- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01064453
Angeliq Regulatory Post Marketing Surveillance (Angeliq rPMS)
November 18, 2013 updated by: Bayer
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.
Study Overview
Status
Completed
Intervention / Treatment
Study Type
Observational
Enrollment (Actual)
4078
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Many Locations, Korea, Republic of
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Sampling Method
Non-Probability Sample
Study Population
Korean women who take Angeliq for postmenopausal symptoms or/and prevention of osteoporosis
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Group 1
|
Take one tablet daily, continuously
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Adverse event collection
Time Frame: At each visit of patient during observational period (6 months)
|
At each visit of patient during observational period (6 months)
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Improvement of menopausal symptoms
Time Frame: After 6 months or at discontinuation of Angeliq (At earlier point)
|
After 6 months or at discontinuation of Angeliq (At earlier point)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
June 1, 2007
Primary Completion (Actual)
December 1, 2012
Study Completion (Actual)
December 1, 2012
Study Registration Dates
First Submitted
February 5, 2010
First Submitted That Met QC Criteria
February 5, 2010
First Posted (Estimate)
February 8, 2010
Study Record Updates
Last Update Posted (Estimate)
November 19, 2013
Last Update Submitted That Met QC Criteria
November 18, 2013
Last Verified
November 1, 2013
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 14841
- AQ0710KR (Other Identifier: company internal)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Osteoporosis, Postmenopausal
-
AmgenCompletedPostmenopausal Osteoporosis (PMO)Japan
-
Deltanoid PharmaceuticalsCompletedPostmenopausal Osteoporosis, Multiple Sites
-
Riphah International UniversityCompletedPostmenopausal Osteoporosis | Postmenopausal OsteopeniaPakistan
-
AmgenCompletedPostmenopausal OsteoporosisUnited States, Canada, Denmark, Germany, Belgium, Colombia, Czechia, Japan, Mexico, Poland, Switzerland, Hungary, Spain, Australia, Romania, United Kingdom, India, Argentina, Brazil, Dominican Republic, Estonia, Latvia, Lithuania, New...
-
Penn State UniversityCalifornia Dried Plum BoardActive, not recruiting
-
Massachusetts General HospitalNational Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)CompletedPostmenopausal OsteoporosisUnited States
-
Sahlgrenska University Hospital, SwedenBioGaia ABCompletedPostmenopausal OsteoporosisSweden
-
Samsung Bioepis Co., Ltd.CompletedPostmenopausal OsteoporosisPoland
-
Organon and CoCompletedOsteoporosis Postmenopausal
-
Nigde Omer Halisdemir UniversityCompletedPostmenopausal OsteoporosisTurkey
Clinical Trials on E2/DRSP (Angeliq, BAY86-4891)
-
BayerUniversity of California, San Francisco; Laboratorium für Klinische Forschung; Diagnostic Cytology LaboratoryCompletedPostmenopauseMexico, United States, Italy, Denmark, Austria, Argentina, Brazil, Russian Federation
-
BayerCompletedVasomotor Symptoms | Hot FlashesUnited States
-
BayerCompleted
-
BayerCompletedOsteoporosis, PostmenopausalJapan
-
BayerCompletedOsteoporosis, PostmenopausalJapan
-
BayerCompleted
-
BayerCompleted
-
Organon and CoCompleted