Angeliq Regulatory Post Marketing Surveillance

Completed

• Conditions: Postmenopausal Period; Osteoporosis, Postmenopausal
• Interventions: Drug: E2/DRSP (Angeliq, BAY86-4891)

• Registration Number: NCT01064453
• Lead Sponsor: Bayer

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-06
• Study First Submitted: 2010-02-05
• Study First Submitted QC: 2010-02-05
• Study First Posted: 2010-02-08
• Primary Completion: 2012-12
• Study Completion: 2012-12
• Status Verified: 2013-11
• Last Update Submitted: 2013-11-18
• Last Update Posted: 2013-11-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 4078

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Group 1	E2/DRSP (Angeliq, BAY86-4891)	-

Primary Outcome Measures

Name	Time	Method
Adverse event collection	At each visit of patient during observational period (6 months)

Secondary Outcome Measures

Name	Time	Method
Improvement of menopausal symptoms	After 6 months or at discontinuation of Angeliq (At earlier point)