Brief Title
Vaginal Progesterone in the Treatment of Cervical Dysplasia Grade I and II
Official Title
Vaginal Progesterone in the Treatment of Cervical Dysplasia Grade I and II: A Phase II Trial
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 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
Study Phase
Phase 2
Study Type
Interventional
Primary Outcome
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.
Secondary Outcome
Change of immunohistochemically detected expression of Langerhans Cells in CIN
Condition
Cervical Intraepithelial Neoplasia
Intervention
progesterone
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Drug
Estimated Enrollment
40
Start Date
August 2004
Completion Date
April 2010
Primary Completion Date
April 2009
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
Gender
Female
Ages
18 Years - 60 Years
Accepts Healthy Volunteers
No
Contacts
Lukas A Hefler, MD, ,
Location Countries
Austria
Location Countries
Austria
Administrative Informations
NCT ID
NCT00247169
Organization ID
UFK-HEF 4
Responsible Party
Principal Investigator
Study Sponsor
Medical University of Vienna
Study Sponsor
Lukas A Hefler, MD, Principal Investigator, Medical University of Vienna
Verification Date
March 2012