Angeliq Regulatory Post Marketing Surveillance (Angeliq rPMS)

Bayer

Status: Completed

Conditions: Postmenopausal Period; Osteoporosis, Postmenopausal

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

Study type: Observational

Funder types: Industry

Identifiers

NCT01064453

AQ0710KR (Other Identifier)

14841

Details and patient eligibility

About

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.

Enrollment: 4,078 patients

Sex: Female

Volunteers: No Healthy Volunteers

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 design

4,078 participants in 1 patient group

Group 1

Treatment:

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