Vaginal Progesterone in the Treatment of Cervical Dysplasia Grade I and II
NCT ID: NCT00247169
Last Updated: 2012-03-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
40 participants
INTERVENTIONAL
2004-08-31
2010-04-30
Brief Summary
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Detailed Description
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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 epithelium. Preliminary studies show that vaginally administered progesterone locally increases the number of LCs.
2. There is no accepted treatment strategy of low grade CIN, i.e., CIN I and II, than await spontaneous regression.
Thus, vaginal progesterone is expected to increase the regression rate of cervical dysplasia grade I and II.
Outcome parameters:
Primary outcome parameters:
To evaluate whether or not a treatment with vaginal progesterone increases regression and remission rates of CIN I and II during a 6-month treatment period.
Secondary outcome parameters:
Change of immunohistochemically detected expression of LCs in CIN.
Methods:
Prospective phase II trial with vaginal progesterone as treatment of CIN I and II. 60 patients receive vaginal micronized progesterone 400mg 1x daily for 10 days/month from menstrual cycle day 16-25 for 6 months. After 3 and 6 months patients are examined for possible regression, persistence, or progression of disease and treated accordingly. Treatment of patients with progressing CIN is being discontinued after 3 months. Follow-up of patients is ensured based on current clinical practice, i.e., regular outpatient visits every 3 months, until the lesion completely regresses.
Diagnosis and main inclusion criteria:
CIN I and II diagnosed by punch biopsy, lesion fully visible, otherwise healthy subjects \< 60 years, no history of breast cancer, patient's compliance
Medication:
Micronized progesterone 400mg 1x daily for 10 days/month from menstrual cycle day 16-25
Duration of treatment:
6 months
Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Interventions
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progesterone
Micronized progesterone 400mg 1x daily for 10 days/month from menstrual cycle day 16-25
Eligibility Criteria
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Inclusion Criteria
2. Transformation zone and lesion margins fully visible
3. Compliant subject
4. Safe contraception
5. Negative pregnancy test
Exclusion Criteria
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
18 Years
60 Years
FEMALE
No
Sponsors
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Medical University of Vienna
OTHER
Responsible Party
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LHefler
Assoc Professor
Principal Investigators
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Lukas A Hefler, MD
Role: PRINCIPAL_INVESTIGATOR
Medical University of Vienna
Locations
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Dept OB/GYN, Med University of Vienna
Vienna, , Austria
Countries
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Other Identifiers
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UFK-HEF 4
Identifier Type: -
Identifier Source: org_study_id
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