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Objective: Women with history of breast cancer (HBC) frequently suffer from vulvovaginal atrophy (VVA). European Vulvovaginal Epidemiology Survey (EVES) sub-analysis assesses the impact of HBC on VVA, sexual life and quality of life (QoL) in postmenopausal women., Materials and Methods: Women with at least one VVA symptom aged 45-75 years were included. EuroQol (EQ-5D-3L) and Day-to-Day Impact of Vaginal Aging (DIVA) questionnaires were filled to investigate QoL. VVA diagnosis was confirmed with objective gynecological examination. Comparison of postmenopausal women with and without HBC, and evaluation of treatment impact on VVA were performed., Results: 1985 postmenopausal women without HBC and 175 with HBC were included. VVA was confirmed in 90.4% of women without HBC and 91.4% of women with HBC. There were no differences in VVA symptoms severity or vulvovaginal discomfort between groups. However, women with HBC who had completed treatment and had surgery 11-20 years previously versus those without HBC presented significantly worse Vaginal Health Index scores, as well as a higher prevalence of VVA objective diagnosis, although their overall symptom severity score was lower. Health status and QoL comparisons were similar., Conclusions: Results support a similar burden in terms of VVA prevalence and symptoms, QoL and sexual function in postmenopausal women with and without HBC.

Objectives: To 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 Design: Cross-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 Measures: Association between treatments for VVA and symptom frequency., Results: Women 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., Conclusions: Postmenopausal 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., (Copyright © 2019. Published by Elsevier B.V.)

Objective: This subanalysis of the European Vulvovaginal Epidemiology Survey study aimed to assess the correlation of vulvovaginal atrophy (VVA) symptoms and severity, when confirmed by objective gynecologic examination, with the quality of life of postmenopausal women., Methods: Women aged 45 to 75 years with confirmation of last menstrual period more than 12 months before, who attended menopause or gynecology centers, were included. Those women had at least one VVA symptom filled in a group of questionnaires, including EuroQol-EQ-5D-3L and Day-to-Day Impact of Vaginal Aging (DIVA). To confirm the VVA diagnosis, an objective gynecologic examination was also performed., Results: Of a total of 2,160 evaluable women, 66.3%, 30.5%, and 11.2% suffered from severe vaginal, vulvar, and urinary symptoms, respectively. VVA was confirmed in more than 90% of the participants. Mean (±SD) EQ-5D-3L score was 0.892 ± 0.144 and mean (±SD) score on the associated visual analog scale was 71.7 ± 16.0. Mean (±SD) DIVA score was 0.922 ± 0.653. For both EQ-5D-3L and DIVA, the overall scores and most of the dimensions/components were statistically significantly worse for women with severe VVA symptoms (vulvar and urinary) compared with women not affected by severe symptoms. Quality of life questionnaires showed worse scores in women where the diagnosis of VVA was confirmed by gynecologic examination., Conclusions: Severe VVA symptoms showed a direct association with worse quality of life in postmenopausal women. This important effect on the quality of life of many women should be recognized as equivalent to those from other conditions and pathologies of which there is greater awareness.

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.

In the absence of a direct head-to-head study, we performed an indirect historical comparison of ospemifene 60 mg (Senshio ® ) vs. local vaginal estrogens in moderate or severe vulvar and vaginal atrophy (VVA). A literature search was carried out of clinical efficacy/safety trials of local vaginal estrogens in VVA approved in Europe. For efficacy comparison, studies had to be placebo-controlled and of 12 weeks' duration. For safety comparison, studies had to be ≥40 weeks' duration. Efficacy endpoints were the difference between active and placebo in change from baseline to week 12 for symptoms, vaginal pH, and maturation value (MV). Safety endpoints were endometrial safety, breast safety, thrombosis, and adverse events. The 12-week improvement over placebo in symptom score was not different for ospemifene 60 mg and 17β-estradiol 10 μg and for ospemifene 60 mg and estriol gel. After 12 weeks, the percentages with vaginal pH <5.0 and <5.5 were better for ospemifene 60 mg than 10 μg 17β-estradiol. Week-12 pH changes were comparable with estriol pessaries or gel and ospemifene 60 mg. The 12-week MV improvements over placebo were similar or better with ospemifene 60 mg compared with 10 μg 17β-estradiol and with estriol pessaries or gel. There was no increased vaginal bleeding, endometrial hyperplasia, or carcinoma (including breast cancer) relative to placebo and no signal for increased risk of venous thromboembolism with ospemifene 60 mg or 10 μg 17β-estradiol, but the confidence intervals for both products do not exclude an increased risk. This historical indirect comparison suggests that ospemifene 60 mg has an efficacy, safety, and tolerability profile comparable to or better than local vaginal estrogens in the treatment of VVA.

Objectives: To determine whether assessment of all moderate-to-severe symptoms at baseline gives a more accurate evaluation of the treatment effect of ospemifene in vulvovaginal atrophy (VVA) than the most bothersome symptom (MBS) approach., Methods: Data were pooled from two pivotal phase-III clinical trials evaluating the efficacy and safety of oral ospemifene 60 mg/day for the treatment of symptoms of VVA (n = 1463 subjects). Symptoms of vaginal dryness, dyspareunia, and vaginal and/or vulvar irritation/itching reported as moderate or severe at baseline were evaluated. Clinically relevant differences between ospemifene and placebo were analyzed using a four-point severity scoring system and presented as improvement, substantial improvement, or relief., Results: Subjects in these studies reported statistically significant improvement, substantial improvement, and relief for vaginal dryness (p < 0.00001), dyspareunia (p < 0.001) and statistically significant improvement and relief for vaginal and/or vulvar irritation/itching (p < 0.01) from baseline to week 12 with ospemifene compared with placebo. A similar trend was observed for women who reported substantial improvement of vaginal and/or vulvar irritation/itching., Conclusions: For drug registration purposes, the use of the MBS model is appealing because of its simplicity and ease of scientific validation. However, the MBS model may underestimate the total magnitude of the clinical benefit of ospemifene treatment for symptomatic women suffering from VVA.

Objectives: To explore clinically relevant differences in severity of vulvar and vaginal atrophy (VVA) in postmenopausal women treated with ospemifene compared with placebo., Methods: Analysis of two multicenter, randomized, double-blind, 12-week phase-III studies in postmenopausal women (40-80 years, with VVA, treated with ospemifene 60 mg/day or placebo (Study 310 and Study 821)). Severity of vaginal dryness and dyspareunia were evaluated using a four-point scoring system and clinically relevant differences between ospemifene and placebo were analyzed and are presented as improvement (reduction in ≥ 1 unit on four-point scoring system), substantial improvement (reduction in 2-3 units on four-point scoring system) and relief (severity score of mild/none after 12 weeks)., Results: In Study 310, significantly more women with a most bothersome symptom of dyspareunia had improvement (68.3% vs. 54.1%; p = 0.0255) or relief (57.5% vs. 41.8%; p = 0.0205) in the severity of dyspareunia from baseline to week 12 with ospemifene compared with placebo. For those with a most bothersome symptom of vaginal dryness, significantly more experienced improvement (74.6% vs. 57.7%; p = 0.0101), substantial improvement (42.4% vs. 26.9%; p = 0.0172) and relief (66.1% vs. 49.0%; p = 0.0140) of vaginal dryness from baseline to week 12 with ospemifene compared with placebo. Proportions of women with improvement/substantial improvement/relief of symptoms of vaginal dryness or dyspareunia were similar in Study 821. Clinically relevant differences were noticeable by week 4., Conclusions: Treatment with ospemifene was consistently associated with greater improvement, substantial improvement or relief in the severity of the most bothersome symptoms of vaginal dryness or dyspareunia compared with placebo.

Objectives: Vulvar/vaginal atrophy (VVA) is one genitourinary condition associated with a decline in estrogen. This may be bothersome for women following menopause. Although the clinical features of VVA and other conditions after menopause have been documented, few studies have quantified the magnitude of association between VVA and other genitourinary conditions., Methods: A VVA cohort was identified from two United States administrative claims databases. A matched cohort of an equal number of controls was randomly selected from a pool of women 40-79 years of age without VVA. Baseline characteristics and medical history were tabulated for the VVA cohort and matched controls. Six genitourinary conditions ('urinary tract infections', 'other/unspecified genitourinary symptoms', 'other inflammatory diseases of female pelvic organs', 'menopausal disorders', 'female genital pain and other symptoms', and 'other/unspecified female genital disorders') were hypothesized a priori to be associated with VVA. Adjusted incidence rate ratios measured the strength of association of VVA with each condition., Results: A total of 9080 women aged 40-79 years with newly diagnosed VVA during 2000-2010 were identified. The mean age of VVA patients and matched controls was 60.2 years. At baseline, a significantly (p < 0.001) higher proportion of women in the VVA cohort had a diagnosis of angina, osteoporosis, migraines, insomnia, or anxiety, or received estrogen supplementation or selective estrogen receptor modulators. VVA patients had a significantly (p < 0.001) higher incidence of each of the genitourinary conditions compared to controls. The condition most strongly associated with VVA with a relative risk of 6.2 was 'other inflammatory diseases of female pelvic organs'., Conclusions: Women with VVA have a greater risk of genitourinary conditions compared to those without. The overall prevalence of VVA and other genitourinary conditions may be underreported as claims data only captures information for patients under medical care and many women do not seek consultation for VVA symptoms.

Among the countries in Central and Eastern Europe, Hungary has a high oral contraceptive prevalence rate. Until recently, however, Hungarian women have not had access to combined oral contraceptives with new, third-generation progestogens. Marvelon (30 micrograms ethinylestradiol and 150 micrograms desogestrel) was first introduced in 1981 in Western Europe and has, in a number of different studies, proven an effective and well-tolerated oral contraceptive with no effect on blood pressure and a favorable lipid profile. Marvelon was introduced in Hungary in October 1991. Prior to its introduction, a multicenter study was undertaken in Hungary with Marvelon to confirm the clinical results of studies from other countries. The present study confirmed Marvelon to be an effective, well-tolerated combined oral contraceptive with no relevant effect on blood pressure. Remarkable improvements were noted, especially with regard to side-effects, in switchers from other oral contraceptives. It is concluded that Marvelon is a valuable extension of the range of contraceptive methods available in Hungary.

A survey was held among 155 gynecologists of the former Czech and Slovak Federal Republic (CSFR) who visited a national gynecological congress. The sample was fairly comparable to the total group of Czech and Slovak gynecologists concerning sex, age and county. Questions were asked on personal and professional characteristics, experience with the provision of contraception, attitudes toward family planning and knowledge about contraception. Almost all gynecologists rejected abortion as a birth control method and mentioned the lack of sex education, non-use of contraception and the widespread use of traditional contraceptive methods as main reasons for the high prevalence of abortion. About 60% of the physicians thought that at least some women would rather have an abortion than use contraception. According to the physicians, special family planning services should be developed and delivered by gynecologists. Opinions on proper services for teenagers varied. Only a few physicians felt that patients should pay the full price of contraceptives. Physicians' knowledge about the pill was found to be insufficient. The physicians overestimated the knowledge of their female patients about the pill. Apart from books and journals, colleagues and pharmaceutical firms were reported as important information sources. Overall, the present survey showed that introduction of well structured pre- and postgraduate courses in family planning should be encouraged.

A survey was made of 375 Russian gynecologists. The questionnaire on family planning and contraceptives was distributed at the beginning of three local educational symposia. Almost all participants filled in the questionnaire on attitudes, knowledge and experience with family planning. The sample consisted of departmental specialists and heads of departments/clinics, working mainly at in- or out-patient women's health clinics. The mean age was 37 years; 83% were women, living in medium-sized or large cities (80%). Half of them had been working as a gynecologist for more than 10 years. Only 55% had been trained in family planning. The main reasons mentioned for the high abortion rate in Russia were the lack of education, non-involvement of male partner, and lack of modern contraceptives. Most of the gynecologists were in favor of special family planning clinics with special attention to services for the users. About half of the physicians knew how the pill works and estimated that 41% of women know that the pill contains estrogens. Sixty-two percent found that patients are badly informed about available contraception. Main sources of information on contraception were journals/books, colleagues and mass media. The majority reported having a directive style of patient counseling, and stated that parents should be informed of their teenagers' sexual experiences. The more experienced physicians with a training in family planning were better informed on contraception and showed a more patient-concerned attitude. It is concluded that health care providers should be the main target group of training and education in family planning, and need the support of Western European family planning organizations.

For decades, abortion has been the principal birth control method for Soviet women. As indicated by some earlier local surveys, most couples use unreliable methods. Little is known about the latest trends in contraceptive use affected by the recent general liberalization of Soviet society, including more open attitudes about sex. A survey was conducted in 1991 via a questionnaire in the popular 'Health' magazine with national circulation. A total of 8059 women returned the questionnaire. The sample is selective with an overrepresentation of young and better educated urban residents, mostly from Russia and the Ukraine. Some 81% reported use of a contraceptive method during the last 5 years. Traditional methods still prevail (41% used withdrawal, rhythm and douche). Among women younger than 25 years there is a clear trend toward use of modern methods (IUD 35% and the pill 10%), although their notion of the 'pros" and 'cons' is biased. Of the respondents, 20% used a barrier method, mainly condom. The preferred method is the IUD (51%) and the pill (18%). Abortions resulting from contraceptive failure were reported by 60% of women. Eighty-nine percent considered pregnancy termination more dangerous than its prevention. For only 12% of respondents, a physician was the main source of contraceptive information, although 49% addressed him for advice. The results indicate a gap between conservative birth control practice and preferences of Russian women, with a positive general trend in the near future.