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Menopause clinical trials

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NCT ID: NCT03461380 Completed - Menopause Clinical Trials

Effect of Menopause Relief EP-40 in Women With Menopausal Symptoms

Start date: October 1, 2018
Phase: Phase 2
Study type: Interventional

This study compares the efficacy of a fixed combination of black cohosh (EP-40) and Rhodiola rosea (EPR-7) with low (6.5 mg) and high doses (500 mg) of a standardized black cohosh extract only in adult woman with menopausal complaints.

NCT ID: NCT03408678 Completed - Clinical trials for Diabetes Mellitus, Type 2

Determinants of Type 2 Diabetes Risk in Middle-aged Black South African Men and Women

Start date: January 23, 2017
Phase:
Study type: Observational

There is little known about menopause in African women, whose phenotype differs to Caucasian women, and no data is available on middle-aged black South African men. Accordingly, the study aims to examine the changes in sex hormone levels over the menopausal transition in women, and in men of the same age, and explore the effects on body fat distribution and insulin sensitivity and secretion, dissecting the specific roles of glucocorticoids and inflammatory mediators, in the context of HIV. Research questions and hypotheses: 1. Does the decrease in sex hormones that occur with ageing increase circulating cortisol and/or inflammatory markers, and directly and/or indirectly via increases in central fat mass, decrease insulin sensitivity in middle-aged black South African men and women? Hypothesis: The mechanism underlying the decrease in insulin sensitivity (outcome) associated with the decline in sex hormones (exposure) that occurs with ageing is mediated via an increase in centralization of body fat (mediator), which is due to an increase in inflammation and cortisol production. 2. How does HIV alter the relationship between sex hormones, inflammation and cortisol levels, and subsequently body fat distribution and insulin sensitivity? Hypothesis: HIV infection will exacerbate the effects of the decline in sex hormones with ageing, leading to further increases in inflammation and cortisol production, and a consequent increase in the centralization of body fat and decrease in insulin sensitivity. 3. Does adipose tissue glucocorticoid and inflammatory gene expression differ between pre- and post-menopausal women, with and without HIV, and how do these relate to body fat distribution and insulin sensitivity and secretion? Hypothesis: Adipose tissue estrogen receptor beta (ERβ), 11-beta hydroxysteroid dehydrogenase type 1 (11HSD1) activity and pro-inflammatory markers will be higher in post- compared to pre-menopausal women, which will be exacerbated by HIV infection. This will be associated with down-regulation of subcutaneous adipose tissue (SAT) adipogenic genes, increased visceral adipose tissue (VAT), a decrease in insulin sensitivity and secretion, and consequently an increased risk for type 2 diabetes (T2D).

NCT ID: NCT03370991 Completed - Hypertension Clinical Trials

Blueberries for Improving Vascular Endothelial Function in Postmenopausal Women With Elevated Blood Pressure

Start date: December 2, 2017
Phase: N/A
Study type: Interventional

Postmenopausal women are at an increased risk of developing cardiovascular disease (CVD) largely due to accelerated aging-related modifications to vascular health following menopause. The vascular endothelium is responsible for producing chemicals that are essential for proper vasodilation and blood flow and therefore is involved in maintaining normal blood pressure. A major modification that occurs during aging and is accelerated during menopause is termed vascular endothelial dysfunction which is characterized by impaired endothelium-dependent dilation. This can lead to increased blood pressure, atherosclerosis, and increased risk of CVD and death. Nitric oxide (NO) is a chemical produced by the endothelium and is essential for normal endothelial function and cardiovascular health. Vascular endothelial dysfunction is primarily caused by reduced NO bioavailability secondary to excessive oxidative stress. Approximately 3/4 of postmenopausal women have elevated blood pressure or hypertension which further worsens endothelial function and increases CVD risk through increased oxidative stress and inflammation. Blueberries are rich in phytochemicals including anthocyanins, phenolic acids, and pterostilbene. These phytochemicals and their metabolites are known to attenuate oxidative stress and inflammation. The overall goal of the current study is to assess the efficacy of blueberries to improve vascular endothelial dysfunction in this high-risk population and to gain insight into underlying mechanisms. 58 postmenopausal women with elevated blood pressure and stage 1-HTN will be asked to consume 22 grams freeze-dried blueberry powder or placebo powder per day for 12 weeks. Vascular endothelial function will be assessed at baseline and 12 weeks. Measurements indicative of vascular nitric oxide production, oxidative stress, inflammation, cardiometabolic health, cognitive function, and blueberry phytochemical metabolism will be measured at baseline and 12 weeks. Blood pressure will be assessed at baseline and 4, 8, and 12 weeks.

NCT ID: NCT03363997 Completed - Menopause Clinical Trials

Pharmacokinetics and Pharmacodynamics of 3 Dosages of Estriol After Continuous Vaginal Administration for 21 Days

Start date: September 23, 2016
Phase: Phase 1
Study type: Interventional

This clinical trial evaluated the pharmacokinetics and pharmacodynamics of estriol in healthy post-menopausal women after the application of one vaginal ring containing one of three different dosages of estriol (100 mg (Test 1), 300 mg (Test 2) or 600 mg (Test 3)) with continuous delivery (0.125, 0.250 or 0.500 mg/day) for 21 days. And also, characterized its safety and tolerability.

NCT ID: NCT03336437 Completed - Menopause Clinical Trials

Estrogen and the Urogenital Microbiome in GSM

Start date: February 1, 2018
Phase: Phase 4
Study type: Interventional

This is a study of how local estrogen treatment affects the microbiome of the vagina and bladder in postmenopausal women experiencing symptoms as part of "Genitourinary Syndrome of Menopause." The goal is to understand more about the underlying microbial changes occurring in menopause and whether these are reversible with estrogen.

NCT ID: NCT03331536 Completed - Osteoporosis Clinical Trials

Skeletal Health in Bariatric Surgery Patients

Start date: March 22, 2018
Phase:
Study type: Observational

The investigators propose a prospective cohort trial that will help to understand the impact of Roux-en-Y gastric bypass (RYGB) and sleeve gastrectomy (SG) in pre- and post-menopausal female bariatric patients.

NCT ID: NCT03313739 Completed - Menopause Clinical Trials

An Educational Intervention Based on the Teach Back Method on Self-care Practice Among Menopausal Women

Start date: July 12, 2016
Phase: N/A
Study type: Interventional

This study was conducted to assess the effects of an educational program that had designed based on teach back method in order to improve self-care competency among menopausal women.

NCT ID: NCT03311880 Completed - Menopause Clinical Trials

Evaluating a Cognitive Remediation Intervention for Women During the Menopausal Transition

Start date: January 17, 2018
Phase: N/A
Study type: Interventional

The goal in this study is to evaluate the effectiveness of a cognitive remediation program that was designed specifically to address the concerns related to cognitive difficulties that are often reported among women in the menopausal transition. This cognitive remediation program has been created to provide our clients with an opportunity to learn more about the relation between menopause and cognitive function, to learn new strategies to enhance thinking skills (e.g., memory, attention) and to hear about lifestyle changes that are known to have a beneficial effect on mental functioning.

NCT ID: NCT03281655 Completed - Menopause Clinical Trials

Visnadine, Prenylflavonoids and Bovine Colostrum to Treat Vulvovaginal Atrophy in Postmenopausal Women

Start date: December 2016
Phase: Phase 2
Study type: Interventional

The effects of a new vaginal cream containing visnadine (0.30%), prenylflavonoids (0.10%) and bovine colostrum (1%) will be evaluated in post-menopausal sexually active women affected by vulvovaginal atrophy (VVA). In a prospective cohort study, post-menopausal women affected by VVA will be enrolled. All women will undergo vaginal health index score (VHIS) evaluation and will complete the female sexual function index (FSFI) questionnaire at baseline evaluation (T0) and following 15 days of vaginal cream treatment with one application per day (T1). All the side effects will be recorded and an independent data safety and monitoring committee will evaluate the results of the study.

NCT ID: NCT03254251 Completed - Hypertension Clinical Trials

The Effects of Stair Climbing on Arterial Stiffness, Blood Pressure and Leg Strength in Stage-1 Postmenopausal Women

Start date: January 9, 2017
Phase: N/A
Study type: Interventional

We used a parallel experimental design. Following an initial screening and familiarization session of study tests and procedures, eligible postmenopausal women were randomly assigned to a stair climbing (SC) group or non-exercising control group. SC training session was progressive program, and was performed 4 days a week for 12 weeks. Measurements were collected at baseline and after 12 weeks during the same time of day (±1 hour) in the morning following an overnight fast and abstinence from caffeinated drinks, alcohol, and between 48 and 72 hours after the last exercise session.