Effect of raloxifene on sexual function in older postmenopausal women with osteoporosis.
OBJECTIVE
To assess the effect of raloxifene compared with placebo on sexual function in older postmenopausal women undergoing therapy for the treatment of osteoporosis.


METHODS
A subset (12%) of English-speaking women in the United States and Canada participating in the Multiple Outcomes of Raloxifene Evaluation Trial were asked to complete a sexual function questionnaire at baseline and after 36 months of treatment. The Multiple Outcomes of Raloxifene Evaluation Trial is a multicenter, randomized, blinded, placebo-controlled clinical trial, in which 7,705 postmenopausal women with osteoporosis were randomly assigned to one of three groups: raloxifene hydrochloride 60 mg per day or 120 mg per day or placebo. In this substudy, 943 women completed the sexual function questionnaire at both visits. Because preliminary analyses showed no differences by raloxifene dose (n = 302 for 60 mg per day; n = 322 for 120 mg/day), the two groups were combined and compared with the placebo group (n = 319). For the given sample size, we had 80% power (alpha =.05, two-sided, ratio of raloxifene to placebo = 2:1) to detect a 10%-16% difference in the proportion of women experiencing no change in sexual function between placebo and treatment groups.


RESULTS
Overall, sexual function and changes in sexual function from baseline to study end between the raloxifene and placebo groups did not differ. In particular, there were no differences in sexual desire or frequency of sexual activity between the groups. Among sexually active women, there were no differences in enjoyment, satisfaction, orgasm, or reported sexual problems.


CONCLUSIONS
Sexual function in older postmenopausal women with osteoporosis is not affected by treatment with raloxifene.
Modugno
Francesmary
F
Department of Epidemiology, Graduate School of Public Health, University of Pittsburgh, Pittsburgh, Pennsylvania 15261, USA. fm@cs.cmu.edu
Ness
Roberta B
RB
Ewing
Susan
S
Cauley
Jane A
JA
D000328:Adult; D000367:Age Factors; D000368:Aged; D000369:Aged, 80 and over; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D004334:Drug Administration Schedule; D015914:Estrogen Replacement Therapy / Q000379:methods*; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D016015:Logistic Models; D008875:Middle Aged; D015999:Multivariate Analysis; D015663:Osteoporosis, Postmenopausal / Q000175:diagnosis / Q000188:drug therapy*; D011336:Probability; D020849:Raloxifene Hydrochloride / Q000008:administration & dosage*; D012016:Reference Values; D018570:Risk Assessment; D020845:Selective Estrogen Receptor Modulators / Q000008:administration & dosage*; D019529:Sexuality / Q000187:drug effects*; D016896:Treatment Outcome
D020845:Selective Estrogen Receptor Modulators; D020849:Raloxifene Hydrochloride