Trial Condition(s):
Postmenopausal Period, Osteoporosis, Postmenopausal
Angeliq regulatory Post Marketing Surveillance (Angeliq rPMS)
Bayer Identifier:
14841
ClinicalTrials.gov Identifier:
EudraCT Number:
Not Available
EU CT Number:
Not Available
Study Completed
Trial Purpose
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.
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
Trial Summary
Enrollment Goal
4078
Trial Dates
Phase
N/A
Could I receive a placebo?
No
Products
Angeliq (E2/DRSP, BAY86-4891)
Accepts Healthy Volunteers
No
Where to Participate
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Locations
| Locations | |
|---|---|
Locations Investigative Site Many Locations, South Korea | Contact Us: E-mail: [email protected] Phone: Not Available |
Trial Design
Angeliq regulatory Post Marketing Surveillance
Trial Type:
Observational
Intervention Type:
Drug
Trial Purpose:
N/A
Allocation:
N/A
Blinding:
N/A
Assignment:
N/A
Trial Arms:
1
Primary Outcome
- Adverse event collectionTimeframe: At each visit of patient during observational period (6 months)
Secondary Outcome
- Improvement of menopausal symptomsTimeframe: After 6 months or at discontinuation of Angeliq (At earlier point)
Additional Information
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