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Completed

NCT Number: NCT01004809

AVODART® Alopecia Post-marketing Surveillance (PMS)

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

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Key information

Conditions

Alopecia Hair Diseases Hypotrichosis Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year–41 year

Sex eligibility

Male

Study type

Observational

Primary location

GSK Investigational Site

Daejeon, 301-721, South Korea

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

dutasteride

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.

Primary outcomes

  1. Occurrence of adverse event after dutasteride administration

    Time frame: 2 years

Secondary outcomes

  1. Occurrence of unexpected adverse drug reaction after dutasteride administration

    Time frame: 2 years

  2. Occurrence of serious adverse events after dutasteride administration

    Time frame: 2 years

  3. Effectiveness of dutasteride judged by a physician

    Time frame: 2 years

Sponsors and collaborators

Lead sponsor

GlaxoSmithKline

Industry

Registry information

Official study title

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

Acronym: AVODART®PMS

Important dates

Study start
2010
Primary completion
2012
Study completion
2012
First posted
Oct 30, 2009
Registry last updated
Jun 19, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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