PRE-EMPT
Research type
Research Study
Full title
PRE-EMPT: Preventing Recurrence of Endometriosis by Means of long acting Protestogen Therapy
IRAS ID
101577
Contact name
Patricia Burns
Contact email
Eudract number
2013-001984-21
ISRCTN Number
ISRCTN97865475
Duration of Study in the UK
7 years, 9 months, 30 days
Research summary
Summary of Research
Endometriosis is a common condition where cells similar to those within the lining of the womb are found in abnormal locations elsewhere in the body, commonly within the pelvis. Like the lining of the womb itself, these cells go through a phase of growth followed by breakdown and bleeding. This internal bleeding within the pelvis causes inflammation, the formation of scar tissue (adhesions) and is associated with pain. Endometriosis occurs in 6-10% of women of reproductive age. The condition is painful and can have a serious impact on their lives. Many will need surgery to remove areas of endometriosis in order to relieve pain. However, symptoms of endometriosis tend to return and women need to go through repeated surgery including removal of their womb and ovaries.
Previous research has suggested that medicines containing female hormones (progestogens) can reduce the chances of symptoms returning. Treatments in this class are contraceptives and include a coil, injections or the pill. However, these studies were done with small numbers of participants and were unable to provide definitive results.
We now wish to carry out 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 or as coil, which is inserted into the womb, where it remains for up to 5 years), or 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. This information will be vital in terms of future clinical decision making in an area of uncertainty.Summary of Results
What was the question? Endometriosis is a condition where cells similar to ones that line the womb are found elsewhere in the body. Endometriosis affects 1 in 10 women, many of whom have surgery for persistent pain. Unfortunately, symptoms often return, and some women will need repeat operations. Hormonal contraceptives can prevent the return of endometriosis-related pain. These are either long-acting reversible contraceptives (injections or a coil, fitted inside the womb) or the combined oral contraceptive pill (often called “the pill”). We do not know which is the best option. The aim of this trial was to find out which of these two hormone treatments was more effective in terms of symptom relief, avoidance of further surgery and costs. What did we do? 405 women with endometriosis, who were not intending to get pregnant, participated in a clinical trial. Half of the participants took long-acting reversible contraceptives, and the other half took the pill for three years following endometriosis surgery. The choice of treatment was made at random by a computer to ensure a fair comparison, although those allocated to the long-acting contraceptive could choose between injections or the coil. Participants completed questionnaires about their symptoms and life quality at intervals up to three years. What did we find? Both treatments were equally good at reducing pain but more women using the pill had repeat operations. The pill was a little more costly overall but associated with a slightly higher quality of life. What does this mean? Both treatments are equally effective in reducing pain up to three years after surgery for endometriosis. The differences in costs are small and the choice of treatment should be based on personal preferenceREC name
East of Scotland Research Ethics Service REC 2
REC reference
14/ES/1004
Date of REC Opinion
30 Aug 2013
REC opinion
Favourable Opinion