Ospemifene, a novel selective estrogen receptor modulator for treating dyspareunia associated with postmenopausal vulvar and vaginal atrophy

@article{Portman2013OspemifeneAN,
  title={Ospemifene, a novel selective estrogen receptor modulator for treating dyspareunia associated with postmenopausal vulvar and vaginal atrophy},
  author={David J. Portman and Gloria A Bachmann and James A. Simon},
  journal={Menopause},
  year={2013},
  volume={20},
  pages={623–630}
}
ObjectiveThe aim of this work was to study the role of ospemifene, a novel selective estrogen receptor modulator, in the treatment of vulvar and vaginal atrophy in postmenopausal women with moderate to severe dyspareunia and physiological vaginal changes. MethodsThis multicenter phase 3 study used a randomized, double-blind, parallel-group design to compare the efficacy, safety, and tolerability of oral ospemifene 60 mg/day versus placebo. A total of 605 women aged 40 to 80 years who self… 
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.
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.
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.
The efficacy and safety of ospemifene in treating dyspareunia associated with postmenopausal vulvar and vaginal atrophy: a systematic review and meta-analysis.
TLDR
A meta-analysis indicates that ospemifene to be an effective and safe treatment for dyspareunia associated with postmenopausal vulvar and vaginal atrophy.
spemifene , a non-oestrogen selective oestrogen receptor modulator or the treatment of vaginal dryness associated with postmenopausal ulvar and vaginal atrophy : A randomised , placebo-controlled , phase II trial
Objective: To evaluate the efficacy and safety of ospemifene, a novel selective oestrogen receptor modulator, in the treatment of vaginal dryness in postmenopausal women with vulvovaginal atrophy
Ospemifene for the treatment of postmenopausal vulvar and vaginal atrophy: recommendations for clinical use
TLDR
Ospemifene is an approved oral option for postmenopausal women seeking treatment for VVA with bothersome dyspareunia, particularly for those who have tried and failed over-the-counter options or do not want vaginal therapies.
Ospemifene for the treatment of dyspareunia associated with vulvar and vaginal atrophy: potential benefits in bone and breast
TLDR
Ospemifene is a SERM with a unique estrogen agonist/antagonist tissue profile that was recently approved in the US for the treatment of dyspareunia associated with vulvar and vaginal atrophy in postmenopausal women and warrants further clinical investigation for thetreatment and prevention of osteoporosis and breast cancer.
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.
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.
Profile of Ospemifene in the Breast
  • S. Berga
  • Medicine
    Reproductive Sciences
  • 2013
TLDR
Clinical trials, including 3 long-term studies assessing the overall safety of ospemifene, support that ospEMifene is generally well tolerated, with beneficial effects on the vagina, neutral effect on the breast, and minimal effects onThe endometrium.
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TLDR
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.
Effects of ospemifene, a novel SERM, on hormones, genital tract, climacteric symptoms, and quality of life in postmenopausal women: a double-blind, randomized trial
TLDR
Ospemifene at daily doses of 30 to 90 mg did not stimulate endometrium or aggravate hot flashes but clearly had a rather strong estrogenic effect on the vaginal epithelium during a 3-month treatment period, as evidenced by an increase in intermediate and superficial cells in repeat Pap smears.
One-year long-term safety extension study of ospemifene for the treatment of vulvar and vaginal atrophy in postmenopausal women with a uterus
TLDR
Daily doses of ospemifene 30 mg and ospEMifene 60 mg yielded few treatment-emergent adverse events and demonstrated no significant endometrial changes during the 1-year treatment of vulvar and vaginal atrophy in postmenopausal women with a uterus.
Effects of ospemifene (FC-1271a) on uterine endometrium, vaginal maturation index, and hormonal status in healthy postmenopausal women.
TLDR
The study suggests that a safe and well tolerated dose of ospemifene for potential clinical use may be between 25 and 100 mg, and suggests that the highest dose level (200 mg) induced more subjective adverse reactions, especially hot flushes, than lower doses.
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TLDR
Ospemifene, at the dose of 90 mg/day, was more estrogenic than raloxifenes, as shown by changes in serum follicle-stimulating hormone and sex hormone-binding globulin levels.
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INTRODUCTION Vulvovaginal atrophy results from estrogen deficiency and affects a large number of postmenopausal women. Symptoms include vaginal dryness, itching, irritation, and dyspareunia. AIM
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The results of the pilot study show that ospemifene may lack genotoxic and toxic effects while having a favourable pharmacokinetic profile.
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TLDR
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