FIN3001

• Research type

  Research Study

• Full title

  A Phase III assessor-blinded randomised parallel group multi-centre study to compare efficacy and safety of two r-hFSH formulations (AFOLIA vs Gonal-f®) in women for assisted reproductive treatment

• IRAS ID

  52593

• Contact name

  Yakoub Khalaf

• Sponsor organisation

  Finox AG

• Eudract number

  2010-019287-37

• ISRCTN Number

  n/a

• Clinicaltrials.gov Identifier

  n/a

• Research summary

  This study is intended to bring more treatment options to women needing assisted reproductive treatment. At present, Gonal-f© is widely used in women undergoing ovulation induction. Gonal-f© is a state-of -the-art, recombinant Follicle Stimulating Hormone, approved by the European Health Authorities and well characterized in its purity and biological activity. However, it is important to patients and to the public to make recombinant Follicle Stimulating Hormone available to a larger population of patients in a more economical and possibly a more convenient form. Therefore a very similar product ‘AFOLIA’ has been developed. This study will answer the question whether AFOLIA is just as safe and effective as Gonal-f©. The potential befits to the study participants will free medical treatment for their assisted reproduction treatment. The study involves treatments that would anyway be given to the participating patients as part of their normal therapy. Treatment cycles last on average 12 days and may be repeated as needed. Women 20 to 38 years old needing Assisted Conception would be eligible to participate. The study design is a simple comparison of the two products. One third of the patients receive Gonal-f©; the other two-thirds receive AFOLIA. The study is blinded: the people assessing the study results don’t know which of the two medicines were used by any patient. The sponsor of AFOLIA, Finox AG is funding this research. Patients will be recruited at The Assisted Conception Unit at Guy’s Hospital in London.

• REC name

  London - Surrey Borders Research Ethics Committee

• REC reference

  10/H0806/48

• Date of REC Opinion

  30 Jul 2010

• REC opinion

  Further Information Favourable Opinion