Angeliq Regulatory Post Marketing Surveillance (Angeliq rPMS)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Bayer
ClinicalTrials.gov Identifier:
NCT01064453
First received: February 5, 2010
Last updated: November 18, 2013
Last verified: November 2013
  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: 4078
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01064453

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

Additional Information:
No publications provided

Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT01064453     History of Changes
Other Study ID Numbers: 14841, AQ0710KR
Study First Received: February 5, 2010
Last Updated: November 18, 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 August 26, 2014