Improving diagnosis of cervical precancerous lesions in older women
Improving Diagnostic in Cervical Dysplasia: A Randomized Study With Local Estrogen Prior to Colposcopy
This study is testing if using vaginal estrogen before a cervical exam can help doctors see precancerous changes in the cervix more clearly in women aged 50 and older.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 150 (estimated) |
| Ages | 50 Years and up |
| Sex | Female |
| Sponsor | University of Aarhus Academic / other |
| Locations | 1 site (Randers) |
| Trial ID | NCT05283421 on ClinicalTrials.gov |
What this trial studies
This study evaluates whether providing vaginal estrogen pretreatment can enhance the diagnosis of cervical precancerous lesions in women aged 50 and older undergoing colposcopy. Cervical cancer, largely caused by HPV, is a significant health concern, and accurate diagnosis of precancerous lesions is crucial for effective treatment. The study employs a double-blind methodology, comparing the effects of estrogen versus a placebo on the visibility of the transformation zone during colposcopy. By optimizing current diagnostic procedures, the study aims to improve outcomes for women at risk of cervical cancer.
Who should consider this trial
Good fit: Ideal candidates are postmenopausal women aged 50 and older who are referred for colposcopy due to positive HPV tests or abnormal cervical cytology.
Not a fit: Patients who have used estrogen in the last three months or have a history of cervical radiotherapy or surgery may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved diagnostic accuracy for cervical precancerous lesions, potentially reducing the incidence of cervical cancer in older women.
How similar studies have performed: While there have been studies focusing on cervical cancer diagnostics, the specific approach of using vaginal estrogen in this context is novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Postmenopausal (defined as no bleeding ≥1 year) women referred for colposcopy aged ≥ 50 years. * Women referred for colposcopy due to a positive HPV test and/or an abnormal cervical cytology. * Women referred for colposcopy due to previous abnormal cervical histology with minimum 6. months since last colposcopy with biopsies. Exclusion Criteria: * Use of estrogen within the last 3 months regardless of administration form. * previous cervical radiotherapy, cervical amputation and/or cone biopsy * pregnancy
Where this trial is running
Randers
- Department of Gynecology and Obstetrics — Randers, Denmark (Recruiting)
Study contacts
- Principal investigator: Marianne Esbjerg, GCP-investigator — University of Copenhagen
- Study coordinator: Vibe M Bertelsen, MD, PhD student
- Email: vibebert@rm.dk
- Phone: +4578421069
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.