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Menopause clinical trials

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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.

NCT ID: NCT01538836 Completed - Obesity Clinical Trials

Calorie Restriction, Protein Supplementation and Metabolic Health

CRPS
Start date: January 2012
Phase: N/A
Study type: Interventional

The purpose of this study is to determine whether consuming additional protein 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: NCT01507454 Completed - Menopause Clinical Trials

Vagifem® Used for the Treatment of Atrophic Vaginitis Due to Oestrogen Deficiency

Start date: April 2006
Phase: N/A
Study type: Observational

This study is conducted in Europe. The aim of this study is to investigate the self-reported impact of Vagifem® (estradiol) treatment on urogenital discomfort in women with atrophic vaginitis due to oestrogen deficiency.

NCT ID: NCT01487304 Completed - Menopause Clinical Trials

Impact of Professional Societies' Recommendations on Practical Use of Hormone Replacement Therapy

Start date: April 2005
Phase: N/A
Study type: Observational

This study is conducted in Europe. The aim of this study is to verify the therapeutic effects of low-dose hormone replacement therapy (HRT) in female patients over adequately long time period in normal clinical practice conditions in the Czech Republic.

NCT ID: NCT01486979 Completed - Menopause Clinical Trials

Pharmacokinetic Assessment of the Absorption of Estradiol in Postmenopausal Women With Atrophic Vaginitis

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

This trial is conducted in Europe. The aim of this trial is to to evaluate the extent of systemic absorption of estradiol during treatment with two different doses of estradiol in postmenopausal women with atrophic vaginitis.

NCT ID: NCT01477632 Completed - Healthy Clinical Trials

Bioavailability of Three Oral Formulations for Hormone Replacement Therapy in Postmenopausal Women

Start date: March 2005
Phase: Phase 1
Study type: Interventional

This trial is conducted in Europe. The aim of this trial is to determine the extent of bioavailability of two low dose estradiol/norethisterone acetate (NETA) preparations with a marketed estradiol/norethisterone acetate (NETA) preparation.

NCT ID: NCT01436513 Completed - Menopause Clinical Trials

A Study To Compare The Amount Of Premarin Components That Is Absorbed Into The Blood Of Japanese Healthy Postmenopausal Women Following Oral Administration Of Two Different Tablets Of Premarin Under Fast and Fed Conditions.

Start date: October 2011
Phase: Phase 1
Study type: Interventional

The purpose of this study is to assess the bioequivalence and food effect for a new Premarin formulation compared with a Premarin reference tablet in Japanese healthy postmenopausal women.

NCT ID: NCT01418209 Completed - Menopause Clinical Trials

MsFLASH-03: Comparative Efficacy of Low-Dose Estradiol and Venlafaxine XR for Treatment of Menopausal Symptoms

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

The primary objective of this study is to determine the efficacy of both low-dose oral (by mouth) 17-ß-estradiol and the non-hormonal drug venlafaxine XR compared to placebo in reducing hot flashes. Included in this objective is the intention to compare venlafaxine XR to estradiol therapy, to provide evidence of the relative efficacy of venlafaxine to what is currently considered the most established but also a controversial therapy. 17-ß-estradiol is a type of estrogen. Venlafaxine XR is the extended release (XR) version of venlafaxine. Venlafaxine XR is an serotonin-norepinephrine reuptake inhibitor (SNRI). A placebo is a substance containing no medication.

NCT ID: NCT01308814 Completed - Depression Clinical Trials

Perimenopausal Estrogen Replacement Therapy Study

PERT
Start date: October 2010
Phase: Phase 2/Phase 3
Study type: Interventional

Study Background and Objectives: In the U.S. the majority of heart disease deaths are in women, not men. Much of the gender disparity in CVD rates relate to the burden of CV risk in women after the menopause. Depression has been associated with an increased risk for CVD morbidity and mortality. Even histories of recurrent depression in euthymic individuals are associated with elevated CV risk. Understanding the depression-CVD link may have particular relevance for women since women experience depression at a rate twice that of men. Substantial convergent evidence indicates that ovarian failure (estrogen deprivation) is one likely mechanism contributing to both CVD and depression in women. The perimenopause, a time associated with a two-fold increase in rates of depression, may provide an ideal opportunity for studying the pathophysiology of CV risk and depression in women. The primary objective of this study is to examine the prophylactic role of estradiol in the development of depressive symptoms and the progression of cardiovascular risk in perimenopausal women with or without histories of depression. The investigators predict that women susceptible to depression will be particularly vulnerable to the acceleration of CVD in the context of the perimenopause and, consequently, will show differentially greater benefit of estradiol treatment during the menopause transition for both indices of CV risk (e.g. inflammation, endothelial function, stress reactivity), as well as depressive symptoms.

NCT ID: NCT01293747 Completed - Menopause Clinical Trials

Pharmacokinetics of Injectable Estradiol and Progesterone Microspheres Suspension

Start date: February 2011
Phase: Phase 1
Study type: Interventional

Phase I pharmacokinetic study Main objective: To determine plasmatic profiles and pharmacokinetic parameters of estradiol and progesterone on each of the formulations studied, after multiple-dose administration Study design: Randomized, controlled, open-label, parallel, pharmacokinetic study Sites: 1 Subjects: 30 postmenopausal women