NCT01064453

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
4,078

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2007

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2007

Completed
2.7 years until next milestone

First Submitted

Initial submission to the registry

February 5, 2010

Completed
3 days until next milestone

First Posted

Study publicly available on registry

February 8, 2010

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2012

Completed
Last Updated

November 19, 2013

Status Verified

November 1, 2013

Enrollment Period

5.5 years

First QC Date

February 5, 2010

Last Update Submit

November 18, 2013

Conditions

Postmenopausal PeriodOsteoporosis, Postmenopausal

Keywords

MenopauseMenopausal symptomsPrevention of osteoporosis in menopausal womenEstrogen deficiency symptomsHormone replacement therapy

Outcome Measures

Primary Outcomes (1)

  • Adverse event collection

    At each visit of patient during observational period (6 months)

Secondary Outcomes (1)

  • Improvement of menopausal symptoms

    After 6 months or at discontinuation of Angeliq (At earlier point)

Study Arms (1)

Group 1

Drug: E2/DRSP (Angeliq, BAY86-4891)

Interventions

E2/DRSP (Angeliq, BAY86-4891)DRUG

Take one tablet daily, continuously

Group 1

Eligibility Criteria

Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Korean women who take Angeliq for postmenopausal symptoms or/and prevention of osteoporosis

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Unknown Facility

Many Locations, South Korea

Location

MeSH Terms

Conditions

Osteoporosis, Postmenopausal

Interventions

estradiol-drospirenone combination

Condition Hierarchy (Ancestors)

OsteoporosisBone Diseases, MetabolicBone DiseasesMusculoskeletal DiseasesMetabolic DiseasesNutritional and Metabolic Diseases

Study Officials

  • Bayer Study Director

    Bayer

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 5, 2010

First Posted

February 8, 2010

Study Start

June 1, 2007

Primary Completion

December 1, 2012

Study Completion

December 1, 2012

Last Updated

November 19, 2013

Record last verified: 2013-11

Locations

KR(1)