Validation of the Menopause Transition Scale (MTS).

OBJECTIVE: All women will experience menopause transition, and a majority will experience symptoms that negatively affect their quality of life. Current validated menopause symptom scales are time consuming, phrased in clinical language, and difficult to adopt for digital use. This study seeks to validate a short novel survey which can be reliably completed without coaching and accurately represents the experience of the menopause transition. METHODS: We developed a patient-centric questionnaire (Menopause Transition Scale, MTS) to examine for symptoms of menopause. Survey responders represented a total of 144 women with at least one symptom of menopause. Survey responders included women affected by cancer aged 30 to 65 (n = 72) and women not affected by cancer aged 45 to 60 (n = 72). Cronbach Alpha was used to examine for internal consistency and dimensionality was assessed using exploratory factor analysis. The cross-validation was analyzed against established patient scales using Spearman correlations or Chi-Square analysis, as appropriate. RESULTS: The MTS questions showed internal consistency with a Cronbach Alpha of 0.63. The individual questions loaded into three unique domains. The MTS overall correlated with validated scales for menopause symptoms, the Menopause-Specific Quality of Life Questionnaire (r = -0.86, P < 0.0001) and Greene Climacteric Scale (r = -0.65, P < 0.0001). Libido correlated with scales (P = 0.0150) and subscales (r = -0.70, P < 0.0001) relating low sexual desire. Energy (r = -0.62, P < 0.0001), Mood (r = -0.48, P < 0.0001), and Hot Flashes/Night Sweats (r = -0.77, P < 0.0001) correlated with scales and subscales related to mood, depression, and vasomotor symptoms. The majority of our responders expressed mild vaginal bleeding. The highest frequency of severe symptoms were low libido and poor energy. CONCLUSIONS: The MTS is a short thorough patient-centric survey that is readily amenable to digital adoption to measure symptoms of menopause as women transition in the out-patient setting. Further study is needed for the longitudinal assessment of symptoms through the transition process and the response of women to therapeutic options.Video Summary: http://links.lww.com/MENO/A938.

17ß-estradiol/progesterone in a single, oral, softgel capsule (TX-001HR) significantly increased the number of vasomotor symptom-free days in the REPLENISH trial.

OBJECTIVE: To examine responder rates and vasomotor symptom-free days with oral 17ß-estradiol/progesterone (E2/P4; TX-001HR) versus placebo in the REPLENISH trial. METHODS: REPLENISH (NCT01942668) was a phase 3, randomized, double-blind, placebo-controlled, multicenter trial, evaluating single, oral, softgel E2/P4 capsules in postmenopausal women (40-65 y) with a uterus and vasomotor symptoms (VMS). Women with moderate to severe hot flushes (≥7/d or ≥50/wk) were randomized (VMS substudy) to daily E2/P4 (mg/mg) of 1/100, 0.5/100, 0.5/50, 0.25/50, or placebo. Proportions of women with ≥50% or ≥75% reductions in moderate to severe VMS (responders), and those with no severe VMS as well as the weekly number of days without moderate to severe VMS with TX-001HR versus placebo were determined. Mixed model repeated measures was used to analyze data and Fisher exact test was employed to compare E2/P4 versus placebo. RESULTS: Seven hundred twenty-six women were eligible for the VMS efficacy analysis (E2/P4 1/100 [n = 141], 0.5/100 [n = 149], 0.5/50 [n = 147], 0.25/50 [n = 154], or placebo [n = 135]). Significantly more women treated with all E2/P4 doses versus placebo were ≥50% responders and ≥75% responders at weeks 4 and 12 (P < 0.05) and also had significantly more days per week without moderate to severe VMS at week 12 (1.9-3.0 d for E2/P4 versus 1.3 d for placebo; P < 0.05). The proportion of women without severe hot flushes at week 12 was 43% to 56% for all E2/P4 doses versus 26% for placebo (P ≤ 0.01). CONCLUSIONS: Women treated with E2/P4 had a greater response to treatment with more VMS-free days than with placebo. The E2/P4 1/100 dose (Bijuva [E2 and P4] capsules) represents an oral treatment option for postmenopausal women with moderate to severe VMS and a uterus.

Menopause Management Knowledge in Postgraduate Family Medicine, Internal Medicine, and Obstetrics and Gynecology Residents: A Cross-Sectional Survey.

OBJECTIVE: To evaluate the knowledge of and nature of training for menopause management in postgraduate residents. PARTICIPANTS AND METHODS: A cross-sectional, anonymous survey was e-mailed to trainees at all postgraduate levels in family medicine, internal medicine, and obstetrics and gynecology at US residency programs between January 11, and July 4, 2017. The survey was adapted from an existing instrument and included questions regarding knowledge of hormone therapy (HT) and other menopause management strategies, availability and type of training in menopause medicine, and demographic information. RESULTS: Of the 703 surveys sent, a total of 183 residents representing 20 US residency programs responded (26.0% response rate). Most trainees were between 26 and 30 years of age (133 of 172 [77.3%]), female (114 of 173 [65.9%]), and believed it was important or very important to be trained to manage menopause (165 of 176 [93.8%]). Although most respondents answered some of the menopause competency questions correctly, important gaps were identified. Of 183 participants, 63 (34.4%) indicated they would not offer HT to a symptomatic, newly menopausal woman without contraindications, and only 71 (38.7%) indicated they would prescribe HT until the natural age of menopause to a prematurely menopausal woman. Of 177 respondents, 36 (20.3%) reported not receiving any menopause lectures during residency, and only 12 of 177 (6.8%) reported feeling adequately prepared to manage women experiencing menopause. CONCLUSION: Family medicine, internal medicine, and obstetrics and gynecology residency trainees recognize the importance of training in menopause management, but important knowledge gaps exist. Investing in the education of future clinicians to provide evidence-based, comprehensive menopause management for the growing population of midlife women is a priority.

Clinical intervention to reduce central obesity and menopausal symptoms in women aged 35 to 55 years.

OBJECTIVE: Central obesity is a risk factor for cardiovascular disease and diabetes. Women commonly increase central fat deposition during the menopausal transition. The purpose of this demonstration project was to determine whether a personalized sex-specific intervention, WAIPointes (WAI stands for Who Am I), could reduce central obesity in women undergoing perimenopausal transition. METHODS: Eighty-three of 103 women aged 35 to 55 years and experiencing symptoms of the menopausal transition completed a 6-month WAIPointes demonstration project; 75 consented to data review.Sex-specific history was obtained on visit 1; directed physical examination for body mass index, body fat percentage, waist circumference, and blood pressure were performed at each of four or five subsequent monthly visits. Other tests were ordered as necessary to determine risk stratification.Participants were assessed for menopause status, and they reported activity and menopausal symptoms at each visit. Personalized strategies for health improvement were developed in partnership. Women served as their own controls. Data from visit 2 were compared with data from visit 4. RESULTS: The intervention reduced waist circumference and diastolic blood pressure and improved self-reported menopausal symptoms and physical activity levels. CONCLUSIONS: Although further study is needed, findings suggest that the WAIPointes program offers potential as an effective office-based clinical intervention to reduce cardiovascular risk factors and symptoms of menopause in women during the menopausal transition.