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Menopause clinical trials

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NCT ID: NCT01778985 Completed - Menopause Clinical Trials

Effect of Preoperative Estrogen Treatment on Connective Tissues of the Pelvic Floor

PET
Start date: December 2012
Phase: Phase 4
Study type: Interventional

This is a study to determine how vaginal estrogen cream given for several weeks before pelvic reconstructive therapy will effect elastic fiber assembly in the muscularis layer of the vaginal wall. Postmenopausal women with at least Stage 2 pelvic organ prolapse will receive either estrogen vaginal cream or placebo cream 6-8 weeks prior to reconstructive surgery. At time of surgery, full thickness biopsies will be obtained from a standardized location at the top of vagina. The investigators will measure the thickness of the vaginal muscularis, elastic fiber number and morphology, and analyze if elastic fiber synthesis or degradation is affected by estrogen therapy. The results will provide important data to support a larger clinical trial to determine if preoperative and maintenance estrogen therapy alter long-term success rates of pelvic reconstructive surgery for pelvic organ prolapse.

NCT ID: NCT01778712 Completed - Obesity Clinical Trials

Developing an Intervention to Prevent Visceral Adipose Tissue Accumulation

Start date: April 2012
Phase: N/A
Study type: Interventional

The aim of this study is to develop an intervention that will produce a sustained improvement in physical activity and chronic stress as a means to slow the menopause-related accumulation of visceral adipose tissue in mid-life women.

NCT ID: NCT01757340 Completed - Obesity Clinical Trials

Calorie Restriction With Leucine Supplementation

Start date: September 2012
Phase: N/A
Study type: Interventional

The purpose of this study is to determine whether consuming additional leucine during calorie restriction induced weight loss has beneficial or harmful effects on multi-organ (liver, muscle, adipose tissue) insulin sensitivity, colonocyte proliferation rates, the gut microbiome, muscle mass and function, and bone mineral density in obese, postmenopausal women.

NCT ID: NCT01730989 Not yet recruiting - Menopause Clinical Trials

Estromineral Serena Plus and Symptomatic Menopause

Start date: November 2012
Phase: N/A
Study type: Interventional

Oestrogen hormone deficiency in menopause leads to symptoms of which hot flushes, night sweats, insomnia and mood changes are the most frequent and, ultimately, worsen the quality of life. The gradual decline of oestrogen from peri-menopause results in altered function of many neurotransmitters, such as dopamine, melatonin and neuropeptides including beta-endorphins, which modulate the function of the hypothalamus and are involved in body thermoregulation. In post-menopause, dopaminergic activity is significantly reduced and stimulus of the D2 receptors is effective in relieving hot flushes and in reducing the accompanying psychological symptoms. The use of hormone replacement therapy, which is generally prescribed in the case of moderate or severe symptoms, is limited due to real contraindications or simply the woman's refusal to take the therapy, despite the presence of symptoms requiring its use. A food supplement, named Estromineral (E), based on natural ingredients such as isoflavones, the absorption of which is increased by the presence of Lactobacillus sporogenes, and Vitamin D3 and calcium, strengthening bone mineralization, has been found to be effective at reducing vasomotor symptoms. To potentiate the effect of E on the most frequent symptoms in menopause, it was considered rational to add the extracts of magnolia, active on psycho-affective symptoms, and chaste tree, acting on both hot flushes and psychological symptoms and a new food supplement was developed: Estromineral Serena Plus (ESP). Estromineral Serena Plus is an association of isoflavones with added Lactobacillus, chaste tree and magnolia, active on menopausal vasomotor symptoms and on psycho-affective symptoms.

NCT ID: NCT01705249 Completed - Healthy Clinical Trials

Bleeding Profile With Continuous Hormone Replacement Therapy of Activelle® in Postmenopausal Women

Start date: August 14, 2001
Phase: Phase 4
Study type: Interventional

This study is conducted in Europe. The aim of this study is to investigate the bleeding profile after switch from Trisekvens® to Activelle® (1.0 mg estradiol / 0.5 mg norethisterone acetate (NETA)).

NCT ID: NCT01679899 Completed - Clinical trials for Type 2 Diabetes Mellitus

Effect of Anti-diabetic Drugs on Bone Metabolism and Glycemic Variability

BoneGlyc
Start date: December 2012
Phase: Phase 4
Study type: Interventional

This is a Monocentric, Prospective, Randomized, Open-label, Comparative, Phase IV Study, to compare the effects of Vildagliptin and Gliclazide MR on Markers of Bone Remodeling, Bone Mineral Density and Glycemic Variability in Postmenopausal Women with Type 2 Diabetes. A total of 38 women with documented Type 2 Diabetes and menopause will be enrolled. The active treatment will include a 50 mg dose of vildagliptin OD twice a day. As comparator, gliclazide MR will be administered at a dose of 60 to 120 mg OD once a day.

NCT ID: NCT01633814 Terminated - Aging Clinical Trials

Hormone Replacement and Neural Cardiovascular Control in Postmenopausal Women

Start date: September 2011
Phase: N/A
Study type: Interventional

Older women have an exaggerated increase in blood pressure during exercise. However, the reasons for this are unclear. It is important to investigate this phenomenon because a greater blood pressure response to exercise has been associated with an increased risk of stroke and mortality in otherwise healthy individuals. A unique aspect of aging in women is the profound change in hormone levels (i.e. estrogen and progesterone) associated with menopause. The influence of changes in estrogen and progesterone levels on the cardiovascular responses to exercise is poorly understood. However, it has been suggested that these hormones might change the responsiveness of the cardiovascular system. Possible mechanisms that could account for these changes are the arterial baroreflex and feedback from the exercising muscle (known as the exercise pressor reflex), both of which are known to powerfully modulate blood pressure during exercise. However, to date, few human studies have thoroughly examined the influence of changes in hormone levels on baroreflex function during exercise or the exercise pressor reflex in older women. As such, the purpose of this research project is to assess baroreflex function and the exercise pressor reflex in older women after transdermal estrogen alone, transdermal estrogen plus progesterone, progesterone alone and placebo.

NCT ID: NCT01596010 Completed - Healthy Clinical Trials

Investigation of 2 Different Oral Formulations of Estradiol and Norethisterone in Healthy Women

Start date: October 2007
Phase: Phase 1
Study type: Interventional

This trial is conducted in Europe. The aim of this trial is to investigate whether a reformulated estradiol/norethisterone acetate (NETA) formulation is bioequivalent to that of Kliogest® (estradiol/norethisterone acetate (NETA) in healthy women.

NCT ID: NCT01543399 Completed - Menopause Clinical Trials

Vascular Effect of Tibolone in the Brachial Artery

TDILA
Start date: March 2012
Phase: N/A
Study type: Interventional

The interruption of the secretion of sex steroids occurring during menopause, causes a change in vascular pattern at various levels. As a result, several agencies have side effects that interfere with women's health. The use of hormone replacement therapy has contributed to the improvement in these effects. In previous studies the investigators showed the effect of sex steroids in premenopausal women in the conjugated equine estrogens, medroxyprogesterone acetate and tibolone in menopausal women, on the central retinal arteries. The aim of this study is to evaluate the effects of Tibolone in Flow-Mediated Dilatation of the brachial artery.

NCT ID: NCT01539317 Completed - Breast Cancer Clinical Trials

Therapy to Prevent Sexual Pain in Breast Cancer Survivors

Start date: December 2011
Phase: Phase 3
Study type: Interventional

The purpose of this protocol is to determine whether pain with sexual intercourse can be reduced in menopausal, breast cancer survivors and to evaluate the effectiveness of a non-hormonal therapy (Lidocaine Liquid) vs. a placebo liquid in reducing pain. The investigators hypothesize that the pain arises in the vulvar vestibule. The investigators predict that the localized use of lidocaine will be more efficacious than use of placebo liquid.