ospemifene and Syndrome

Genitourinary syndrome of menopause (GSM) seriously affects the quality of life of women in this stage and patients with breast cancer, but optimal treatment options as well as risks associated with the complication remain controversial. We aimed at exploring the safest and most effective treatment for genitourinary syndrome of menopause. The study was performed following a pre-established protocol registered on PROSPERO (CRD42020180807). We searched through PubMed, Embase, Scopus, Cochrane Library, Web of Science and ScienceDirect electronic databases, clinicaltrials.gov and OVID for relevant data on Genitourinary syndrome of menopause provided by March 2020. Randomised controlled trials (RCTs) on women presenting with some or all the signs and symptoms for genitourinary syndrome of menopause were extracted and analyzed based on the Bayesian theory. The key variables were additionally evaluated using the network sub-analyses, standard pairwise comparisons, regression analysis and subgroup and sensitivity analyses. The pooled estimates were quantified as odd ratios or mean differences where appropriate, at 95 % confidence intervals. In the end, 29 randomized controlled trials (RCTs) evaluating 5 different treatment regimens for genitourinary syndrome of menopause, involving 8311 patients, were included in the study. Laser therapy had excellent effect on vaginal dryness, dysparunia, urinary incontinence, proportion of parabasal cells, pH and VHI. Vaginal estrogen also had significant effects on these aspects, although its effect was inferior to that of laser therapy. Ospemifene therapy was however superior to laser and vaginal estrogen therapies in ameliorating sexual function, however, it presents a high risk of developing adverse events and endometrial hyperplasia. Moisturizer/lubricant was effective on dysparunia, proportion of parabasal cells and vaginal pH. In regression analysis, age was an essential factor affecting vaginal dryness and pH treatment effect. Compared with other currently available interventional treatments for genitourinary syndrome of menopause, laser therapy, followed by vaginal estrogen, confers superior clinical outcomes for most aspects associated with the disease. In addition, they pose relatively low risks of developing adverse events. Ospemifene and DHEA therapies on their part significantly improve sexual function of women with GSM. A strong relationship between treatment effect and age provides insights for future studies on

Topics: Bayes Theorem; Dehydroepiandrosterone; Estrogens; Female; Female Urogenital Diseases; Humans; Laser Therapy; Menopause; Network Meta-Analysis; Randomized Controlled Trials as Topic; Syndrome; Tamoxifen; Treatment Outcome

To examine mammographic density before and after at least 1 year of vaginal estrogen use in a small cohort of healthy postmenopausal women and women with a personal history of breast cancer.. We extracted data via chart review of patients from a single practitioner's menopause specialty clinic in Baltimore, MD. Mammographic change was primarily determined via the Bi-RADS scoring system, including the Bi-RADS density score. In addition, we conduct a narrative review of the current literature on the usage of local estrogen therapy, and systemic and local alternatives in the treatment of genitourinary syndrome of menopause (GSM) in breast cancer survivors.. Twenty healthy postmenopausal women and three breast cancer survivors fit our inclusion criteria. Amongst these two groups, we did not find an increase in mammographic density after at least 1 year and up to 18 years of local vaginal estrogen. Ospemifene use in one patient did not appear to be associated with any change in Bi-RADS score. Our narrative review found little data on the effects of vaginal estrogen therapy or newer alternative systemic therapies such as ospemifene on mammographic density.. Low-dose vaginal estrogen use for 1 or more years in a small cohort of women with GSM did not appear to be associated with any changes in breast density or Bi-RADS breast cancer risk scores in the majority of study participants, including three breast cancer survivors. Larger long-term controlled clinical trials should be conducted to examine the effects of low-dose vaginal estrogen on mammographic density in women with and without a personal history of breast cancer. Furthermore, relative efficacy and risk of vaginal estrogen compared with other forms of treatment for GSM should also be studied in long-term trials.

Topics: Administration, Intravaginal; Adult; Aged; Breast; Breast Neoplasms; Cancer Survivors; Estrogens; Female; Female Urogenital Diseases; Humans; Mammography; Middle Aged; Postmenopause; Retrospective Studies; Syndrome; Tamoxifen; Treatment Outcome

Ospemifene is a selective estrogen receptor modulator recently approved by the FDA for the treatment postmenopausal women experiencing moderate-to-severe dyspareunia and by the EMA for the treatment of moderate-to-severe symptomatic genitourinary syndrome of menopause (GSM) in women who are not suitable candidates for local vaginal estrogen therapy.. This review offers an explanation of the pharmacodynamics and of the pharmacokinetics of ospemifene, and gives readers a complete overview of Phase II and III studies on the clinical efficacy, tolerability and safety of this agent in the setting of GSM.. Ospemifene is efficacious for improving vaginal dryness or dyspareunia as the patient-identified most bothersome symptom, and Phase III clinical trials (4648 patients) have shown good efficacy in terms of improvement of objective and subjective signs and measures of GSM in postmenopausal women. Future studies with a long-term follow-up are required to better elucidate its safety profile. In particular, on the basis of preclinical and early clinical findings of antagonistic to neutral effect on breast tissue, more research is needed to assess the treatment with ospemifene in breast cancer survivors.

Topics: Animals; Dyspareunia; Female; Female Urogenital Diseases; Humans; Menopause; Postmenopause; Selective Estrogen Receptor Modulators; Syndrome; Tamoxifen

The term genitourinary syndrome of menopause (GSM) emerged following a consensus conference held in May 2013. GSM is a more descriptive term than vulvovaginal atrophy (VVA) and does not imply pathology. However there are concerns that GSM is all encompassing and includes not only symptoms resulting from estrogen deficiency, but also those arising from the effects of ageing and other processes on the bladder and pelvic floor. Focusing on symptoms related to estrogen deficiency, the update provides a practical guide for health and allied health professionals on the impact of GSM on women and their partners, assessment, management and areas for future research. As GSM is a chronic condition, long term therapy is required. Hormonal, nonhormonal, laser and alternative and complementary therapies are described.

Topics: Atrophy; Complementary Therapies; Estrogen Replacement Therapy; Estrogens; Female; Humans; Laser Therapy; Menopause; Norpregnenes; Quality of Life; Selective Estrogen Receptor Modulators; Sexuality; Syndrome; Tamoxifen; Vagina; Vulva

The vagina, vulva, vestibule, labia majora/minora, and bladder trigone have a high concentration of estrogen receptors; therefore, they are a sensitive biological indicator of serum levels of these hormones in women. The estrogen loss in postmenopausal women produces a dysfunction called genitourinary syndrome of menopause. The principal therapeutic goal in the genitourinary syndrome of menopause is to relieve symptoms. Treatment options, as well as local and systemic hormonal treatment are changes in lifestyle and non-hormonal treatments mainly based on the use of moisturizers and lubricants. New treatments that have recently appeared are ospemifeme, the first selective hormone receptor modulator for dyspareunia and vulvovaginal atrophy treatment, and the use of vaginal laser. This review has been written with the intention of giving recommendations on the prevention and treatment of genitourinary syndrome of menopause.

Topics: Androgens; Atrophy; Dyspareunia; Estrogen Replacement Therapy; Estrogens; Female; Female Urogenital Diseases; Humans; Laser Therapy; Life Style; Lubricants; Menopause; Postmenopause; Selective Estrogen Receptor Modulators; Syndrome; Tamoxifen; Vagina; Vulva; Women's Health

The study aimed to assess the effects of ospemifene on vulvar vestibule in postmenopausal women with vulvar pain and dyspareunia. Fifty-five postmenopausal women used oral ospemifene 60 mg/d for 60 d. Symptoms of dryness, burning, and dyspareunia were evaluated on a 10 cm visual analog scale. Visual examination of the vulvar vestibule was also conducted. Patients also underwent current perception threshold (CPT) testing obtained from the vulvar vestibule. Fifty-five patients (94.6%) completed the treatment. Hot flashes were the most frequent adverse effects, but this led to a discontinuation of therapy in three patients (5.4%). After therapy, there was a statistically significant decrease from the baseline in the mean scores for dryness, burning, and dyspareunia and reduction of vestibular trophic score (baseline value of 11.2-4.2 after the therapy, p ≤ 002) and cotton swab test scores (2.81 compared with 1.25, p = .001). There was a difference in CPT values for all nerve fibers and more consistent for C fibers (-38% of sensitivity). These results confirm the efficacy of ospemifene on postmenopausal vestibular symptoms and signs; moreover, the drug was effective in normalizing vestibular innervation sensitivity.

Topics: Administration, Buccal; Dyspareunia; Electric Stimulation; Female; Hot Flashes; Humans; Middle Aged; Pain Measurement; Pain Perception; Pilot Projects; Postmenopause; Syndrome; Tamoxifen; Vulva; Vulvar Vestibulitis; Vulvodynia