Pharmacodynamic Study Goserelin 3.6mg Injection Administered Subcutaneously in Premenopausal Patients with Breast Cancer
NCT03936933 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 6
Last updated 2025-02-17
Summary
A two arm, multi centric, randomized, open label, parallel, multiple dose pharmacodynamic study in premenopausal patients with advanced breast cancer.
Conditions
Interventions
- DRUG
-
Goserelin acetate 3.6 mg Injection
3.6 mg, Subcutaneously at every 28 days
- DRUG
-
ZOLADEX® 3.6mg Injection
3.6 mg, Subcutaneously at every 28 days
Sponsors & Collaborators
-
Eurofarma Laboratorios S.A.
lead INDUSTRY
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 59 Years
- Sex
- FEMALE
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2020-10-30
- Primary Completion
- 2024-09-30
- Completion
- 2025-01-30
Countries
- India
Study Locations
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