Angeliq Regulatory Post Marketing Surveillance

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01064453

Acronym

Angeliq rPMS

Enrollment

4078

Registered

2010-02-08

Start date

2007-06-30

Completion date

2012-12-31

Last updated

2013-11-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Osteoporosis, Postmenopausal, Postmenopausal Period

Keywords

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

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.

Interventions

DRUGE2/DRSP (Angeliq, BAY86-4891)

Take one tablet daily, continuously

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

FEMALE

Healthy volunteers

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

Design outcomes

Primary

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

Secondary

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

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026