Improving diagnosis of cervical precancerous lesions in older women

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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, Post.doc.
• Email: vibebert@rm.dk
• Phone: +4578420189

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.