Treatment Trials

581 Clinical Trials for Various Conditions

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RECRUITING
A Study to Investigate Safety, Tolerability and Pharmacokinetics of LAE102 in Postmenopausal Women
Description

The purpose of the study is to evaluate the safety, tolerability and pharmacokinetics (PK) of LAE102 in healthy postmenopausal women

RECRUITING
Protein and Exercise for Postmenopausal Women's Wellbeing
Description

The goal of this clinical trial is to learn if consuming a higher protein diet that includes one serving of beef each day, in combination with resistance exercise, improves wellbeing in postmenopausal women. It will also tell us about how higher protein intake changes body composition and blood values related to health. The main questions it aims to answer are: * Does higher protein intake combined with resistance training improve mood and sleep in postmenopausal women? * What other health benefits to postmenopausal women experience when the follow a higher protein diet and participate in resistance exercise? Researchers will compare three groups 1) postmenopausal women living their daily lives as usual, 2) postmenopausal women consuming a higher protein diet, and 2) postmenopausal women consuming a higher protein diet and participating in resistance training. Participants will: * Consume a higher protein diet for 16 weeks * Participate in an at-home resistance training for 16 weeks * Keep a diary of their food intake, sleep habits, and mood * Have health assessments every 4 weeks

Conditions
RECRUITING
Inspiratory Muscle Training in Postmenopausal Women
Description

This study is being conducted by the Department of Kinesiology within the School of Public Health at Indiana University Bloomington. The purpose of this study is to better understand how inspiratory muscle strength training affects cardiovascular health and mood disturbance in postmenopausal women.

RECRUITING
Short-term Circuit Training on Muscle Mass and Quality of Life in Sedentary Postmenopausal Women
Description

The purpose of this graduate student research study is to provide healthcare professionals with evidence of the potential of circuit strength training in improving the physical and psychosocial well-being of postmenopausal women.

Conditions
COMPLETED
Remote Mindfulness-Based Physical Activity Intervention for Postmenopausal Women
Description

The purpose of this study is to figure out if postmenopausal women find a mindfulness audio recording acceptable for use along with physical activity, and to find out if this tool is helpful in increasing daily physical activity.

Conditions
COMPLETED
Study to Assess the Effect of Co-Administration of AZD9833 on the Pharmacokinetics of Midazolam, of Omeprazole, of Celecoxib and of Dabigatran Etexilate in Healthy Postmenopausal Female Volunteers
Description

This study will be a fixed sequence drug-drug interaction study in healthy postmenopausal females, conducted at multiple study sites

TERMINATED
Vaginal Dehydroepiandrosterone (DHEA) in Postmenopausal Breast Cancer Survivors on Aromatase Inhibitors
Description

The purpose of this research is to gather information on the safety and effectiveness of Intrarosa®, also known as Dehydroepiandrosterone (DHEA), and prasterone. By doing this study, the investigators hope to learn if Intrarosa® can improve vaginal discomfort. Participants will be assigned to one of two groups. One group will use Intrarosa® once a day. The other group will use Replens™ two times a week.

COMPLETED
Markers of Atherosclerosis in Overweight, Postmenopausal Women Following Daily Watermelon Consumption
Description

The primary purpose of this study is to determine the effectiveness of six weeks of watermelon puree supplementation, compared to control (no treatment), on blood antioxidant capacity, inflammation markers in the blood, biomarkers of metabolism in the blood, and cardiovascular disease markers in the blood, and biomarkers in the blood related to watermelon ingestion in overweight post-menopausal women. The secondary purpose is to compare body composition and body mass between the watermelon supplement group and the control group.

COMPLETED
12 Weeks of Resistance Band Exercise Impacts on Metabolic Syndrome Progression in Postmenopausal Women
Description

The purpose of this study was to examine the impacts of a 12-week resistance band exercise program on insulin resistance, blood lipid profiles, body composition, and blood pressure in postmenopausal women with obesity. Thirty-six postmenopausal women participated in this study. Participants were randomly allocated into the resistance band training group (EX, n = 18) or the control group (CON, n = 18). The EX group performed a resistance band exercise training program 60 minutes per day, 3 times per week, for 12 weeks. The CON group did not participate in any exercise, dietary, or behavioral intervention. Blood glucose, insulin, homeostatic model of insulin resistance (HOMA-IR), blood lipids, blood pressure, and body composition were measured before and after 12 weeks of EX or CON.

COMPLETED
12 Weeks of Resistance Band Exercise Impacts on Adiposity, Hormones, and Blood Pressure in Postmenopausal Women
Description

The purpose of this study was to examine the impacts of a 12-week resistance band exercise program on body composition, aging-related hormones, and blood pressure in postmenopausal women with stage 1 hypertension. Twenty postmenopausal women with hypertension participated in this study. Participants were randomly allocated into the resistance band training group (EX, n = 10) or the control group (CON, n = 10). The EX group performed a resistance band exercise training program at jump rope training program at 40-70% of their heart rate reserve (HRR) 5 days/week for 12 weeks (sessions 60 minutes in duration). The CON group did not participate in any exercise, dietary, or behavioral intervention. Body composition, aging-related hormones (growth hormone, insulin-like growth factor 1, dehydroepiandrosterone, and estradiol), and blood pressure were measured before and after the 12-weeks study.

COMPLETED
The Interaction Between Diabetes and Estradiol on Human Brain Metabolism in Postmenopausal Women
Description

The primary aim of this study is to test whether type 2 diabetes interacts with estradiol on brain metabolism in vivo in humans. This will be accomplished by imaging brain metabolism using positron emission tomography before and after short-term administration of transdermal 17β-estradiol in 10 postmenopausal women with diabetes and 10 non-diabetic postmenopausal women.

COMPLETED
Study to Assess the Safety and Efficacy of Ribociclib (LEE011) in Combination With Letrozole for the Treatment of Men and Pre/Postmenopausal Women With HR+ HER2- aBC
Description

The purpose of this study is to collect additional safety and efficacy data for the combination of ribociclib + letrozole in men and pre/postmenopausal women with HR+HER2- advanced breast cancer and no prior hormonal treatment for advanced disease..

Conditions
COMPLETED
TXV13-01 Estradiol Vaginal Softgel Capsules in Treating Postmenopausal Women With Symptoms of Vulvar and Vaginal Atrophy
Description

The study was designed to evaluate the efficacy and safety of TX-12-004-HR 10 μg in treating moderate to severe symptoms of vaginal atrophy associated with menopause after 14 days of treatment, and to estimate the effect size and variability of vulvovaginal atrophy endpoints. In addition, the systemic exposure to estradiol from single and multiple doses of TX-12-004-HR was to be investigated.

COMPLETED
Study Assessing the Efficacy and Safety of Alpelisib Plus Fulvestrant in Men and Postmenopausal Women With Advanced Breast Cancer Which Progressed on or After Aromatase Inhibitor Treatment.
Description

To determine whether treatment with alpelisib plus fulvestrant prolonged progression-free survival (PFS) compared to fulvestrant and placebo in men and postmenopausal women with hormone receptor positive (HR+), human epidermal growth factor receptor-2 (HER2)-negative advanced breast cancer, who received prior treatment with an aromatase Inhibitor (AI) either as (neo)adjuvant or for advanced disease.

Conditions
COMPLETED
Study of Efficacy and Safety of LEE011 in Men and Postmenopausal Women With Advanced Breast Cancer.
Description

The main aim of this study was to evaluate the efficacy and safety of adding ribociclib to fulvestrant in men and postmenopausal women with hormone receptor positive (HR+), HER2-negative advanced breast cancer.

COMPLETED
Estradiol Vaginal Softgel Capsules in Treating Symptoms of Vulvar and Vaginal Atrophy in Postmenopausal Women
Description

This study will assess the safety and efficacy of a new formulation of vaginal estradiol for the treatment of symptoms of vulvar and vaginal atrophy in postmenopausal women.

TERMINATED
Neoadj ph 2 AI Plus Everolimus in Postmenopausal Women w/ ER Pos/HER2 Neg, Low Risk Score
Description

The purpose of this study is to see whether adding everolimus to hormone treatment before breast surgery will increase the chances of shrinking the breast cancer in those patients with hormone-responsive breast cancer and a lower Oncotype DX® Recurrence Score ( 25 or less), compared to prior experience with hormone therapy alone. Everolimus is a drug currently approved for use by the United States Food and Drug administration (FDA) for the treatment of patients with advanced or metastatic kidney or breast cancer. Everolimus is considered investigational for non-metastatic breast cancer patients.

Conditions
COMPLETED
Exercise Intervention in Preventing Breast Cancer Recurrence in Postmenopausal Breast Cancer Survivors
Description

This randomized pilot trial studies how well an exercise intervention works in preventing breast cancer from coming back in postmenopausal breast cancer survivors. Regular exercise may be able to train the body to repair deoxyribonucleic acid (DNA) more efficiently and to respond to inflammation more proficiently, helping to prevent primary and recurrent breast cancer.

COMPLETED
A Double-blind Study to Assess the Efficacy and Safety of Denosumab Produced by Two Different Processes in Postmenopausal Women With Osteoporosis
Description

This study will compare the effect of denosumab produced by two different manufacturing processes on bone mineral density at the lumbar spine in postmenopausal women with osteoporosis.

COMPLETED
Vaginal Estrogen for the Prevention of Recurrent Urinary Tract Infection in Postmenopausal Women
Description

The investigators would like to know if the use of vaginally applied estrogen can prevent the problem of repeated urinary tract infections (UTI) in women who have gone through menopause. The investigators will use two forms of vaginal estrogen that are available by prescription (a ring and a cream) and compare their efficacy to that of a placebo (without any active ingredient). The investigators are going to look at if the vaginal estrogen can prevent UTIs altogether and also the number of UTIs each group experiences over a 6 month period. After 6 months, all subjects will receive vaginal estrogen and the women on the non-active treatment will be able to choose whether they would like to use either the estrogen ring or cream. The investigators will then be able to compare the number of UTIs on and off active vaginal estrogen treatment within those subjects who started on the placebo. The investigators are also going to look at quality of life before and during treatment using questionnaires and whether subjects stop using the treatments or do not use them as directed (compliance).

COMPLETED
Study of Efficacy and Safety of LEE011 in Postmenopausal Women With Advanced Breast Cancer
Description

The primary purpose of this study was to assess the efficacy of ribociclib, as measured by progression free survival (PFS), in postmenopausal women with hormone receptor positive (HR+), human epidermal growth factor receptor 2 negative (HER2-) advanced breast cancer who received no prior treatment for advanced disease.

COMPLETED
Communication & Peer Support Effects on Physical Activity in Overweight Postmenopausal Women
Description

This randomized clinical trial studies the feasibility of tailored physical activity intervention that is administered using Interactive Voice Response technology and cell phones. Interactive voice response and health coach support may motivate overweight postmenopausal women to stick to their exercise regimen to reduce the risk of getting breast cancer.

COMPLETED
Study to Evaluate Safety and Efficacy of WC3011 (Estradiol Vaginal Cream) in Postmenopausal Women With Dyspareunia
Description

The purpose of the study is to determine if WC3011 is safe and effective in treating the symptom of painful intercourse secondary to vulvovaginal atrophy as measured by participant self-assessment when compared to vehicle.

COMPLETED
Preoperative Hormone Therapy for Postmenopausal Women With ER+ Clinical Stage T2-4 Tumors
Description

This phase II trial studies how well exemestane before surgery works in treating postmenopausal patients with newly diagnosed estrogen receptor positive stage II-III breast cancer. Estrogen can cause the growth of breast cancer cells. Hormone therapy using exemestane may fight breast cancer by blocking the use of estrogen by the tumor cells.

COMPLETED
Blueberry Consumption Improves Vascular Function and Lowers Blood Pressure in Postmenopausal Women With Pre- and Stage 1-hypertension
Description

Cardiovascular disease (CVD) continues to be the leading cause of death in the U.S. Americans have been more concerned about their blood cholesterol levels and dietary cholesterol intakes rather than their overall cardiovascular health risk factors leading to CVD such as hypertension, vascular dysfunction, inadequate consumption of fruits and vegetables and physical activity. Statistics show that approximately 91% of individuals with CVD have vascular dysfunction which is attributed to endothelial and autonomic dysfunction leading to increased arterial stiffness. The investigators long-term goal is to provide feasible and effective dietary ways for pre- and stage 1- hypertensive individuals to normalize their blood pressure (BP), improve vascular function and thereby reducing their cardiovascular risk and enhancing the quality of life. Blueberries are a rich source of phenolic compounds and these compounds may play an important role in promoting cardiovascular health. Considering the strong possibility that phytochemicals present in blueberry work additively or synergistically, it would be ideal to investigate the cardioprotective effects of blueberry as a whole. The investigators overall objective to bring forth evidence that blueberry consumption will reduce BP and cardiovascular risk factors including endothelial dysfunction, arterial stiffness, and autonomic dysfunction in pre- and stage 1-hypertensive postmenopausal women. The investigators hypothesize that blueberry supplementation will improve vascular function and will lower blood pressure in postmenopausal women with pre-hypertension. The findings of this study will provide a foundation for disseminating feasible, safe approaches for preventing and combating hypertension at its early stage which does not require drug therapy.

Conditions
COMPLETED
A Study of Abiraterone Acetate Plus Prednisone With or Without Exemestane in Postmenopausal Women With Estrogen Receptor-Positive (ER+) Metastatic Breast Cancer Progressing After Letrozole or Anastrozole Therapy
Description

The purpose of this study is to assess the safety and efficacy of oral abiraterone acetate plus oral prednisone and oral abiraterone acetate plus oral prednisone plus oral exemestane, each compared with oral exemestane alone, in postmenopausal women with estrogen receptor-positive (ER+) metastatic (spreading) breast cancer that has relapsed after treatment with letrozole or anastrozole.

COMPLETED
Study to Evaluate the Safety and Efficacy of BA058 (Abaloparatide) for Prevention of Fracture in Postmenopausal Women
Description

The purpose of this study is to determine whether BA058 (abaloparatide), a parathyroid hormone-related peptide, is effective in preventing fractures in postmenopausal women with severe osteoporosis who are at risk of fractures.

COMPLETED
A Pharmacokinetic and Randomized Trial of Neoadjuvant Treatment With Anastrozole Plus AZD0530 in Postmenopausal Patients With Hormone Receptor Positive Breast Cancer
Description

The investigators propose to conduct a Phase I/randomized Phase II study design in order to test the tolerability and efficacy of AZD0530 (also called saracatinib) when used together with anastrozole in therapy for ER+ and/or PR+, postmenopausal breast cancer. The Phase I pharmacokinetic (PK) cohort of the study (cohort A) in postmenopausal women with metastatic breast cancer 2008-2009 showed initial safety,tolerability and good bioavailability of both drugs and determined the doses for use in the ongoing Phase II trial. In the randomized Phase II cohort of the study (cohort B), postmenopausal women with newly diagnosed, previously untreated ER+, HER2 negative breast cancer that is at least 2 cm or more in diameter by clinical exam or radiology will be randomized to either neoadjuvant treatment with anastrozole plus placebo, or anastrozole in combination with AZD0530 (saracatinib). The Phase II cohort will permit extended assays of tolerability, initial estimates of efficacy, and the investigation of molecular predictors of drug efficacy.

Conditions
COMPLETED
Effects of California Walnuts on Vascular Function in Postmenopausal Women
Description

To determine the potential acute cardiovascular benefits of California Walnuts in postmenopausal women of ages 55-70. Primary outcome measures: * Vascular function * Platelet reactivity We hypothesize that the consumption of California walnuts will improve vascular function and platelet reactivity.

COMPLETED
Serum Estradiol Levels In Postmenopausal Women With Breast Cancer Receiving Adjuvant Aromatase Inhibitors and Vaginal Estrogen
Description

The purpose of this study is to see if Vagifem® 10mcg is safe for women who have had breast cancer. Vagifem is an estrogen product. It is a tiny tablet that is inserted into the vagina. It relieves vaginal dryness. Women who have had breast cancer are usually told not to take estrogen. This is because estrogen use can lead to a breast cancer recurrence or a new primary breast cancer. It is unclear if the estrogen in Vagifem is only absorbed in the vagina. It may be absorbed into the blood stream for a short time and may cause a brief rise in your estrogen level. However, there is no clear evidence that this would cause any bad effects in patients with breast cancer. How much, if any, of these topical estrogens are absorbed through the vagina is not known. We also do not know what the impact is of low dose estrogen absorption on breast cancer outcomes. Also, the absorption should decrease as the mucus membranes are restored after estrogen exposure.