Vaginal Progesterone in the Treatment of Cervical Dysplasia Grade I and II

Cervical Intraepithelial Neoplasia Clinical Trial

Official title:

Vaginal Progesterone in the Treatment of Cervical Dysplasia Grade I and II: A Phase II Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00247169
• Other study ID #: UFK-HEF 4
• Status: Completed
• Phase: Phase 2
• First received: October 31, 2005
• Last updated: March 8, 2012
• Start date: August 2004
• Est. completion date: April 2010

Study information

• Verified date: March 2012
• Source: Medical University of Vienna
• Contact: n/a
• Is FDA regulated: No
• Health authority: Austria: Büro des Arzneimittelbeirates des Bundesministeriums für soziale Sicherheit und Generationen
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: April 2010
• Est. primary completion date: April 2009
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 60 Years

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma in Situ
• Cervical Intraepithelial Neoplasia
• Uterine Cervical Dysplasia

Intervention

Drug:
• progesterone
Micronized progesterone 400mg 1x daily for 10 days/month from menstrual cycle day 16-25

Locations

Country	Name	City	State
Austria	Dept OB/GYN, Med University of Vienna	Vienna

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of Vienna

Country where clinical trial is conducted

Austria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.		6 months	No
Secondary	Change of immunohistochemically detected expression of Langerhans Cells in CIN		6 months	No