Urine collection from non-pregnant peri- and post-menopausal women
Research type
Research Study
Full title
Collection of urine samples from non-pregnant peri- and post-menopausal women
IRAS ID
214675
Contact name
Jorg Taubel
Contact email
Sponsor organisation
SPD Development Company Limited, Clearblue Innovation Centre
Duration of Study in the UK
0 years, 3 months, 1 days
Research summary
This research project involves at-home urine collection from up to 300 peri- and post- menopausal women by Richmond Pharmacology Ltd (RPL) and is sponsored by SPD Development Company (hereafter referred to as SPD). SPD are a diagnostic research company who manufacture pregnancy test kits and other reproductive health products. \nRPL will be responsible for the volunteer recruitment and consenting, checking eligibility, and sending and receiving the urine collection supplies and forms to and from the volunteers. The volunteers be asked to fill out the relevant forms and collect the urine sample(s) at home and send the forms and samples to RPL. \nThe information collected from volunteers will include demographic data, medical history, and follow up of potential pregnancy for peri-menopausal women; in order to assess Inclusion/Exclusion criteria. The volunteers who are eligible for the study will be required to collect 1 urine sample (post-menopausal women) or 2 urine samples; 7 days apart (peri-menopausal women) and send the sample together with completed forms to RPL. The urine samples and information collected from the volunteers will be sent to SPD by RPL. \nSPD will use the urine samples for product development and validation purposes. i.e. The urine samples from non-pregnant volunteers will be processed to determine the concentration of hCG (human chorionic gonadotropin which is a hormone produced by the embryo after implantation and is used as a detection method in some pregnancy kits), and potentially other urinary biomarkers related to pregnancy and fertility (e.g. FSH:follicle stimulating hormone/P3G:pregnanediol-3-glucuronide/LH:luteinising hormone/E3G:oestrone-3-glucuronide).\n
REC name
London - City & East Research Ethics Committee
REC reference
16/LO/1738
Date of REC Opinion
3 Oct 2016
REC opinion
Further Information Favourable Opinion