drugset / Trial / NCT01183143

Convenience and Safety of Assisted Reproductive Technology Procedures Using a Gonal-F Filled by Mass (Fbm) Liquid Formulation Applied by Pen for Ovulation Induction and In-vitro Fertilization

NCT01183143

Phase 3 Completed 215 enrolled Merck KGaA, Darmstadt, Germany
NaSingle-groupOpen-labelTreatment

Summary

This was a prospective, open-label, non-comparative, Phase IIIb trial to assess the convenience, safety and efficacy of the new Gonal-F fbm \[recombinant follicle stimulating hormone (r-FSH)\] liquid formulation, in common setting for ovulation induction (OI) and also in in-vitro fertilization (IVF).

Timeline

Start
2004-05-11
Primary completion
2006-03-02
Completion
2006-03-02

Drugs

EvaluationDrugModalityDoseRoute
Subject Gonal-f Protein / enzyme biologic 75 iu Subcutaneous
Subject Gonal-f Protein / enzyme biologic 150 iu Subcutaneous
Subject Gonal-f Protein / enzyme biologic 225 iu Subcutaneous