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The issue of vaginal dryness in genitourinary syndrome of menopause (GSM) and its pervasive impact on women's quality of life is often overlooked. Extensive surveys conducted worldwide reveal limited understanding of vaginal dryness among public and health-care providers. Physician knowledge on menopause medicine varies globally, highlighting the need for standardized training. Effective communication between physicians and patients plays a crucial role in diagnosing and treating GSM symptoms. There are multiple treatment options to improve vaginal lubrication, including hormonal and non-hormonal therapies, along with lifestyle modifications. Tailoring treatments to individual patient preferences is crucial for compliance. Overall, GSM is multifaceted, from the prevalence of vaginal dryness to the nuances of treatment preferences. The urgency of widespread education and awareness of this matter must be underscored to meet the aim of enhancing the well-being and quality of life for women. [ABSTRACT FROM AUTHOR]

A randomized controlled study was conducted to evaluate the safety and efficacy of radiofrequency treatment in postmenopausal women not willing to use or presenting a contraindication for menopause hormone therapy (MHT) and suffering from genitourinary syndrome of menopause (GSM). A prospective randomized open study evaluated the effect of radiofrequency treatment versus a gel (control group) in postmenopausal women suffering from GSM. Patients were assessed at baseline and after 10–12 weeks of treatment for severity of vulvovaginal atrophy, dyspareunia, pH, vaginal smear maturation index, Vaginal Health Index and Female Sexual Function Index. The difference at baseline and after 10–12 weeks of treatment and the difference in improvement were tested between groups by a two-sample t-test and the Mann–Whitney test. Due to the COVID-19 pandemic, we were only able to treat 48 patients (24 patients using radiofrequency and 24 patients using a gel). Globally, at the end of the study, there were no differences in changes of the measured outcomes between the group of women treated with radiofrequency and the control group. Radiofrequency treatment was found to be safe, but was not superior to a gel, although the study lacked power. The study was registered at ClinicalTrials.gov (NCT03857893). [ABSTRACT FROM AUTHOR]

This study aimed to measure safety, systemic pharmacokinetics and preliminary efficacy of a vaginal tamoxifen capsule (DARE-VVA1) among postmenopausal women with moderate-to-severe vulvovaginal atrophy. This was a randomized, placebo-controlled, double-blind, phase 1/2 study of DARE-VVA1, in four doses (1, 5, 10 and 20 mg). Seventeen women were enrolled and 14 completed the 8-week treatment. DARE-VVA1 was safe. All adverse events were of mild or moderate severity and distributed similarly among active and placebo groups. Plasma tamoxifen concentrations were highest among women using DARE-VVA1 20 mg, but the maximum mean (standard deviation) plasma tamoxifen concentrations on day 1 (2.66 ± 0.85 ng/ml) and day 56 (5.69 ± 1.87 ng/ml) were <14% of those measured after one oral tamoxifen dose. Active study product users had significant decreases from pre-treatment baseline in vaginal pH and proportion of vaginal parabasal cells (p = 0.04 for both endpoints), with women randomized to the 10 mg or 20 mg dose experiencing the largest treatment impact. The severity of vaginal dryness and dyspareunia decreased significantly from baseline with active study product use (p = 0.02 for both endpoints). DARE-VVA1 is safe and results in minimal systemic exposure to tamoxifen. Preliminary efficacy data support further development of this product. [ABSTRACT FROM AUTHOR]

This study aimed to evaluate the self-reported satisfaction of Spanish postmenopausal women currently treated for vulvovaginal atrophy (VVA) symptoms. The CRETA (CRoss sectional European sTudy on Adherence) is a multicenter cross-sectional study conducted in 29 public and private hospitals in Spain, which enrolled postmenopausal women receiving treatment with ospemifene, local hormone therapy (HT) or vaginal moisturizers for VVA. After the prior informed consent of the patients, sociodemographic and treatment perception data were collected using a structured questionnaire. Among 752 women who completed the survey, the satisfaction score was significantly higher for the group treated with ospemifene (mean 8.3 ± 1.4) compared with the local HT group (7.2 ± 1.7) and the vaginal moisturizer group (6.5 ± 2.1) according to a 10-point Likert scale (p < 0.0001). Compared to vaginal moisturizers and local HT, participants treated with ospemifene reported the highest adherence (96.7% vs. 70.2% and 78.6%, respectively) and the lowest number of missed doses in the last month (0.6 ± 1.3 standard deviation [SD] vs. 3.5 ± 4.3 SD and 2.0 ± 2.8 SD, respectively) (p < 0.0001). Ospemifene was significantly perceived as easy to use (83.9% vs. 44.9% and 58.6%, respectively; p < 0.0001), efficacious in reducing the time to relieve symptoms (17.1% vs. 7.0% and 6.7%, p = 0.0005 and p = 0.0006, respectively) and convenient for sexual life (53.1% vs. 25.6% and 42.3%, p < 0.0001 and p = 0.0234, respectively). Among postmenopausal women with VVA, treatment with ospemifene has the most positive perceptions and the highest overall satisfaction level and could be an optimal therapeutic approach, maximizing patient adherence. [ABSTRACT FROM AUTHOR]

Vulvovaginal atrophy (VVA) is a chronic progressive condition that involves the genital and lower urinary tracts, related to the decrease of serum estrogenic levels when menopause occurs. The definition of genitourinary syndrome of menopause (GSM) is a medically more accurate, all-encompassing and publicly acceptable term than VVA. Due to the chronic progressive trend of GSM, symptoms tend to reappear after the cessation of therapy, and frequently long-term treatment is required. First-line therapies include vulvar and vaginal lubricant or moisturizers, and, in the case of failure, low-dose vaginal estrogens are the preferred pharmacological therapy. Populations of patients, such as breast cancer (BC) survivors, are affected by iatrogenic GSM symptoms with concerns about the use of hormonal therapies. The non-ablative erbium:YAG laser and the fractional microablative CO2 vaginal laser are the two main lasers evaluated for GSM treatment. The aim of this comprehensive review is to report the efficacy and safety of Er:YAG and CO2 vaginal lasers for GSM treatment. Vaginal laser therapy has been demonstrated to be effective in restoring vaginal health, improving VVA symptoms and sexual function. The data suggest that both Er:YAG and CO2 vaginal lasers are safe energy-based therapeutic options for management of VVA and/or GSM symptoms in postmenopausal women and BC survivors. [ABSTRACT FROM AUTHOR]

It is estimated that the 25–50% of women who are reaching menopause every year report symptoms related to the genitourinary syndrome of menopause (GSM). The symptoms are not due simply to lack of estrogen. One possible contributing cause of symptoms is the vaginal microbiota. The vaginal microbiota is a dynamic entity and plays a critical role in the pathogenic interplay of postmenopausal changes. Treatment of this syndrome depends on the severity and type of the symptoms and on the preferences and expectations of women. As there are many treatment options, therapy should be individualized. While new evidence on the role of Lactobacilli in premenopause is emerging, the role of Lactobacilli is still unclear in GSM and the impact of microbiota on vaginal health remains conflictual. However, some reports show promising data on the effect of probiotic therapy in menopause. In the literature there are few studies and small population samples on the role of an exclusive therapy with Lactobacilli and further data will be mandatory. Studies involving large numbers of patients and different intervention periods will be necessary to obtain evidence of the preventive and curative role of vaginal probiotics. [ABSTRACT FROM AUTHOR]

The vagina is traditionally thought of as a passive organ in the female reproductive system, serving primarily as a passageway for menstrual blood, sexual intercourse and childbirth. However, recent research has shed light on the vagina's role as an endocrine organ that plays a crucial role in female hormonal balance and overall health. Particularly, growing evidence shows that the human vagina can be considered both as source and target of androgens, in view of the novel concept of 'intracrinology'. Besides the well-known role of estrogens, androgens are also crucial for the development and maintenance of healthy genitourinary tissues in women. As androgen levels decline with age, and estrogen levels fall during the menopausal transition, the tissues in the vagina, together with those in the urinary tract, become thinner, drier and less elastic, leading to a variety of uncomfortable and sometimes painful symptoms, clustered in the genitourinary syndrome of menopause (GSM). Given the lack of testosterone-based or androstenedione-based products approved by regulatory agencies to treat GSM, the possibility of using intravaginal prasterone, which works by providing a local source of dehydroepiandrosterone (DHEA) to the vaginal tissues, appears to be a targeted treatment. Further studies are needed to better assess its safety and efficacy. [ABSTRACT FROM AUTHOR]

Local estrogen therapy (LET) is the mainstay of treatment for vaginal dryness, dyspareunia and other urogenital symptoms because it may reverse some pathophysiological mechanisms associated with decreasing endocrine function and increasing aging. Over the years, several vaginal products including different formulations (tablets, rings, capsules, pessaries, creams, gels and ovules) and molecules (estradiol [E2], estriol [E3], promestriene, conjugated equine estrogens and estrone) have been used with superimposable therapeutic results. Low-dose and ultra-low-dose LET is the gold standard due to its minimal systemic absorption, with circulating E2 levels persistently remaining in the postmenopausal range. In healthy postmenopausal women, preference among the various products is presently the main driver and dissatisfaction with LET seems high, namely because of the delayed use in those with severe symptoms of genitourinary syndrome of menopause (GSM). Specific concerns remain in high-risk populations such as breast cancer survivors (BCS), especially those under treatment with aromatase inhibitors. Based on the multitude of symptoms under the umbrella of GSM definition, which includes vulvovaginal atrophy (VVA), it is mandatory to investigate specific effects of LET on quality of life, sexual function and genitourinary conditions by conducting studies with a patient-tailored focus. [ABSTRACT FROM AUTHOR]

The demand for non-hormonal therapies for vulvovaginal atrophy (VVA) is increasing due to an increasing number of patients surviving long term post cancer diagnosis, as well as increased public knowledge of the symptoms of menopause and availability of non-hormonal therapies. Treatment options are wide-ranging and encompass different formulations and methods of application. This review summarizes the key characteristics of the main forms of these therapies, as well as considering the current evidence for each of them and where future clinical studies should be directed. Care for VVA may be in primary care, or under gynecology or oncology. Further research requirements include the need for long-term data as well larger randomized controlled trials into alternatives where vaginal estrogen cannot be used as first-line treatment. Widespread education of health-care providers and patients on VVA and the impact on quality of life is urgently needed, as well as increased use of non-hormonal methods in routine clinical practice. [ABSTRACT FROM AUTHOR]

Vulvovaginal atrophy (VVA) is a chronic and progressive disease that affects sexuality and quality of life. VVA is preventable and treatable, but requires long-term and often sequential treatment. Sequential treatment consists of designing a strategy that uses one or more medications for a long enough time to achieve the desired benefits with minimal risk and maximum adherence. Currently available therapeutic options consist of topical over-the-counter products (including non-hormonal lubricants and moisturizers applied to the vagina), systemic hormone therapy and estrogens, and prescribed vaginal dehydroepiandrosterone (DHEA). In addition, we have a selective estrogen receptor modulator, ospemifene, and new energy-based treatments (laser and radiofrequency). There are clear differences between the treatments both in the mechanism of action and in the efficacy. Compliance is very low, and patients complain about the use of the vaginal route, often due to its low efficacy, or express fear of the long-term use of estrogens or the price of the treatments. We believe that, as a first option, and for physiological, preventive and efficacy reasons, we should consider the prescription of treatments that work on estrogen receptors. As a second option, there are vaginal moisturizers, which are effective on symptoms but do not prevent or improve conditions. Finally, techniques using heat, which although each time represent a clearer alternative, but on the other hand are the cost and the long-term safety data, give us a third option. Of course, we consider that vulvar moisturizers and lubricants can be used at any time. [ABSTRACT FROM AUTHOR]

Numerous surveys have documented that sexuality and/or sexual activity is important to women at all stages of adulthood, including postmenopause. Genitourinary syndrome of menopause (GSM) and hypoactive sexual desire disorder (HSDD) are common disorders in postmenopausal women and may co-occur. Both are often undiagnosed due to a lack of knowledge of the disorder, health-care professional discomfort in discussing sexual problems or a lack of routine screening. It is incumbent upon health-care professionals to identify and differentiate these conditions in women through a biopsychosocial assessment, and may require a focused physical examination. Numerous treatments, both non-pharmacologic and pharmacologic, are available to address GSM and HSDD. [ABSTRACT FROM AUTHOR]

Vulvovaginal atrophy (VVA) is an underdiagnosed and undertreated chronic condition resulting in physiological and histological changes in the genitourinary tract of postmenopausal women. Treatment of moderate to severe VVA includes local estrogens, dehydroepiandrosterone (DHEA) and oral ospemifene, a third-generation selective estrogen receptor modulator (SERM). Due to venous thromboembolism (VTE) safety concerns classically associated with the SERM class, and as part of its original marketing authorization approval (MAA), the European Medicines Agency (EMA) requested the performance of a 5-year post-authorization safety study (PASS) to study the incidence rate of VTE among women receiving ospemifene. The results have led to important regulatory changes to ospemifene's labeling, extending its indication and eliminating concerted risk management measures. A panel of experts discussed and reached consensus on the impact of these regulatory changes on clinical practice, reflecting on the reassurance of ospemifene's benefit–risk balance and recommending its positioning as a first-line pharmacological treatment option for moderate to severe VVA together with local therapies. In a scenario where different treatments present similar efficacy and safety profiles, a shared decision between clinician and patient, according to her needs and preferences over time, is fundamental to improve adherence and persistence with sequential treatment, contributing to the achievement of health outcomes. [ABSTRACT FROM AUTHOR]

Many breast cancer survivors (BCS) suffer the consequences of antineoplastic treatments that induce a hypoestrogenic state, leading to chronic climacteric symptoms such as genitourinary syndrome of menopause (GSM), arousing significant alteration in their quality of life. Non-hormonal therapies (NHT) are first-line treatments, safe but with mild efficacy. When facing moderate–severe GSM, the options for BCS are limited: local estrogen therapy, considered the 'gold standard' but with concerns about safety; vaginal androgens and prasterone, which seem to trigger an activation of estrogen and androgen receptors of the vaginal epithelium layers, without activating estrogen receptors on other tissues, being potentially safe but still without strong evidence in favor of BCS; vaginal lasers, which appear to improve vascularization of vaginal mucosa by stimulating the remodeling of the underlying connective tissue, but with contradictory results of efficacy in recent randomized clinical trials; and ospemifene, an oral selective estrogen receptor modulator presenting mild vaginal estrogenic potency and anti-estrogenic effect at the endometrial and breast level, but still not recommended for use in BCS in recent North American Menopause Society guidelines. There is a need for further studies evaluating objectively the efficacy and safety of these promising therapeutic options. On the other hand, sexuality must be seen as a multifactorial issue, where GSM is only part of the problem; evidence shows that sexual counseling improves the quality of life of BCS. Finally, there is a need to limit the underdiagnosis and undertreatment of GSM in BCS; the primary goal of physicians treating BCS regarding this issue has to be the provision of information of what to expect regarding genital and sexual symptoms to BCS and to counsel on early first-line treatments that may help prevent more severe GSM. [ABSTRACT FROM AUTHOR]

Overactive bladder (OAB) is a complex and multifactorial syndrome associated with urinary frequency, urgency and incontinence. The menopause-associated hormonal changes play a role in the development of this condition. Vaginal estrogens are effective in improving OAB in postmenopausal women (PMW) with vulvovaginal atrophy (VVA). Ospemifene is a selective estrogen receptor modulator licensed for the treatment of VVA. This study aimed to evaluate the effects of ospemifene on OAB symptoms in PMW with VVA. Forty PMW suffering from OAB and VVA received oral ospemifene (60 mg/day) for 12 weeks. All patients were assessed with a urodynamic study, a 3-day bladder diary and validated questionnaires (International Consultation on Incontinence Questionnaire – Urinary Incontinence Short Form [ICIQ-UI SF] and International Consultation on Incontinence Questionnaire – Overactive Bladder [ICIQ-OAB]) at enrollment and at the end of the study. Cytometric capacity, bladder compliance and verbal sensory threshold responses during bladder filling were improved after treatment. The voiding diary showed a significant reduction of daily voids, urge urinary incontinence episodes and nocturnal events. The median overall scores of the ICIQ-UI and ICIQ-OAB were also significantly improved. Our study suggest that treatment with ospemifene in PMW suffering from OAB is associated with a reduction of OAB symptoms due to a decreased bladder sensitivity and with an improvement in quality of life. [ABSTRACT FROM AUTHOR]

This study aimed to evaluate the safety and efficacy of vulvovaginal intradermal injections of polynucleotides (PN) combined with hyaluronic acid (HA) in postmenopausal women affected by vulvovaginal atrophy (VVA). Postmenopausal women affected by VVA were treated with vulvar and vaginal intradermal injections of one prefilled syringe of 2 ml PN/HA every 2 weeks for four sessions. Patients were evaluated at T0 (baseline), T1 (after session 4) and T2 (1 month after session 4). Evaluation of the treatment was assessed by three international validated questionnaires: Vaginal Health Index (VHI), Vulvar Health Index (VuHI) and Female Sexual Function Index (FSFI). The Wilcoxon matched-paired signed-rank test was used to compare the differences in VHI, VuHI, FSFI and FSFI domains within the groups. Statistical significance was set at p < 0.05. Fifty patients were included in the study (mean age 59.9 ± 7.6 years). Overall, the VHI, VuHI and FSFI reported statistically significant differences between baseline and T1 (p < 0.001) and between baseline and T2 (p < 0.001). All FSFI domains registered a statistically significant increase between baseline and T2 (p < 0.001). No complications or side effects were observed. Vulvovaginal intradermal injection of PN/HA is a safe, effective treatment, is not expensive and is a reproducible procedure in postmenopausal women with VVA. [ABSTRACT FROM AUTHOR]

Postmenopausal vulvovaginal pain and atrophy require appropriate and sensitive outcomes that correlate with the genital discomfort, symptoms and expected changes. In some studies, hormone and laser treatments do not detect benefits due to the fact that appropriate measuring tools were not used. While some studies have demonstrated placebo effects for both therapeutic approaches, others support that sham-intervention could be a therapeutic by creating a conditioning reflex. However, obtained results are directly related with the quality of outcomes: you get what you measure. It is imperative to follow the Core Outcomes in Menopause global initiative. [ABSTRACT FROM AUTHOR]

The aim of the study was to evaluate the clinical response and collagen remodeling in the vaginal wall after three sessions of carbon dioxide (CO2) laser application. Fourteen postmenopausal women with vulvovaginal atrophy, aged 45–65 years and sexually active, were evaluated with clinical questionnaires, gynecological examinations and histological techniques before and after 20 weeks of treatment (ClinicalTrials.gov NCT03939078). Treatment consisted of 3-monthly sessions of the CO2 laser. Clinical questionnaires included the Vaginal Health Index, the Female Sexual Function Index and the International Consultation on Incontinence Questionnaires Short Form. Biopsies were taken from the lateral vaginal wall at week 0 (left wall) and week 20 (right wall). Tissue samples were stained with hematoxylin and eosin, Periodic Acid-Schiff, Picrosirius Red Stain and Orcein dyes. Immunohistochemical study was used to quantify collagens I and III in the samples. The mean age was 54.4 ± 4.5 years, and the average time of amenorrhea was 7.6 ± 5.1 years. The Female Sexual Function Index and the Vaginal Health Index Score values increased while the International Consultation on Incontinence Questionnaire Short Form score decreased after the programmed treatment. There was no significant change in vaginal pH. Histological studies showed increases in the total and superficial epithelial cell layers, and type III collagen fibers (from 10.86 ± 7.66 to 16.87 ± 3.96, p < 0.05), and immunohistochemical studies confirmed the significant increase in collagen III. Histological findings revealed epithelial atrophy reversal and collagen remodeling of the vaginal wall. Immunohistochemical analysis showed an increase in collagen type III fibers. [ABSTRACT FROM AUTHOR]

Vulvovaginal pathology impairs the quality of life of both women in menopause and those who are not. Different therapies have been proposed, mainly related to estrogen therapy in postmenopausal women. However, some contraindications limit its use, and different moisturizers or lubricants have been tested. Hyaluronic acid is a promising and widely used vaginal medical treatment with a moisturizing action and appears to provide a solution. For this reason, we performed a systematic review of the literature. We searched for original articles without date restriction until 30 April 2020. We included all clinical trials which administered local hyaluronic acid in the vulva or vagina. Only English studies and those performed in humans were eligible. Seventeen original studies were included in the review (from randomized controlled trials to longitudinal studies). Hyaluronic acid was generally found to be effective in improving vulvovaginal symptoms (dyspareunia, itching, burning, dryness) and signs (bleeding, atrophy, vaginal pH). In conclusion, hyaluronic acid has the properties to be an efficient moisturizer for women suffering from vulvovaginal atrophy who have contraindications for estrogen therapy and for vulvovaginal signs and symptoms affecting sexual well-being. However, a well-designed randomized controlled trial is needed in order to clarify its efficacy and safety profile. [ABSTRACT FROM AUTHOR]

This study aimed to clarify the efficacy of intravaginal CO2-laser treatment in postmenopausal women with genitourinary syndrome of menopause (GSM). This double-blind, randomized, sham-controlled trial included postmenopausal women diagnosed with GSM and bothersome dryness and dyspareunia. Treatment consisted of three sessions. Active CO2-laser treatments (active group) were compared to sham treatments (sham group) with the primary endpoints being changes in dryness and dyspareunia intensity, as assessed by the 10-cm visual analog scale. Secondary endpoints were as follows: changes in Female Sexual Function Index (FSFI; total score and all domains), itching, burning, dysuria, and Urogenital Distress Inventory (UDI-6); incidence of symptoms; and presence of adverse events. All outcomes were evaluated at baseline and 4 months post baseline. Fifty-eight women (28 in the active group and 30 in the sham group) were eligible for inclusion. In the active group, dryness, dyspareunia, FSFI (total score), itching, burning, dysuria, and UDI-6 were significantly improved (mean [standard deviation] –5.6 [2.8], −6 [2.6], 12.3 [8.9], −2.9 [2.8], −2.3 [2.8], −0.9 [2.1], and −8.0 [15.3], respectively). In the sham group, dryness, itching, and burning were significantly improved (–1.9 [2], −1.4 [1.9], and −1 [1.9], respectively). All changes were in favor of the active group. After completion of the protocol, the proportion of participants with dryness, dyspareunia, and sexual dysfunction was significantly lower in the active group compared to those in the sham group (all p < 0.005). CO2 laser could be proposed as an effective alternative treatment for the management of GSM as it is superior to sham treatments. [ABSTRACT FROM AUTHOR]

Vaginal dryness is common during and after menopause due to declining estrogen. It is one of the symptoms of vulvovaginal atrophy (VVA), which is part of the genitourinary syndrome of menopause. This can be distressing for women and cause pain, discomfort, and dyspareunia. Vaginal dryness affects over 50% of postmenopausal women but is under-reported and thus under-treated due to barriers to seeking help. Estrogen replacement can resolve symptoms, but may be contraindicated or not desired by all women. Over-the-counter vaginal moisturizers and lubricants can ease the symptoms of VVA. However, their chemical composition varies enormously and some are known to cause detrimental effects due to unphysiological pH, osmolality, and additives. The primary purpose of this review is to assess both their efficacy and safety. Women should be directed toward products that are as 'body-similar' as possible to vaginal secretions in terms of pH and osmolality. Products with potentially harmful ingredients should be avoided. Lubricants can be trialed for sexual activity and moisturizers for symptom control, even if topical or systemic menopause hormone therapy is being used. [ABSTRACT FROM AUTHOR]

Transvaginal laser therapies are being increasingly used for a variety of indications, particularly genitourinary syndrome of the menopause and stress urinary incontinence. This article reviews the current data pertaining to the place of these devices in current clinical practice. Whilst there has been a rapid increase in the number of publications over the last few years, many of the studies are of small numbers, short duration, and poor quality and are device-sponsored. The evidence suggests that vaginal laser therapy with either the erbium-doped yttrium aluminum garnet laser (FotonaSmooth®) or the CO2 laser (MonaLisa Touch®) is an effective intervention for the relief of symptoms of vulvovaginal atrophy in symptomatic women. The benefits of three laser treatments appear to last for at least 12 months and the procedure is generally well tolerated, with transient minor discomfort being the most common adverse event. Whilst the vaginal laser certainly has the potential to be an alternative treatment to vaginal estrogens for those groups of women, such as breast cancer patients, who cannot take them, there are still many unanswered questions about the role of vaginal laser therapy in clinical practice, particularly in relation to standard conservative management. The place of vaginal laser therapy in other conditions such as stress urinary incontinence is less clear. The outcomes from several ongoing randomized trials should help to answer some of these questions. In the meantime, the use of vaginal laser devices should be confined to clinical trials. [ABSTRACT FROM AUTHOR]

Objectives: This study aimed to assess the efficacy and safety of hyaluronic acid-based vaginal pessaries (Hydeal-D) in the treatment of vulvovaginal atrophy (VVA). Study design: The study was a prospective, multicenter clinical investigation of VVA topical treatment in 40 postmenopausal women. Patients applied one Hydeal-D pessary every 3 days for 3 months. Main outcome measures: The primary endpoint was the amelioration of VVA signs after treatment, evaluated by measuring the change from baseline of the Vaginal Health Index (VHI) score. Secondary endpoints included the evaluation of other VVA-related signs and symptoms, safety, and patient-reported and clinician-reported satisfaction and treatment tolerability. Results: The 3-month treatment with Hydeal-D vaginal pessaries showed efficacy for all analyzed endpoints. Improvement exceeded threshold values of VVA diagnosis, sexual dysfunction, and distress, confirming clinically relevant amelioration of VVA symptoms. Changes from baseline conditions confirmed significant improvement of all parameters including the VHI, vaginal pH, patients' perception of VVA symptoms, sexual function, and vaginal maturation. Patients' overall satisfaction was very high after 1 month of treatment and increased further after 3 months. No severe adverse events were reported. Conclusions: Significant amelioration of VVA-related signs indicates that Hydeal-D vaginal pessaries are an effective, safe, and well-tolerated non-hormonal therapeutic option for VVA in postmenopausal women. [ABSTRACT FROM AUTHOR]

The number of women surviving longer after a cancer diagnosis is increasing. This means that more awareness regarding their health is required. This review will focus on vulvovaginal atrophy (VVA)/genitourinary syndrome of menopause, one of the most distressing adverse iatrogenic effects of the menopause, secondary to cancer therapies. The cancer therapies themselves, such as radiotherapy, chemotherapy, and surgery, have a direct impact on the lower genital tract which interplays with the ensuing hypoestrogenic state of the menopause. Symptoms of VVA are still under-reported and undertreated as neither clinicians nor patients are forthcoming in discussing the problem, despite its profound negative impact on quality of life. In terms of treatment of VVA, this review will look at the use of various options, including estrogen post cancer diagnosis, as well as considering newer emerging therapies such as dehydroepiandrosterone, ospemifene, and laser. The care of a woman post cancer diagnosis should be a multidisciplinary responsibility. However, further research is required into emerging treatment options as well as long-term safety data, to ensure all health-care providers and women are fully informed and confident to effectively address the impact of VVA post cancer diagnosis. [ABSTRACT FROM AUTHOR]

Genitourinary syndrome of menopause (GSM) is a common condition affecting up to 50% of postmenopausal women and up to 70% of postmenopausal breast cancer survivors. GSM is a chronic condition with a significant impact on sexual health and quality of life. The mainstay of treatment has been with symptomatic relief using topical emollients or lubricants. Second-line treatment is with topical vaginal estrogens to restore the physiology of the vaginal epithelium. For some, the latter is not suitable or acceptable. Newer treatments with ospemifene and vaginal lasers have now been introduced. The two main types of laser currently used for the treatment of GSM are the fractional microablative CO2 laser and the non-ablative photothermal erbium:YAG laser. We present a study protocol for a multicenter, prospective, non-inferiority, single-blinded, randomized controlled trial comparing the fractional microablative CO2 laser versus the photothermal non-ablative erbium:YAG laser for the management of GSM. We will recruit 88 postmenopausal women across two sites who will be randomized to one of the two laser groups. Participants will all have GSM symptoms and a Vaginal Health Index Score < 15. All participants will receive an active treatment. Each participant will receive three applications of vaginal laser 1 month apart and will be followed up at 1 month, 6 months, and 12 months. Our primary outcomes will look at all changes of GSM symptoms (dryness, dyspareunia, itching, burning, dysuria, frequency, urgency), urinary incontinence (if present), and overall sexual satisfaction. Both subjective and objective means will be used to assess participants. The findings of this trial have the potential to allow clinicians and women suffering from GSM to make an informed decision when opting for a specific laser type. The trial will add to the current growing body of evidence for the safe use of vaginal lasers in GSM as an alternative treatment. We hope this trial will provide robust and long-term data for the safe use of both lasers. [ABSTRACT FROM AUTHOR]

The loss of sex steroids (e.g. estradiol, dehydroepiandrosterone [DHEA], progesterone) that causes menopause commonly affects a woman's general health and produces bothersome physical changes that may interfere with normal sexual and genitourinary functioning. Although both over-the-counter and prescription treatments are available, there remains a large unmet need, as less than 10% of women are treated. Adrenal DHEA and its sulfate are the most abundant steroids in humans. Here we review the development of intravaginal prasterone, the synthetic equivalent to endogenous DHEA. Prasterone is approved by the US Food and Drug Administration for the treatment of moderate to severe dyspareunia, a symptom of vulvar and vaginal atrophy, due to menopause. Prasterone has been shown to decrease the pain associated with dyspareunia, and to improve vaginal pH, as well as superficial and parabasal cell counts, while maintaining serum hormone levels within the range of those seen in normal postmenopausal women. Unlike other menopausal prescription therapies, intravaginal prasterone does not carry a boxed warning, thus allowing the clinician and patient to engage in meaningful and reassuring discussion around a new approach that treats this common, debilitating condition. [ABSTRACT FROM AUTHOR]

Genitourinary syndrome of menopause including vulvovaginal atrophy is commonly experienced by postmenopausal women, reducing their quality of life. The aim of this review is to assess current treatment options within the framework of recent management guidelines. Recommendations include use of treatments addressing both symptoms and the underlying pathophysiology, and proactive patient discussion. Both prescription and non-prescription options are recognized, including non-hormone-based approaches. Local therapy is preferable in the primary treatment of genitourinary syndrome of menopause symptoms as risk of adverse events is reduced, although long-term safety data are limited. Management of patients with a history of breast cancer requires careful consideration, although estrogen therapy has not been associated with increased risk of breast cancer or of recurrence. Treatment should consider ongoing cancer therapy. As multiple, comparable options exist, treatment choice may be due to experience and patient preference. Best management requires effective patient-physician communication and shared decision-making. [ABSTRACT FROM AUTHOR]

Objectives: The primary objective of the European Vulvovaginal Epidemiological Survey (EVES) was to assess, at a country level, the prevalence of postmenopausal women with vulvovaginal atrophy (VVA) confirmed by gynecological clinical assessment among all postmenopausal women attending menopause centers.Method: Women aged 45-75 years old with their last menstrual period more than 12 months before and who attended menopause or gynecology centers were included. If they had at least one VVA symptom, women filled a number of questionnaires including the EuroQoL-EQ-5D3L and Day-to-Day Impact of Vaginal Aging (DIVA). Then a gynecological examination was performed to confirm the VVA diagnosis.Results: A total of 2160 evaluable patients were included in the study. VVA was confirmed in 90% of the patients. Compared with patients without confirmed VVA (n = 206), patients with confirmed VVA (n = 1954) were significantly older (p < 0.001), had more severe symptoms (p < 0.001 for vaginal and vulvar symptoms, p < 0.05 for urinary ones) and had a lower quality of life as assessed by EQ-5D3L (p = 0.012) and DIVA (p < 0.001).Conclusion: VVA is highly prevalent among postmenopausal women. Gynecological clinical assessment of VVA is associated with severe symptoms and impaired quality of life and therefore should be promoted for appropriate clinical assessment and early therapeutic intervention. [ABSTRACT FROM AUTHOR]

Objectives: To evaluate the efficacy and safety of estriol for the treatment of vulvovaginal atrophy in postmenopausal women.Methods: A systematic literature review was performed. We searched the following electronic databases: Medline, Cochrane, Embase, Lilacs, CINHAL and Google Scholar. The studies selected included controlled clinical trials and quasi-experimental studies. Selections were made in pairs and independently, first by title and abstract and then complete texts.Results: We identified 188 studies, 22 of which met the inclusion criteria; 13 were controlled clinical trials and nine were quasi-experimental, and 1217 women were included. These studies confirmed the efficacy of local estrogens to treat symptoms of vulvovaginal atrophy with few adverse effects reported. Following treatment, serum estriol levels rose, peaking at 1 h. At the 6-month follow-up, there was no increase in serum estriol in treated women.Conclusions: The available evidence (of low and moderate quality) shows that, when administered vaginally, estriol preparations appear to be safe for women who have risk factors related to systemic estrogen therapy. [ABSTRACT FROM AUTHOR]

Objective: To evaluate the effects of CO2 laser in the treatment of vulvovaginal atrophy (VVA) in postmenopausal women.Methods: VVA was assessed in 87 postmenopausal women (mean age 58.6 ± 6.9 years) before and after the treatment. The protocol consisted of three monthly treatments and included the treatment of vulva. Subjective measures included VAS (Visual Analog Scale) both for vaginal dryness and dyspareunia; DIVA (Day-by-day Impact of Vaginal Aging); a questionnaire on treatment satisfaction and one about the degree of pain during the procedure. Objective measures included VHI (Vaginal Health Index) and VVHI (Vulvo-Vaginal Health Index). Time points of the study were at the screening visit (T0), at baseline (T1), at week 4 (T2), at week 8 (T3), after 3 months since the last laser application (T4), after 6 months (T5), after 9 months (T6), after 12 months (T7) and after 15 months (T8).Results: Treatment induced significant improvement in the VAS score. After treatment, VHI and VVHI indicated no VVA and this improvement was long lasting. Multivariate analysis showed that the time of follow-up was correlated with better VHI and VVHI (p < 0.001). DIVA improved over time (p < 0.001).Conclusions: This study shows that CO2 laser treatment induces a significant and long-lasting improvement of symptoms. [ABSTRACT FROM AUTHOR]

Objectives: Our aim was to explore the experiences of Iranian postmenopausal women who sought medical help for their symptomatic vulvovaginal atrophy (VVA).Methods: Five focus group discussions (FGDs) were conducted. Participants had to be postmenopausal; had bothersome symptoms of VVA for which they came to the clinic; had previously sought medical help for their VVA; and had confirmed physical signs of VVA upon examination by a gynecologist.Results: Twenty-five women, aged 49-60 years participated in the five FGDs. Twenty women said they currently had >1 VVA symptom at presentation to the clinic. Four major themes emerged from the women's narrative stories: (1) negative impact of VVA on women's life, (2) psychological distress associated with VVA, (3) negative impact of VVA on marriage and relationship, (4) inadequate symptom relief from available treatments due to lack of awareness of VVA treatment options. None of the participants reported ongoing treatment of their VVA with local low-dose estrogen. Women further commented that, although local estrogen products were costly, they would like to use them if they were prescribed.Conclusions: Considering the negative impact of VVA symptoms on women's lives, health professionals in Iran should be prescribing approved and effective therapies for symptomatic women. [ABSTRACT FROM AUTHOR]

Vaginal dryness is a common condition that is particularly prevalent during and after the menopause, and is one of the symptoms of vulvovaginal atrophy/genitourinary syndrome of menopause. The impact of vaginal dryness on interpersonal relationships, quality of life, daily activities, and sexual function can be significant, but is frequently underestimated. Furthermore, barriers exist to treatment-seeking, and this condition is often underreported and undertreated. Greater education about vaginal dryness and the range of available treatments is essential to encourage more women to seek help for this condition. Personal lubricants and moisturizers are effective at relieving discomfort and pain during sexual intercourse for women with mild to moderate vaginal dryness, particularly those who have a genuine contraindication to estrogen, or who choose not to use estrogen. However, there is a distinction between lubricants and moisturizers, and notable differences between commercially available products. Women should be advised to choose a product that is optimally balanced in terms of both osmolality and pH, and is physiologically most similar to natural vaginal secretions. A series of recommendations for the use of vaginal lubricants and moisturizers, either on their own or in combination with systemic or topical hormone replacement therapy, is presented. [ABSTRACT FROM AUTHOR]

Objective: The aim was to analyze the opinion of the male partner of women treated for vulvovaginal atrophy (VVA) with intravaginal 0.50% DHEA (prasterone), thus providing information on both members of the couple.Methods: On a voluntary basis, in a prospective, randomized, double-blind and placebo-controlled phase-III clinical trial, the male partner filled a questionnaire at baseline and at 12 weeks stating his observations related to his penis and intercourse before and after VVA treatment.Results: Sixty-six men having a partner treated with intravaginal DHEA and 34 others having a partner treated with placebo answered the questionnaires. Concerning the feeling of vaginal dryness of their female partner, the severity score following DHEA treatment improved by 81% (0.76 units) over placebo (p = 0.0347). Thirty-six percent of men having a partner treated with DHEA did not feel the vaginal dryness of the partner at the end of treatment compared to 7.8% in the placebo group. When analyzing the situation at 12 weeks compared to baseline, an improved score of 1.09 units was the difference found for the DHEA group compared to 0.76 for the placebo group (p = 0.05 vs. placebo). In the DHEA group, 38% of men scored very improved compared to 18% in the placebo group. No adverse event has been reported.Conclusion: The male partner had a very positive evaluation of the treatment received by his female partner. [ABSTRACT FROM AUTHOR]

Many millions of postmenopausal women continue to suffer in silence from symptoms resulting from estrogen-deficient atrophy of the vulva, vagina and urinary tract whilst the medical profession continues to debate what the condition should be called, how it should be assessed and whether it should be universally treated. It is high time that a unified approach was adopted by all medical societies to reach a consensus on definitions, recognition and management. With the development of the nomenclature for genitourinary syndrome of the menopause (GSM), advances in GSM assessment tools and quality-of-life questionnaires and novel therapeutic interventions, the signs are positive that a new era is finally dawning. [ABSTRACT FROM AUTHOR]

Objectives To prove non-inferiority of the first non-hormonal vaginal cream in Germany, Vagisan® Moisturising Cream (CREAM), compared to a non-hormonal vaginal gel (GEL) for vulvovaginal atrophy (VVA) symptom relief. Method This was a 12-week multicenter, open-label, prospective, randomized, two-period, cross-over phase-III trial. The primary endpoint was the cumulative VVA subjective symptom score of the respective treatment period. Secondary endpoints were assessment of single VVA subjective and objective symptoms, VVA objective symptom score, vaginal pH, safety parameters, overall assessment of efficacy, tolerability and evaluation of product properties. In total, 117 women were randomly allocated to either one of the two treatments, each administered for 4 weeks; 92 women were included in the per-protocol analysis (primary analysis). The main outcome measure was cumulative VVA subjective symptom score. Results Regarding VVA symptom relief, results confirmed non-inferiority of CREAM compared to GEL and even indicated superiority of CREAM. Frequency and intensity of subjective symptoms and objective findings were clearly reduced, with CREAM showing better results compared to GEL. Mean VVA objective symptom score significantly decreased; improvement was significantly greater with CREAM. Vaginal pH decreased only following CREAM treatment. Tolerability was superior for CREAM: burning and itching, mostly rated as mild, occurred markedly less often with CREAM than with GEL. Overall satisfaction with treatment efficacy, tolerability and most product properties were rated significantly superior for CREAM. Conclusions Subjective and objective VVA symptoms were reliably and safely reduced by both non-hormonal topical products. However, efficacy and tolerability of CREAM were shown to be superior to GEL. [ABSTRACT FROM AUTHOR]

Objective While daily intravaginal administration of 0.50% (6.5 mg) dehydroepiandrosterone (DHEA, prasterone) for 12 weeks has shown clinically and statistically significant effects on moderate to severe (MS) dyspareunia as the most bothersome symptom (MBS), the present study analyzes the effect of a reduced dosing regimen on MBS vaginal dryness. Method Daily intravaginal 0.50% prasterone for 2 weeks followed by twice weekly for 10 weeks versus placebo. Results Maximal beneficial changes in vaginal parabasal and superficial cells and pH were observed at 2 weeks as observed for intravaginal 10 μg estradiol (E2). This was followed by a decrease or lack of efficacy improvement after switching to twice-weekly dosing. The decrease in percentage of parabasal cells, increase in percentage of superficial cells and decrease in vaginal pH were all highly significant ( p < 0.0001 to 0.0002 over placebo) at 12 weeks. In parallel, the statistical significance over placebo ( p value) on MBS vaginal dryness at 6 weeks was 0.09 followed by an increase to 0.198 at 12 weeks. For MBS dyspareunia, the p value of 0.008 at 6 weeks was followed by a p value of 0.077 at 12 weeks, thus illustrating a decrease of efficacy at the lower dosing regimen. The improvements of vaginal secretions, color, epithelial integrity and epithelial surface thickness were observed at a p value < 0.01 or 0.05 over placebo at 2 weeks, with a similar or loss of statistical difference compared to placebo at later time intervals. No significant adverse event was observed. Vaginal discharge related to the melting of Witepsol was reported in 1.8% of subjects. Conclusion The present data show that daily dosing with 0.50% DHEA for 2 weeks followed by twice-weekly dosing is a suboptimal treatment of the symptoms/signs of vulvovaginal atrophy resulting from a substantial loss of the efficacy achieved at daily dosing. [ABSTRACT FROM AUTHOR]

Objective To investigate the effects of fractional microablative CO2 laser on sexual function and overall satisfaction with sexual life in postmenopausal women with vulvovaginal atrophy (WA). Method This prospective study included 77 postmenopausal women (mean age 60.6 ± 6.2 years) treated for WA symptoms with the fractional microablative CO2 laser system (SmartXide2 V2LR, Monalisa Touch, DEKA, Florence, Italy). Sexual function and quality of life were evaluated with the Female Sexual Function Index (FSFI) and the Short Form 12 (SF-12), respectively, both at baseline and at 12-week follow-up. A 10-mm visual analog scale was used to measure the overall satisfaction with sexual life and the intensity of WA symptoms (vaginal burning, vaginal itching, vaginal dryness, dyspareunia and dysuria) before and after the study period. Results We observed a significant improvement in the total score and the scores in each specific domain of the FSFI at 12-week follow-up compared to baseline (p< 0.001). After concluding the laser treatment, the overall satisfaction with sexual life significantly improved (p< 0.001). Seventeen (85%) out of 20 (26%) women, not sexually active because of WA severity at baseline, regained a normal sexual life at the 12-week follow-up. Finally, we also found a significant improvement in each WA symptom (p < 0.001) and in quality- of-life evaluation, both for the scores in the physical (p = 0.013) and mental (p = 0.002) domains. Conclusions Fractional microablative CO2 laser treatment is associated with a significant improvement of sexual function and satisfaction with sexual life in postmenopausal women with WA symptoms. [ABSTRACT FROM AUTHOR]

Objectives The primary objective of this study was to evaluate the correlation among symptoms, signs, and the number of lactobacilli in postmenopausal vaginal atrophy. The secondary objective was to develop a new parameter to improve the correlation. Study design A cross-sectional descriptive study. Methods Naturally postmenopausal women aged 45-70 years with at least one clinical symptom of vaginal atrophy of moderate to severe intensity were included in this study. All of the objective parameters (vaginal atrophy score, vaginal pH, the number of lactobacilli, vaginal maturation index, and vaginal maturation value) were evaluated and correlated with vaginal atrophy symptoms. A new parameter of vaginal atrophy, vaginal atrophy symptoms II, was developed and consists of the two most bothersome symptoms (vaginal dryness and dyspareunia). Vaginal atrophy symptoms II was analyzed for correlation with the objective parameters. Results A total of 132 naturally postmenopausal women were recruited for analysis. Vaginal pH was the only objective parameter found to have a weak correlation with vaginal atrophy symptoms (r = 0.273, p = 0.002). The newly developed vaginal atrophy symptoms II parameter showed moderate correlation with vaginal pH (r = 0.356, p < 0.001) and a weak correlation with the vaginal atrophy score (r = 0.230, p < 0.001). History of sexual intercourse within 3 months was associated with a better correlation between vaginal atrophy symptoms and the objective parameters. Conclusion Vaginal pH was significantly correlated with vaginal atrophy symptoms. The newly developed vaginal atrophy symptoms II was associated with a better correlation. The vaginal atrophy symptoms II and vaginal pH may be better tools for clinical evaluation and future study of the vaginal ecosystem.. [ABSTRACT FROM AUTHOR]

Objective Our aim was to systematically review published articles for the prevalence of persistent estrogen depletion symptoms among women aged 65+ years. Methods A systematic literature search of English-language publications was performed using MEDLINE, EMBASE, CINAHL, and PsycINFO. Twenty-three studies that included information on the prevalence of vasomotor and/or urogenital atrophy symptoms among older women (65 + years) met our inclusion criteria. Risk of bias of the included studies was assessed using a risk-of-bias tool explicitly designed for the systematic review of prevalence studies. Results The available data suggest that vasomotor symptoms are experienced by a considerable proportion of older women, that symptoms of urogenital atrophy including urinary incontinence are widespread, and that women remain sexually active well into later life. A high degree of variability was observed for the prevalence of estrogen deficiency symptoms for women age 65+ years. Discrepancies in modes of recruitment, sampling procedures, time frames over which symptoms were assessed and use of different and non-validated assessment tools contributed to the inconsistencies across the published studies. Conclusion Larger and appropriately sampled studies, employing validated questionnaires, are still needed to establish the prevalence of persistent estrogen depletion symptoms in women aged 65 + years. [ABSTRACT FROM AUTHOR]

Background In 2012, the Board of Directors of the International Society for the Study of Women's Sexual Health (ISSWSH) and the Board of Trustees of The North American Menopause Society (NAMS) acknowledged the need to review current terminology associated with genitourinary tract symptoms related to menopause. Methods The two societies cosponsored a terminology consensus conference, which was held in May 2013. Results and Conclusion Members of the consensus conference agreed that the term genitourinary syndrome of menopause (GSM) is a medically more accurate, all-encompassing, and publicly acceptable term than vulvovaginal atrophy. GSM is defined as a collection of symptoms and signs associated with a decrease in estrogen and other sex steroids involving changes to the labia majora/minora, clitoris, vestibule/introitus, vagina, urethra and bladder. The syndrome may include but is not limited to genital symptoms of dryness, burning, and irritation; sexual symptoms of lack of lubrication, discomfort or pain, and impaired function; and urinary symptoms of urgency, dysuria and recurrent urinary tract infections. Women may present with some or all of the signs and symptoms, which must be bothersome and should not be better accounted for by another diagnosis. The term was presented and discussed at the annual meeting of each society. The respective Boards of NAMS and ISSWSH formally endorsed the new terminology - genitourinary syndrome of menopause (GSM) - in 2014. [ABSTRACT FROM AUTHOR]

Objective This pilot study aimed to assess the efficacy and feasibility of fractional CO2 laser in the treatment of vulvovaginal atrophy (VVA) in postmenopausal women. Methods VVA symptoms were assessed before and after three applications of laser over 12 weeks in 50 women (age 59.6 ± 5.8 years) dissatisfied with previous local estrogen therapies. Subjective (visual analog scale) and objective (Vaginal Health Index Score, VHIS) measures were used during the study period to assess VVA. Quality of life was measured by using the SF-12. A subjective scale to evaluate the degree of pain related to the laser application and the degree of difficulty to perform the laser procedure was used. Results Fractional CO2 laser treatment was effective to improve VVA symptoms (vaginal dryness, vaginal burning, vaginal itching, dyspareunia, dysuria; p < 0.001) at 12-week follow-up, as well as the VHIS (13.1 ± 2.5 at baseline vs. 23.1 ± 1.9; p < 0.001). Both physical and mental scores of quality of life were significantly improved in comparison with baseline ( p < 0.001). Satisfaction with the laser procedure was reported by 42 women (84%) and a minimal discomfort was experienced at the first laser application, mainly because of the insertion and the movements of the probe. Finally, the technique was very easy to perform in all women starting from the second application at week 4 and no adverse events were recorded during the study period. Conclusions A 12-week treatment with the fractional CO2 laser was feasible and induced a significant improvement of VVA symptoms by ameliorating vaginal health in postmenopausal women. Further controlled studies should be performed to confirm the present data and to assess the long-term effects of the laser procedure on vaginal tissues. [ABSTRACT FROM AUTHOR]

Vulvovaginal atrophy-related symptoms exert a negative impact on the quality of life of up to 50% of postmenopausal women. Many of them decline to use topical vaginal estrogen, which is the standard effective therapy, due to the adverse publicity over recent years, and seek for alternatives. Further, there are no safety studies to support the use of topical vaginal estrogen in breast cancer survivors, and it is considered as contraindicated by many health-care professionals. Vaginal moisturizers and lubricants as well as regular sexual activity may be helpful to such women. Vaginal moisturizers may have an equivalent efficacy to topical vaginal estrogen and should be offered to women wishing to avoid the use of hormonal therapy. Lubricants are usually used during sexual intercourse to provide temporary relief from vaginal dryness and dyspareunia; however, they have no long-term therapeutic effects. We provide in this systematic review up-to-date information, for women and health-care professionals, about the use, safety and efficacy of the available vaginal moisturizers and lubricants. [ABSTRACT FROM AUTHOR]

Objective To evaluate the systemic effect of therapy with conjugated equine estrogen (CEE) vaginal cream on bone turnover markers in postmenopausal women. Methods This study was conducted in 40 spontaneously menopausal women aged 40-60 years who complained of vulvovaginal symptoms. Subjects were instructed to self-administer 1 g CEE vaginal cream (CEE 0.625 mg) once daily for 12 weeks (continuous phase), then twice weekly for the next 12 consecutive weeks (intermittent phase). Serum levels of bone turnover markers and estradiol and the vaginal maturation index were evaluated at baseline, 12 and 24 weeks after treatment initiation. Results Levels of C-terminal cross-linked telopeptide of type I collagen (CTx) were significantly decreased at 12 weeks and 24 weeks when compared to baseline values (median (range) 0.435 (0.171-0.859) and 0.391 (0.122-0.714) vs. 0.562 (0.250-1.290) ng/ml (p< 0.001 and < 0.001), respectively), but there was no significant difference between the levels at 12 and 24 weeks. Levels of procollagen type I N-terminal propeptide (P1NP) and osteocalcin levels were significantly decreased after 24 weeks when compared to pretreatment levels (mean (standard deviation) 41.74 (11.76) vs. 50.02 (17.71) ng/ml (p = 0.002) for P1NP and 23.91 (7.11) vs. 27.54 (8.67) ng/ml (p<0.001) for osteocalcin, respectively). Estradiol levels were significantly increased and the vaginal maturation index was significantly improved after 12 and 24 weeks when compared to baseline. Conclusions CEE vaginal cream significantly decreased the bone resorption marker (CTx) in postmenopausal women after completion of the continuous-treatment phase. There was no significant further decrease after the intermittent phase. The effects on the markers of bone formation and bone turnover (P1NP and osteocalcin) were apparent only at 24 weeks. The two treatment phases moderately increased serum estradiol levels and significantly improved the vaginal maturation index. [ABSTRACT FROM AUTHOR]

Menopausal women very often complain of vulvovaginal atrophy (VVA)-related symptoms, which mainly include dryness, irritation, dyspareunia and pain. The ideal therapeutic approach is to use systemic or intravaginal estrogen, which has proved to be effective. However, because of safety concerns that were raised after the publication of the Women’s Health Initiative data, non-estrogenic and non-hormonal therapies for VVA have been developed and heavily promoted. Many menopause specialists believe that the flow of information on the newer products indicated for VVA seems to include an inaccurate message, which downgrades the use of estrogenic preparations and upgrades modern non-estrogenic therapies. Both media and medical sources have created an atmosphere of exaggerated worries over intravaginal estrogen therapies, which are not substantiated by hard clinical facts. [ABSTRACT FROM PUBLISHER]