BE Trial of Liquid versus Freeze-dried Pergoveris®
Research type
Research Study
Full title
An Open-label, Randomized, Two-period, Two sequence Crossover Trial to Assess the Bioequivalence of the Liquid Formulation versus the Freeze-dried Formulation of 900 IU r-hFSH and 450 IU r-hLH in Pergoveris®, Administered Subcutaneously in Pituitary Suppressed Healthy Premenopausal Female Subjects.
IRAS ID
165044
Contact name
Peter Adura
Contact email
Sponsor organisation
Merck KGaA
Eudract number
2014-003506-32
Duration of Study in the UK
0 years, 3 months, 1 days
Research summary
Barrenness can result from failure to produce enough follicle stimulating hormone (FSH) and luteinising hormone (LH). In such cases the ovaries fail to produce an egg during menstrual cycles – a condition referred to as anovulation. This can be treated by giving replacement FSH and LH hormones. Pergoveris is a medication that contains both FSH and LH. It’s used for the treatment of anovulation in women who do not produce enough FSH and LH.
A new, liquid form of Pergoveris is being tested in this study. It is easier to self-inject and dosing is more precise. It’ll be compared with the current, freeze-dried form, to see if the liquid version gets into the blood stream as easily as the current version. Several blood samples will be taken to check this. One dose of each form will be given 2 weeks apart.
38 healthy female subjects will take part in the study - only women because Pergoveris is used to treat women only. They’d have normal ovaries on internal ultrasound scan, have a normal result form a cervical smear test, be taking the combined oral contraceptive pill and tolerating it well. Their usual pill will be replaced with another called Marvelon while in the study. If Marvelon has sufficiently reduced the levels of FSH and LH after taking it for around 14 days, they’d continue in the study and receive one of the medication forms. They’ll undergo another ultrasound check of the ovaries 7 days later. Those women in whom there’s a suggestion that their ovaries are overly stimulated won’t be given the second dose. At the end of the study, the subjects’ ovaries will again be checked. The whole study will last for about 77 days. The subjects will stay on the unit for 2 nights during each of Periods 1 and 2.REC name
London - West London & GTAC Research Ethics Committee
REC reference
14/LO/1820
Date of REC Opinion
21 Oct 2014
REC opinion
Unfavourable Opinion