Fiona Margaret Jane

A Randomized Trial of Oral DHEA Treatment for Sexual Function, Well-Being, and Menopausal Symptoms in Postmenopausal Women with Low Libido

INTRODUCTION Dehydroepiandrosterone (DHEA) and its sulfate DHEAS, which are the most abundant steroids in women, decline with age. We have shown association between low sexual function and low circulating DHEAS levels in women. AIM The aim of this study was to evaluate whether restoration of circulating DHEA levels in postmenopausal women to the levels seen in young individuals improves sexual function. METHODS Ninety-three postmenopausal women not using concurrent estrogen therapy were enrolled in a 52-week randomized, double-blind, placebo controlled trial and received either DHEA 50 mg or placebo (PL) daily. MAIN OUTCOME MEASURES Efficacy was assessed through 26 weeks. The main outcome measures were the change in total satisfying sexual events (SSE) and the change in the Sabbatsberg Sexual Self-Rating Scale (SSS) total score. Secondary measures were the Psychological General Well-Being Questionnaire (PGWB), and the Menopause-Specific Quality of Life Questionnaire (MENQOL). Hormonal levels, adverse events (AEs), serious adverse events (SAEs) and clinical labs were evaluated over 52 weeks. RESULTS Eighty-five participants (91%) were included in the 26-week efficacy analysis. There were no significant differences between the DHEA and PL groups in the change in total SSE per month or the SSS, PGWB, and MENQOL change scores. Overall AE reports and number of withdrawals as a result of AEs were similar in both groups; however more women in the DHEA group experienced androgenic effects of acne and increased hair growth. CONCLUSIONS In this study treatment of postmenopausal women with low sexual desire with 50 mg/day DHEA resulted in no significant improvements in sexual function over PL therapy over 26 weeks.

The safety of 52 weeks of oral DHEA therapy for postmenopausal women

OBJECTIVE The aim of this study was to evaluate the safety of 52 weeks of DHEA 50mg daily oral dose given to postmenopausal women with low libido to improve sexual function. METHOD 93 postmenopausal women were enrolled in a 52-week randomised, double-blind, placebo-controlled trial and received either DHEA 50mg or placebo (PL) daily. The effects of DHEA versus placebo on lipid profile, insulin-glucose homeostasis and the endomentrium were assessed over 52 weeks. RESULTS Oral DHEA, 50mg/day, was not associated with any effects on blood lipids or insulin resistance. The pattern of breakthrough bleeding did not substantially differ between the DHEA and PL groups and no significant adverse endometrial effects were apparent. CONCLUSIONS The use of 50mg oral DHEA did not significantly alter lipid profile, insulin sensitivity or adversely affect the endometrium in postmenopausal women.

A practitioner's toolkit for managing the menopause

Abstract Objective A number of learned societies, including the International Menopause Society, have produced position statements pertaining to the use of postmenopausal hormone therapy. These documents are highly informative but are not designed for use by primary-care physicians and nurse practitioners during routine consultations. Our aim was to produce a toolkit for practitioners that could be used during office consultations to assist them in the assessment and management of the menopause. Methods We used clinical experience in primary care, combined with published diagnostic algorithms, positions statements from learned medical societies and relevant peer-reviewed literature to develop assessment and management algorithms relevant to the primary care of women age 40 years and older. Results The resultant ‘Practitioner’s Toolkit for Managing the Menopause’ comprises algorithms for the reasons why a woman might present, determination of menopausal status, key information that should be ascertained, issues that may influence treatment decision-making, hormonal and non-hormonal treatment options, symptom management and patient review, and a brief supporting document. Conclusions We believe these algorithms and supporting document provide an accessible desktop tool for health-care practitioners caring for women at midlife. The toolkit has been endorsed by the International Menopause Society for global use.

Testosterone Improves Antidepressant‐Emergent Loss of Libido in Women: Findings from a Randomized, Double‐Blind, Placebo‐Controlled Trial

INTRODUCTION Female sexual dysfunction is a side effect of selective serotonin reuptake inhibitor (SSRI)/serotonin noradrenalin reuptake inhibitor (SNRI) therapy. AIMS The aim of this study is to investigate the efficacy of transdermal testosterone (TT) as a treatment for SSRI/SNRI-emergent loss of libido. METHODS This was a double-blind, randomized, placebo-controlled study. Forty-four women, aged 35-55 years, on a stable dose of SSRI or SNRI with treatment-emergent loss of libido were randomly allocated to treatment with a TT patch delivering 300 mcg of testosterone/day or an identical placebo patch (Pl) for 12 weeks. MAIN OUTCOME MEASURES The primary outcome measure was the change in the Sabbatsberg Sexual Self-rating Scale (SSS) total score over 12 weeks. The 4-week frequency of Satisfactory Sexual Events (SSEs) and the Female Sexual Distress Scale-Revised (FSDS-R) were also measured. RESULTS At baseline, there were no differences between the treatment groups. At week 12, the change in the SSS score did not differ between the two groups. The increase in the 4-week frequency of SSEs was significantly greater for the TT group than for the Pl group (an increase of 2.3 events vs. 0.1, P = 0.02). The between-group difference in the change in the FSDS-R score approached statistical significance (P = 0.06). The mean total serum testosterone level at 12 weeks in the TT group was 2.1 nmol/L. No women withdrew because of androgenic adverse events. CONCLUSIONS TT therapy resulted in a significant increase in the number of SSEs compared with Pl therapy in women with SSRI/SNRI-emergent loss of libido. The lack of improvement in the SSS total score may reflect lack of sensitivity of this instrument for the measurement of change in sexual function. This provides the first evidence that TT therapy may be a treatment option for women with SSRI/SNRI-emergent loss of libido who need to remain on their antidepressant therapy.

Transdermal testosterone improves verbal learning and memory in postmenopausal women not on oestrogen therapy

The aim of this study was to examine the effects of testosterone on verbal learning and memory in postmenopausal women.

Continuous-combined oral estradiol/drospirenone has no detrimental effect on cognitive performance and improves estrogen deficiency symptoms in early postmenopausal women: a randomized placebo-controlled trial

Objective This study aimed to explore the effects of continuous-combined estradiol 1 mg/drospirenone 2 mg (E2D) on cognitive performance in healthy, recently postmenopausal women. Methods A 6-month randomized, double-blind, placebo-controlled study was carried out in a university research center. Participants were 23 healthy postmenopausal women aged 49 to 55 years. Cognitive performance was assessed with a computerized cognitive battery administered to all participants on 0, 12, and 26 weeks. Functional magnetic resonance imaging was performed on 13 participants before and after treatment using tasks of verbal fluency and mental rotation. Results E2D was not associated with an overall effect on cognitive performance. Functional magnetic resonance imaging results showed no difference between the groups for verbal fluency or mental rotation task performance at baseline. The mental rotation task was associated with increased blood oxygen level–dependent signalling in the placebo group in both occipital lobes and in the left superior parietal lobe after 26 weeks (P < 0.05), with no changes over time seen in the treatment group. The total menopausal symptom and sexual function domain scores improved after treatment in women randomized to E2D compared with the placebo group (both P < 0.05). Similarly, systolic blood pressure, weight, and body mass index were significantly lower in women randomized to E2D at 26 weeks (P < 0.05). Conclusions E2D has no detrimental effect on cognitive performance in early postmenopausal women. E2D significantly improves menopausal symptoms, sexual function, systolic blood pressure, and weight.

Drugs for the treatment of menopausal symptoms

Importance of the field: Over the last decade, the management of the menopause has attracted extensive public and professional debate and has become one of the most controversial areas in clinical practice. Areas covered in this review: This review provides an overview of the field, primarily from a clinical practice perspective. However, as we have incorporated in this ‘big-picture’ snapshot of the field both conventional and complementary approaches to managing the menopause, it is not an exhaustive review of the literature. What the reader will gain: By reviewing menopausal management from the perspective of practicing clinicians, we hope readers will gain insight into decision making processes appropriate for dealing with symptomatic women. Take home message: Although most women do not require pharmacotherapy for menopausal symptoms, many are severely affected by estrogen deficiency at and beyond menopause and, for such women, hormone therapy is important if they are to retain an acceptable quality of life. This article considers the drug treatment of the symptomatic postmenopausal woman and the safety issues related to these medications.

Metformin for overweight women at midlife: a double-blind, randomized, controlled trial.

Abstract Aim This study was undertaken to determine whether metformin would ameliorate insulin resistance, reduce weight and waist circumference and improve lipids in obese, but not morbidly obese, euglycemic women. Methods Obese women (body mass index (BMI) ≥ 30 and < 40 kg/m2 and/or waist circumference > 88 cm), aged 35–65 were randomized (1:1) to metformin 850 mg or identical placebo, twice daily for 26 weeks. The primary outcome was the change in insulin resistance determined by the homeostasis model of assessment (HOMA-IR). Secondary outcomes included fasting insulin, glucose, weight, waist circumference and BMI. Results Of the 125 women screened, 117 enrolled and 100 women, mean age 53 years, were included in the primary intention-to-treat analysis. Metformin resulted in statistically significant between-group difference in the change in HOMA-IR (change in median − 0.04 vs. placebo + 0.1, p = 0.018) and BMI (mean change − 1.00 kg/m2; 95% confidence interval (CI) 1.37 to − 0.62 vs. placebo mean change 0.00; 95% CI − 0.29 to 0.28, p < 0.001). Statistically significant reductions in HbA1c (p = 0.008) and fasting insulin (p = 0.03) and a borderline decrease in high density lipoprotein cholesterol (p = 0.07) were also observed for metformin, compared with placebo. No effects were seen for waist circumference, fasting glucose or other lipids. Conclusion Treatment of euglycemic, obese, middle-aged women with metformin 1700 mg per day reduced insulin resistance and weight compared with placebo. Further studies are needed to determine whether the use of metformin will prevent the progression of insulin resistance to type 2 diabetes mellitus in obese women.

Intra-vaginal testosterone improves sexual satisfaction and vaginal symptoms associated with aromatase inhibitors.

Context Intravaginal testosterone (IVT) is a potential treatment of vulvovaginal atrophy (VVA) associated with aromatase inhibitor (AI) use. Objective To investigate the effects of IVT on sexual satisfaction, vaginal symptoms, and urinary incontinence (UI) associated with AI use. Design Double-blind, randomized, placebo-controlled trial. Setting Academic clinical research center. Participants Postmenopausal women taking an AI with VVA symptoms. Intervention IVT cream (300 μg per dose) or identical placebo, self-administered daily for 2 weeks and then thrice weekly for 24 weeks. Main Outcomes and Measures The primary outcome was the change in the sexual satisfaction score on the Female Sexual Function Index (FSFI). Secondary outcomes included vaginal symptoms and responses to the Profile of Female Sexual Function, the Female Sexual Distress Scale-Revised (FSDS-R), and the Questionnaire for UI Diagnosis. Serum sex steroids were measured. Results A total of 44 women were randomly assigned and 37 provided evaluable data, (mean age 56.4 years, SD 8.8 years). At 26 weeks, the mean between-group difference in the baseline-adjusted change in FSFI satisfaction scores was significantly greater for the IVT group than the placebo group (mean difference 0.73 units; 95% CI, 0.02 to 1.43; P = 0.043). IVT cream resulted in significant improvements, compared with placebo, in FSDS-R scores (P = 0.02), sexual concerns (P < 0.001), sexual responsiveness (P < 0.001), vaginal dryness (P = 0.009), and dyspareunia (P = 0.014). Serum sex steroid levels did not change. Few women had UI symptoms, with no treatment effect. Conclusion IVT significantly improved sexual satisfaction and reduced dyspareunia in postmenopausal women on AI therapy. The low reporting of UI among women on AI therapy merits further investigation.

Mothers’ Experiences of a Women’s Health and Empowerment Program for Mothers of a Child with a Disability

Substantial research identifies mothers of children with a disability as a vulnerable group with compromised health outcomes and restrictions for their own self-care, social, economic and leisure participation. This study investigated perceptions and experiences of mothers following attendance at health education and empowerment workshops (Healthy Mothers Healthy Families). Mixed methods evaluated mothers’ experiences. A pragmatic qualitative approach was applied to data analysis of interviews with mothers (N = 19). Four themes emerged: Changes for me; Changes for my family; Wisdom gained; and Worthwhile workshops. Mothers described feeling validated and empowered in this facilitated group intervention and valued education about women’s health, tailored research findings, individualised goal setting, time to learn and share with other mothers, and the workshop environment.