Contributions of authors
Lucy H.R. Whitaker (https://orcid.org/0000-0002-7678-6551) (clinical lecturer in obstetrics and gynaecology) contributed to methodology, and investigation including mechanism of action studies and led writing of the final monograph report.
Lee J. Middleton (https://orcid.org/0000-0003-4621-1922) (reader in clinical trials, senior statistician) contributed to conceptualisation, funding acquisition, methodology, supervision, formal analysis, visualisation and data curation, writing of the original draft and review/editing of the final report.
Lee Priest (https://orcid.org/0000-0002-0070-2294) (trial manager) contributed to methodology, project administration, visualisation, writing of the original draft and review/editing of the final report.
Smita Odedra (https://orcid.org/0000-0001-6495-7782) (trial manager) contributed to project administration and review/editing of the final report.
Versha Cheed (https://orcid.org/0000-0002-6713-0913) (statistician) contributed to formal analysis, visualisation, data curation and writing of the original draft.
Elaine P. Nicholls (https://orcid.org/0000-0001-5643-616X) (human resources consultant, management and development) contributed to conceptualisation, funding acquisition, methodology and review/editing of the final report.
Alistair R.W. Williams (https://orcid.org/0000-0002-7085-4525) (professor of pathology) contributed to conceptualisation, funding acquisition, investigation, methodology, formal analysis, validation, writing of the original draft and review/editing of the final draft.
Neil Roberts (https://orcid.org/0000-0001-5538-8653) (professor of medical physics and imaging science) contributed to conceptualisation, funding acquisition, investigation, methodology, formal analysis, validation, writing of the original draft and review/editing of the final draft.
Clive E. Stubbs (https://orcid.org/0000-0003-2690-6583) (trial management team leader, clinical trials) contributed to project administration, resources, supervision and review/editing of the final draft.
Konstantinos Tryposkiadis (https://orcid.org/0000-0002-2516-1180) (statistician) contributed to formal analysis, visualisation, data curation and writing of the original draft.
Hannah Bensoussane (https://orcid.org/0000-0002-6266-8204) (statistician) contributed to formal analysis, visualisation, data curation and writing of the original draft.
Rohan Chodankar (https://orcid.org/0000-0001-8881-1681) (clinical research fellow, obstetrics and gynaecology) contributed to the investigation, data analysis and visualisation (endometrial Part A, mechanism of action study) and writing of the final report.
Alison A. Murray (https://orcid.org/0000-0003-3719-3291) (postdoctoral researcher, reproductive sciences) contributed to the investigation, data analysis and visualisation (endometrial Part A, mechanism of action study) and review/editing of the final report.
Moira Nicol (https://orcid.org/0000-0002-5503-5281) (postdoctoral researcher, reproductive sciences) contributed to the investigation, formal analysis (endometrial Part A, mechanism of action study), project administration and review/editing of the final report.
Aleksandra O. Tsolova (https://orcid.org/0000-0002-0273-5815) (PhD student, reproductive sciences) contributed to investigation, formal analysis (endometrial Part A, mechanism of action study) and review/editing of the final report.
Kaiming Yin (https://orcid.org/0000-0002-8069-1117) (academic researcher, medical physics) contributed to investigation, formal analysis and visualisation (MRI stereology Part B, mechanism of action study) and writing of the final report.
Marcos Cruz (https://orcid.org/0000-0002-4767-530X) (professor of medical physics) contributed to formal analysis (MRI stereology Part B, mechanism of action study) and review/editing of the final report.
Hui Wei Leow (https://orcid.org/0000-0002-4341-7610) (medical student) contributed to investigation formal analysis and visualisation (MRI DCE Part C, mechanism of action study) and writing of the original draft.
Lucy E. Kershaw (https://orcid.org/0000-0001-9510-7940) (senior research fellow, clinical sciences) contributed to methodology, investigation, formal analysis and visualisation (MRI DCE Part C, mechanism of action study), writing of the original draft and review/editing of the final report.
Suzanne L. McLenachan (https://orcid.org/0000-0002-0263-9559) (consultant, clinical radiology) contributed to formal analysis and validation (MRI stereology Part B, mechanism of action study) and review/editing of the final draft.
Graham McKillop (https://orcid.org/0000-0002-9326-0076) (consultant, clinical radiology) contributed to formal analysis and validation (MRI stereology Part B, mechanism of action study) and review/editing of the final draft.
Jane Walker (https://orcid.org/0000-0003-1119-291X) (consultant, clinical radiology) contributed to resources and investigation and review/editing of the final draft.
Scott I. Semple (https://orcid.org/0000-0002-4008-7564) (professor of medical imaging and physics) contributed to conceptualisation, funding acquisition and methodology, and review/editing of the final draft.
T. Justin Clark (https://orcid.org/0000-0002-5943-1062) (professor of obstetrics and gynaecology) contributed to conceptualisation, funding acquisition, investigation, and methodology, supervision of research activities in Birmingham Women’s Hospital and review/editing of the final draft.
Mary Ann Lumsden (https://orcid.org/0000-0003-2998-9185) (professor of obstetrics and gynaecology) contributed to conceptualisation, funding acquisition, investigation and methodology, supervision of research activities in Glasgow Royal Infirmary and review/editing of the final draft.
Dharani Hapangama (https://orcid.org/0000-0003-0270-0150) (professor of gynaecology) contributed to conceptualisation, funding acquisition, investigation and methodology, supervision of research activities in Liverpool Women’s Hospital and review/editing of the final draft.
Lucky Saraswat (https://orcid.org/0000-0002-5434-7750) (senior clinical lecturer, obstetrics and gynaecology) contributed to supervision of research activities in Aberdeen Royal Infirmary and review/editing of the final draft.
Siladitya Bhattacharya (https://orcid.org/0000-0002-4588-356X) (professor of obstetrics and gynaecology) contributed to conceptualisation, funding acquisition, investigation, methodology and review/editing of the final draft.
Paul Smith (https://orcid.org/0000-0002-1430-5732) (clinical lecturer, obstetrics and gynaecology) contributed to conceptualisation, funding acquisition, investigation, methodology and review/editing of the final draft.
Jane Daniels (https://orcid.org/0000-0003-3324-6771) (professor of clinical trials) contributed to conceptualisation, funding acquisition, investigation and methodology, supervision, writing of the original draft and review/editing of the final report.
Hilary Critchley (https://orcid.org/0000-0003-1913-4044) (professor of reproductive medicine and chief investigator) contributed to conceptualisation, funding acquisition, investigation and methodology, supervision of research activities, writing of the original draft and review/editing of the final report.
Members of the UCON Collaborative Group
Chief investigator – Hilary Critchley, University of Edinburgh
Co-investigators
Siladitya Bhattacharya, University of Aberdeen
Justin Clark, University of Birmingham
Jane Daniels, University of Nottingham
Dharani Hapangama, University of Liverpool
Mary Ann Lumsden, University of Glasgow
Lee Middleton, University of Birmingham
Elaine Nicholls (PPI representative)
Neil Roberts, University of Edinburgh
Scott Semple, University of Edinburgh
Paul Smith, University of Birmingham
Alistair Williams, University of Edinburgh
Trial management group
Emma Barlow, University of Birmingham
Versha Cheed, University of Birmingham
Hilary Critchley, University of Edinburgh
Jane Daniels, University of Nottingham
Max Feltham, University of Birmingham
Arshad Mahmood, University of Birmingham
Lee Middleton, University of Birmingham
Smita Odedra, University of Birmingham
Lee Priest, University of Birmingham
Neil Roberts, University of Edinburgh
Clive Stubbs, University of Birmingham
Konstantionos Tryoskiadis, University of Birmingham
Lucy Whitaker, University of Edinburgh
Alistair Williams, University of Edinburgh
Additional Birmingham Clinical Trials Unit staff
Julia Seely, BCTU Programmer and data manager
Recruiting site principal investigators and support staff
Aberdeen Royal Infirmary, Aberdeen: Lucky Sarawat,* Siladitya Bhattacharya, Sandra Cant, Pat Cooper, Diane Crowe, Diane Ledingham, Minimol Paulose, Fiona Payne, Judith Wilson.
Birmingham Women’s Hospital, Birmingham: Justin Clark,* Faye Andrews, Fiona Beale, Prathiba de Silva, Raji Ganesan, Virginia Iqbal, Shanteela McCooty, Clare McPake, Siobhan O’Connor, Hammara Sattar, Paul Smith, Helen Stevenson, Jennifer Taylor.
Burnley General Hospital and Royal Blackburn Hospital, East Lancashire Hospitals NHS Trust: Kalsang Bhatia,* Bev Hammond, Santhi Kumar, Rebekah Mcrimmon, Cathie Melvin, Matthew Milner, Pam Sikora, Victoria Taylor.
Glasgow Royal Infirmary, Glasgow: Mary Ann Lumsden,* Joan Blevings, Isobel Crawford, Cecelia Lyons Lorna McKay, Therese McSorley, David Millan, Anne Marie Munro, Kirsten Paterson, Carol Ruth.
Liverpool Women’s Hospital, Liverpool: Dharani Hapangama,* Kathie Cooke, Pat Cooper, Pam Corlett, Howida Shawki, Gillian Smith, Elaine Willis.
Royal Gwent Hospital, Newport: Leena Gokhale,* Joanne Carter, Jane Gray, Patricia James, Tracy James, Emma Mills, Victoria Richards-Green.
North Manchester General Hospital and the Royal Oldham Hospital, Pennine Acute Trust: Sachchidananda Maiti,* Shabaz Hussein, Rachel Newport, Grainne O’Connor, Jennifer Philbin, Mfon Sam, Zainab Sarwar.
Prince Charles Hospital, Gurnos: Sanjay Chawathe,* Sean Dodington, David McRae, Lisa Mellish, Jamie Tucker, Joanna Wilson.
Royal Infirmary of Edinburgh, Edinburgh: Hilary Critchley,* Ruaridh Buchan, Rohan Chodankar, Catherine Hall, Barbara Hamilton, Sharon McPherson, Catherine Murray, Jane Reavey, Jane Walker, Lucy Whitaker, Tatiana White, Alistair Williams.
University Hospital, Crosshouse: Inna Sokolova,* Danielle Gilmour, Margo Henry, Lynne McNeil.
Wrexham Maelor Hospital, Wrexham: Geeta Kumar,* Huyam Abdelsalam, Sarah Davies, Emma Hall, Rachel Hughes, Sue Lord, Vicki Saul, Jane Stockport.
* principal investigator.
Trial steering committee (independent members)
Christian Becker, University of Oxford
Ying Cheong (chair from 7 June 2017), University of Southampton
Emma Crosbie, University of Manchester
Emily O’Toole (PPI representative)
Lesley Regan, Imperial College London
Jim Thornton (chair until 6 June 2017), University of Nottingham
Sanjay Vyas, University of Bristol
Data monitoring committee
Patrick Chien, University of Dundee
Lelia Duley, Nottingham Clinical Trials Unit, Nottingham
Richard Gray (chair), Clinical Trials Service Unit and Epidemiological Studies unit (CTSU), Oxford
Glenn McGluggage, Queen’s University of Belfast
Mechanistic study team
Endometrial studies
University of Edinburgh: Rohan Chodankar, Hilary Critchley, Alison Murray, Moira Nicol, Aleks Tsolova, Lucy Whitaker
MRI studies
University of Edinburgh: Hilary Critchley, Emi Hojo, Lucy Kershaw, Amanda Leow, Graham McKillop, Suzanne McLenachan, Neil Roberts, Scott Semple, Jane Walker, Lucy Whitaker, Kaiming Yin. Radiographers at the Clinical Research Imaging Centre, Queen’s Medical Research Institute, University of Edinburgh
University of Cantabria: Marcos Cruz
Sponsor
ACCORD: NHS Lothian and University of Edinburgh
Monitoring and audit teams led by Elizabeth Craig and Lorn McKenzie
Authors wish to thank Tatiana White, MRC Centre for Reproductive Health, University of Edinburgh for assistance with finalisation of manuscript preparation and submission.
Publications
Whitaker LHR, Middleton LJ, Daniels JP, Williams ARW, Priest L, Odedra S, et al. Ulipristal acetate versus levonorgestrel-releasing intrauterine system for heavy menstrual bleeding (UCON): A randomised controlled phase III trial. EClinicalMedicine 2023;60:101995. https://doi.org/10.1016/j.eclinm.2023.101995
Yin K, Whitaker L, Hojo E, McLenachan S, Walker J, McKillop G, et al. Measurement of changes in uterine and fibroid volume during treatment of heavy menstrual bleeding (HMB). Human Reproduction Open 2023;3:hoad021. https://doi.org/10.1093/hropen/hoad021
Chodankar, RR, Murray A, Nicol M, Whitaker LHR, Williams ARW and Critchley HOD. The endometrial response to modulation of ligand-progesterone receptor pathways is reversible. Fertil Steril 2021;116(3):882–95.
Patient data
This work uses data provided by patients and collected by the NHS as part of their care and support. Using patient data is vital to improve health and care for everyone. There is huge potential to make better use of information from people’s patient records, to understand more about disease, develop new treatments, monitor safety and plan NHS services. Patient data should be kept safe and secure, to protect everyone’s privacy, and it is important that there are safeguards to make sure that it is stored and used responsibly. Everyone should be able to find out about how patient data are used. (#datasaveslives). You can find out more about the background to this citation here: https://understandingpatientdata.org.UK/data-citation.
Ethics statement
The trial had a favourable ethical opinion from the London (Bloomsbury) National Research Ethics Service Committee (REC No 14/LO/1602) and clinical trial authorisation from the Medicines and Healthcare products Regulatory Agency (MHRA; EudraCT No: 2014-003408-65). Amendments to the protocol, required as a consequence of the two urgent safety measures, were based on the MHRA guidance to monitor the safety of existing and new participants.
Data-sharing statement
All data requests should be submitted to the corresponding author for consideration. Access to anonymised data may be granted after review.
Disclaimers
This report presents independent research. The views and opinions expressed by authors in this publication are those of the authors and do not necessarily reflect those of the NHS, the NIHR, the MRC, the EME programme or the Department of Health and Social Care. If there are verbatim quotations included in this publication the views and opinions expressed by the interviewees are those of the interviewees and do not necessarily reflect those of the authors, those of the NHS, the NIHR, the EME programme or the Department of Health and Social Care.