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

@article{Bachmann2010OspemifeneET,
  title={Ospemifene effectively treats vulvovaginal atrophy in postmenopausal women: results from a pivotal phase 3 study},
  author={Gloria A Bachmann and Janne Komi},
  journal={Menopause},
  year={2010},
  volume={17},
  pages={480-486}
}
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… 
Ospemifene, a novel selective estrogen receptor modulator for treating dyspareunia associated with postmenopausal vulvar and vaginal atrophy
TLDR
In this study, once-daily oral ospemifene 60 mg was effective for the treatment of vulvar and vaginal atrophy in postmenopausal women with dyspareunia.
The clinical relevance of the effect of ospemifene on symptoms of vulvar and vaginal atrophy
TLDR
Treatment with ospemifene was consistently associated with greater improvement, substantial improvement or relief in the severity of the most bothersome symptoms of vaginal dryness or dyspareunia compared with placebo.
Ospemifene, a non-oestrogen selective oestrogen receptor modulator for the treatment of vaginal dryness associated with postmenopausal vulvar and vaginal atrophy: a randomised, placebo-controlled, phase III trial.
TLDR
Once-daily oral ospemifene 60 mg was effective for the treatment of VVA in postmenopausal women with vaginal dryness in a 12 week, multicentre, randomised, double-blind, parallel-group phase III study of women with VVA.
Systematic indirect comparison of ospemifene versus local estrogens for vulvar and vaginal atrophy
TLDR
Ospemifene 60 mg has an efficacy, safety, and tolerability profile comparable to or better than local vaginal estrogens in the treatment of VVA, but the confidence intervals for both products do not exclude an increased risk.
Ospemifene in clinical practice for vulvo-vaginal atrophy: results at 3 months of follow-up of use
TLDR
This study in routine clinical practice conditions confirms the results previously reported by randomized controlled trials, including a significant improvement in VVA, sexual function, quality of life, and satisfaction with the treatment.
Female sexual function improved with ospemifene in postmenopausal women with vulvar and vaginal atrophy: results of a randomized, placebo-controlled trial
TLDR
In a large, randomized, double-blind, placebo-controlled trial, ospemifene 60 mg/day significantly improved FSD in women with VVA and consistent effects across FSFI domains were observed.
Ospemifene for the treatment of vulvar and vaginal atrophy: A meta-analysis of randomized trials. Part I: Evaluation of efficacy.
TLDR
The present meta-analysis suggests that ospemifene 60 mg is associated with significant improvement in the morphological and physiological features of the vaginal mucosa that correlate with the symptoms associated with postmenopausal VVA.
Ospemifene 12-month safety and efficacy in postmenopausal women with vulvar and vaginal atrophy
TLDR
The findings of this 52-week study confirm the tolerance and efficacy of oral ospemifene previously reported in short- and long-term studies.
Efficacy and safety of ospemifene in postmenopausal women with moderate-to-severe vaginal dryness: a phase 3, randomized, double-blind, placebo-controlled, multicenter trial
TLDR
Ospemifene was effective and well tolerated for the treatment of moderate-to-severe vaginal dryness in postmenopausal women with VVA.
Safety and efficacy of ospemifene for the treatment of dyspareunia associated with vulvar and vaginal atrophy due to menopause
TLDR
Results of Phase III clinical trials showed that ospemifene significantly improved the vaginal maturation index, decreased vaginal pH, and decreased severity of the self-identified most bothersome symptom (dyspareunia or vaginal dryness) compared to placebo.
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