Vaginal Progesterone in the Treatment of Cervical Dysplasia Grade I and II

• Status: Completed
• Trial end date: 2010-04-01
• Target enrollment: 0
• Participant gender: Female

Summary

The investigators want to test whether treatment with a natural progesterone intravaginally increases the cure rate of cervical intraepithelial neoplasia grade I and II.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Medical University of Vienna
• Treatments: Progesterone

Criteria

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