Basic Trial Information
Trial Description
     Summary
     Further Trial Information
     Eligibility Criteria
Trial Contact Information

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs Phase II Treatment Active 18 to 60 Other UFK-HEF 4 NCT00247169

Trial Description

Summary

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

Further Study Information

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

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 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

Trial Contact Information

Trial Lead Organizations/Sponsors

Universitaetsklinik fuer Innere Medizin I

Lukas A Hefler, MD

Principal Investigator

Lukas A Hefler, MD		Ph: +43 1 40400 Ext.2962
		Email: l_hefler@yahoo.com

Austria
	Vienna
	Universitaetsklinik fuer Innere Medizin I
		Lukas A Hefler, MD	Ph: +43 1 40400 2962
			Email: l_hefler@yahoo.com
		Lukas A Hefler, MD	Principal Investigator

Link to the current ClinicalTrials.gov record.
NLM Identifer NCT00247169
Information obtained from ClinicalTrials.gov on May 27, 2008