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Angeliq Regulatory Post Marketing Surveillance

2014-08-27 03:16:03 | BioPortfolio

Summary

Angeliq regulatory Post-Marketing Surveillance (PMS) is to get data about safety and efficacy in real practice for the indication approved by Korea Food and Drug Administration (KFDA). This is non-internventional, prospective, multi-center study.Target number of patients is 4500.

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Conditions

Postmenopausal Period

Intervention

E2-1mg/DRSP (Angeliq, BAY86-4891)

Location

Many Locations
Korea, Republic of

Status

Recruiting

Source

Bayer

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:16:03-0400

Clinical Trials [558 Associated Clinical Trials listed on BioPortfolio]

Effect of Angeliq on Blood Pressure (BP) in Postmenopausal Hypertensive Women

The objective of the study is to evaluate the effects of Angeliq on BP over a period of 8 weeks in postmenopausal women who may benefit from hormone replacement therapy (HRT) for the relie...

Effects of Angeliq and Prempro on Blood Pressure and Sodium Sensitivity in Postmenopausal Women With Prehypertension

The main purpose of this study is to compare the effects of treatment of two different formulations of Angeliq® and Prempro on blood pressure in post-menopausal women with prehypertension...

Efficacy and Tolerability of Angeliq in Thai Women

To evaluate the safety, tolerability, and efficacy of Angeliq in Thai post menopausal women with hot flushes and other climacteric symptoms.

Safety/Efficacy Study of Drospirenone/Estradiol to Treat Postmenopausal Chinese Women With Vasomotor Symptoms.

The study evaluates in Chinese post-menopausal women the combination of drospirenone 2 mg and estradiol 1 mg for the treatment of climacteric symptoms, such as hot flushes (vasomotor sympt...

A Prospective Multicenter Non-interventional Cohort Study on Patients'Satisfaction With Angeliq® Micro in Real Clinical Practice Conducted in Russia

To evaluate the patients' satisfaction with Angeliq Micro in real clinical practice after 13 cycles of treatment.

PubMed Articles [4315 Associated PubMed Articles listed on BioPortfolio]

The function of miR-218 and miR-618 in postmenopausal osteoporosis.

Postmenopausal osteoporosis (POMP) is a serious disorder with significant physical, psychosocial, and financial consequences, which greatly reduce the postmenopausal women's life quality. The related ...

Premenstrual Syndrome Diagnosis: A Comparative Study between the Daily Record of Severity of Problems (DRSP) and the Premenstrual Symptoms Screening Tool (PSST).

Objective To validate the premenstrual symptoms screening tool (PSST) in relation to the daily record of severity of problems (DRSP) for premenstrual syndrome (PMS) and premenstrual dysphoric disord...

Sleep Duration and Quality Among Women Aged 40?59, by Menopausal Status.

Data from the National Health Interview Survey, 2015 ? Among those aged 40?59, perimenopausal women (56.0%) were more likely than postmenopausal (40.5%) and premenopausal (32.5%) women to sleep less t...

Changes in bone mineral density related to changes in serum 25-OH vitamin D concentrations over a two-year period in postmenopausal women.

Cardiovascular disease and mortality after breast cancer in postmenopausal women: Results from the Women's Health Initiative.

Cardiovascular disease (CVD) is the leading cause of morbidity and mortality among older postmenopausal women. The impact of postmenopausal breast cancer on CVD for older women is uncertain. We hypoth...

Medical and Biotech [MESH] Definitions

Reduction of bone mass without alteration in the composition of bone, leading to fractures. Primary osteoporosis can be of two major types: postmenopausal osteoporosis (OSTEOPOROSIS, POSTMENOPAUSAL) and age-related or senile osteoporosis.

A gonadal stromal neoplasm composed only of THECA CELLS, occurring mostly in the postmenopausal OVARY. It is filled with lipid-containing spindle cells and produces ESTROGENS that can lead to ENDOMETRIAL HYPERPLASIA; UTERINE HEMORRHAGE; or other malignancies in postmenopausal women and sexual precocity in girls. When tumors containing theca cells also contain FIBROBLASTS, they are identified as thecoma-fibroma tumors with less active hormone production.

The period in the MENSTRUAL CYCLE that is optimal for FERTILIZATION of the OVUM and yielding PREGNANCY. The duration of fertile period depends on the life span of male GAMETES within the female reproductive tract and the time of OVULATION. It usually begins a few days before ovulation and ends on the day of ovulation.

The period shortly before, during, and immediately after giving birth.

The maximum exposure to a biologically active physical or chemical agent that is allowed during an 8-hour period (a workday) in a population of workers, or during a 24-hour period in the general population, which does not appear to cause appreciable harm, whether immediate or delayed for any period, in the target population. (From Lewis Dictionary of Toxicology, 1st ed)

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