Angeliq Regulatory Post Marketing Surveillance

Osteoporosis, Postmenopausal Clinical Trial

— Angeliq rPMS  

Official title:

Angeliq Regulatory Post Marketing Surveillance

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01064453
• Other study ID #: 14841
• Secondary ID: AQ0710KR
• Status: Completed
• Phase: N/A
• First received: February 5, 2010
• Last updated: November 18, 2013
• Start date: June 2007
• Est. completion date: December 2012

Study information

• Verified date: November 2013
• Source: Bayer
• Contact: n/a
• Is FDA regulated: No
• Health authority: South Korea: Korea Food and Drug Administration (KFDA)
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 4078
• Est. completion date: December 2012
• Est. primary completion date: December 2012
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

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

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Osteoporosis
• Osteoporosis, Postmenopausal
• Postmenopausal Period

Intervention

Drug:
• E2/DRSP (Angeliq, BAY86-4891)
Take one tablet daily, continuously

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Bayer

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adverse event collection		At each visit of patient during observational period (6 months)	Yes
Secondary	Improvement of menopausal symptoms		After 6 months or at discontinuation of Angeliq (At earlier point)	No

External Links

•   Click here and search for drug information provided by the FDA.
•   Click here and search for information on any recalls, market or product safety alerts by the FDA which might have occurred with this product.