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Postmenopause clinical trials

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NCT ID: NCT00550433 Completed - Postmenopause Clinical Trials

Study Evaluating Bazedoxifene/CE in Postmenopausal Women

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

The purpose of this clinical trial is to study the blood levels of a drug (conjugated estrogens) in the body from one dosage form compared to another. The four formulations of the study drug that eligible participants will receive will contain the same amounts of the same medications. In addition, information will also be obtained regarding the safety and tolerability of the formulations given to healthy postmenopausal women.

NCT ID: NCT00543634 Completed - Postmenopause Clinical Trials

Study Comparing Premarin®/MPA, PREMPRO® and Provera® in Healthy Postmenopausal Women

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

The purpose of the study is to evaluate the safety and efficacy of new tablet formulations of Premarin®/medroxyprogesterone (MPA).

NCT ID: NCT00522873 Completed - Postmenopause Clinical Trials

Endometrial Safety Study

Start date: August 2007
Phase: Phase 3
Study type: Interventional

The study is designed to investigate the safety of the investigational product for the lining of the uterus (endometrium).

NCT ID: NCT00515593 Completed - Osteoporosis Clinical Trials

PROPOSE Quality - PReOtact in Postmenopausal OStEoporosis - Quality of Life Study (FP-004-DE)

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

The objectives of the study are - to describe the quality of life at the beginning of the Preotact® treatment and at the end of the observational period (Qualeffo-41 questionnaire) - pain assessment at the beginning of the Preotact® treatment and at the end of the observational period (VAS score) - to describe bone mineral density at the beginning of the Preotact® treatment and at the end of the observational period (T-Score) - to describe incidence of bone fractures caused by osteoporosis as well as of other pathological findings of the skeleton after the beginning of the Preotact® treatment - to describe serum level of calcium and the bone resorption marker desoxypyridinoline (DPD) and N- respectively C-terminal crosslink-telopeptide (CTX and NTX) at the beginning of the Preotact® treatment and at the end of the observational period (only in subgroup of patients, where the physician sees a need to measure these parameters) - to document all adverse drug reactions after the beginning of the Preotact® treatment - the analysis of subgroups with different risk for bone fractures caused by osteoporosis at the beginning of the Preotact® treatment - to assess the manageability and functioning of the Pen system for injection of Preotact® (self administered questionnaire)

NCT ID: NCT00484107 Completed - Postmenopause Clinical Trials

Tolerability & Safety of Premarin Vaginal Cream in Indian Postmenopausal Women

Start date: September 2005
Phase: Phase 4
Study type: Observational

This post-marketing study will provide local safety and tolerance data on the use of Premarin® vaginal cream.

NCT ID: NCT00479778 Completed - Postmenopause Clinical Trials

Study Of Pharmacokinetic (PK) Profile of Bazedoxifene (BZA) in 2 BZA/Conjugated Estrogen Forms

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

The purpose of the study is to understand how bazedoxifene is absorbed in the body when it is given in combination with 2 different formulations of conjugated estrogens. It is an open label study with no placebo control or comparator drugs. Subjects will take one dose of the investigation formulation daily for 14 days.

NCT ID: NCT00472927 Completed - Postmenopause Clinical Trials

Bioequivalence Study of 3 New Formulations of Premarin/MPA Compared With Premarin/MPA (Prempro)

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

To evaluate three new investigational tablet formulations of the Food and Drug Administration (FDA) approved medication Prempro™, Premarin combined with medroxyprogesterone acetate (MPA).

NCT ID: NCT00455741 Completed - Aging Clinical Trials

Postmenopausal Women Estrogen and Progesterone Infusion

Start date: November 2000
Phase: Phase 1/Phase 2
Study type: Interventional

The purpose of the study is to study the effects of aging, estrogen and progesterone on the brain. Specifically, we want to look at how the hypothalamus and pituitary (two small glands in the brain) respond to estrogen. The pituitary gland is controlled by the hypothalamus. The hypothalamus secretes GnRH (Gonadotropin-Releasing Hormone) that signals the pituitary to secrete the reproductive hormones, LH (Luteinizing Hormone) and FSH (Follicle Stimulating Hormone). These hormones act on the ovaries and signal the ovaries to produce estrogen and progesterone. Estrogen in the bloodstream then acts on the brain to modulate this system with changes in LH and FSH. Early changes associated with low levels of estrogen are inhibitory (estrogen negative feedback) while higher levels of estrogen (such as those present when a follicle in the ovary is ready to ovulate) stimulate LH to cause ovulation (positive feedback). This study will determine: 1) hypothalamic and pituitary levels of glucose uptake (as a measure of brain metabolic activity) at baseline and in association with estrogen negative feedback on LH (24 hr) and estrogen positive feedback on LH (72 hr); and 2) the effect of aging on estrogen feedback on LH, assessing negative feedback (nadir ~ 24 hr) and positive feedback (peak between 72 and 96 hr).

NCT ID: NCT00435175 Completed - Postmenopause Clinical Trials

Acute Metabolic Effects of Estradiol

Start date: June 2005
Phase: N/A
Study type: Interventional

Estradiol promotes and maintains the typical female phenotype characterized by subcutaneous fat accumulation. There is evidence to suggest that this effect relies on the ability of estradiol to increase the amount of anti-lipolytic α2A-adrenergic receptors, but whether this requires long-term exposure to estradiol or is the result of an immediate effect is not clear. Objective: To study acute effects of a single dose (4 mg) of 17β-estradiol on regional and systemic lipolysis.

NCT ID: NCT00425776 Completed - Breast Cancer Clinical Trials

Treatment of Hot Flushes in Breast Cancer Patients With Acupuncture

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

In a randomized 3-group clinical study acupuncture is used for the relief of menopausal hot flushes and sleep disturbances in women treated for breastcancer. The three groups consists of 35 women given acupuncture once a week five times and 35 women given shamacupuncture once a week five times and 35 women with no kind of treatment. Se-estradiol and endorphin is measured before and after the acupuncture. We want to state that acupuncture given five times once a week has a significant better effect on hot flushes and sleeping disturbances than shamacupuncture or no treatment at all. We also want to measure if there are any changes in se-estradiol and endorphine