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Open-label, multi-center, randomized parallel group study to assess the pharmacokinetic (PK) profile of Zoreline 3.6 mg goserelin subcutaneous implant (test product, Novalon S.A.) and of Zoladex® 3.6 mg goserelin subcutaneous implant (reference product, AstraZeneca UK Limited) in women with confirmed endometriosis.

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Trial Profile

Open-label, multi-center, randomized parallel group study to assess the pharmacokinetic (PK) profile of Zoreline 3.6 mg goserelin subcutaneous implant (test product, Novalon S.A.) and of Zoladex® 3.6 mg goserelin subcutaneous implant (reference product, AstraZeneca UK Limited) in women with confirmed endometriosis.

Status: Completed
Phase of Trial: Phase II

Latest Information Update: 17 Jan 2019

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At a glance

  • Drugs Goserelin (Primary)
  • Indications Endometriosis
  • Focus Pharmacokinetics
  • Sponsors Novalon Pharmaceuticals

    • Most Recent Events

    • 21 Dec 2018 According to Mithra Pharmaceuticals media release, in February 2018, the company had announced positive PK results from this one-month formulation study.
    • 19 Dec 2017 Status changed from recruiting to completed.
    • 02 Feb 2017 New trial record

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