AVODART® Alopecia Post-marketing Surveillance (PMS) (AVODART®PMS)

June 18, 2018 updated by: GlaxoSmithKline

An Open Label, Multi-centre, Non-interventional Post-marketing Surveillance to Monitor the Safety and Effectiveness of AVODART® Administered in Korean Androgenetic Alopecia Patients According to the Prescribing Information

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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

Study Type

Observational

Enrollment (Actual)

712

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 41 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Sampling Method

Probability Sample

Study Population

Patients administrated dutasteride with male pattern hair loss (androgenetic alopecia)

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Other
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Dutasteride
Patients administrated dutasteride with male hair loss
Drug: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Occurrence of adverse event after dutasteride administration
Time Frame: 2 years
2 years

Secondary Outcome Measures

Outcome Measure
Time Frame
Occurrence of unexpected adverse drug reaction after dutasteride administration
Time Frame: 2 years
2 years
Occurrence of serious adverse events after dutasteride administration
Time Frame: 2 years
2 years
Effectiveness of dutasteride judged by a physician
Time Frame: 2 years
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

GlaxoSmithKline

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 29, 2010

Primary Completion (Actual)

December 1, 2012

Study Completion (Actual)

December 21, 2012

Study Registration Dates

First Submitted

October 29, 2009

First Submitted That Met QC Criteria

October 29, 2009

First Posted (Estimate)

October 30, 2009

Study Record Updates

Last Update Posted (Actual)

June 19, 2018

Last Update Submitted That Met QC Criteria

June 18, 2018

Last Verified

June 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 113797

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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