Ricardo Maamari

Clarifying Vaginal Atrophy's Impact on Sex and Relationships (CLOSER) survey: Emotional and physical impact of vaginal discomfort on North American postmenopausal women and their partners

ObjectiveThis study aims to determine the emotional and physical impact of vaginal atrophy on North American postmenopausal women and their male partners. MethodsA weighted sample of 1,000 married or cohabiting North American postmenopausal women aged 55 to 65 years with vaginal discomfort and 1,000 male partners of postmenopausal women aged 55 to 65 years who experienced vaginal discomfort participated in the Clarifying Vaginal Atrophy’s Impact on Sex and Relationships (CLOSER) online survey to determine the impact of vaginal discomfort and local estrogen therapy on intimacy, relationships, and women’s self-esteem. ResultsVaginal discomfort caused most surveyed North American women to avoid intimacy (58%), experience loss of libido (64%), and experience pain associated with sex (64%). Most surveyed North American men also believed that vaginal discomfort caused their partners to avoid intimacy (78%), experience loss of libido (52%), and find sex painful (59%). Approximately 30% of North American women and men cited vaginal discomfort as the reason they ceased having sex altogether. North American women who used local estrogen therapy to treat their vaginal discomfort reported less painful sex (56%), more satisfying sex (41%), and improved sex life (29%). Most men reported looking forward to having sex (57%) because of their partner’s use of local estrogen therapy. ConclusionsLocal estrogen therapy ameliorates the negative impact of vaginal atrophy on the intimate relationships of North American postmenopausal women and their male partners. Additional education and awareness efforts about the symptoms of and available treatments for vaginal atrophy may be of further benefit to North American partners.

Treatment of postmenopausal vaginal atrophy with 10-µg estradiol vaginal tablets

Postmenopausal estrogen deficiency can lead to symptoms of urogenital atrophy. Individuals with urogenital atrophy have symptoms that include vaginal dryness, vaginal and vulval irritation, vaginal soreness, pain and burning during urination (dysuria), increased vaginal discharge, vaginal odour, vaginal infections, recurrent urinary tract infections, pain associated with sexual activity (dyspareunia) and vaginal bleeding associated with sexual activity. Despite the frequency and effects of vaginal atrophy symptoms, they are often under-reported and, consequently, under-treated. Therefore, care of a menopausal woman should include a physical assessment of vaginal atrophy and a dialogue between the physician and the patient that explores existing symptoms and their effect on vulvovaginal health, sexuality and quality-of-life issues. The development of the ultra-low-dose 10-µg estradiol vaginal tablets is in line with the requirements of regulatory agencies and womens health societies regarding the use of the lowest effective hormonal dose. Because of its effectiveness and safety profiles, in addition to its minimal systemic absorption, the 10-µg estradiol vaginal tablet can offer greater reassurance to health-care providers and postmenopausal women with an annual estradiol administration of only 1.14 mg.

Attitudes and approaches to vaginal atrophy in postmenopausal women: a focus group qualitative study.

Abstract Objective The impact of postmenopausal vaginal atrophy and womens coping strategies were evaluated through international focus groups. Methods Three-hour focus groups of three to five postmenopausal women who had symptoms of vaginal atrophy but had not sought treatment were conducted in Canada, Sweden, the United States, and the United Kingdom. Participants were asked about their experience with menopause and vaginal atrophy, including use of non-prescription treatments and their interactions with health-care providers. Women were classified as one of five personality types, based on their interaction with the world (individualism or belonging) and strategies for coping with stress (control or liberation). Results Vaginal atrophy was not recognized as a medical condition by focus group participants, and women had not used treatments for vaginal atrophy apart from non-prescription lubricants. Women who had discussed vaginal atrophy symptoms with their doctor felt their concerns were dismissed as a normal part of aging, and they did not receive counseling about treatment options such as low-dose estrogen therapy. Those whose coping strategy involved dominance, combatting, or individualism were more likely to seek treatment than those whose strategy involved submission, acceptance, or belonging. Women who used control to cope with menopausal changes were more likely to respond to information validated by perceived experts than were those who used a strategy of release. Conclusions Womens reactions to their vaginal atrophy varied according to personality. Use of a personality-based approach to patient counseling may encourage patients to discuss vaginal atrophy with their health-care provider and seek treatment.

One-year treatment persistence with local estrogen therapy in postmenopausal women diagnosed as having vaginal atrophy

Objective:Estrogen therapy is considered to be the most effective treatment of vaginal atrophy (VA) symptoms. This retrospective study compares rates of pharmacy refill-based treatment persistence in women treated for VA with local estrogen therapy (LET) creams versus low-dose vaginally administered tablets. Methods:Study cohort included treatment-naive women aged 45 years or older within the IMS PharMetrics Plus claims database who filled one or more prescriptions for a LET cream or tablet between January 1, 2010 and September 30, 2012. Index LET was the first observed LET claim in pharmacy records. Persistence was defined as the number of consecutive days of treatment available of the index LET during the 12-month follow-up period. In adjusted analyses, we compared the risks of discontinuation of index therapy. Results:Of 30,197 women eligible for analysis, 12,187 (40.4%) initiated treatment with conjugated estrogens vaginal cream, 11,574 (38.3%) initiated treatment with estradiol vaginal cream, and 6,436 (21.3%) initiated treatment with 10-&mgr;g vaginal estradiol tablets (formulation introduced in 2010). Cohorts were comparable on age, geography, and baseline comorbidities. During the 12-month follow-up period, 86.2% to 89.4% of cream users discontinued LET after the first prescription compared with 57.8% of tablet users (P < 0.0001). A greater proportion of tablet initiators than cream users were fully (100%) persistent during the 12-month follow-up period. Mean treatment duration was 103.4 days for tablets versus 44.6 to 48.1 days for creams (P < 0.0001). After adjustment for baseline characteristics, tablet initiators had a lower risk of discontinuation compared with cream users (P < 0.0001). Conclusions:Low-dose LET tablets, compared with cream formulations, are associated with greater persistence in the treatment of VA.

The CLOSER survey: impact of postmenopausal vaginal discomfort on women and male partners in the UK.

Objective To understand the physical and emotional impact of postmenopausal vaginal discomfort on relationships between women and their male partners. Study design In a quantitative, Internet-based survey, 8200 individuals from the UK, Denmark, Sweden, Norway, Finland, France, Italy, US and Canada (postmenopausal, married/cohabiting women, aged 55–65 years, who had experienced vaginal discomfort, and male partners of such women) completed a structured questionnaire. Main outcome measures Results for respondents from the UK (500 men, 500 women), expressed as percentages of women/men describing particular answers, are reported. Results Avoiding physical intimacy because of vaginal discomfort was reported by 69% of women and 76% of male partners, mainly due to concern about sex being painful (women 63%; men 61%); 18% of women considered vaginal discomfort had created emotional distance between them and their partners. Local estrogen treatment was used by 21% of women, among whom 58% subsequently reported less painful sex. Following such treatment, 33% of women and 30% of male partners reported an improved sex life, while 33% of women and 34% of male partners described becoming emotionally closer. Although 73% of women did not consider enough information about vaginal discomfort to be available, 60% would consult a physician to obtain this. Conclusions Although vaginal discomfort has a substantial impact on postmenopausal women and their partners, improvements in sexual and emotional relationships can follow use of local estrogen therapy. Not all women may be aware of therapeutic options; healthcare providers can improve outcomes by more openly communicating and initiating discussion with patients.

Women's preferences toward attributes of local estrogen therapy for the treatment of vaginal atrophy

OBJECTIVES Decreased estrogen production due to menopause is often associated with vaginal atrophy, and estrogen therapy is the most effective treatment for the management of this condition. This study investigated womens preferences relating to various aspects of local estrogen therapy (LET) for the treatment of postmenopausal vaginal atrophy. STUDY DESIGN The study involved 423 women aged >50 years who were resident in Sweden, had experienced menopausal changes in and around the vagina, and had used LET for these changes. The women completed an online questionnaire. MAIN OUTCOME MEASURES The questionnaire involved a discrete choice experiment to determine womens willingness to pay for different characteristics of therapy. Time of LET appliance, use of disposable applicators with small tablets compared with both dosing syringes with vaginal cream and vagitories, and therapy that did/did not cause smudges/leakage were all considered. RESULTS The women had no significant preference as to the time of day LET should be used. However, quantifying other preferences suggested that respondents were willing to pay € 66.58 or € 60.32 per month extra for using disposable applicators with small tablets rather than dosing syringes with vaginal cream or vagitories, respectively, and to avoid smudges/leakage. CONCLUSIONS This survey suggests that women may prefer using disposable applicators with small tablets to deliver LET and value therapy that does not cause smudges/leakage. It is possible that if women are able to use their preferred form of LET, improved uptake or adherence of such medication may enhance the management of postmenopausal vaginal atrophy.

Prevalence of postmenopausal symptoms in North America and Europe.

Objective:This study aims to evaluate differences and similarities in the prevalence of postmenopausal symptoms and their impact on postmenopausal women and male partners of postmenopausal women in North America and Europe. Methods:The Internet-based survey Clarifying Vaginal Atrophys Impact on Sex and Relationships (CLOSER) was conducted in North America and Europe. The questionnaire included questions on symptoms experienced by women after menopause and the impact of these symptoms overall and specifically on emotional and physical relationships. This study included 8,200 respondents: 4,100 were postmenopausal women who had experienced vaginal discomfort and 4,100 were male partners of postmenopausal women with this symptom. Differences were significant at the 95% level of confidence. Results:The survey identified vaginal dryness, hot flashes, night sweats, disrupted sleep, and weight gain as the top five symptoms experienced by postmenopausal women in North America and Europe. Overall, symptoms were found to be more prevalent in women from the United States, United Kingdom, and Canada (P < 0.05), and less prevalent in women from Sweden and Italy compared with other countries. In regards to the impact of symptoms overall and on emotional and physical relationships, the greatest number of women from the United States, United Kingdom, and Canada found the impact to be “worse than expected.” Conclusions:The impact of postmenopausal symptoms on relationships is greater in women from countries where symptoms are more prevalent. Postmenopausal women and male partners of postmenopausal women may benefit from greater education about menopause and open discussions with their healthcare provider.

Ultra-low-dose vaginal estrogen tablets for the treatment of postmenopausal vaginal atrophy

ABSTRACT Vaginal atrophy is a common chronic condition affecting up to 57% of postmenopausal women. The decrease in estrogen following cessation of menses can lead to bothersome symptoms that include vaginal dryness and irritation, pain and burning during urination (dysuria), urinary tract infections, and pain (dyspareunia) and bleeding during sexual activities. These symptoms can be safely and effectively managed with the use of local estrogen therapy, which reduces the risks associated with long-term systemic hormone therapy. The ultra-low-dose 10 μg estradiol vaginal tablet is the lowest approved dose available and has an annual estradiol exposure of only 1.14 mg. Its development addresses recommendations from regulatory agencies and womens health societies regarding the use of the lowest hormonal dose. The 10 μg vaginal tablet displays minimal estradiol absorption, causes no increased risk of endometrial hyperplasia or carcinoma, and provides significant symptom relief. The clinical evidence presented here may offer greater reassurance to health-care professionals and postmenopausal women that vaginal atrophy can be treated safely and effectively.