View clinical trials related to Menopause.
Filter by:This is a phase II study intended to determine the effect of progesterone 5, 10 and 20 mg tablets compared to progesterone 100 mg capsules on the endometrial thickness of post-menopausal women under hormone therapy with estradiol.
Design: Open-label randomised multicenter international strategic trial of older women on combination antiretroviral therapy (cART) containing tenofovir-emtricitabine (TDF/FTC) with HIV RNA suppression for > 6 months to : 1. Immediate switch of TDF/FTC to tenofovir alafenamide-emtricitabine (TAF/FTC) while continuing the third antiretroviral agent.; 2. Delayed switch; with switch of TDF/FTC to TAF/FTC at 48 weeks while continuing the third agent. Follow up of all subjects to 96 weeks. Subject Population: The anticipated sample size is 128 HIV infected women aged 45-55 years (peri or early post menopause). . Primary endpoint: Percentage change from baseline bone mineral density (BMD) at the lumbar spine at weeks 48 and 96. Secondary Endpoints: BMD change at hip, trabecular bone score, estimated bone strength by high resolution peripheral quantitative computerized tomography (HR-pQCT), muscle quality, geriatric assessment; biomarkers of bone, immune activation and inflammation; HIV viral suppression; safety, lipid and renal function, cardiovascular risk scores at weeks 48 and 96. Expected Outcomes: To determine if a switch from TDF/FTC to TAF?FTC improves BMD to a degree correlating with a decreased risk of fragility fracture in aging HIV infected women. Secondary outcomes will assess bone strength using new imaging modalities, timing of switch, and renal health. This data will be used by health policy makers and providers to determine the proper use of TAF/FTC in the aging HIV population.
As a natural part of the menopause the ovaries production of sex hormones declines. This can lead to different menopausal related symptoms. About two-thirds of postmenopausal women experience hot flushes and 10-20% find these hot flushes very stressful. The aim of this study is to determine and evaluate the efficacy of acupuncture on menopausal symptoms; in particular hot flushes. The study will be a randomized controlled trial. Primary outcome is change in hot flushes. Secondary outcome is change in other menopausal related symptoms.
The main objective of this study is to measure changes in the thickness of the vaginal lining (epithelium + underlying stroma) between 0 and 8 weeks after injection.
This study is being conducted to further understand the elimination pathways, metabolite profile and pharmacokinetic (PK) profile of carbon 14 labelled estetrol ([14C] estetrol).
Duavee is a hormone receptor modulator that has been approved for the treatment of menopausal symptoms in menopausal women. The goal of this 8-week randomized, double blind, placebo controlled pilot study, is to determine whether this medication alleviates menopausal symptoms in women with MS. The investigators will secondarily determine whether addressing menopausal symptoms ameliorates MS symptoms and, on MRIs, is not triggering worsening inflammation.
This is a multi-centered, randomized prospective single blinded clinical trial comparing CO2 fractionated vaginal laser therapy and vaginal estrogen cream therapy in the treatment of vulvovaginal atrophy/GSM.
The 2010 Dietary Guidelines for Americans emphasizes consumption of 4.5 cups of fruits and vegetables daily but the average intake of US adults is only 2.6 cups. This low consumption of fruits and vegetables results in a limited availability of certain nutrients found in these foods such as carotenoids. Dietary carotenoids have health-promoting properties and are known to fight against disease. Although, maintaining adequate vitamin D status is critical for overall skeletal health and the prevention of osteoporosis, vitamin D insufficiency is also widespread in the United States. Eggs, egg yolk in particular, are known to be a good source of lipid and may improve the absorption of carotenoids and vitamin D found in co-consumed vegetables in young and older women. Therefore, the investigators are interested to see if consuming eggs with cooked vegetables will increase carotenoids and vitamin D absorption.
This study will access the safety and efficacy of three doses of estradiol vaginal capsules in postmenopausal women with vulvovaginal atrophy.
The project aimed at identifying neuropsychobiological signatures of pharmacological sex-steroid hormone manipulations in healthy women as a risk model for depression. The study is a double-blind, randomized, placebo-controlled study. Investigators included 63 healthy female volunteers with regular menstrual cycles between 23 and 35 days. Participants were randomized to active Gonadotrophin-Releasing-Hormone agonist (GnRHa) (goserelin 3.6 mg implant) or placebo (saline injection) intervention, which was initiated in the mid follicular phase (i.e. cycle day 22.6 ±2.5). Sixty women completed follow-up and entered the analyses, except for a few drop outs on some domains. The following domains were addressed at baseline and at follow-up (16±3 days post intervention), (which corresponded to the early ovarian suppression phase of the biphasic hormone response to GnRHa): 1) serotonin transporter binding as imaged by 11CDASB Positron Emission Tomography (PET), 2) functional Magnetic Resonance Imaging (fMRI) emotional processing, 3) fMRI reward processing, 3) rating state fMRI (rsfMRI), 4) structural MRI, 5) Neuropsychology, 6) Psychophysiology, 7) Hypothalamus-Pituitary-Adrenal cortex (HPA)-axis dynamics, 8) Peripheral markers of immunoactive cell responses, 9) Epigenetic factors. Psychometrics in terms of self reported mental distress and interview based ratings were monitored across the intervention period to monitor potential symptoms of mental distress and psychopathology. Also ovarian hormone responses, peripheral blood markers, and side effects scores were collected across the intervention period.