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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 [615 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 [4222 Associated PubMed Articles listed on BioPortfolio]

Comparative Effect of rhPTH(1-84) on Bone Mineral Density and Trabecular Bone Score in Hypoparathyroidism and Postmenopausal Osteoporosis.

Parathyroid hormone (PTH) (1-84) improves lumbar spine (LS) areal bone mineral density (aBMD) and trabecular bone score (TBS) in hypoparathyroidism over a 2-year treatment period. Studies in osteoporo...

Remote intervention using smartphone for rural women suffering from premenstrual syndrome: A propensity score matched analysis.

Timely treatment of premenstrual syndrome (PMS) is not always available for rural women, because the local medical resources are insufficient. The efficacy of remote intervention by smartphone on PMS ...

P 132 - In postmenopausal period: How are balance and posture affected?

Low pretreatment serum concentration of vitamin D at breast cancer diagnosis in postmenopausal women.

The aim of the study was to evaluate the rate of and risk factors for low pretreatment vitamin D (VitD) levels in postmenopausal breast cancer (BC) women, compared with postmenopausal women without BC...

Phase 2a Safety, Pharmacokinetics, and Acceptability of Dapivirine Vaginal Rings in US Postmenopausal Women.

Postmenopausal women have unique sociobiological human immunodeficiency virus (HIV) risks. We evaluated the safety, pharmacokinetics, and acceptability of a microbicide dapivirine (DPV) vaginal ring (...

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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