Angeliq Regulatory Post Marketing Surveillance (Angeliq rPMS)
This study has been completed.
Sponsor:
Bayer
Information provided by:
Bayer
ClinicalTrials.gov Identifier:
NCT01064453
First received: February 5, 2010
Last updated: January 4, 2013
Last verified: January 2013
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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.
| Condition | Intervention |
|---|---|
|
Postmenopausal Period Osteoporosis, Postmenopausal |
Drug: E2/DRSP (Angeliq, BAY86-4891) |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
| Official Title: | Angeliq Regulatory Post Marketing Surveillance |
Resource links provided by NLM:
Further study details as provided by Bayer:
Primary Outcome Measures:
- Adverse event collection [ Time Frame: At each visit of patient during observational period (6 months) ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- Improvement of menopausal symptoms [ Time Frame: After 6 months or at discontinuation of Angeliq (At earlier point) ] [ Designated as safety issue: No ]
| Enrollment: | 4221 |
| Study Start Date: | June 2007 |
| Study Completion Date: | December 2012 |
| Primary Completion Date: | December 2012 (Final data collection date for primary outcome measure) |
| Groups/Cohorts | Assigned Interventions |
|---|---|
| Group 1 |
Drug: E2/DRSP (Angeliq, BAY86-4891)
Take one tablet daily, continuously
|
Eligibility| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Study Population
Korean women who take Angeliq for postmenopausal symptoms or/and prevention of osteoporosis
Criteria
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
Contacts and Locations More Information
Additional Information:
No publications provided
| Responsible Party: | Medical Director, Bayer Healthcare AG |
| ClinicalTrials.gov Identifier: | NCT01064453 History of Changes |
| Other Study ID Numbers: | 14841, AQ0710KR |
| Study First Received: | February 5, 2010 |
| Last Updated: | January 4, 2013 |
| Health Authority: | South Korea: Korea Food and Drug Administration (KFDA) |
Keywords provided by Bayer:
|
Menopause Menopausal symptoms Prevention of osteoporosis in menopausal women Estrogen deficiency symptoms Hormone replacement therapy |
Additional relevant MeSH terms:
|
Osteoporosis Osteoporosis, Postmenopausal Bone Diseases, Metabolic Bone Diseases Musculoskeletal Diseases |
Drospirenone and ethinyl estradiol combination Reproductive Control Agents Physiological Effects of Drugs Pharmacologic Actions Therapeutic Uses |
ClinicalTrials.gov processed this record on May 23, 2013