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Improving diagnostics in cervical dysplasia

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2024-517151-12-00
Enrollment
150
Registered
2024-08-29
Start date
2024-09-01
Completion date
Unknown
Last updated
2026-01-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Patients are either or both HPV positive and has cervical cell changes/dysplasia.

Brief summary

Between groups, primary outcomes will be: • Scoring of the visibility of the SCJ by the colposcopist as TZ1, TZ2 and TZ3. • Representation of the TZ in at least 25% of the cervical biopsies from each patient described by the pathologist.

Detailed description

Between groups, secondary outcomes will be: • The patients' report on possible side effects during pretreatment. • The proportionen of CIN2+ found in biopsies. • The proportion of diagnostics conization. • Explore for each patient which biopsy represent the most severe histopathologic result by comparing the first biopsy with the other three.

Interventions

DRUGPlacebo til vagifem vaginal tablet 10 mikrogram.
DRUGVagifem 10 mikrogram vaginaltabletter

Sponsors

Region Midtjylland
Lead SponsorOTHER

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
Between groups, primary outcomes will be: • Scoring of the visibility of the SCJ by the colposcopist as TZ1, TZ2 and TZ3. • Representation of the TZ in at least 25% of the cervical biopsies from each patient described by the pathologist.

Secondary

MeasureTime frame
Between groups, secondary outcomes will be: • The patients' report on possible side effects during pretreatment. • The proportionen of CIN2+ found in biopsies. • The proportion of diagnostics conization. • Explore for each patient which biopsy represent the most severe histopathologic result by comparing the first biopsy with the other three.

Countries

Denmark

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026