexual desire, and the frequency of arousability and of sexual fantasies compared with those with placebo. Vaginal lubrication was significantly improved on tibolone. Twenty-five of 38 (66%) subjects correctly guessed when they were on active treatment. Tibolone was well tolerated. CONCLUSIONS:Tibolone was associated with significant improvements in sexual function in postmenopausal women, reflecting both its estrogenic and androgenic properties. There were significantly greater increases in vaginal blood flow with tibolone in response to erotic fantasy but not film, suggesting two possible pathways of female sexual response.
Authors: Steven R Cummings; Bruce Ettinger; Pierre D Delmas; Peter Kenemans; Victoria Stathopoulos; Pierre Verweij; Mirjam Mol-Arts; Lenus Kloosterboer; Lori Mosca; Claus Christiansen; John Bilezikian; Eduardo Mario Kerzberg; Susan Johnson; Jose Zanchetta; Diederich E Grobbee; Wilfried Seifert; Richard Eastell Journal: N Engl J Med Date: 2008-08-14 Impact factor: 91.245