Overview

A Randomized, Multicentre, Open Label, Evaluator Blinded Study to Evaluate Safety and Efficacy of Folitime® of Gemabiotech S.A., Versus Gonal-f ® of Merck Serono, in Patients With Infertility Undergoing ART

Status:
Completed

Trial end date:
2016-12-01

Target enrollment:

Participant gender:

Summary

This is an open-label, Phase 3, randomized, two arms, multicenter, prospective, experimental study of Folitime® (a new biosimilar formulation of r-hFSH, follitropin alfa) versus the original one (Gonal-f ®).

Phase:

Phase 3

Details

Lead Sponsor:

Gema Biotech S.A.

Collaborators:

QUID Quality in Drugs and Devices Latin American Consulting SRL
QUID-Quality in Drugs and Devices Latin American Consulting SRL

Treatments:

Follicle Stimulating Hormone