{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,6,13]],"date-time":"2026-06-13T13:53:08Z","timestamp":1781358788169,"version":"3.54.1"},"reference-count":81,"publisher":"National Institute for Health and Care Research","license":[{"start":{"date-parts":[[2024,9,1]],"date-time":"2024-09-01T00:00:00Z","timestamp":1725148800000},"content-version":"unspecified","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"funder":[{"DOI":"10.13039\/501100000664","name":"Health Technology Assessment programme","doi-asserted-by":"publisher","award":["11\/114\/01"],"award-info":[{"award-number":["11\/114\/01"]}],"id":[{"id":"10.13039\/501100000664","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["journalslibrary.nihr.ac.uk"],"crossmark-restriction":false},"short-container-title":["Health Technol Assess"],"abstract":"<jats:title>Abstract<\/jats:title>\n<jats:sec id=\"abs1-1\"><jats:title>Background<\/jats:title>\n<jats:p>Endometriosis affects 1 in 10 women, many of whom have surgery for persistent pain. Recurrence of symptoms following an operation is common. Although hormonal treatment can reduce this risk, there is uncertainty about the best option.<\/jats:p>\n<\/jats:sec>\n<jats:sec id=\"abs1-2\"><jats:title>Objectives<\/jats:title>\n<jats:p>To evaluate the clinical and cost-effectiveness of long-acting progestogen therapy compared with the combined oral contraceptive pill in preventing recurrence of endometriosis-related pain and quality of life.<\/jats:p>\n<\/jats:sec>\n<jats:sec id=\"abs1-3\"><jats:title>Design<\/jats:title>\n<jats:p>A multicentre, open, randomised trial with parallel economic evaluation. The final design was informed by a pilot study, qualitative exploration of women\u2019s lived experience of endometriosis and a pretrial economic model.<\/jats:p>\n<\/jats:sec>\n<jats:sec id=\"abs1-4\"><jats:title>Setting<\/jats:title>\n<jats:p>Thirty-four United Kingdom hospitals.<\/jats:p>\n<\/jats:sec>\n<jats:sec id=\"abs1-5\"><jats:title>Participants<\/jats:title>\n<jats:p>Women of reproductive age undergoing conservative surgery for endometriosis.<\/jats:p>\n<\/jats:sec>\n<jats:sec id=\"abs1-6\"><jats:title>Interventions<\/jats:title>\n<jats:p>Long-acting progestogen reversible contraceptive (either 150 mg depot medroxyprogesterone acetate or 52 mg levonorgestrel-releasing intrauterine system) or combined oral contraceptive pill (30 \u00b5g ethinylestradiol, 150 \u00b5g levonorgestrel).<\/jats:p>\n<\/jats:sec>\n<jats:sec id=\"abs1-7\"><jats:title>Main outcome measures<\/jats:title>\n<jats:p>The primary outcome was the pain domain of the Endometriosis Health Profile-30 questionnaire at 36 months post randomisation. The economic evaluation estimated the cost per quality-adjusted life-years gained.<\/jats:p>\n<\/jats:sec>\n<jats:sec id=\"abs1-8\"><jats:title>Results<\/jats:title>\n<jats:p>Four hundred and five women were randomised to receive either long-acting reversible contraceptive (<jats:italic>N<\/jats:italic>\u2005=\u2005205) or combined oral contraceptive pill (<jats:italic>N<\/jats:italic>\u2005=\u2005200). Pain scores improved in both groups (24 and 23 points on average) compared with preoperative values but there was no difference between the two (adjusted mean difference: \u22120.8, 95% confidence interval \u22125.7 to 4.2; <jats:italic>p<\/jats:italic>\u2005=\u20050.76). The long-acting reversible contraceptive group underwent fewer surgical procedures or second-line treatments compared with the combined oral contraceptive group (73 vs. 97; hazard ratio 0.67, 95% confidence interval 0.44 to 1.00).<\/jats:p>\n<jats:p>The mean adjusted quality-adjusted life-year difference between two arms was 0.043 (95% confidence interval \u22120.069 to 0.152) in favour of the combined oral contraceptive pill, although this cost an additional \u00a3533 (95% confidence interval 52 to 983) per woman.<\/jats:p>\n<\/jats:sec>\n<jats:sec id=\"abs1-9\"><jats:title>Limitations<\/jats:title>\n<jats:p>Limitations include the absence of a no-treatment group and the fact that many women changed treatments over the 3 years of follow-up. Use of telephone follow-up to collect primary outcome data in those who failed to return questionnaires resulted in missing data for secondary outcomes. The COVID pandemic may have affected rates of further surgical treatment.<\/jats:p>\n<\/jats:sec>\n<jats:sec id=\"abs1-10\"><jats:title>Conclusions<\/jats:title>\n<jats:p>At 36 months, women allocated to either intervention had comparable levels of pain, with both groups showing around a 40% improvement from presurgical levels. Although the combined oral contraceptive was cost-effective at a threshold of \u00a320,000 per quality-adjusted life-year, the difference between the two was marginal and lower rates of repeat surgery might make long-acting reversible contraceptives preferable to some women.<\/jats:p>\n<\/jats:sec>\n<jats:sec id=\"abs1-11\"><jats:title>Future work<\/jats:title>\n<jats:p>Future research needs to focus on evaluating newer hormonal preparations, a more holistic approach to symptom suppression and identification of biomarkers to diagnose endometriosis and its recurrence.<\/jats:p>\n<\/jats:sec>\n<jats:sec id=\"abs1-12\"><jats:title>Trial registration<\/jats:title>\n<jats:p>This trial is registered as ISRCTN97865475. https:\/\/doi.org\/10.1186\/ISRCTN97865475.<\/jats:p>\n<\/jats:sec>\n<jats:sec id=\"abs1-13\"><jats:title>Funding<\/jats:title>\n<jats:p>This award was funded by the National Institute for Health and Care Research (NIHR) Health Technology Assessment programme (NIHR award ref: 11\/114\/01) and is published in full in <jats:italic>Health Technology Assessment<\/jats:italic>; Vol. 28, No. 55. See the NIHR Funding and Awards website for further award information.<\/jats:p>\n<jats:p>The NIHR recognises that people have diverse gender identities, and in this report, the word \u2018woman\u2019 is used to describe patients or individuals whose sex assigned at birth was female, whether they identify as female, male or non-binary.<\/jats:p>\n<\/jats:sec>","DOI":"10.3310\/sqwy6998","type":"journal-article","created":{"date-parts":[[2024,9,11]],"date-time":"2024-09-11T16:08:10Z","timestamp":1726070890000},"page":"1-77","update-policy":"https:\/\/doi.org\/10.3310\/crossmarkpolicy","source":"Crossref","is-referenced-by-count":7,"title":["Preventing recurrence of endometriosis-related pain by means of long-acting progestogen therapy: the PRE-EMPT RCT"],"prefix":"10.3310","author":[{"ORCID":"https:\/\/orcid.org\/0000-0003-1486-0071","authenticated-orcid":true,"given":"Kevin G","family":"Cooper","sequence":"first","affiliation":[{"name":"Department of Gynaecology, Aberdeen Royal 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