Trial Condition(s):

Postmenopausal Period, Osteoporosis, Postmenopausal

Angeliq regulatory Post Marketing Surveillance (Angeliq rPMS)

Bayer Identifier:

14841

ClinicalTrials.gov Identifier:

NCT01064453

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
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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
Status
LocationsStatus
Locations

Investigative Site

Many Locations, South Korea

Status
Completed

Trial Design