Angeliq Regulatory Post Marketing Surveillance
Information source: Bayer
Information obtained from ClinicalTrials.gov on December 08, 2011
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: Recruiting
Sponsored by: Bayer Official(s) and/or principal investigator(s):
Bayer Study Director, Study Director, Affiliation: Bayer
Overall contact:
Bayer Clinical Trials Contact, Email: clinical-trials-contact@bayerhealthcare.com
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
Bayer Clinical Trials Contact, Email: clinical-trials-contact@bayerhealthcare.com
Many Locations, Korea, Republic of; Recruiting
Additional Information
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Starting date: June 2007
Last updated: November 22, 2011
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