| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Advanced Prostate Cancer | Drug: Inj. Goserelin (Test) Subcutaneously Drug: Inj. Zoladex (Reference) Subcutaneously | Phase 3 |
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 68 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Official Title: | A Two Arm, Multi Centric, Randomised, Open Label, Parallel Study to Compare Pharmacodynamics of Goserelin 10.8mg Injection (Sponsor) Administered Subcutaneously With the Reference Drug ZOLADEX® 10.8mg Injection (AstraZeneca Pharmaceuticals LP) in Patients With Advanced Prostate Cancer |
| Estimated Study Start Date : | November 1, 2019 |
| Estimated Primary Completion Date : | May 1, 2020 |
| Estimated Study Completion Date : | November 1, 2020 |
| Arm | Intervention/treatment |
|---|---|
|
Experimental: Inj. Goserelin (Test) Subcutaneously
10.8 mg, Subcutaneously at every 3 month
|
Drug: Inj. Goserelin (Test) Subcutaneously
10.8 mg, subcutaneously at every 3 month
|
|
Active Comparator: Inj. Zoladex (Reference) Subcutaneously
10.8 mg, Subcutaneously at every 3 month
|
Drug: Inj. Zoladex (Reference) Subcutaneously
10.8 mg, Subcutaneously at every 3 month
|
| Ages Eligible for Study: | 18 Years to 75 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | Male |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
| Contact: Cassiano Berto | +551150908600 ext 8412 | cassiano.berto@eurofarma.com.br | |
| Contact: Sandra Rodrigues | +551150908600 ext 8417 | sandra.rodrigues@eurofarma.com.br |
| Tracking Information | |||||
|---|---|---|---|---|---|
| First Submitted Date ICMJE | April 29, 2019 | ||||
| First Posted Date ICMJE | May 3, 2019 | ||||
| Last Update Posted Date | May 3, 2019 | ||||
| Estimated Study Start Date ICMJE | November 1, 2019 | ||||
| Estimated Primary Completion Date | May 1, 2020 (Final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
To evaluate and compare the pharmacodynamics of test product against reference product and establish non inferiority. [ Time Frame: 24 weeks ] Proportion of patients achieving castrate level of serum testosterone (Serum testosterone ≤ 0.5 ng/ml) at the end of 24 weeks
|
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| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | No Changes Posted | ||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||
| Current Other Pre-specified Outcome Measures | Not Provided | ||||
| Original Other Pre-specified Outcome Measures | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Goserelin 10.8mg Injection in Treatment of Advanced Prostate Cancer | ||||
| Official Title ICMJE | A Two Arm, Multi Centric, Randomised, Open Label, Parallel Study to Compare Pharmacodynamics of Goserelin 10.8mg Injection (Sponsor) Administered Subcutaneously With the Reference Drug ZOLADEX® 10.8mg Injection (AstraZeneca Pharmaceuticals LP) in Patients With Advanced Prostate Cancer | ||||
| Brief Summary | A two arm, multi centric, randomized, open label, parallel, two doses pharmacodynamics study in patients with advanced prostate cancer. | ||||
| Detailed Description | Not Provided | ||||
| Study Type ICMJE | Interventional | ||||
| Study Phase ICMJE | Phase 3 | ||||
| Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: None (Open Label) Primary Purpose: Treatment |
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| Condition ICMJE | Advanced Prostate Cancer | ||||
| Intervention ICMJE |
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| Study Arms ICMJE |
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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Unknown status | ||||
| Estimated Enrollment ICMJE |
68 | ||||
| Original Estimated Enrollment ICMJE | Same as current | ||||
| Estimated Study Completion Date ICMJE | November 1, 2020 | ||||
| Estimated Primary Completion Date | May 1, 2020 (Final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE |
Inclusion Criteria:
Exclusion Criteria:
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| Sex/Gender ICMJE |
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| Ages ICMJE | 18 Years to 75 Years (Adult, Older Adult) | ||||
| Accepts Healthy Volunteers ICMJE | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Listed Location Countries ICMJE | Not Provided | ||||
| Removed Location Countries | |||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT03936218 | ||||
| Other Study ID Numbers ICMJE | EF 161 | ||||
| Has Data Monitoring Committee | Yes | ||||
| U.S. FDA-regulated Product |
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| IPD Sharing Statement ICMJE |
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| Responsible Party | Eurofarma Laboratorios S.A. | ||||
| Study Sponsor ICMJE | Eurofarma Laboratorios S.A. | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE | Not Provided | ||||
| PRS Account | Eurofarma Laboratorios S.A. | ||||
| Verification Date | April 2019 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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