Angeliq Regulatory Post Marketing Surveillance

• Status: Completed
• Trial end date: 2012-12-01
• Target enrollment: 0
• Participant gender: Female

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.

• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Bayer
• Treatments: Drospirenone and ethinyl estradiol combination

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