AVODART® Alopecia Post-marketing Surveillance (PMS)

NCT ID: NCT01004809

Last Updated: 2018-06-19

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

712 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-04-29

Study Completion Date

2012-12-21

Brief Summary

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Post-marketing surveillance(PMS) to monitor the safety and effectiveness of dutasteride in Korean androgenetic alopecia patients

Detailed Description

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An open label, multi-centre, non-interventional post-marketing surveillance to monitor the safety and effectiveness of dutasteride administered in Korean androgenetic alopecia patients according to the prescribing information

Conditions

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Alopecia

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Study Groups

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Dutasteride

Patients administrated dutasteride with male hair loss

Dutasteride

Intervention Type DRUG

Basically there is no treatment allocation. Subjects who would be administered of dutasteride at their physicians' discretion will be enrolled. Dosage regimen will be recommended according to the prescribing information. Subjects will be enrolled consecutively.

Interventions

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Dutasteride

Basically there is no treatment allocation. Subjects who would be administered of dutasteride at their physicians' discretion will be enrolled. Dosage regimen will be recommended according to the prescribing information. Subjects will be enrolled consecutively.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Men (18-41 years of age) with male pattern hair loss (androgenetic alopecia)
* Subjects with no experience of treatment using dutasteride
* Subjects who the investigator believes that they can and will comply with the requirements of the protocol
* Subjects who prescribed with dutasteride according to the Prescribing Information

Exclusion Criteria

* Considering the nature of observational study, GSK Korea encourages the doctors participating in this study to enrol the subjects prescribed with dutasteride following the locally approved Prescribing Information. Subject who give informed consent is enrolled. However, if institution waives the requirement for informed consent, informed consent is not required. In this case, monitoring does not proceed.
Minimum Eligible Age

18 Years

Maximum Eligible Age

41 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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GlaxoSmithKline

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

Locations

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GSK Investigational Site

Daejeon, , South Korea

Site Status

Countries

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South Korea

Other Identifiers

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113797

Identifier Type: -

Identifier Source: org_study_id

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