Preventing recurrence of endometriosis by means of long acting protestogen therapy
| ISRCTN | ISRCTN97865475 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN97865475 |
| Clinical Trials Information System (CTIS) | 2013-001984-21 |
| Protocol serial number | 16166 |
| Sponsor | NHS Grampian (UK) |
| Funder | National Institute for Health Research |
- 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
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
Scientific
University of Aberdeen
Polwarth Building
Foresterhill
Aberdeen
AB25 2ZD
United Kingdom
| Phone | +44 (0)1224 554800 |
|---|---|
| kevin.cooper@nhs.net |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised; Interventional; Design type: Treatment |
| Secondary study design | Randomised controlled trial |
| Study type | Participant information sheet |
| Scientific title | PRE-EMPT: Preventing Recurrence of Endometriosis by Means of long acting Progestogen Therapy |
| Study acronym | PRE-EMPT |
| Study objectives | 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(s) | East of Scotland Research Ethics Service (EoSRES), 12/09/2013, ref: 14/ES/1004 |
| Health condition(s) or problem(s) studied | 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 |
| Primary outcome measure(s) |
Recurrence of symptoms, evaluated by the pain domain of the EHP-30 questionnaire |
| Key secondary outcome measure(s) |
1. All other symptom and quality of life (QoL) domains of the EHP-30 |
| Completion date | 30/06/2021 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Mixed |
| Lower age limit | 16 Years |
| Upper age limit | 45 Years |
| Sex | Female |
| Target sample size at registration | 400 |
| Total final enrolment | 403 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 01/05/2014 |
| Date of final enrolment | 28/02/2019 |
Locations
Countries of recruitment
- United Kingdom
- Scotland
Study participating centres
AB25 2ZD
United Kingdom
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Data sharing statement to be made available at a later date |
| IPD sharing plan | The 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? |
|---|---|---|---|---|---|
| Results article | 15/05/2024 | 21/05/2024 | Yes | No | |
| Results article | 01/09/2024 | 12/09/2024 | Yes | No | |
| HRA research summary | 28/06/2023 | No | No | ||
| Other publications | Internal pilot focus group results | 11/03/2017 | Yes | No | |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
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.
