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Angeliq Regulatory Post Marketing Surveillance (Angeliq rPMS)

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ClinicalTrials.gov Identifier: NCT01064453
Recruitment Status : Completed
First Posted : February 8, 2010
Last Update Posted : November 19, 2013
Sponsor:
Information provided by (Responsible Party):
Bayer

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.

Condition or disease Intervention/treatment
Postmenopausal Period Osteoporosis, Postmenopausal Drug: E2/DRSP (Angeliq, BAY86-4891)

Study Type : Observational
Actual Enrollment : 4078 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Angeliq Regulatory Post Marketing Surveillance
Study Start Date : June 2007
Actual Primary Completion Date : December 2012
Actual Study Completion Date : December 2012

Group/Cohort Intervention/treatment
Group 1 Drug: E2/DRSP (Angeliq, BAY86-4891)
Take one tablet daily, continuously




Primary Outcome Measures :
  1. Adverse event collection [ Time Frame: At each visit of patient during observational period (6 months) ]

Secondary Outcome Measures :
  1. Improvement of menopausal symptoms [ Time Frame: After 6 months or at discontinuation of Angeliq (At earlier point) ]


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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01064453


Locations
Korea, Republic of
Many Locations, Korea, Republic of
Sponsors and Collaborators
Bayer
Investigators
Study Director: Bayer Study Director Bayer

Additional Information:
Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT01064453     History of Changes
Other Study ID Numbers: 14841
AQ0710KR ( Other Identifier: company internal )
First Posted: February 8, 2010    Key Record Dates
Last Update Posted: November 19, 2013
Last Verified: November 2013

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
Metabolic Diseases
Drospirenone and ethinyl estradiol combination
Reproductive Control Agents
Physiological Effects of Drugs