Feasibility study in female HV and endometriosis patients taking COCP
Research type
Research Study
Full title
An outpatient feasibility study to determine normal ranges and variability for urinary oestradiol (E2) levels in healthy volunteers and in patients with endometriosis taking the combined oral contraceptive pill (COCP)
IRAS ID
279284
Contact name
Ulrike Lorch
Contact email
Duration of Study in the UK
0 years, 1 months, 21 days
Research summary
Richmond Pharmacology are conducting a clinical study aimed at improving the diagnosis and treatment of endometriosis. Endometriosis is a debilitating disease that can cause women a significant amount of pain over many years. Some studies suggest that around 10% of women of reproductive age have endometriosis and despite this, it is poorly understood and remains difficult to treat in many individuals1. \n\nOestrogen is the primary female sex hormone and is produced in several different forms in the human body. Oestradiol (E2) is a type of oestrogen that has a number of different roles including the development and maintenance of reproductive tissues. This study aims to confirm whether endometriosis patients on the combined oral contraceptive pill (COCP) have higher urine E2 levels compared to normal controls also taking the COCP. There is no investigational medicinal product involved in this study. Instead, it aims to determine a set of normal ranges for urinary E2 in both healthy volunteers and patients with endometriosis. Previous studies having suggested that urine E2 levels are decreased following surgical removal of endometrial lesions and thus, E2 has the potential to be used as a marker of response to treatment.\n\nTwo cohorts are planned. One will include 10 healthy volunteers and the other 20 volunteers who have endometriosis. The study is a short, non-residential study. Following standard screening procedures to determine suitability, on Day 1, 4 and 8 samples of blood and urine will be taken. On Day 4, volunteers will be asked to collect their first morning urine sample at home and bring it to the unit for analysis. Volunteers will be discharged on Day 8 following blood and urine sample collection. If they do not wish to continue the COCP, they will be advised on alternative methods of contraception by our Research Physicians.\n\nReferences\n1.\thttps://www.ncbi.nlm.nih.gov/pubmed/25408753\n
REC name
London - London Bridge Research Ethics Committee
REC reference
20/LO/0272
Date of REC Opinion
9 Apr 2020
REC opinion
Favourable Opinion