HT treatment with estrogens alone or in combination with progestogens was associated with a small to moderate improvement in sexual function , particularly in pain , when used in women with menopausal symptoms or in early postmenopause ( within five years of amenorrhoea ) , but not in unselected postmenopausal women .
The current evidence does not suggest an important effect of tibolone or of SERMs alone or combined with estrogens on sexual function .
BACKGROUND The perimenopausal and postmenopausal periods are associated with many symptoms , including sexual complaints .
OBJECTIVES To assess the effect of hormone therapy ( HT ) on  sexual function in perimenopausal and postmenopausal women .
Safety and efficacy of tibolone in breast-cancer patients with vasomotor symptoms: a double-blind, randomised, non-inferiority trial.
BACKGROUND Vasomotor symptoms and bone loss are complications frequently induced by adjuvant treatment for breast cancer .  Tibolone prevents both side-effects , but its effect on cancer recurrence is unknown . The aim of this study was to show non-inferiority of tibolone to placebo regarding risk of recurrence in breast-cancer patients with climacteric complaints . METHODS Between July 11 , 2002 , and Dec 20 , 2004 , women surgically treated for a histologically confirmed breast cancer ( T(1 - 3)N(0 - 2)M(0 ) ) with vasomotor symptoms were r and omly assigned to either tibolone 2.5 mg daily or placebo at 245 centres in 31 countries . R and omisation was done by use of a central ised interactive voice response system , stratified by centre , with a block size of four . The primary endpoint was breast-cancer recurrence , including contralateral breast cancer , and was analysed in the intention-to-treat ( ITT ) and per- protocol population s ; the margin for non-inferiority was set as a hazard ratio of 1.278 . This study is registered with Clinical Trials.gov , number NCT00408863 . FINDINGS Of the 3148 women r and omised , 3098 were included in the ITT analysis ( 1556 in the tibolone group and 1542 in the  placebo group ) . Mean age at r and omisation was 52.7 years ( SD 7.3 ) and mean time since surgery was 2.1 years ( SD 1.3 ) . 1792 of 3098 ( 58 % ) women were node positive and 2185 of 3098 ( 71 % ) were oestrogen-receptor positive . At study entry , 2068 of 3098 ( 67 % ) women used tamoxifen and 202 of 3098 ( 6.5 % ) women used  aromatase inhibitors  . The mean daily number of hot flushes was 6.4 ( SD 5.1 ) . After a median follow-up of 3.1 years ( range 0.01 - 4.99 ) , 237 of 1556 ( 15.2 % ) women on tibolone had a cancer recurrence , compared with 165 of 1542 ( 10.7 % ) on placebo ( HR 1.40 [ 95 % CI 1.14 - 1.70 ] ; p=0.001 ) . Results in the per- protocol population were similar ( 209 of 1254 [ 16.7 % ] women in the tibolone group had a recurrence vs 138 of 1213 [ 11.4 % ] women in the placebo group ; HR 1.44 [ 95 % CI 1.16 - 1.79 ] ; p=0.0009 ) . Tibolone was not different from placebo with regard to other safety outcomes , such as mortality ( 72 patients vs 63 patients , respectively ) , cardiovascular events ( 14 vs 10 , respectively ) , or gynaecological cancers ( 10 vs 10 , respectively ) . Vasomotor symptoms and bone-mineral density improved significantly with tibolone , compared with placebo . INTERPRETATION Tibolone increases the risk of recurrence in breast cancer patients , while relieving vasomotor symptoms and preventing bone loss . FUNDING Schering-Plough ( formerly NV Organon , Oss , Netherl and s )
HT treatment with estrogens alone or in combination with progestogens was associated with a small to moderate improvement in sexual function , particularly in pain , when used in women with menopausal symptoms or in early postmenopause ( within five years of amenorrhoea ) , but not in unselected postmenopausal women .
The current evidence does not suggest an important effect of tibolone or of SERMs alone or combined with estrogens on sexual function .
BACKGROUND The perimenopausal and postmenopausal periods are associated with many symptoms , including sexual complaints .
OBJECTIVES To assess the effect of hormone therapy ( HT ) on  sexual function in perimenopausal and postmenopausal women .