drugset / Trial / NCT01687712

Phase III Study Comparing Efficacy and Safety of AFOLIA vs Gonal-f® RFF in Women (35 to 42) Undergoing IVF

NCT01687712

Phase 3 Completed 1100 enrolled Fertility Biotech AG
RandomizedParallel-groupDouble-blindTreatment

Summary

The purpose of this study is to show that AFOLIA, a recombinant manufactured human follicle stimulating hormone (r-hFSH) has a similar efficacy and safety profile compared to Gonal-f® RFF.

Timeline

Start
2013-11-25
Primary completion
2015-09-10
Completion
2016-11-14

Drugs

EvaluationDrugModalityDoseRoute
Comparator Gonal-f Protein / enzyme biologic 225 iu Subcutaneous

Indications