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

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ClinicalTrials.gov Identifier: NCT01004809
Recruitment Status : Completed
First Posted : October 30, 2009
Last Update Posted : August 4, 2014
Sponsor:
Information provided by (Responsible Party):

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
Alopecia Drug: Dutasteride

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
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 : April 2010
Primary Completion Date : December 2012
Study Completion Date : December 2012

Resource links provided by the National Library of Medicine

Drug Information available for: Dutasteride
U.S. FDA Resources

Groups and Cohorts

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.


Outcome Measures

Primary Outcome Measures :
  1. Occurrence of adverse event after dutasteride administration [ Time Frame: 2 years ]

Secondary Outcome Measures :
  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 ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 41 Years   (Adult)
Sexes 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT01004809     History of Changes
Other Study ID Numbers: 113797
First Posted: October 30, 2009    Key Record Dates
Last Update Posted: August 4, 2014
Last Verified: July 2014

Keywords provided by GlaxoSmithKline:
Dutasteride

Additional relevant MeSH terms:
Alopecia
Alopecia Areata
Hypotrichosis
Hair Diseases
Skin Diseases
Pathological Conditions, Anatomical
Dutasteride
5-alpha Reductase Inhibitors
Steroid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs