Status:
COMPLETED
Vaginal Progesterone in the Treatment of Cervical Dysplasia Grade I and II
Lead Sponsor:
Medical University of Vienna
Conditions:
Cervical Intraepithelial Neoplasia
Eligibility:
FEMALE
18-60 years
Phase:
PHASE2
Brief 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.
Detailed Description
Background: 1. The development of cervical intraepithelial neoplasia (CIN) was linked to a decreased local immune response as evidenced by a decrease of Langerhans' cell (LC) count in the cervical ep...
Eligibility Criteria
Inclusion
- Histological evidence of CIN I and II
- Transformation zone and lesion margins fully visible
- Compliant subject
- Safe contraception
- Negative pregnancy test
Exclusion
- Lesion related
- CIN III, (micro)-Invasive Cancer
- Endocervical lesion, upper margin of lesion not visible on colposcopy
- Non-compliance of patient
- PAP V
- Drug related
- Age \> 60
- Hypersensitivity to progesterone or any component of the formulation
- Thrombophlebitis
- Undiagnosed vaginal bleeding
- Carcinoma of the breast
- Cerebral apoplexy
- Severe liver dysfunction
- Pregnancy
- Depression
- Diabetes
- Epilepsy
- Migraine
- Renal dysfunction
- Asthma
- HIV infection
- Hepatitis B or C
- Concurrent use of anticoagulants
- Uncontrolled hypertension (\> 160/90 mmHg)
- Breast cancer in personal history
- Concurrent hormonal therapy including OC
- Clinical laboratory related
- Hemoglobin \< 11 g/dl
- Leukocytes \< 4,0 x 109/L
- Platelet count \< 100 x 109/L
- Serum bilirubin \> 2 x above upper cut-off value
- Serum GOT \> 2 x above upper cut-off value
- Serum GPT \> 2 x above upper cut-off value
- Serum alkaline phosphatase \> 2 x above upper cut-off value
- Serum creatinine \> 2 x above cut-off value
Key Trial Info
Start Date :
August 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2010
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT00247169
Start Date
August 1 2004
End Date
April 1 2010
Last Update
March 9 2012
Active Locations (1)
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1
Dept OB/GYN, Med University of Vienna
Vienna, Austria