{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,6,3]],"date-time":"2026-06-03T14:24:02Z","timestamp":1780496642166,"version":"3.54.1"},"reference-count":50,"publisher":"BMJ","issue":"6","license":[{"start":{"date-parts":[[2024,6,22]],"date-time":"2024-06-22T00:00:00Z","timestamp":1719014400000},"content-version":"unspecified","delay-in-days":21,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"}],"content-domain":{"domain":["bmj.com"],"crossmark-restriction":true},"short-container-title":["BMJ Open"],"accepted":{"date-parts":[[2024,5,29]]},"published-print":{"date-parts":[[2024,6]]},"abstract":"<jats:sec>\n                    <jats:title>Introduction<\/jats:title>\n                    <jats:p>Colposcopy is the most important diagnostic tool to detect cervical precancerous lesions and thereby prevention of cervical cancer. Due to age-dependent changes of the cervix, colposcopy is challenging in postmenopausal women, as the majority will have a non-visible transformation zone, resulting in increased risk of missing disease, a diagnostic cone biopsy and prolonged follow-up with repeated colposcopies. This study will be among the first to investigate, if treatment with vaginal oestrogen prior to colposcopy will improve the colposcopy performance, to ensure accurate and timely diagnosis of precancerous cervical lesions among postmenopausal women.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods and analysis<\/jats:title>\n                    <jats:p>A randomised blinded controlled multicentre study. Enrolment will be performed at gynaecology departments in Central Denmark Region and Region of Southern Denmark. A total of 150 postmenopausal women aged \u226550 years referred for colposcopy due to abnormal cervical screening results will be randomised 1:1 to either pretreatment with vaginal application of Vagifem 30 \u00b5g or placebo once a day for 14 days prior to colposcopy. The primary outcome will be to compare the percentage of women in the two groups with a visible transformation zone at colposcopy, and biopsies representative of the transformation zone. Secondary outcomes will be the proportion of detected cervical intraepithelial neoplasia grade 2 or higher in\u2009the cervical biopsies; the proportion of diagnostics cone biopsies; the patients\u2019 report on possible side effects and compliance to the pretreatment.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Ethics and dissemination<\/jats:title>\n                    <jats:p>\n                      The study has been approved by the Central Denmark Region Committee on Biomedical Research Ethics (1-10-72-34-22), the Central Denmark Regions\u2019 Research Unit (1-16-02-72-22) and The Danish Health Authority (Danish Medicine Agency; 2022015030). The study\u2019s EudraCT number is (1-23-456; 2022-000269-42) and it is registered on\n                      <jats:ext-link xmlns:xlink=\"http:\/\/www.w3.org\/1999\/xlink\" ext-link-type=\"uri\" xlink:href=\"www.clinicaltrials.gov\">www.clinicaltrials.gov<\/jats:ext-link>\n                      . The local Good Clinical Practice (GCP) unit will supervise and monitor the study closely before, during and after the study period. Findings will be disseminated in peer-reviewed scientific journals and presented in relevant conferences.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Trial registration number<\/jats:title>\n                    <jats:p>\n                      <jats:ext-link xmlns:xlink=\"http:\/\/www.w3.org\/1999\/xlink\" ext-link-type=\"clintrialgov\" xlink:href=\"NCT05283421\">NCT05283421<\/jats:ext-link>\n                      .\n                    <\/jats:p>\n                  <\/jats:sec>","DOI":"10.1136\/bmjopen-2023-082833","type":"journal-article","created":{"date-parts":[[2024,6,23]],"date-time":"2024-06-23T10:45:15Z","timestamp":1719139515000},"page":"e082833","update-policy":"https:\/\/doi.org\/10.1136\/crossmarkpolicy","source":"Crossref","is-referenced-by-count":4,"title":["Improving diagnostic of cervical dysplasia among postmenopausal women aged \u226550 years using local vaginal oestrogen treatment prior to colposcopy: study protocol for a multicentre randomised controlled trial (the IDEAL study)"],"prefix":"10.1136","volume":"14","clinical-trial-number":[{"clinical-trial-number":"nct05283421","registry":"10.18810\/clinical-trials-gov"},{"clinical-trial-number":"nct05283421","registry":"10.18810\/clinical-trials-gov"},{"clinical-trial-number":"nct05283421","registry":"10.18810\/clinical-trials-gov"}],"author":[{"ORCID":"https:\/\/orcid.org\/0000-0003-3663-9431","authenticated-orcid":false,"given":"Vibe Munk","family":"Bertelsen","sequence":"first","affiliation":[{"name":"Department of Gynecology and Obstetrics, Randers Regional Hospital, Randers, Denmark"},{"name":"University Research Clinic for Cancer Screening and Department of Public Health Programmes, Randers Regional Hospital, Randers, Denmark"},{"name":"Department of Clinical Medicine, Aarhus University, Aarhus, Denmark"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-6285-6694","authenticated-orcid":false,"given":"Mette","family":"Tranberg","sequence":"additional","affiliation":[{"name":"University Research Clinic for Cancer Screening and Department of Public Health Programmes, Randers Regional Hospital, Randers, Denmark"},{"name":"Department of Clinical Medicine, Aarhus University, Aarhus, Denmark"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-1424-6170","authenticated-orcid":false,"given":"Lone Kjeld","family":"Petersen","sequence":"additional","affiliation":[{"name":"Department of Gynecology and Obstetrics, Odense University, Odense, Denmark"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Berit","family":"Booth","sequence":"additional","affiliation":[{"name":"Department of Gynecology and Obstetrics, Randers Regional Hospital, Randers, Denmark"},{"name":"Department of Gynecology and Obstetrics, Odense University, Odense, Denmark"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Pinar","family":"Bor","sequence":"additional","affiliation":[{"name":"Department of Gynecology and Obstetrics, Aarhus University, Aarhus, Denmark"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"239","published-online":{"date-parts":[[2024,6,23]]},"reference":[{"key":"2025121220225019000_14.6.e082833.1","first-page":"5147","article-title":"Elderly women above screening age diagnosed with cervical cancer have a worse prognosis","volume":"34","author":"Darlin","year":"2014","journal-title":"Anticancer Res"},{"key":"2025121220225019000_14.6.e082833.2","doi-asserted-by":"crossref","first-page":"150","DOI":"10.1111\/aogs.13057","article-title":"The temporal and age-dependent patterns of hysterectomy-corrected cervical cancer incidence rates in Denmark: a population-based cohort study","volume":"96","author":"Hammer","year":"2017","journal-title":"Acta Obstet Gynecol Scand"},{"key":"2025121220225019000_14.6.e082833.3","doi-asserted-by":"crossref","DOI":"10.1136\/bmj.f7361","article-title":"Effect of ageing on cervical or vaginal cancer in Swedish women previously treated for cervical intraepithelial neoplasia grade 3: population based cohort study of long term incidence and mortality","volume":"348","author":"Strander","year":"2014","journal-title":"BMJ"},{"key":"2025121220225019000_14.6.e082833.4","doi-asserted-by":"crossref","first-page":"354","DOI":"10.1080\/0284186X.2017.1355110","article-title":"Cervical screening in Denmark - a success followed by stagnation","volume":"57","author":"Lynge","year":"2018","journal-title":"Acta Oncol"},{"key":"2025121220225019000_14.6.e082833.5","unstructured":"Lone Kjeld Petersen D . 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