Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 11:13 PM
Ignite Modification Date:
2025-12-24 @ 11:13 PM
NCT ID:
NCT00247169
Eligibility 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
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Maximum Age:
60 Years
Study:
NCT00247169
Study Brief:
Protocol Section:
NCT00247169