Effect of raloxifene on the response to conjugated estrogen vaginal cream or nonhormonal moisturizers in postmenopausal vaginal atrophy.
OBJECTIVE
To study the effect of raloxifene on the response to conjugated estrogen cream or nonhormonal moisturizer in postmenopausal women with preexisting signs of vaginal atrophy.


METHODS
Postmenopausal women with preexisting and untreated vaginal atrophy were enrolled in this parallel, placebo-controlled, randomized study. A total of 187 women were randomized to four treatment groups: daily oral raloxifene (60 mg per day) or a placebo in a double-blind manner plus one application of conjugated estrogen cream (0.5 g) or one applicator full of nonhormonal moisturizer, open label. The conjugated estrogen cream or nonhormonal moisturizer was applied daily for the first 2 weeks, and then twice weekly thereafter for 3 months. Efficacy of treatment regimens on signs and symptoms of vaginal atrophy was evaluated by monitoring objective and subjective parameters.


RESULTS
Signs and symptoms of vaginal atrophy improved in all four treatment groups. Raloxifene did not diminish the magnitude of improvement when administered with either vaginal preparation. Conjugated estrogen cream produced a statistically greater improvement in signs (P <.05) but not in individual symptoms or overall satisfaction relative to nonhormonal moisturizer.


CONCLUSIONS
Postmenopausal women with evidence of preexisting vaginal atrophy may use either low-dose conjugated estrogen cream or nonhormonal moisturizer to treat the atrophy concurrently with raloxifene (60 mg per day).
Parsons
Anna
A
University of South Florida, College of Medicine, Department of Obstetrics and Gynecology, Tampa, Florida 33606, USA. aparsons@hsc.usf.edu
Merritt
Diane
D
Rosen
Amy
A
Heath
Hunter
H
Siddhanti
Suresh
S
Plouffe
Leo
L
D000282:Administration, Intravaginal; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D001284:Atrophy / Q000188:drug therapy / Q000473:pathology; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D004334:Drug Administration Schedule; D004359:Drug Therapy, Combination; D004966:Estrogens, Conjugated (USP) / Q000008:administration & dosage*; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008875:Middle Aged; D017698:Postmenopause / Q000187:drug effects / Q000502:physiology; D011336:Probability; D020849:Raloxifene Hydrochloride / Q000008:administration & dosage*; D012016:Reference Values; D012680:Sensitivity and Specificity; D012720:Severity of Illness Index; D016896:Treatment Outcome; D014621:Vagina / Q000473:pathology*; D014622:Vaginal Creams, Foams, and Jellies / Q000627:therapeutic use; D014623:Vaginal Diseases / Q000188:drug therapy* / Q000473:pathology
D004966:Estrogens, Conjugated (USP); D014622:Vaginal Creams, Foams, and Jellies; D020849:Raloxifene Hydrochloride