Study Completed

Postmenopausal Period, Osteoporosis, Postmenopausal

Bayer Identifier:

14841

ClinicalTrials.gov Identifier:

NCT01064453

EudraCT Number:

Not Available

EU CT Number:

Not Available

Angeliq regulatory Post Marketing Surveillance

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.

Key Participants Requirements

Sex

Female

Age

NaN - N/A

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

June 2007 - December 2012

Phase

N/A

Could I Receive a placebo

Products

Angeliq (E2/DRSP, BAY86-4891)

Accepts Healthy Volunteer

Where to participate

Status	Institution	Location
Completed		Many Locations, Korea, Republic Of

Primary Outcome

Adverse event collection
Time Frame:
At each visit of patient during observational period (6 months)
Safety Issue:
Yes

Secondary Outcome

Improvement of menopausal symptoms
Time Frame:
After 6 months or at discontinuation of Angeliq (At earlier point)
Safety Issue:
No

Trial design

Angeliq regulatory Post Marketing Surveillance

Trial Type

Observational

Intervention Type

Drug

Trial Purpose

N/A

Allocation

N/A

Blinding

N/A

Assignment

N/A

Trial Arms

N/A

Additional Information

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