To Evaluate the Convenience, Safety and Efficacy of Follitropin Alfa Liquid Pen Compared With Follitropin Beta Liquid Pen

Phase 3 Completed 34 enrolled Merck KGaA, Darmstadt, Germany Merck Serono GmbH, Germany · collab

RandomizedParallel-groupOpen-labelTreatment

Summary

This was a prospective, randomised, open comparative monocentric phase IIIb study to evaluate the convenience, safety and efficacy of follitropin alfa (Gonal-f) liquid pen compared with follitropin beta (Puregon) liquid pen.

Timeline

Start: 2003-11
Primary completion: 2004-09
Completion: 2004-09

Publications

Results Porter R, Kissel C, Saunders H, Keck C. Patient and nurse evaluation of recombinant human follicle-stimulating hormone administration methods: comparison of two follitropin injection pens. Curr Med Res Opin. 2008 Mar;24(3):727-35. doi: 10.1185/030079908X273291. Epub 2008 Jan 28.

Drugs

Evaluation	Drug	Modality	Dose	Route
Comparator	Follitropin beta	Protein / enzyme biologic	300 iu	Subcutaneous
Comparator	Follitropin beta	Protein / enzyme biologic	600 iu	Subcutaneous
Subject	Gonal-f	Protein / enzyme biologic	300 iu	Subcutaneous
Subject	Gonal-f	Protein / enzyme biologic	450 iu	Subcutaneous
Subject	Gonal-f	Protein / enzyme biologic	900 iu	Subcutaneous

To Evaluate the Convenience, Safety and Efficacy of Follitropin Alfa Liquid Pen Compared With Follitropin Beta Liquid Pen

Summary

Timeline

Publications

Drugs

Indications