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Menopause clinical trials

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NCT ID: NCT00860886 Completed - Menopause Clinical Trials

Premenopausal Hormone Concentrations in a Population of Women at Very Low Risk of Breast Cancer

Start date: March 2, 2009
Phase:
Study type: Observational

Background: - Incidence of breast cancer is very low in Mongolia (6.6/100,000), especially in rural areas. Over the past 15 years, there has been considerable economic growth in Mongolia, resulting in migration to urban centers such as the capital, Ulaanbaatar, from areas with nomadic or semi-nomadic lifestyles. This recent migration offers an opportunity to study the endocrine profiles of premenopausal women as they acculturate to a more Western lifestyle. Objectives: - To obtain new data on premenopausal endocrine and growth factor concentrations to assess possible variations by migration status within Ulaanbaatar; that is, to compare women who have been living in Ulaanbaatar for the longest period of time with those who have recently moved to Ulaanbaatar. - To compare data from Mongolia with data from the United States (and possibly China), where women are at higher risk of breast cancer. Eligibility: - A sample of 375 premenopausal women will be drawn from a larger sample of mothers whose children are participating in a study conducted by Harvard Medical School. Only mothers of girls will be included in this cross-sectional study. Women ages 25 44 years who are not pregnant or breastfeeding are eligible. Design: - A total of 30 ml (three 10 ml samples) of whole blood will be collected. Women will be asked to provide a spot urine sample. These samples will be sent periodically to the NCI biorespository during the course of the study for testing. A portion of a sample for each participant will be kept in Ulaanbaatar in case of problems in delivery to the United States. - The following hormones will be evaluated: testosterone, androstenedione, dehydroepiandrosterone (DHEA), DHEA-sulfate, estrone, estradiol, estriol, progesterone, prolactin, placental lactogen, IGF-1 and IGFBP-3, VEGF, soluble endoglin, and possibly other angiogenic proteins. - Socioeconomic status and medical and lifestyle information will be assessed by questionnaire, including ethnicity, occupation, education, and migration status (e.g., whether she moved from a rural area and time since migration). Breast cancer risk factors such as age at first pregnancy, age at first menstruation, gravidity (total number of pregnancies), parity (total number of childbirths), smoking status, alcohol use, and dietary intake will also be determined. (These questionnaires will have been pilot tested and revised before the start of this study.) The Global Physical Activity Questionnaire, developed by the World Health Organization, will assess physical activity. - Mean and median premenopausal hormone concentrations of previously collected blood samples from women in the United States who are at high breast cancer risk will be compared with the Mongolian samples. In addition, Chinese data will be compared if available.

NCT ID: NCT00859703 Completed - Breast Cancer Clinical Trials

Study to Assess Efficacy of Risedronate in Preventing Bone Loss in Postmenopausal Women Treated for Breast Cancer

RISAROS
Start date: November 2009
Phase: Phase 3
Study type: Interventional

Aromatase inhibitor therapy is in France the adjuvant reference treatment for postmenopausal women with early-stage breast cancer. This treatment induces bone loss and a higher risk of fractures. This study aimed to document the effect of bisphosphonate therapy in preventing bone loss and osteoporotic fractures in postmenopausal women with aromatase inhibitor treatment for breast cancer

NCT ID: NCT00808132 Completed - Osteoporosis Clinical Trials

Study Evaluating The Effects Of Bazedoxifene/Conjugated Estrogens On Endometrial Safety And Postmenopausal Osteoporosis

Start date: January 2009
Phase: Phase 3
Study type: Interventional

The purpose of this research study is to evaluate the safety and effectiveness of this investigational drug for the treatment of menopausal symptoms while protecting the endometrium (uterine lining) and preventing postmenopausal osteoporosis. Subject participation will last approximately 14.5 months.

NCT ID: NCT00799734 Completed - Menopause Clinical Trials

Chinese Medicine Therapy on Menopausal Symptoms

Start date: April 2009
Phase: N/A
Study type: Interventional

The objective of this study is to evaluate whether a Chinese medicine formula (Erxian Decoction,EXD) is effective in alleviating menopausal symptoms, improving sex hormone profile and bone turn-over.

NCT ID: NCT00794690 Completed - Menopause Clinical Trials

Safety Study of Black Cohosh Use by Postmenopausal Women on the Liver

CR-LIVER
Start date: January 2008
Phase: N/A
Study type: Interventional

Black Cohosh extract is a form of phytoestrogen (estrogen of plant origin) that is effective in controlling bothersome hot flushes, while avoiding the dangers of using hormones. Recent case reports pointed to potential toxicity of black cohosh on the liver. The investigators are trying to verify or refute such allegations.

NCT ID: NCT00775242 Completed - Menopause Clinical Trials

Efficacy and Safety of Estradiol and Progesterone Microspheres for the Treatment of Climacteric Symptoms.

Start date: April 2007
Phase: Phase 2/Phase 3
Study type: Interventional

During menopause a woman's body slowly produces less of the hormones estrogen and progesterone. Lower hormone levels in menopause may lead to hot flashes, vaginal dryness and osteoporosis. To help with these problems, women are often given estrogen or estrogen with progestin. The purpose of this study is to assess and compare the efficacy and safety of three doses of estradiol and progesterone for the treatment of the climacteric symptoms

NCT ID: NCT00697463 Completed - Osteoporosis Clinical Trials

Forteo for the Treatment of Unexplained Osteoporosis in Premenopausal Women

IOPForteo
Start date: August 20, 2008
Phase: Phase 2/Phase 3
Study type: Interventional

Idiopathic osteoporosis (IOP) is an uncommon disorder in which otherwise healthy young individuals sustain one or more low-trauma fractures. Teriparatide [PTH(1-34)], which is FDA approved for treatment of osteoporosis in men and postmenopausal women, works by stimulating bone formation. The investigators hypothesize that teriparatide will significantly increase bone density (BMD) and improve bone structure in premenopausal women with IOP.

NCT ID: NCT00630435 Completed - Menopause Clinical Trials

Study Comparing 3 New Formulations of Premarin® 0.625 mg/MPA 2.5 mg With a Reference Formulation

Start date: February 2008
Phase: Phase 1
Study type: Interventional

The purpose of this trial is to determine the equivalence of 3 new formulations of a Premarin®/medroxyprogesterone acetate (MPA) combination tablet to the currently marketed dosage form (Prempro® [TM]). This study will be performed in healthy postmenopausal women. Each subject will participate in the study for approximately 14 weeks, including a screening evaluation within 3 weeks before the study, and four, 6-day, 5-night inpatient periods with at least a 21-day washout interval between each dose administration.

NCT ID: NCT00626769 Completed - Menopause Clinical Trials

Third Year Evaluation on Genistein Efficacy and Safety

Start date: July 2005
Phase: Phase 2/Phase 3
Study type: Observational

BACKGROUND: Recent evidences showed that the phytoestrogen genistein positively affects bone metabolism with no clinically significant adverse effects in a cohort of osteopenic, postmenopausal women. However, there is still a knowledge gap regarding the long-term safety of genistein on the breast, the uterus, the thyroid gland and its efficacy in postmenopausal women. OBJECTIVE: To assess the safety profile of genistein on mammary and thyroid glands and endometrium and cardiovascular apparatus and its effects on bone metabolism after a 3-year therapy with pure, standardized genistein (54 mg/day).

NCT ID: NCT00626340 Completed - Depression Clinical Trials

Brain Imaging Study in Menopausal Women With and Without Major Depressive Disorder

Start date: July 1999
Phase: Phase 4
Study type: Interventional

The purpose this study is to measure cortical gama-aminobutyric acid levels (GABA) levels in menopausal women with major depressive disorder and healthy subjects using nuclear magnetic resonance spectroscopy (MRS). Measurements will be compared in 1) menopausal healthy subjects before and after estrogen replacement, and after fourteen days of medroxyprogesterone administration; and 2) in depressed menopausal subjects before and after treatment of their depression with antidepressant alone, estrogen alone or antidepressant plus estrogen. Cortical GABA levels will be correlated with plasma GABA and neurosteroid levels. Neurosteroids to be measured include progesterone, allopregnanolone, pregnenolone, and pregnenolone sulfate.