Condition category
Urological and Genital Diseases
Date applied
20/03/2014
Date assigned
20/03/2014
Last edited
12/02/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

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, or no treatment.

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)

When is the study starting and how long is it expected to run for?
March 2014 to September 2019

Who is funding the study?
National Institute for Health Research (UK)

Who is the main contact?
Prof Siladitya Bhattacharya
s.bhattacharya@abdn.ac.uk

Trial website

Contact information

Type

Scientific

Primary contact

Prof Siladitya Bhattacharya

ORCID ID

Contact details

University of Aberdeen
Polwarth Building
Foresterhill
Aberdeen
AB25 2ZD
United Kingdom
-
s.bhattacharya@abdn.ac.uk

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 Protestogen Therapy

Acronym

PRE-EMPT v1.0

Study hypothesis

We wish to carry out 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.

More details can be found at: http://public.ukcrn.org.uk/Search/StudyDetail.aspx?StudyID=16166

Ethics approval

13/NS/0103

Study design

Randomised; Interventional; Design type: Treatment

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

GP practices

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below 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 clinician’s decision.

Intervention type

Other

Phase

Phase IV

Drug names

Primary outcome measures

Recurrence of symptoms as 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

01/09/2019

Reason abandoned

Eligibility

Participant inclusion criteria

Investigators will be asked to confirm each eligibility criteria at randomisation.

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 or no treatment.

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

Planned Sample Size: 750; UK Sample Size: 750

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

14/03/2014

Recruitment end date

01/09/2019

Locations

Countries of recruitment

United Kingdom

Trial participating centre

University of Aberdeen
Aberdeen
AB25 2ZD
United Kingdom

Sponsor information

Organisation

NHS Grampian (UK)

Sponsor details

Foresterhill House
Ashgrove Road West
Aberdeen
AB25 2ZB
United Kingdom

Sponsor type

Hospital/treatment centre

Website

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

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes

12/02/2016: Plain English summary added.