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

Sponsor
GlaxoSmithKline (Industry)
Overall Status
Completed
CT.gov ID
NCT01004809
Collaborator
(none)
712
Enrollment
1
Location
31.8
Duration (Months)
22.4
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase

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 Design

Study Type:
Observational
Actual Enrollment :
712 participants
Observational Model:
Other
Time Perspective:
Prospective
Official 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
Study Start Date :
Apr 29, 2010
Actual Primary Completion Date :
Dec 1, 2012
Actual Study Completion Date :
Dec 21, 2012

Arms and Interventions

Arm 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.

Outcome Measures

Primary Outcome Measures

  1. Occurrence of adverse event after dutasteride administration [2 years]

Secondary Outcome Measures

  1. Occurrence of unexpected adverse drug reaction after dutasteride administration [2 years]

  2. Occurrence of serious adverse events after dutasteride administration [2 years]

  3. Effectiveness of dutasteride judged by a physician [2 years]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 41 Years
Sexes Eligible for Study:
Male
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 GSK Investigational Site Daejeon Korea, Republic of 301-721

Sponsors and Collaborators

  • GlaxoSmithKline

Investigators

  • Study Director: GSK Clinical Trials, GlaxoSmithKline

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT01004809
Other Study ID Numbers:
  • 113797
First Posted:
Oct 30, 2009
Last Update Posted:
Jun 19, 2018
Last Verified:
Jun 1, 2018
Keywords provided by GlaxoSmithKline
Dutasteride
Additional relevant MeSH terms:
Alopecia
Alopecia Areata
Dutasteride

Study Results

No Results Posted as of Jun 19, 2018