RESEARCH SUPPORT, NON-U.S. GOV'T
Add like
Add dislike
Add to saved papers

Ospemifene effectively treats vulvovaginal atrophy in postmenopausal women: results from a pivotal phase 3 study.

OBJECTIVE: The aim of this study was to study the efficacy and safety of ospemifene, a new selective estrogen receptor modulator, in the treatment of vulvovaginal atrophy in postmenopausal women.

METHODS: A randomized, double-blind phase 3 study in which 826 postmenopausal women were randomized 1:1:1 to receive treatment with ospemifene 30 or 60 mg/day or placebo orally for 12 weeks was conducted. The primary inclusion criteria were having 5% or less superficial cells on the vaginal smear (maturation index), vaginal pH greater than 5.0, and at least one moderate or severe symptom of vulvovaginal atrophy. The four coprimary endpoints were the change from baseline to 12 weeks in the percentage of superficial and parabasal cells on the vaginal smear, change in vaginal pH, and change in severity of most bothersome symptom (vaginal dryness or dyspareunia) compared with placebo. All participants were given a nonhormonal vaginal lubricant for use as needed.

RESULTS: Ospemifene was statistically significantly superior to placebo in each of the coprimary endpoints at the 60-mg dose. Statistically significant results were achieved for all coprimary endpoints with the 30-mg dose except for dyspareunia. Ospemifene was well tolerated at both doses and demonstrated a favorable safety profile.

CONCLUSIONS: Ospemifene was shown to be effective and well tolerated for the treatment of the symptoms of vaginal dryness and dyspareunia associated with vulvovaginal atrophy over and above the use of provided lubricants.

Full text links

For the best experience, use the Read mobile app

Group 7SearchHeart failure treatmentPapersTopicsCollectionsEffects of Sodium-Glucose Cotransporter 2 Inhibitors for the Treatment of Patients With Heart Failure Importance: Only 1 class of glucose-lowering agents-sodium-glucose cotransporter 2 (SGLT2) inhibitors-has been reported to decrease the risk of cardiovascular events primarily by reducingSeptember 1, 2017: JAMA CardiologyAssociations of albuminuria in patients with chronic heart failure: findings in the ALiskiren Observation of heart Failure Treatment study.CONCLUSIONS: Increased UACR is common in patients with heart failure, including non-diabetics. Urinary albumin creatininineJul, 2011: European Journal of Heart FailureRandomized Controlled TrialEffects of Liraglutide on Clinical Stability Among Patients With Advanced Heart Failure and Reduced Ejection Fraction: A Randomized Clinical Trial.Review

Get seemless 1-tap access through your institution/university

For the best experience, use the Read mobile app

Read by QxMD is copyright © 2021 QxMD Software Inc. All rights reserved. By using this service, you agree to our terms of use and privacy policy.

Get seemless 1-tap access through your institution/university

For the best experience, use the Read mobile app