Efficacy and Safety of FSH-GEX™ in Comparison With 150 IU Gonal-f®

Phase 2 Completed 267 enrolled Glycotope GmbH

RandomizedParallel-groupSingle-blindTreatment

Summary

The aim of the current study was the determination of the recommended standard treatment dose of FSH-GEX(TM) in women undergoing intracytoplasmic sperm injection (ICSI) treatment as assessed by follicle growth.

Timeline

Start: 2013-01-08
Primary completion: 2013-07
Completion: 2013-07-30

Publications

Results Griesinger G, Dietrich B, Stockl L, Eckert K, Goletz S, Tandler-Schneider A. Fully human glyco-optimized recombinant FSH (follitropin epsilon) - a randomized, comparator-controlled phase II clinical trial. Reprod Biomed Online. 2020 Feb;40(2):331-341. doi: 10.1016/j.rbmo.2019.09.003. Epub 2019 Sep 16.

Drugs

Evaluation	Drug	Modality	Dose	Route
Comparator	Gonal-f	Protein / enzyme biologic	150 iu	Subcutaneous
Subject	Recombinant human follicle stimulating hormone (r-hFSH)	Protein / enzyme biologic	52.5 iu	Subcutaneous
Subject	Recombinant human follicle stimulating hormone (r-hFSH)	Protein / enzyme biologic	75 iu	Subcutaneous
Subject	Recombinant human follicle stimulating hormone (r-hFSH)	Protein / enzyme biologic	112.5 iu	Subcutaneous
Subject	Recombinant human follicle stimulating hormone (r-hFSH)	Protein / enzyme biologic	150 iu	Subcutaneous

Efficacy and Safety of FSH-GEX™ in Comparison With 150 IU Gonal-f®

Summary

Timeline

Publications

Drugs

Indications