AlopeciaAVODART®PMSNCT01004809
AVODART® Alopecia Post-marketing Surveillance (PMS)
An observational study of Alopecia, run by GlaxoSmithKline at 1 site in South Korea.
Trial summary
Post-marketing surveillance(PMS) to monitor the safety and effectiveness of dutasteride in Korean androgenetic alopecia patients Read more about this study
- Who is it for?
- Ages 18 to 41 years, men only
- Conditions the study is for
- Alopecia
- What is being tested?
- Dutasteride
- How many people
- 712 participants
- Where
- 1 siteSouth Korea
- Study dates
- 29 Apr 2010to 21 Dec 2012
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 41 years
- Men only
- No healthy volunteers
- Adult
Study population: Patients administrated dutasteride with male pattern hair loss (androgenetic alopecia)
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
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
Post-marketing surveillance(PMS) to monitor the safety and effectiveness of dutasteride in Korean androgenetic alopecia patients
Read the 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
- Conditions
- Alopecia
- Being tested
- Dutasteride
- Keywords
- Dutasteride
- Medical subject headings
- Alopecia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DutasterideDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Dutasteride | Patients administrated dutasteride with male hair loss Receives: Drug: Dutasteride |
What is being measured
The primary outcome is the main question the study is designed to answer.
Occurrence of adverse event after dutasteride administration
Measured: 2 years
Secondary outcomes (3)
Occurrence of unexpected adverse drug reaction after dutasteride administration
Measured: 2 years
Occurrence of serious adverse events after dutasteride administration
Measured: 2 years
Effectiveness of dutasteride judged by a physician
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2009 (estimated)
- Study start29 Apr 2010
- Primary completion1 Dec 2012
- Study completion21 Dec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AlopeciaStudies of the same condition, open and under way.
- More trials run by GlaxoSmithKlineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 712 participants (actual)
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- GSK Clinical Trials, Study director, GlaxoSmithKline
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01004809
- Sponsor's protocol ID
- 113797
- Acronym
- AVODART®PMS
- Status last verified
- Jun 2018
- First submitted
- 29 Oct 2009
- Last updated
- 19 Jun 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01004809
- Acronym / sponsor ID
- AVODART®PMS / 113797
- Conditions
- Alopecia
- Keywords
- Dutasteride
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 712 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- 29 Apr 2010
- Primary completion
- 1 Dec 2012 (actual)
- Study completion
- 21 Dec 2012 (actual)
- First posted
- 30 Oct 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Post-marketing surveillance(PMS) to monitor the safety and effectiveness of dutasteride in Korean androgenetic alopecia patients
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
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Dutasteride | – | Drug: DutasteridePatients administrated dutasteride with male hair loss |
Who may qualify
- Ages
- 18 to 41 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Patients administrated dutasteride with male pattern hair loss (androgenetic alopecia)
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DutasterideBasically 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. | Drug | Dutasteride |
Primary outcome
Occurrence of adverse event after dutasteride administration
Time frame: 2 years
3 secondary outcomes
Occurrence of unexpected adverse drug reaction after dutasteride administration
Time frame: 2 years
Occurrence of serious adverse events after dutasteride administration
Time frame: 2 years
Effectiveness of dutasteride judged by a physician
Time frame: 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jun 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
GSK Clinical Trials study director
GlaxoSmithKline
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Alopecia, run by GlaxoSmithKline at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Jun 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Occurrence of adverse event after dutasteride administration (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jun 2018; AzTrials last refreshed its copy on 7 Nov 2026.