Clinical trial · Interventional
Vaginal Progesterone in the Treatment of Cervical Dysplasia Grade I and II
Vaginal Progesterone in the Treatment of Cervical Dysplasia Grade I and II: A Phase II Trial
NCT00247169CI-TRIAL-00006439completedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The investigators want to test whether treatment with a natural progesterone intravaginally increases the cure rate of cervical intraepithelial neoplasia grade I and II.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cervical Intraepithelial Neoplasia | Cervical Intraepithelial Neoplasia | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| progesterone | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- To evaluate whether or not a treatment with vaginal progesterone 400mg 1x daily for 10 days/month from menstrual cycle day 16-25 for 6 months increases regression rates of CIN I and II.
- timeFrame
- 6 months
Secondary outcomes (1)
- measure
- Change of immunohistochemically detected expression of Langerhans Cells in CIN
- timeFrame
- 6 months
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 60 Years
Show eligibility criteria text
Inclusion Criteria: 1. Histological evidence of CIN I and II 2. Transformation zone and lesion margins fully visible 3. Compliant subject 4. Safe contraception 5. Negative pregnancy test Exclusion Criteria: Lesion related 1. CIN III, (micro)-Invasive Cancer 2. Endocervical lesion, upper margin of lesion not visible on colposcopy 3. Non-compliance of patient 4. PAP V Drug related 1. Age \> 60 2. Hypersensitivity to progesterone or any component of the formulation 3. Thrombophlebitis 4. Undiagnosed vaginal bleeding 5. Carcinoma of the breast 6. Cerebral apoplexy 7. Severe liver dysfunction 8. Pregnancy 9. Depression 10. Diabetes 11. Epilepsy 12. Migraine 13. Renal dysfunction 14. Asthma 15. HIV infection 16. Hepatitis B or C 17. Concurrent use of anticoagulants 18. Uncontrolled hypertension (\> 160/90 mmHg) 19. Breast cancer in personal history 20. Concurrent hormonal therapy including OC Clinical laboratory related 1. Hemoglobin \< 11 g/dl 2. Leukocytes \< 4,0 x 109/L 3. Platelet count \< 100 x 109/L 4. Serum bilirubin \> 2 x above upper cut-off value 5. Serum GOT \> 2 x above upper cut-off value 6. Serum GPT \> 2 x above upper cut-off value 7. Serum alkaline phosphatase \> 2 x above upper cut-off value 8. Serum creatinine \> 2 x above cut-off value
References
Publications (0)
Data not yet available
No reference posted for this study.