Participants needed for the PRE-EMPT Clinical Trial
Endometriosis UK is proud to announce that we are the partner of a clinical trial funded by the National Institute for Health Research called PRE-EMPT (Preventing Recurrence of Endometriosis by Means of Long Acting Progestogen Therapy). At this stage we are helping to recruit participants for the pilot study.
About the study
The PRE-EMPT trial is a research study that aims to address the question, “Do progesterone containing contraceptives reduce the recurrence of pain following initial surgery to remove endometriosis, and if so, which is better – the contraceptive coil, injection or pill?”
The PRE-EMPT trial will be a large randomised controlled clinical trial in which women undergoing surgery for endometriosis will be randomly allocated to take long acting progestogens - either as three monthly injections, as a contraceptive coil, long term treatment with the oral contraceptive pill or no treatment. The trial will provide information on which treatment is the most effective in terms of symptom relief, side-effects, acceptability and costs. The information will be vital in directing future clinical decision making in the area of endometriosis treatment.
In the pilot phase, 6 hospitals are taking part – Aberdeen, Edinburgh, Oxford, Birmingham Women’s, Cambridge and UCL in London. Researchers hope to recruit 100 women during 2014. If enough women can be recruited, the trial will widen out to many more hospitals across the country and researchers will aim to recruit 750 women in total.
Who can participate in the trial?
All women about to have a laparoscopy can participate. Those with deep or bowel endometriosis will not be able to participant. As the three progesterone treatments are all contraceptives, women intending to get pregnant will not be eligible to take part. However, if a participant’s circumstances change and she does desire a baby – she will be able to stop the treatment and pull out of the trial.
What would women be who participate be asked to do?
Women will be asked to allow themselves to be randomly assigned to a treatment group – the coil, the injection, the pill or no treatment.
The random allocation of treatment is the best way to test the effectiveness of the treatments. This allows researchers to know that any differences seen between the rates of pain recurrence between women are due to the treatment and not due to other factors. However, not everyone will accept being be assigned to these three treatments, or to no treatment following surgery. Therefore, in the PRE-EMPT will be flexible. As long as women are prepared to accept at least two of the four options – the coil, the injection, the pill or no treatment after surgery, they can participate.
How can I find out more about this study and whether I can take part?
For further information about the study, call 0121 415 9109 / 9110 or email email@example.com
If you are interested in participating, you will need to ask your GP to refer you to one of the clinics available during the pilot study. You will then be notified of your eligibility to take part in the study.
- Aberdeen Royal Infirmary
- Birmingham Women’s Hospital
- University College London Hospitals
- John Radcliffe Hospital (Oxford University Hospitals NHS Trust)
- Addenbrookes Hospital
- Edinburgh Royal Infirmary