The European Vulvovaginal Epidemiological Survey (EVES): prevalence, symptoms and impact of vulvovaginal atrophy of menopause.

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.

Systematic indirect comparison of ospemifene versus local estrogens for vulvar and vaginal atrophy.

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 17ß-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 17ß-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 17ß-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 17ß-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.

Effect of ospemifene on moderate or severe symptoms of vulvar and vaginal atrophy.

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.

The clinical relevance of the effect of ospemifene on symptoms of vulvar and vaginal atrophy.

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.

Multicenter study in Hungary with a 30 micrograms ethinylestradiol- and 150 micrograms desogestrel-containing monophasic oral contraceptive.

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.

Reproductive health in central and eastern Europe: priorities and needs.

The countries in Central and Eastern Europe combine induced abortion as the method of choice for family planning with low contraceptive use (Hungary and Slovenia excepted). This widespread use of induced abortion has a negative influence on reproductive and general public health, and an effort should be made to introduce modern, effective family planning. Both information, education and communication (IEC) programmes (for the users) and training in contraceptive technology and counselling (for the providers) is badly needed, as well as a continuing supply of contraceptives. In order to design optimal programmes, more research into knowledge, attitude and practice with regard to sexuality, sexual behaviour and contraception is urgently needed. So far, little research into contraceptive behaviour and its determinants has been done in Central and Eastern Europe, but the few data that are available point towards a lack of contraceptive knowledge in both the population and amongst contraception providers. The cultural differences between Western and Eastern industrialized countries are often underestimated or ignored, but because of the special situation in the countries in Central and Eastern Europe, education programmes which were successful elsewhere in the world may not work in these countries and may require extensive adaption to local needs and customs. Alternatively, special education programmes need to be developed. Programmes, especially those addressing contraception, should be combined with a long-term commitment for support and the provision of contraceptives.

Practice, attitudes and knowledge of Czech and Slovak gynaecologists concerning contraception.

PIP: 155 Czech and Slovak gynecologists completed questionnaires during the National Gynecological Congress held during November 4-6, 1992. Information was solicited on experience in family planning and practice, knowledge, and attitudes concerning contraception. The average age was 42.8 years, 33% were women, and 52% had practiced as gynecologists for 6-20 years. 93% rejected abortion as a method of birth control, while 10% stated that abstinence is more detrimental to health than abortion. The combined pill and the IUD were prescribed always (80%) or very often (60%). Over 90% perceived OCs, the IUD, and male or female sterilization as very reliable. Also, 75-90% perceived vaginal douche, rhythm, withdrawal, and the cervical mucus methods as rather reliable. Fewer gynecologists working in outpatient clinics perceived the OC as completely reliable (31%) as compared to hospital staff gynecologists (61%). Younger gynecologists also tended to be more positive about OCs than older ones. Regarding safety, only 8% mentioned the IUD, and 10% mentioned injectables and implants. 85% of gynecologists living in Prague perceived condoms as very safe compared to 50% of their colleagues elsewhere. Gynecologists working in hospitals, those with postgraduate training, over 40 years of age, and with more than 10 years of experience were less positive about the safety of the IUD. The perceived safety of OCs and of the IUD influences prescription rates. IUDs, OCs, injectables and implants, female and male sterilization, condoms, diaphragms, and rhythm method were perceived as most convenient. Convenience was significantly correlated with the prescription rate of IUDs. The attitude concerning the suitability of contraceptives for women under 35 years of age was correlated with the prescription rate of OCs, IUDs, and condoms. 51% of the physicians were familiar with the action of hormonal contraception. Only 45% knew that OCs were also safe for smokers below 35 years. The perceived side effects and benefits of OCs and IUDs were also evaluated.^ieng

Attitudes of Czech and Slovak gynecologists toward family planning.

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.

Family planning in Russia: experience and attitudes of gynecologists.

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.

Contraception in Russia: attitude, knowledge and practice of doctors.

PIP: 375 physicians from Russia completed a questionnaire at 3 symposia on modern contraceptive and human reproduction. Of these 375 physicians, 98% were obstetrician-gynecologists, 67% has no experience in family planning (FP). 44.5% had no training in FP, 83% were women, and their mean age was 37 years. Most frequently prescribed modern contraceptives were oral contraceptives (OCs) (50% often) and the IUD (59% often). More than 75% of respondent considered OCs, the IUD, and male and female sterilization to be very reliable. 41% and 92% respectively, did not know the efficacy of injectables/implants and the cervical mucus method. At least 50% considered the rhythm method, withdrawal, cervical mucus method, and vaginal douches to be not very reliable. 73% considered abortion to be an unsafe method. 30% did not know about the level of safety of injectables/implants. They perceived the IUD, OCs, injectables/implants, and female and male sterilization to be the most convenient methods. At least 60% considered withdrawal, abortion, abstinence, vaginal douches, and vaginal barriers to be inconvenient methods. Just 27% knew how OCs work. 13% considered OCs to never be safe. 65% thought the low-dose OCs are safe for nonsmokers under 35 years old. Most physicians considered the IUD and OCs to be the most suitable methods for all women. Woman's age contributed the most to physician opinions on contraception with female sterilization. Leading perceived side effects of OCs were gain (71%) and irregular bleeding (14%). The major perceived risks of OC use were thrombosis (35%), bleeding problems (21%), cardiovascular disease (16%), and depression (15%). 63% considered heavy menstrual blood loss to be the most disturbing side effect of IUD use. The leading perceived increased risks of IUD use were pelvic inflammatory disease (63%), ectopic pregnancy (54%), and anemia (27%). The misperceptions about modern contraception indicate a need for an exchange of information and skills between FP organizations in Western Europe and those in Russia.^ieng

Contraceptive practice and attitudes in former Soviet women.

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.