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Angeliq Regulatory Post Marketing Surveillance

Information source: Bayer
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Postmenopausal Period; Osteoporosis, Postmenopausal

Intervention: E2/DRSP (Angeliq, BAY86-4891) (Drug)

Phase: N/A

Status: Completed

Sponsored by: Bayer

Official(s) and/or principal investigator(s):
Bayer Study Director, Study Director, Affiliation: Bayer

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-interventional , prospective, multi-center study. Target number of patients is 4500.

Clinical Details

Official title: Angeliq Regulatory Post Marketing Surveillance

Study design: Observational Model: Cohort, Time Perspective: Prospective

Primary outcome: Adverse event collection

Secondary outcome: Improvement of menopausal symptoms

Eligibility

Minimum age: N/A. Maximum age: N/A. Gender(s): Female.

Criteria:

Inclusion Criteria:

- Hormone replacement therapy for estrogen deficiency symptoms in postmenopausal women

more than 1 year postmenopause

- Prevention of osteoporosis in postmenopausal women at high risk of future fractures

who are intolerant of, or contraindicated for, other medicinal products approved for the prevention of osteoporosis Exclusion Criteria:

- Undiagnosed genital bleeding

- Known, past or suspected cancer of the breast

- Known or suspected estrogen-dependent malignant tumors (e. g. endometrial cancer)

- Untreated endometrial hyperplasia

- Previous idiopathic or current venous thromboembolism (e. g. deep venous thrombosis,

pulmonary embolism)

- Active or recent arterial thromboembolic disease (e. g. angina, myocardial infarction)

- Acute liver disease, or a history of liver disease as long as liver function tests

have failed to return to normal

- Porphyria

- Severe renal insufficiency or acute renal failure

- Known hypersensitivity to the active substances or to any of the excipients

Locations and Contacts

Many Locations, Korea, Republic of
Additional Information

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Starting date: June 2007
Last updated: November 18, 2013

Page last updated: August 23, 2015

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