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Completed

NCT Number: NCT01064453

Angeliq Regulatory Post Marketing Surveillance

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.

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Key information

Conditions

Postmenopausal Period Bone Diseases Bone Diseases, Metabolic Metabolic Diseases Musculoskeletal Diseases Nutritional and Metabolic Diseases Osteoporosis Osteoporosis, Postmenopausal

Sex eligibility

Female

Study type

Observational

Primary location

Many Locations, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

E2/DRSP (Angeliq, BAY86-4891)

Drug

Take one tablet daily, continuously

Primary outcomes

  1. Adverse event collection

    Time frame: At each visit of patient during observational period (6 months)

Secondary outcomes

  1. Improvement of menopausal symptoms

    Time frame: After 6 months or at discontinuation of Angeliq (At earlier point)

Sponsors and collaborators

Lead sponsor

Bayer

Industry

Registry information

Acronym: Angeliq rPMS

Important dates

Study start
2007
Primary completion
2012
Study completion
2012
First posted
Feb 8, 2010
Registry last updated
Nov 19, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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