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A Study to Assess LY01005 Versus Goserelin Comparator (ZOLADEX®) in Patients With Prostate Cancer
Plain-language guide to NCT03450109: phase 1 non-randomized trial of Goserelin, 19 participants. Who took part, design and what was measured.
Key Facts
- Registry ID
- NCT03450109
- Phase
- phase 1
- Status
- completed
- Start
- 2017-12-22
- Completion (planned or actual)
- 2018-10-15
- Participants
- 19 (actual)
- Design
- non-randomized, open label (everyone knows who gets what), other
- Conditions studied
- Cancer of Prostate
- Results posted
- not yet
What This Study Did, in Plain Language
What Was Tested
This registered phase 1 trial tested Goserelin.
A phase I, randomized, open-label and active-control study to assess the PK, PD and safety profiles of LY01005 versus goserelin comparator to be conducted in the USA.
It had two arms (groups): LY01005 (experimental) and Zoladex (active comparator).
The registry classes the interventions as drug.
More on the Plan
This will be a randomized, open-label and active-control study to assess the PK, PD and safety profiles of LY01005 versus goserelin comparator to be conducted in the USA.
Who Took Part
Enrollment: 19 actual participants took part.
It was open to men only aged from 18 years with no upper age limit.
Healthy volunteers were not accepted; participants needed the condition being studied.
The full record lists 1 inclusion and 17 exclusion criteria; among the exclusions: any patient at risk of urinary tract obstruction or spinal cord compression due to potential testosterone surge;; patients with confirmed symptoms or signs related with to cerebral metastasis or radiographically confirmed brain metastases;; patients with a history or presence of any other malignancy except recovered from basal cell carcinoma with no recurrence within the last 3 years;.
How the Study Was Run
Design: non-randomized, parallel-group and open-label.
The Goserelin group and the comparison group ran side by side rather than switching.
Being open-label, the Goserelin study did not mask who received what.
It started in 2017-12-22 with completion listed for 2018-10-15.
It ran at 5 sites in United States (5).
Its stated primary purpose is other.
What This Means in Plain Language
Put simply, this is a phase 1, non-randomized trial of Goserelin in 19 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 Goserelin compound page, all human trials.
Our Notes on the Compound
Goserelin: A GnRH analog implant (Zoladex) used to lower sex-hormone levels in prostate and breast cancer and gynecologic conditions.
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.