STUDY TITLE: Ulipristal acetate versus conventional (ACRONYM) UCON management of heavy menstrual bleeding (HMB; including PIC - This activity is considered a Patient uterine fibroids): a randomised controlled trial and Identification Centre study exploration of mechanism of action. NIHR PORTFOLIO REF: 18534 EudraCT No: 2014-003408-65 NHS ETHICS REF: 14/LO/1602 CHIEF INVESTIGATOR: Prof. Hilary Critchley FUNDER: National Institute for Health Research SPONSOR: NHS Lothian University of Edinburgh MAIN STUDY OBJECTIVE: Determine if UPA is more effective at reducing the burden of HMB symptoms than LNG-IUS after 12 months of treatment. SECONDARY OBJECTIVES: (1) Ascertain whether UPA use beyond 3 months and up to 12 months duration is associated with histological changes to the endometrium, and if so, whether this compromises safety. (2) Ascertain whether UPA is more effective than LNG-IUS in relation to menstrual blood loss, sexual activity, generic quality of life, satisfaction with treatment, patient reported adverse events, and compliance at 3, 6 and 12 months. (3)Determine the response to UPA and LNG-IUS treatment difference in the presence of uterine fibroids in terms of (i) alleviation of HMB and (ii) change in uterine/fibroid volume. RECRUITMENT PERIOD: March 2015 – February 2017 TRIAL POPULATION: Female aged > 18 LOCAL CO-ORDINATOR/FACILITATOR: TEL: 0121 414 7956/ 414 8045 EMAIL: Sheila Bailey/Georgi Dotchin s.m.bailey.20@bham.ac.uk/g.dotchin@bham.ac.uk ADDRESS: Clinical Research Network: Primary Care, Primary Care Clinical Sciences, Learning Centre, University of Birmingham, Edgbaston, Birmingham B15 2TT FAX REPLY: 0121 414 6571 UCON TRIAL YES PLEASE I would be interested in finding out more about this study. NO THANK YOU, I am not interested at this time. It would be helpful to the study team if you could indicate below why your PRACTICE CODE: practice would not wish to be involved at this time: PRACTICE NAME: PRACTICE ADDRESS: Too busy Funding Study not suitable Practice not interested in research Other PRACTICE CONTACT: ROLE: Tel: Email:
STUDY TITLE: Ulipristal acetate versus conventional management of heavy menstrual bleeding (HMB; including uterine fibroids): a randomised controlled trial and exploration of mechanism of action. (ACRONYM) UCON PIC - This activity is considered a Patient Identification Centre study NIHR PORTFOLIO REF: 18534 EudraCT No: 2014-003408-65 NHS ETHICS REF: 14/LO/1602 CHIEF INVESTIGATOR: Prof. Hilary Critchley FUNDER: National Institute for Health Research SPONSOR: NHS Lothian University of Edinburgh MAIN STUDY OBJECTIVE: Determine if UPA is more effective at reducing the burden of HMB symptoms than LNG-IUS after 12 months of treatment. SECONDARY OBJECTIVES: (1) Ascertain whether UPA use beyond 3 months and up to 12 months duration is associated with histological changes to the endometrium, and if so, whether this compromises safety. (2) Ascertain whether UPA is more effective than LNG-IUS in relation to menstrual blood loss, sexual activity, generic quality of life, satisfaction with treatment, patient reported adverse events, and compliance at 3, 6 and 12 months. (3)Determine the response to UPA and LNG-IUS treatment difference in the presence of uterine fibroids in terms of (i) alleviation of HMB and (ii) change in uterine/fibroid volume. RECRUITMENT PERIOD: March 2015 – February 2017 TRIAL POPULATION: Female aged > 18 LOCAL CO-ORDINATOR/FACILITATOR: Sheila Bailey/Georgi Dotchin TEL: 0121 414 7956/ 414 8045 EMAIL: s.m.bailey.20@bham.ac.uk/g.dotchin@bham.ac.uk ADDRESS: Clinical Research Network: Primary Care, Primary Care Clinical Sciences, Learning Centre, University of Birmingham, Edgbaston, Birmingham B15 2TT FAX REPLY: 0121 414 6571 UCON TRIAL YES PLEASE I would be interested in finding out more about this study. NO THANK YOU, I am not interested at this time. It would be helpful to the study team if you could indicate below why your practice would not wish to be involved at this time: Too busy Funding Study not suitable Practice not interested in research Other PRACTICE CODE: PRACTICE NAME: PRACTICE ADDRESS: PRACTICE CONTACT: ROLE: Tel: Email:
EOI-PIC-UCON.docx