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Vaginal Progesterone for Cervical Dysplasia Grade I and II
NCT00247169Phase 2
Key facts
- Status
- Completed
- Start
- Aug 2004
- Primary completion
- Apr 2009
- Countries
- 1
- Sponsor
- Medical University of Vienna
- Modality
- Small Molecules
- Drugs
- progesterone
- Conditions
- cervical intraepithelial neoplasia (CIN)
01
Overview
Phase 2, open-label, single-arm trial of progesterone in cervical intraepithelial neoplasia (CIN), sponsored by Medical University of Vienna. Primary endpoint: Regression and remission rates of CIN I and II at 6 months. Started Aug 2004; status: completed.
02
Design
1 arm- Study design
- Non-randomizedOpen-labelSingle group
Progesterone
Vaginal micronized progesterone 400mg
03
Who it enrols
Women under 60 with histologically confirmed CIN I or II, visible lesions, and no history of breast cancer or other significant comorbidities.
04
Endpoints
Primary
Regression and remission rates of CIN I and II
Secondary
Change of immunohistochemically detected expression of Langerhans Cells
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