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Completed Phase 1 Interventional

A Study to Assess LY01005 Versus Goserelin Comparator (ZOLADEX®) in Patients With Prostate Cancer

ClinicalTrials.gov ID: NCT03450109

Public ClinicalTrials.gov record NCT03450109. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Sep 24, 2026, 8:13 PM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

A Randomized and Open-label Study to Assess Pharmacokinetics, Pharmacodynamics and Safety of LY01005 Versus Goserelin Comparator (ZOLADEX®) Following a Single Administration in Patients With Prostate Cancer

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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.

Study identification

NCT ID
NCT03450109
Recruitment status
Completed
Study type
Interventional
Phase
Phase 1
Lead sponsor
Luye Pharma Group Ltd.
Industry
Enrollment
19 participants

Conditions and interventions

Interventions

Drug

Eligibility (public fields only)

Age range
18 Years and older
Sex
Male
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Dec 21, 2017
Primary completion
Oct 14, 2018
Completion
Oct 29, 2018
Last update posted
Jan 6, 2019

2017 – 2018

United States locations

U.S. sites
5
U.S. states
3
U.S. cities
5
Facility City State ZIP Site status
Pinnacle Research LLC Anniston Alabama 36207 —
South Florida Medical Research Aventura Florida 33180 —
Clinical Research Center of Flordia Pompano Beach Florida 33060 —
Florida Urology Partners Tampa Florida 33615 —
Urology, San Antonio San Antonio Texas 78909 —

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT03450109, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Jan 6, 2019 · Synced Sep 24, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT03450109 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →