check_circleStudy 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
  • - 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
  • - 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
No
Products
Angeliq (E2/DRSP, BAY86-4891)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Completed
Many Locations, Korea, Republic Of

Primary Outcome

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

Secondary Outcome

  • Improvement of menopausal symptoms
    date_rangeTime Frame:
    After 6 months or at discontinuation of Angeliq (At earlier point)
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    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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