Last updated: 04/04/2021 23:30:05
ZAGALLO Capsules Drug Use Investigation
Clinicaltrials.gov ID
Not applicable
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Finalized
Finalized
Trial overview
Official title: ZAGALLO Capsules Drug Use Investigation
Trial description: This post-marketing surveillance (PMS) study is conducted to collect safety and effectiveness data in male subjects with androgenetic alopecia who are treated with dutasteride tablets for the first time. ZAGALLO is a registered trademark of the GSK group of companies.
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:
The incidence of adverse drug reactions
Timeframe: 1 year
Secondary outcomes:
Not applicable
Interventions:
Drug: dutasteride tablets
Enrollment:
6
Observational study model:
Case-Only
Primary completion date:
2019-31-07
Time perspective:
Prospective
Clinical publications:
Yasuyo Nose, Kiyomi Aizawa, Megumi Koyano, Yuki Saito, Yoshiaki Kawano, Terufumi Hara. Safety and effectiveness evaluations of dutasteride in male patients with androgenetic alopecia- Drug use investigation (DUI) report. Prog Med. 2021;
Medical condition
Alopecia
Product
dutasteride
Collaborators
Not applicable
Study date(s)
July 2016 to July 2019
Type
Observational
Phase
Not applicable
Participation criteria
Sex
Male
Age
Not applicable
Accepts healthy volunteers
none
- Subejcts with androgeneteic alopecia
- Subjects who are treated with dutasteride tablets for the first time
- None
Inclusion and exclusion criteria
Inclusion criteria:
- Subejcts with androgeneteic alopecia
- Subjects who are treated with dutasteride tablets for the first time
Exclusion criteria:
- None
Trial location(s)
No location data available.
Study documents
Clinical study report
Available language(s): English
Protocol
Available language(s): English
Statistical analysis plan
Available language(s): English
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
2019-31-07
Actual study completion date
2019-31-07
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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