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Angeliq Regulatory Post Marketing Surveillance

NCT ID: NCT01064453

Last Updated: 2013-11-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

4078 participants

Study Classification

OBSERVATIONAL

Study Start Date

2007-06-30

Study Completion Date

2012-12-31

Brief Summary

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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

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Conditions

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Postmenopausal Period Osteoporosis, Postmenopausal

Keywords

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Menopause Menopausal symptoms Prevention of osteoporosis in menopausal women Estrogen deficiency symptoms Hormone replacement therapy

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Group 1

E2/DRSP (Angeliq, BAY86-4891)

Intervention Type DRUG

Take one tablet daily, continuously

Interventions

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E2/DRSP (Angeliq, BAY86-4891)

Take one tablet daily, continuously

Intervention Type DRUG

Eligibility Criteria

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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
Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Bayer

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Bayer Study Director

Role: STUDY_DIRECTOR

Bayer

Locations

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Many Locations, , South Korea

Site Status

Countries

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South Korea

Other Identifiers

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AQ0710KR

Identifier Type: OTHER

Identifier Source: secondary_id

14841

Identifier Type: -

Identifier Source: org_study_id