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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

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.

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 μg ethinylestradiol and 150 μg 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, welltolerated 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.

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.

(1988). Relation of site of umbilical cord insertion and birth weight. Journal of Obstetrics and Gynaecology: Vol. 9, No. 1, pp. 34-35.