Vulvovaginal Atrophy In Postmenopausal Women Research Articles

Abstract PO4-27-04: GRACE-trial: A randomized active-controlled trial for vulvovaginal atrophy in breast cancer patients on endocrine therapy

Abstract Background: Breast cancer is the most common cancer type in women worldwide. Due to hormone receptor positivity in the majority of the breast cancer tumors is endocrine therapy a crucial part in the treatment landscape of breast cancer. Selective estrogen-receptor modulators or aromatase inhibitors are the used treatment options for endocrine therapy. These medicines generate a hypoestrogenic environment by reducing circulating estrogen or by altering the effect of estrogen on tissue cells by receptor blockade. As a common side effect, vulvovaginal atrophy occurs in a majority of breast cancer patients using endocrine therapy. Vulvovaginal atrophy has a significant impact on physical and psychological wellbeing due to negative influence on quality-of-life, self-esteem and sexuality. As a consequence, adherence of endocrine therapy for the standard duration of 5 to 10 years is challenging, resulting in higher rates of therapy interruption, leading to poorer prognosis with shorter distant disease free survival. The standard treatment for vulvovaginal atrophy in postmenopausal women is based on the use of local hormonal treatment. However, when a patient has a history of breast cancer, delay of treatment and undertreatment are ubiquitous. Methods & design: In this first ever prospective randomized trial breast cancer patients on endocrine therapy with vulvovaginal atrophy will be treated with the available local treatment modalities with a 1:1:1:1 randomization: estrogen, dehydroepiandrosterone, moisturizers and a co-treatment of estrogen and probiotics. Patient-reported outcomes measurements will be implemented to investigate the efficacy of the implemented treatments. These outcome measures include symptom evaluation, impact on quality-of-life and sexuality. Safety of the treatments will be evaluated by assessing systemic sex hormones concentrations. Previous research indicated no increased recurrence risk, yet no randomized trials comparing the different modalities have been published. Primary objectives: Two primary objectives have been determined. Firstly, the efficacy of the different treatment modalities will be assessed. The assessment will be based on patient-reported outcome measurements (PROMs) and clinical evaluations such as vaginal pH and the vaginal maturation index, the latter a direct microscopic evaluation of the vaginal epithelium. Secondly, safety of the different groups will be assessed. Evaluation will be done be measuring sex hormone concentrations systemically, which will be a surrogate for safety evaluation. Secondary objectives: The secondary objective in this study is the identification of microbial alterations after treatment initiation. Identification of these alterations can help in further understanding of the pathophysiology of vulvovaginal atrophy and potentially create opportunities for new treatment strategies towards vulvovaginal atrophy in breast cancer patients on endocrine therapy. Registration: The current study is registered at the European Union Clinical Trials Register (EudraCT number 2021-001921-31). Trial status: Recruitment for the study was commenced in May 2022. At time of manuscript submission, patient recruitment was ongoing. Citation Format: Glenn Vergauwen, Piet Cools, Hannelore Denys, Tom Fiers, Koen van de Vijver, Liv Veldeman, Hans Verstraelen. GRACE-trial: A randomized active-controlled trial for vulvovaginal atrophy in breast cancer patients on endocrine therapy [abstract]. In: Proceedings of the 2023 San Antonio Breast Cancer Symposium; 2023 Dec 5-9; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2024;84(9 Suppl):Abstract nr PO4-27-04.

Sea buckthorn, its bioactive constituents, and mechanism of action: potential application in female reproduction.

Sea buckthorn (Hippophae rhamnoides L.) is a flowering shrub, and its berries have been utilized for decades as a raw ingredient in cuisines and herbal remedies. This evidence-based study focuses on its key bioactive constituents, and mechanism of protective effects with a focus on female reproductive processes. Parts of the plant contain phenols, carotenoids (lycopene, carotene, lutein, and zeaxanthin), flavonoids (isorhamnetin, quercetin, glycosides, and kaempferol), tocopherols, sterols, polyunsaturated fatty acids, minerals, vitamins, omega 3, 6, 9 and rare omega 7 fatty acids etc. Key polyphenolic flavonoids such as isorhamnetin and quercetin are believed to be mainly responsible behind its health benefits (against cardiovascular diseases, metabolic syndrome, obesity etc.) through properties including anti-cancer, antioxidant, and anti-inflammatory activities. These sea buckthorn constituents appear to mediate healthy ovarian cell proliferation, death, and hormone release, as well as decrease ovarian cancer possibly through apoptosis, and hormonal (estrogen) release. Thus, sea buckthorn and its bioactive ingredients may have potential in the management of gynecological problems such as uterine inflammation, endometriosis, and easing symptoms of vulvovaginal atrophy in postmenopausal women (by targeting inflammatory cytokines and vascular endothelial growth factor - VEGF). Apigenin, myricetin, and luteolin have also been recommended as prospective ovarian cancer preventative and adjuvant therapy options as they can inhibit ovarian cancerogenesis by triggering apoptosis and halting the cell cycle in ovarian tumors. Furthermore, its oil (containing carotenoid, sterol, and hypericin) has been speculated as an alternative to estrogen replacement therapy for postmenopausal women particularly to improve vaginal epithelial integrity. However, it is uncertain whether steroid hormone receptors, reactive oxygen species (ROS), and inflammatory regulators are actually behind sea buckhorn's actions. Sea buckthorn, and its compounds' health promoting potential warrants further validation not just in vitro and in animal research, but also in clinical trials to identify and/or standardize optimal methods of delivery of biologically active molecules.

GRACE-trial: a randomised active-controlled trial for vulvovaginal atrophy in patients with breast cancer on endocrine therapy – study protocol

IntroductionBreast cancer is the most common cancer type in women worldwide. Due to hormone receptor positivity in the majority of the breast cancer tumours is endocrine therapy a crucial part...

Intravaginal dehydroepiandrosterone for genitourinary symptoms of the menopause: Is the evidence sufficient?

Intravaginal dehydroepiandrosterone (DHEA) is a locally metabolised estrogen and androgen precursor, licensed in 2018 in the EU for moderate to severe vulvovaginal atrophy in postmenopausal women. A literature search revealed four original trials suitable for appraisal, three evaluating change in dyspareunia or dryness as a primary outcome, one evaluated safety as a primary outcome. In two trials of 255 and 558 women without cancer, the benefit of placebo (nightly vaginal suppositories with a lipophilic base) was a 0.9 and 1 point reduction in dyspareunia as measured on a 3 point scale, an unvalidated outcome measure. With nightly DHEA, dyspareunia was reduced by an additional 0.4 points compared to placebo. When 464 women with gynaecological cancer were randomised, those using nightly plain moisturiser gel reported a reduction of 'most bothersome symptom' (either dyspareunia or dryness) of 1.5 points on a 3 point scale. Those using nightly DHEA reported an additional symptom reduction of 0.3 points. This is also an unvalidated outcome measure. Data evaluating the efficacy of DHEA over placebo is unconvincing and based on unvalidated primary outcome measures that also do not reflect the complex psycho-sexual and socio-cultural components of genitourinary menopausal symptoms. The efficacy and safety data excluded women taking systemic HRT, applies to postmenopausal, not perimenopausal, women and had relatively short follow up. It is important further independent trials use sophisticated and validated assessment tools to better establish the efficacy, safety and cost effectiveness of intravaginal DHEA in clinically representative groups of women before being routinely prescribed.

Efficacy of low-dose vaginal 17β-estradiol versus vaginal promestriene for vulvovaginal atrophy

Objective Vulvovaginal atrophy is frequent, can be bothersome and can impair quality of life in postmenopausal women. The main objective of this prospective, randomized study was to compare the acceptability of low-dose vaginal 17β-estradiol (estradiol) tablets and vaginal promestriene cream in postmenopausal women with moderate-to-severe symptomatic vulvovaginal atrophy. Methods Overall, 120 patients were randomized to receive estradiol or promestriene (n = 60 per group). Acceptability was assessed with a specific questionnaire. Symptom intensity, the Vaginal Health Index (VHI), vaginal pH and the Vaginal Maturation Index were also evaluated. Results Acceptability was higher for estradiol tablets. Compared to promestriene cream, hygiene and ease of use were greater after 4 weeks (p = 0.011 and p = 0.001, respectively) and after 12 weeks (p = 0.009 and p = 0.011, respectively). Reduction of symptom intensity was greater with estradiol. Both treatments improved the VHI and decreased vaginal pH. However, superficial cell percentages increased significantly (p < 0.001) with estradiol but not with promestriene (p = 0.241), with a statistically significant difference between means (p = 0.004). Conclusion Our results support the use of vaginal low-dose estradiol tablets as compared to vaginal promestriene cream for the management of moderate-to-severe symptomatic vulvovaginal atrophy in postmenopausal women. ClinicalTrials.gov Identifier NCT04232813

Efficacy and safety of a new vaginal gel for the treatment of symptoms associated with vulvovaginal atrophy in postmenopausal women: A double-blind randomized placebo-controlled study

ObjectiveThe aim of the present randomized placebo-controlled single-center study was to assess the efficacy and safety of a new vaginal gel (Meclon Idra - Alfasigma) in the treatment of vulvovaginal atrophy (VVA). The gel is composed of sea buckthorn (Hippophaë rhamnoides) oil, aloe vera, 18β-glycyrrhetic acid, hyaluronic acid and glycogen. The study assessed whether the gel can reduce VVA symptoms (vaginal dryness, itching, burning sensation) and improve sexual function in postmenopausal women over 12 weeks. Study DesignPostmenopausal women (n° = 60) reporting VVA symptoms were recruited and randomized in a 1:1 ratio to the gel or placebo. Active vaginal gel or placebo was applied for 14 days and then twice a week for 90 consecutive days. Main outcome measureThe Vaginal Health Index (VHI), including vaginal pH, was used to assess changes in objective signs, whereas the self-reported Female Sexual Function Index (FSFI) was used to investigate sexual function. ResultsMeclon Idra was effective in reducing vaginal pain, dyspareunia and vaginal pH, with the VHI showing significant improvement at day 90 (P < .0001), and in reducing each VVA symptom (vaginal dryness, vaginal itching, burning sensation) at weeks 2 and 4, and the end of the study (P < .0001). The analysis of FSFI scores showed, after the end of treatment, an improvement of sexual function in the active-treatment group, with a statistically significant increase (P < 0.001) in all domains scores and total score (P < 0.001). ConclusionsThe present single-center randomized clinical trial demonstrated the efficacy, tolerability and safety of 12-week treatment with a new vaginal gel in postmenopausal women with symptoms associated with VVA. Based on this trial, the gel seems to be a valid choice as a single, local agent for relieving VVA symptoms and improving sexual function, and to have good compliance.This trial is registered prospectively with the Clinical Trials Registry – India, number CTRI/2019/05/01911.

The 2020 genitourinary syndrome of menopause position statement of The North American Menopause Society.

To update and expand the 2013 position statement of The North American Menopause Society (NAMS) on the management of the genitourinary syndrome of menopause (GSM), of which symptomatic vulvovaginal atrophy (VVA) is a component. A Panel of acknowledged experts in the field of genitourinary health reviewed the literature to evaluate new evidence on vaginal hormone therapies as well as on other management options available or in development for GSM. A search of PubMed was conducted identifying medical literature on VVA and GSM published since the 2013 position statement on the role of pharmacologic and nonpharmacologic treatments for VVA in postmenopausal women. The Panel revised and added recommendations on the basis of current evidence. The Panel's conclusions and recommendations were reviewed and approved by the NAMS Board of Trustees. Genitourinary syndrome of menopause affects approximately 27% to 84% of postmenopausal women and can significantly impair health, sexual function, and quality of life. Genitourinary syndrome of menopause is likely underdiagnosed and undertreated. In most cases, symptoms can be effectively managed. A number of over-the-counter and government-approved prescription therapies available in the United States and Canada demonstrate effectiveness, depending on the severity of symptoms. These include vaginal lubricants and moisturizers, vaginal estrogens and dehydroepiandrosterone (DHEA), systemic hormone therapy, and the estrogen agonist/antagonist ospemifene. Long-term studies on the endometrial safety of vaginal estrogen, vaginal DHEA, and ospemifene are lacking. There are insufficient placebo-controlled trials of energy-based therapies, including laser, to draw conclusions on efficacy and safety or to make treatment recommendations. Clinicians can resolve many distressing genitourinary symptoms and improve sexual health and the quality of life of postmenopausal women by educating women about, diagnosing, and appropriately managing GSM. Choice of therapy depends on the severity of symptoms, the effectiveness and safety of treatments for the individual patient, and patient preference. Nonhormone therapies available without a prescription provide sufficient relief for most women with mild symptoms. Low-dose vaginal estrogens, vaginal DHEA, systemic estrogen therapy, and ospemifene are effective treatments for moderate to severe GSM. When low-dose vaginal estrogen or DHEA or ospemifene is administered, a progestogen is not indicated; however, endometrial safety has not been studied in clinical trials beyond 1 year. There are insufficient data at present to confirm the safety of vaginal estrogen or DHEA or ospemifene in women with breast cancer; management of GSM should consider the woman's needs and the recommendations of her oncologist.

Effectiveness of hyaluronate-based pessaries in the treatment of vulvovaginal atrophy in postmenopausal women

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.

Efficacy and Safety of Hyaluronic Acid Injection on Symptoms of Vulvovaginal Atrophy in Postmenopausal Women

Efficacy and Safety of Hyaluronic Acid Injection on Symptoms of Vulvovaginal Atrophy in Postmenopausal Women

Prasterone: A Review in Vulvovaginal Atrophy.

Vulvovaginal atrophy (VVA) is a progressive condition commonly seen in postmenopausal women. The cessation of ovarian estrogen secretion and a fall in serum levels of dehydroepiandrosterone (DHEA), the remaining source of estrogens and androgens, are thought to promote the development of VVA in this population. Intravaginal prasterone (Intrarosa®) is a synthetic form of DHEA indicated for the treatment of VVA in postmenopausal women presenting with moderate to severe symptoms in the EU; prasterone is also approved in the USA for the treatment of dyspareunia due to menopause. Approval for the treatment of VVA was based on the results of the phase III ERC-231 and -238 trials in which intravaginal prasterone 6.5mg/day significantly improved the signs and symptoms of VVA (as assessed by the percentage of parabasal and superficial cells, vaginal pH and the severity of dyspareunia) compared with placebo. The beneficial effects of prasterone were also evident during 52weeks' treatment in the phase III ERC-230 safety trial. Prasterone was generally well tolerated, with the most common treatment-emergent adverse event being application site discharge. During 52weeks of treatment with prasterone, changes in serum concentrations of estrogenic and androgenic metabolites of DHEA increased from baseline but remained within the normal postmenopausal ranges. Thus, intravaginal prasterone is an effective and generally well-tolerated option for the treatment of VVA in postmenopausal women.

The Long Term Safety and Efficacy of the FemTouch for the Treatment of Vulvovaginal Atrophy in Postmenopausal Women [20M

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Symptom severity and quality of life in the management of vulvovaginal atrophy in postmenopausal women

ObjectivesTo evaluate the association between treatments for vulvovaginal atrophy (VVA) and symptom frequency and severity, quality of life (QoL) and sexual functioning in postmenopausal women. Study designCross-sectional survey conducted in postmenopausal women aged 45–75 years. Data on demographic and clinical variables, as well as vaginal, vulvar and urinary symptoms were collected. The EuroQoL questionnaire (EQ5D3L), the Day-to-Day Impact of Vaginal Aging (DIVA), the Female Sexual Function Index (FSFI) and the Female Sexual Distress Scale - revised (FSDS-R) were filled out. Main outcome measuresAssociation between treatments for VVA and symptom frequency. ResultsWomen on VVA treatment presented with more severe symptoms. The sexual function score was higher in the treated women (FSFI: 15.6 vs 16.7; p = 0.010), as was the score for sexual distress (FSDS-R: 9.2 vs 12.3, p < 0.0005). The systemic hormone group presented with fewer VVA symptoms, lower vaginal impact (DIVA), and better sexual function (FSFI and FSDS-R) and vaginal health. The rates of sexual distress and vulvar atrophy were higher in the non-hormonal treatment group. No significant differences were found according to treatment duration. ConclusionsPostmenopausal women with VVA receiving treatment complained of more severe symptoms than those untreated. Women on systemic treatment had fewer and milder VVA symptoms and presented with better vaginal and vulvar health than women on other treatments. Many women request effective local treatment too late, when VVA symptoms are already severe. Our data suggest that VVA treatments should ideally be initiated when symptoms commence and cause distress, rather than later, when symptoms may have become more severe and even a cause of intolerable distress for the woman.

Commentary on: Treatment to External Labia and Vaginal Canal With CO2 Laser for Symptoms of Vulvovaginal Atrophy in Postmenopausal Women.

Commentary on: Treatment to External Labia and Vaginal Canal With CO2 Laser for Symptoms of Vulvovaginal Atrophy in Postmenopausal Women.

Hormonal, metabolic, and endometrial safety of testosterone vaginal cream versus estrogens for the treatment of vulvovaginal atrophy in postmenopausal women: a randomized, placebo-controlled study

The aim of the study was to evaluate the laboratory and endometrial safety of topical testosterone versus topical estrogen for the treatment of vaginal atrophy in postmenopausal women. This was a randomized, placebo-controlled trial of 60 postmenopausal women aged 40 to 70 years at the Menopause Clinic of CAISM UNICAMP. Women were randomized into three vaginal treatment groups: estrogen, testosterone, or placebo. The treatment was applied 3 times a week for 12 weeks. Hormonal laboratory values of follicle-stimulating hormone, luteinizing hormone, estradiol, estrone, androstenedione, total testosterone, free testosterone, dehydroepiandrosterone, dehydroepiandrosterone sulfate, and sex hormone-binding globulin were assessed at baseline and at 6 and 12 weeks. Metabolic laboratory values of total cholesterol, high-density lipoprotein cholesterol, low-density lipoprotein cholesterol, triglycerides, aspartate aminotransferase, alanine aminotransferase, alkaline phosphatase, and gamma-glutamyl transpeptidase were also assessed at baseline and at 6 and 12 weeks. Endometrial safety was assessed using ultrasonography at baseline and at 12 weeks. After 12 weeks of treatment, there were no significant differences in hormonal or metabolic laboratory values among all three groups. Two participants in the estrogen group had increased serum estradiol after 12 weeks of treatment. No change in endometrial thickening was reported in all three groups. Twelve weeks of treatment with topical testosterone or estrogen in postmenopausal women with symptoms of vaginal atrophy demonstrated laboratory and endometrial safety when compared with placebo.

A medical device containing purified bovine colostrum (Monurelle Biogel) in the treatment of vulvovaginal atrophy in postmenopausal women: Retrospective analysis of urinary symptoms, sexual function, and quality of life.

This study assessed the effectiveness and safety of a medical device containing purified bovine colostrum (Monurelle Biogel; Zambon, Bresso, Italy) in improving vulvovaginal atrophy (VVA), sexual function, urinary symptoms, and quality of life (QoL) in postmenopausal women. In all, 172 postmenopausal women with VVA were included in the study. All women were treated with vaginal Monurelle Biogel daily for 12 weeks. Patients underwent clinical examinations, completed a 3-day voiding diary, and had VVA graded using the Vaginal Health Index (VHI) at baseline and 12 weeks. Patients also completed the Female Sexual Function Index (FSFI), overactive bladder questionnaire (OAB-Q), and the Urogenital Distress Inventory (UDI-6), among others. After 12 weeks, there were significant increases in mean (± SD) VHI (12.53 ± 3.67 vs. 19.31 ± 3.49; P < .0001), the number of patients engaging in regular sexual activity 102 (59.3%) vs. 144 (83.7%), and in the total FSFI score (21.64 ± 2.99 vs. 28.16 ± 1.93; P < .0001) compared with baseline. In addition, there were significant reductions in the mean number of 24-hour voids (9.57 ± 2.12 vs. 7.13 ± 1.22; P < .0001), urgent micturition episodes per 24 hours (1.75 ± 0.76 vs. 1.14 ± 0.87; P = .001), nocturia episodes (1.58 ± 0.85 vs. 0.97 ± 1.18; P = .0002), and urinary incontinence episodes per 24 hours (0.74 ± 0.59 vs. 0.28 ± 0.52; P = .003). Finally, after 12 weeks treatment, there were significant differences in UDI-6 (7.85 ± 0.81 vs. 5.56 ± 1.40), OAB-Q symptom (53.60 ± 12.57 vs. 22.08 ± 9.63), and OAB-Q health-related QoL (21.75 ± 8.51 vs. 69.34 ± 14.59) scores compared with baseline (P < .0001 for all). The Patient Impression of Global Improvement scale revealed global improvement in 143 women (83.14%). Monurelle Biogel is an effective treatment for VVA in postmenopausal women, improving sexual life, urinary symptoms, and QoL.

Клинико-патогенетические аспекты терапии вульвовагинальной атрофии у женщин в постменопаузе

Клинико-патогенетические аспекты терапии вульвовагинальной атрофии у женщин в постменопаузе

Fractional CO2 laser therapy: a new challenge for vulvovaginal atrophy in postmenopausal women

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.

022 Effect of Fractional CO2 Laser on Vulvo-Vaginal Atrophy in Post-Menopausal Women with Dyspareunia Based on FSFI Data

022 Effect of Fractional CO2 Laser on Vulvo-Vaginal Atrophy in Post-Menopausal Women with Dyspareunia Based on FSFI Data

Non-hormonal treatment of vulvo-vaginal atrophy-related symptoms in post-menopausal women

In post-menopausal period vulvo-vaginal atrophy (VVA)-related symptoms may seriously affect women's quality of life. Hormonal replacement therapy effectively relieves these symptoms but it is not always safe or accepted, and a non-hormonal treatment is often needed instead. Over a period of 12 weeks, we tested the effect of a twice-a-week vulvo-vaginal application of a hyaluronic acid, AC collagen, isoflavones and vitamins-based cream (Perilei Pausa®) on 35 women in post-menopausal period, reporting VVA-related symptoms. After 12 weeks of treatment with Perilei Pausa® a significant improvement in vaginal dryness, vulvo-vaginal itching, dyspareunia (P < 0.001), dysuria (P = 0.02), nocturia (P = 0.009) and pollakiuria (P = 0.005) was reported by the women. Colposcopical score assessing the intensity of atrophic colpitis, cervico-vaginal paleness and petechiae was also reduced (P = 0.037, P = 0.016 and P = 0.032, respectively). No significant difference in terms of maturation value of cervico-vaginal epithelium was observed. In conclusion, Perilei Pausa® may represent an effective and safe alternative treatment of symptomatic VVA in post-menopausal women.

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

ObjectiveTo 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 (VVA). Study designA 12 week, multicentre, randomised, double-blind, parallel-group phase III study of women (40–80 years) with VVA and self-reported vaginal dryness as their most bothersome symptom. Main outcome measuresThe co-primary efficacy endpoints were the change from baseline to Week 12 in (1) percentage of parabasal cells in the maturation index (MI), (2) percentage of superficial cells in the MI, (3) vaginal pH, and (4) severity of vaginal dryness. Safety assessments included physical examination, cervical Papanicolaou test and clinical laboratory analyses. Endometrial thickness and histology was also assessed. ResultsA total of 314 women were randomised to once-daily ospemifene 60mg/day (n=160) or placebo (n=154). Significant improvements in the percentages of parabasal and superficial cells in the MI and vaginal pH were observed with ospemifene compared with placebo (p<0.001 for all parameters). The mean change from baseline in severity score of vaginal dryness reported by women receiving ospemifene compared with those receiving placebo approached statistical significance (p=0.080). Improvements in each of the four co-primary endpoints with ospemifene were statistically significant compared to placebo in the per protocol population. The majority of treatment-emergent adverse events were considered mild to moderate in severity. ConclusionsOnce-daily oral ospemifene 60mg was effective for the treatment of VVA in postmenopausal women with vaginal dryness.