AVODART® Alopecia Post-marketing Surveillance (PMS)

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01004809

Acronym

AVODART®PMS

Enrollment

712

Registered

2009-10-30

Start date

2010-04-29

Completion date

2012-12-21

Last updated

2018-06-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Alopecia

Keywords

Dutasteride

Brief summary

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

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

Interventions

DRUGDutasteride

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.

Study design

Observational model

OTHER

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

MALE

Age

18 Years to 41 Years

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame
Occurrence of adverse event after dutasteride administration	2 years

Secondary

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

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026