Angeliq rPMS: Angeliq Regulatory Post Marketing Surveillance

• Sponsor: Bayer (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01064453
• Collaborator: (none)
• Enrollment: 4,078
• Location: 1
• Duration (Months): 66
• Patients Per Site Per Month: 61.8

Study Details

Study Description

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	Phase
Postmenopausal Period; Osteoporosis, Postmenopausal	Drug: E2/DRSP (Angeliq, BAY86-4891)

Study Design

• Study Type: Observational
• Actual Enrollment: 4078 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Angeliq Regulatory Post Marketing Surveillance
• Study Start Date: Jun 1, 2007
• Actual Primary Completion Date: Dec 1, 2012
• Actual Study Completion Date: Dec 1, 2012

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Adverse event collection [At each visit of patient during observational period (6 months)]

Secondary Outcome Measures

1. Improvement of menopausal symptoms [After 6 months or at discontinuation of Angeliq (At earlier point)]

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A and Older
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1		Many Locations		Korea, Republic of

Sponsors and Collaborators

• Bayer

Investigators

• Study Director: Bayer Study Director, Bayer

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Bayer
• ClinicalTrials.gov Identifier: NCT01064453
• Other Study ID Numbers: 14841; AQ0710KR
• First Posted: Feb 8, 2010
• Last Update Posted: Nov 19, 2013
• Last Verified: Nov 1, 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; Drospirenone and ethinyl estradiol combination

Study Results

No Results Posted as of Nov 19, 2013