Preventing recurrence of endometriosis by means of long acting protestogen therapy

ISRCTN ISRCTN97865475
DOI https://doi.org/10.1186/ISRCTN97865475
EudraCT/CTIS number 2013-001984-21
Secondary identifying numbers 16166
Submission date
20/03/2014
Registration date
20/03/2014
Last edited
12/09/2024
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Urological and Genital Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

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

Contact information

Prof Kevin Cooper
Scientific

University of Aberdeen
Polwarth Building
Foresterhill
Aberdeen
AB25 2ZD
United Kingdom

Phone +44 (0)1224 554800
Email kevin.cooper@nhs.net

Study information

Study designRandomised; Interventional; Design type: Treatment
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeTreatment
Participant information sheet Not available in web format, please use the contact details to request a patient information sheet
Scientific titlePRE-EMPT: Preventing Recurrence of Endometriosis by Means of long acting Progestogen Therapy
Study acronymPRE-EMPT
Study objectivesCurrent 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(s)East of Scotland Research Ethics Service (EoSRES), 12/09/2013, ref: 14/ES/1004
Health condition(s) or problem(s) studiedTopic: Reproductive Health; Subtopic: Reproductive Health and Childbirth (all Subtopics); Disease: Reproductive Health & Childbirth
InterventionCombined 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 typeOther
Primary outcome measureRecurrence of symptoms, evaluated by the pain domain of the EHP-30 questionnaire
Secondary outcome measures1. All other symptom and quality of life (QoL) domains of the EHP-30
2. Non-menstrual pelvic pain
Overall study start date14/03/2014
Completion date30/06/2021

Eligibility

Participant type(s)Patient
Age groupMixed
Lower age limit16 Years
Upper age limit45 Years
SexFemale
Target number of participants400
Total final enrolment403
Key inclusion criteria1. 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
Key exclusion criteriaAny 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
Date of first enrolment01/05/2014
Date of final enrolment28/02/2019

Locations

Countries of recruitment

  • Scotland
  • United Kingdom

Study participating centres

University of Aberdeen
Aberdeen
AB25 2ZD
United Kingdom
35 centres
-
United Kingdom

Sponsor information

NHS Grampian (UK)
Hospital/treatment centre

Foresterhill House
Ashgrove Road West
Aberdeen
AB25 2ZB
Scotland
United Kingdom

ROR logo "ROR" https://ror.org/00ma0mg56

Funders

Funder type

Government

National Institute for Health Research
Government organisation / National government
Alternative name(s)
National Institute for Health Research, NIHR Research, NIHRresearch, NIHR - National Institute for Health Research, NIHR (The National Institute for Health and Care Research), NIHR
Location
United Kingdom

Results and Publications

Intention to publish date30/06/2022
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryData sharing statement to be made available at a later date
Publication and dissemination planPlanned publication in a high-impact peer reviewed journal.
IPD sharing planThe current data sharing plans for the current study are unknown and will be made available at a later date.

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Other publications Internal pilot focus group results 11/03/2017 Yes No
HRA research summary 28/06/2023 No No
Results article 15/05/2024 21/05/2024 Yes No
Results article 01/09/2024 12/09/2024 Yes No

Editorial Notes

12/09/2024: Publication reference added.
21/05/2024: Publication reference added.
11/03/2019: The total final enrolment number has been added.
28/01/2019: The recruitment end date was changed from 30/09/2018 to 28/02/2019.
29/08/2018: The recruitment end date was changed from 01/02/2019 to 30/09/2018.
28/08/2018: Contact details updated.
06/08/2018: The recruitment end date was changed from 30/06/2018 to 01/02/2019.
18/01/2018: The recruitment end date has been updated from 31/12/2017 to 30/06/2018.
20/07/2017: Ethics approval information added.
17/07/2017: The following changes were made to the trial record:
1. The overall trial end date was changed from 01/09/2019 to 30/06/2021.
2. The target number of participants was changed from 750 to 400.
3. Publication and dissemination plan and IPD sharing statement.
13/03/2017: Publication reference added.
12/02/2016: Plain English summary added.