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.
Phase of Trial: Phase II
Latest Information Update: 21 Dec 2018
At a glance
- Drugs Goserelin (Primary)
- Indications Endometriosis
- Focus Pharmacokinetics
- Sponsors Novalon Pharmaceuticals
- 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