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Generation of Biological Samples Positive to Triptorelin for Anti-doping Control
Plain-language guide to NCT04189900: phase 1 interventional trial of Triptorelin, 2 participants. Who took part, design and what was measured.
Key Facts
- Registry ID
- NCT04189900
- Phase
- phase 1
- Status
- completed
- Start
- 2019-04-26
- Completion (planned or actual)
- 2019-05-15
- Participants
- 2 (actual)
- Design
- na, open label (everyone knows who gets what), other
- Conditions studied
- Healthy Volunteers
- Results posted
- not yet
What This Study Did, in Plain Language
What Was Tested
This registered phase 1 trial tested Triptorelin.
These drugs are included in the list of prohibited substances of the World Anti-Doping Agency (WADA).
It had 1 arm (groups): Triptorelin (experimental).
The registry classes the interventions as drug.
Who Took Part
2 actual participants took part.
It was open to men only aged from 18 years up to 45 years.
Healthy volunteers could join, not only people with the condition.
Examples of who could join: Male volunteers aged between 18 and 45 years. Able to understand and accept the trial procedures and able to sign an informed consent.
The full record lists 5 inclusion and 15 exclusion criteria; among the exclusions: failure to meet the inclusion criteria; history of allergy, idiosyncrasy, hypersensitivity or adverse reactions to the active substance or similar nonapeptides and to any of the excipients; serious adverse reactions to other medications.
How the Study Was Run
The set-up was single-group and open-label.
Nothing was hidden in this open-label Triptorelin study: the participants and staff both knew the treatment.
Everyone received the same intervention, so there was no separate comparison group inside the trial.
It started in 2019-04-26 with completion listed for 2019-05-15.
It ran at 1 site in Spain.
Its stated primary purpose is other.
What Was Measured
Primary outcome: Urine concentration of triptorelin (time frame: 0-4 hours post-administration). Urine concentration of triptorelin (time frame: 4-8 hours post-administration). Urine concentration of triptorelin (time frame: 8-12 hours post-administration).
It also tracked 5 secondary outcomes, for example Urine concentration of triptorelin metabolites, Urine concentration of triptorelin metabolites, Urine concentration of triptorelin metabolites, Urine concentration of triptorelin metabolites and Urine concentration of triptorelin metabolites.
What This Means in Plain Language
Put simply, this is a phase 1 trial of Triptorelin in 2 people.
Its size is small, so on its own it can only give an early look.
The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.
More context: the Triptorelin compound page, all human trials.
Our Notes on the Compound
Triptorelin: A 10-amino-acid GnRH analog (Trelstar, Decapeptyl, Triptodur) used in prostate cancer, early puberty and fertility protocols.
Related Pages
Source: ClinicalTrials.gov record. This explanation is written by PeptideWhiz from the public record. For research and education only. Not medical advice; no dosing information is given.