Pharmacokinetic Evaluation of Watson rhFSH and GONAL-f®

• Research type

  Research Study

• Full title

  A Comparative Pharmacokinetic Evaluation of Watson rhFSH and Follitropin Alfa (GONAL-f®) Following Single-Dose, Cross-over, Subcutaneous Injections in Healthy Female Volunteers

• IRAS ID

  112715

• Contact name

  Darren Wilbraham

• Sponsor organisation

  Watson Laboratories, Inc.

• Eudract number

  2012-003520-20

• Research summary

  The drug being tested in this study is rhFSH (recombinant human follicle-stimulating hormone). It is being developed for the treatment of infertility. This will be the first time this drug has been given to healthy female volunteers in the European Union. A similar study is planned to begin in the U.S.A. before this study but if this were delayed for any reason, this study would be the first time this drug will be given to healthy female volunteers anywhere in the world. The purpose of this research study is to evaluate how the two products being tested, Gonal-f© and Watson rhFSH, are absorbed and removed from the bloodstream after single doses given by subcutaneous (just under the skin) injections and to prove for all intents and purposes that they are the same. Information about any side effects that may occur will also be collected. We will screen a sufficient number of subjects so that at least 48 healthy female volunteers will complete the study. We estimate that this will involve screening an estimated 255 female volunteers for this study. The reason for this is that after the initial screening visit it is anticipated that some volunteers will be excluded based on admission blood tests, drug screens and ultrasound assessments. The study will take place at Quintiles Drug Research Unit, Quintiles Ltd. It will involve approximately 13 outpatient visits and 2 admission periods over approximately 69 days for volunteers. The information gained in this study will help the sponsor of this study to determine whether rhFSH is suitable for further studies in humans.

• REC name

  London - London Bridge Research Ethics Committee

• REC reference

  12/LO/1486

• Date of REC Opinion

  15 Nov 2012

• REC opinion

  Further Information Favourable Opinion