PurFECT: PURified Fatty acids for Endometriosis Clinical Trial 2
Research type
Research Study
Full title
PurFECT: PURified Fatty acids for Endometriosis Clinical Trial 2
IRAS ID
190333
Contact name
Andrew Horne
Contact email
Sponsor organisation
University of Edinburgh
Eudract number
2013-004938-15
ISRCTN Number
ISRCTN44202346
Duration of Study in the UK
1 years, 0 months, 1 days
Research summary
A feasibility study will be carried out looking at the acceptability of the processes involved in a clinical trial investigating the use of purified fatty acids (PUFA) for the treatment of endometriosis-related pelvic pain. Women with endometriosis-related pain will be recruited from out-patient departments (referred from their direct clinical team). Worst and average pain scores over four weeks will be assessed and if a worst pain score of four is reached on two occasions then they will be randomised to either PUFA or a matched placebo. Participants will then take the intervention for eight weeks. During the final four weeks pain scores will be assessed as before. Participants will be asked to complete validated quality of life questionnaires at baseline and at the end of the study. They will also be asked to complete an acceptability questionnaire at the end of the study. A blood sample will be taken at baseline and at the end of the study to measure PUFA related compound levels. The primary outcome is to determine whether it is possible to achieve acceptable recruitment and retention rates within defined inclusion/exclusion criteria. The secondary outcome is to determine the acceptability to patients of the proposed methods of recruitment, randomisation and treatments. This study will take place in NHS Lothian and at the John Radcliffe Hospital in Oxford. This study will inform a future multi-centre randomised controlled trial.
REC name
South East Scotland REC 01
REC reference
16/SS/0010
Date of REC Opinion
2 Feb 2016
REC opinion
Further Information Favourable Opinion