Last updated: 11/07/2018 06:55:45
AVODART® alopecia post-marketing surveillance (PMS)AVODART®PMS
Clinicaltrials.gov ID
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Finalized
Finalized
Trial overview
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
Trial description: Post-marketing surveillance(PMS) to monitor the safety and effectiveness of dutasteride in Korean androgenetic alopecia patients
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:
Occurrence of adverse event after dutasteride administration
Timeframe: 2 years
Secondary outcomes:
Occurrence of unexpected adverse drug reaction after dutasteride administration
Timeframe: 2 years
Occurrence of serious adverse events after dutasteride administration
Timeframe: 2 years
Effectiveness of dutasteride judged by a physician
Timeframe: 2 years
Interventions:
Drug: Dutasteride
Enrollment:
712
Observational study model:
Other
Primary completion date:
Not applicable
Time perspective:
Prospective
Clinical publications:
Gwang-Seong Choi, Joon Hyung Kim, Shin-Young Oh, Jung-Min Park, Ji-Soo Hong, Yil-Seob Lee, Won-Soo Lee. Safety and Tolerability of the Dual 5-Alpha Reductase Inhibitor Dutasteride in the Treatment of Androgenetic Alopecia. Ann Dermatol. 2016;8(4):444-450.
Medical condition
Alopecia
Product
dutasteride
Collaborators
Not applicable
Study date(s)
April 2010 to December 2012
Type
Observational
Phase
Not applicable
Participation criteria
Sex
Male
Age
18 - 41 years
Accepts healthy volunteers
No
- Men (18-41 years of age) with male pattern hair loss (androgenetic alopecia)
- Subjects with no experience of treatment using dutasteride
- 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.
Inclusion and exclusion 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.
Trial location(s)
Study documents
Scientific result summary
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Refer to study documents
Recruitment status
Finalized
Actual primary completion date
Not applicable
Actual study completion date
2012-21-12
Plain language summaries
Not applicable. GSK’s transparency policy provides for Plain Language Summaries for Interventional studies.
Additional information about the trial
Not applicable
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