drugset / Trial / NCT01687712
Phase III Study Comparing Efficacy and Safety of AFOLIA vs Gonal-f® RFF in Women (35 to 42) Undergoing IVF
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Gonal-f | Protein / enzyme biologic | 225 iu | Subcutaneous |