Full Title: A double blind placebo controlled trial of a combination of methotrexate and gefitinib versus methotrexate alone as a treatment for ectopic pregnancy.
Short Title: GEM3
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Aims of the study:
To assess the effectiveness of a combination of methotrexate (MTX) and gefitinib against MTX alone in terms of the need for surgical intervention for ectopic pregnancy.
1. To assess the effects of a combination MTX and gefitinib, compared with MTX treatment alone, on:
a) The need for further treatment with MTX.
b) The number of days to resolution of the pregnancy (hCG ≤15iu/l).
c) The number of hospital visits associated with treatment until resolution or scheduled/emergency surgery.
2. To assess the safety and tolerability of combination MTX and gefitinib compared with methotrexate treatment alone.
Study design: A multi-centre double-blind placebo-controlled randomised trial of a combination of methotrexate and gefitinib versus methotrexate and placebo alone as a treatment for ectopic pregnancy with a mechanistic study.
Sample size: 328 participants (164 participants per group) and 30 randomised patients for the mechanistic study (Edinburgh only).
Study Duration: 24 months.
Acknowledgement: This project is funded by the Efficacy and Mechanism Evaluation (EME) Programme, an MRC and NIHR partnership.
Disclaimer: The views expressed in this publication are those of the author(s) and not necessarily those of the MRC, NHS, NIHR or the Department of Health.
The EME Programme is funded by the MRC and NIHR, with contributions from the CSO in Scotland and NISCHR in Wales and the HSC R&D Division, Public Health Agency in Northern Ireland.
Chief Investigator: Prof Andrew Horne, Royal Infirmary of Edinburgh.
Study Co-Sponsors: University of Edinburgh and NHS Lothian ACCORD.
Funding: NHS National Institue for Health Research Efficacy and Mechanism Evaluation Programme.
EudraCT Number: 2015-005013-76
REC Reference No: 16/SS/0014