Trials / Completed
CompletedNCT03936218
Goserelin 10.8mg Injection in Treatment of Advanced Prostate Cancer
A Two Arm, Multi Centric, Randomised, Open Label, Parallel Study to Compare Pharmacodynamics of Subcutaneous Goserelin 10.8mg Injection (Sponsor) With ZOLADEX® 10.8mg Injection (AstraZeneca) in Patients With Advanced Prostate Cancer
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 94 (actual)
- Sponsor
- Eurofarma Laboratorios S.A. · Industry
- Sex
- Male
- Age
- 18 Years – 75 Years
- Healthy volunteers
- Not accepted
Summary
A two arm, multi centric, randomized, open label, parallel, two doses pharmacodynamics study in patients with advanced prostate cancer.
Detailed description
A phase III, two arm, multi centric, randomized, open label, parallel, two doses pharmacodynamics study in patients with advanced prostate cancer. Each patient will have 25 visits total. Total duration of the study will be 183 days (including up to 14 days of screening).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Inj. Goserelin (Test) Subcutaneously | 10.8 mg, subcutaneously at every 3 month |
| DRUG | Inj. Zoladex (Reference) Subcutaneously | 10.8 mg, Subcutaneously at every 3 month |
Timeline
- Start date
- 2020-09-30
- Primary completion
- 2023-11-30
- Completion
- 2024-04-01
- First posted
- 2019-05-03
- Last updated
- 2025-04-17
Locations
1 site across 1 country: India
Source: ClinicalTrials.gov record NCT03936218. Inclusion in this directory is not an endorsement.