A crossover study to assess the bioequivalence of FD vs. liquid r-hLH.

• Research type

  Research Study

• Full title

  An open-label, randomized, two-period, two-sequence crossover, single-centre trial to assess the bioequivalence of a single dose of 900 IU of freeze-dried r-hLH (Luveris®) versus a single 900 IU dose of the liquid formulation of Luveris® in the Pre-Filled Pen, administered subcutaneously (s.c.) in pituitary suppressed healthy premenopausal female subjects.

• IRAS ID

  91434

• Contact name

  Darren Wilbraham

• Sponsor organisation

  Merck Serono S.A. - Geneva

• Eudract number

  2011-004778-27

• Research summary

  Freeze-Dried (FD) Luveris© is currently in use worldwide. It is a synthetic hormone used to stimulate a follicle (egg) to develop and mature. The therapy is used when a woman desires pregnancy and her ovaries can produce a follicle but her body does not produce the right balance of hormones to make the follicle mature. The form in use is in a freeze-dried powder that has to be mixed with water prior to injection. A liquid form in a pre-filled pen device which does not require mixing up before use has been developed by Merck Serono (the Sponsor, a pharmaceutical company). The purpose of the study is to compare these two different forms of the medication and check that they behave in exactly the same way. We will compare the safety, tolerability and the way the body handles (absorbs, distributes, breaks down and excretes) the liquid version in comparison to the freeze-dried version of Luveris© in healthy young female volunteers. This study is being carried out on behalf of the Sponsor by Quintiles and will be conducted at Quintiles Drug Research Unit at Guy's Hospital, London. Up to 54 healthy female volunteers will be enrolled onto the study. The study will consist of a screening period, followed by a hormone suppression period in which volunteers will be switched onto an established oral contraceptive pill called Marvelon©, followed by 2 treatment periods (7 days each) of Luveris© separated by approximately 14 days, followed by a follow-up visit 3-4 weeks after the final dose. Volunteers will receive each form of Luveris© (one in each period). It will be given as four injections under the skin in each of the treatment period. Blood tests and ultrasound scans of the reproductive system will be performed to assess the effect of each form of Luveris©.

• REC name

  North West - Greater Manchester Central Research Ethics Committee

• REC reference

  11/IE/0167

• Date of REC Opinion

  1 Dec 2011

• REC opinion

  Further Information Favourable Opinion