Regulatory Post Marketing Surveillance Study in Korea

NCT ID: NCT01788722

Last Updated: 2018-08-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

3223 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-07-19

Study Completion Date

2017-08-11

Brief Summary

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The objective of the study is to investigate and collect post marketing data on the safety and efficacy of Visanne at follow-up visit after about 6 months of treatment and - for a subset of patients - at optional long-term follow-up visit after about 1 year of treatment under daily practice treatment conditions in Korean women and to obtain data on drug utilization on treatment for endometriosis.

Detailed Description

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Conditions

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Endometriosis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Group 1

Dienogest (Visanne, BAY86-5258)

Intervention Type DRUG

Patients in daily life clinical practice treatment receiving Visanne (dienogest 2mg) according to indication on the label.

Interventions

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Dienogest (Visanne, BAY86-5258)

Patients in daily life clinical practice treatment receiving Visanne (dienogest 2mg) according to indication on the label.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Signed and dated informed consent
* Women diagnosed by a physician as having endometriosis
* Women who are prescribed Visanne(dienogest 2mg)for the first time during the study period

Exclusion Criteria

\- All contraindications according to the local marketing authorization have to be considered.
Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Bayer

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Bayer Study Director

Role: STUDY_DIRECTOR

Bayer

Locations

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Multiple Locations, , South Korea

Site Status

Countries

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South Korea

Other Identifiers

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VS1310KR

Identifier Type: OTHER

Identifier Source: secondary_id

16625

Identifier Type: -

Identifier Source: org_study_id

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