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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT01004809
First received: October 29, 2009
Last updated: July 31, 2014
Last verified: July 2014
  Purpose

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


Condition Intervention
Alopecia
Drug: Dutasteride

Study Type: Observational
Study Design: 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

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Occurrence of adverse event after dutasteride administration [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Occurrence of unexpected adverse drug reaction after dutasteride administration [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Occurrence of serious adverse events after dutasteride administration [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Effectiveness of dutasteride judged by a physician [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Enrollment: 712
Study Start Date: April 2010
Study Completion Date: December 2012
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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.

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

  Eligibility

Ages Eligible for Study:   18 Years to 41 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

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

Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01004809

Locations
Korea, Republic of
GSK Investigational Site
Daejeon, Korea, Republic of, 301-721
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

No publications provided

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT01004809     History of Changes
Other Study ID Numbers: 113797
Study First Received: October 29, 2009
Last Updated: July 31, 2014
Health Authority: Korea: MFDS(Ministry of Food and Drug Safety)

Keywords provided by GlaxoSmithKline:
Dutasteride

Additional relevant MeSH terms:
Alopecia
Alopecia Areata
Hair Diseases
Hypotrichosis
Pathological Conditions, Anatomical
Skin Diseases
Dutasteride
5-alpha Reductase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses
Urological Agents

ClinicalTrials.gov processed this record on November 24, 2014