Plain English Summary
Background and study aims
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. The aim of this study is to compare the effectiveness of these different treatment options in women undergoing surgery for endometriosis.
Who can participate?
Women aged 16-45 with no immediate plans to conceive who are undergoing surgery for endometriosis
What does the study involve?
Participants are randomly allocated to take either long-acting progestogens (either as three monthly injections or as a coil, which is inserted into the womb where is remains for five years), or long-term treatment with the oral contraceptive pill.
What are the possible benefits and risks of participating?
The study 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.
Where is the study run from?
University of Aberdeen (UK) and 35 other centres, BCTU is the coordinating centre
When is the study starting and how long is it expected to run for?
March 2014 to June 2021
Who is funding the study?
National Institute for Health Research (UK)
Who is the main contact?
Prof. Kevin Cooper
kevin.cooper@nhs.net
Trial website
Contact information
Type
Scientific
Primary contact
Prof Kevin Cooper
ORCID ID
Contact details
University of Aberdeen
Polwarth Building
Foresterhill
Aberdeen
AB25 2ZD
United Kingdom
+44 (0)1224 554800
kevin.cooper@nhs.net
Additional identifiers
EudraCT number
2013-001984-21
ClinicalTrials.gov number
Protocol/serial number
16166
Study information
Scientific title
PRE-EMPT: Preventing Recurrence of Endometriosis by Means of long acting Progestogen Therapy
Acronym
PRE-EMPT
Study hypothesis
Current study hypothesis as of 17/07/2017:
A large randomised controlled trial in which women undergoing surgery for endometriosis will be randomly allocated to take long acting progestogens (either as three monthly injections or as a coil, which is inserted into the womb where is remains for five years), or long term treatment with the oral contraceptive pill.
Previous study hypothesis:
A large randomised controlled trial in which women undergoing surgery for endometriosis will be randomly allocated to take long acting progestogens (either as three monthly injections or as a coil, which is inserted into the womb where is remains for five years), or long term treatment with the oral contraceptive pill, or no treatment.
Ethics approval
East of Scotland Research Ethics Service (EoSRES), 12/09/2013, ref: 14/ES/1004
Study design
Randomised; Interventional; Design type: Treatment
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details to request a patient information sheet
Condition
Topic: Reproductive Health; Subtopic: Reproductive Health and Childbirth (all Subtopics); Disease: Reproductive Health & Childbirth
Intervention
Combined oral contraceptive pill, if an option and allocated by randomisation:
Initial prescription dispensed by gynaecologist, before discharge, or else as soon as possible by GP or at family planning clinic. Subsequent prescriptions by GP or at family planning clinic.
DMPA injection, if an option and allocated by randomisation:
Initial injection by gynaecologist, before discharge, or else as soon as possible by GP or family planning clinic. Subsequent 3 monthly injections by GP or at family planning clinic.
LNG-IUS insertion, if an option and allocated by randomisation:
Initial insertion by gynaecologist, either during laparoscopy or before discharge, or else as soon as possible by GP or at family planning clinic.
Laparoscopy
All participants will have a laparoscopy to diagnose endometriosis and for excision/ablation or endometrial lesions if found. These will be either in a single procedure or two procedures, depending on clinicianÂ’'s decision.
Intervention type
Other
Phase
Phase IV
Drug names
Primary outcome measure
Recurrence of symptoms, evaluated by the pain domain of the EHP-30 questionnaire
Secondary outcome measures
1. All other symptom and quality of life (QoL) domains of the EHP-30
2. Non-menstrual pelvic pain
Overall trial start date
14/03/2014
Overall trial end date
30/06/2021
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Women aged 16-45
2. No immediate plans to conceive
3. Are scheduled to have laparoscopic conservative surgery, or a diagnostic laparoscopy with concurrent surgery if endometriosis is found, for pelvic pain associated with endometriosis
(Pilot phase) willing to be randomised to at least one long-acting progestogen (LNG-IUS/DMPA) and COCP
Participant type
Patient
Age group
Adult
Gender
Female
Target number of participants
400
Total final enrolment
403
Participant exclusion criteria
Any women, who at the point of randomisation have any of the following, are not eligible for the trial:
1. Current infertility (trying for a baby, receiving or contemplating fertility treatment)
2. Deep infiltrating endometriosis, involving the bowel or rectovaginal septum, and requiring complex surgery, whether pre-planned or identified at laparoscopy
3. Contraindications to the use of hormonal treatment with oestrogen or progestogens
4. Suspicion of malignancy
Recruitment start date
01/05/2014
Recruitment end date
28/02/2019
Locations
Countries of recruitment
United Kingdom
Trial participating centre
University of Aberdeen
Aberdeen
AB25 2ZD
United Kingdom
Trial participating centre
35 centres
-
United Kingdom
Funders
Funder type
Government
Funder name
National Institute for Health Research
Alternative name(s)
NIHR
Funding Body Type
government organisation
Funding Body Subtype
Federal/National Government
Location
United Kingdom
Results and Publications
Publication and dissemination plan
Planned publication in a high-impact peer reviewed journal.
IPD sharing statement
The current data sharing plans for the current study are unknown and will be made available at a later date.
Intention to publish date
30/06/2022
Participant level data
To be made available at a later date
Basic results (scientific)
Publication list
2017 results in: https://www.ncbi.nlm.nih.gov/pubmed/28283026