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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
LHefler, Medical University of Vienna
ClinicalTrials.gov Identifier:
NCT00247169
First received: October 31, 2005
Last updated: March 8, 2012
Last verified: March 2012

October 31, 2005
March 8, 2012
August 2004
April 2009   (final data collection date for primary outcome measure)
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. [ Time Frame: 6 months ] [ Designated as safety issue: No ]
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.
Complete list of historical versions of study NCT00247169 on ClinicalTrials.gov Archive Site
Change of immunohistochemically detected expression of Langerhans Cells in CIN [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Change of immunohistochemically detected expression of Langerhans Cells in CIN
Not Provided
Not Provided
 
Vaginal Progesterone in the Treatment of Cervical Dysplasia Grade I and II
Vaginal Progesterone in the Treatment of Cervical Dysplasia Grade I and II: A Phase II Trial

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

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

Interventional
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Cervical Intraepithelial Neoplasia
Drug: progesterone
Micronized progesterone 400mg 1x daily for 10 days/month from menstrual cycle day 16-25
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
40
April 2010
April 2009   (final data collection date for primary outcome measure)

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
Female
18 Years to 60 Years
No
Contact information is only displayed when the study is recruiting subjects
Austria
 
NCT00247169
UFK-HEF 4
Not Provided
LHefler, Medical University of Vienna
Medical University of Vienna
Not Provided
Principal Investigator: Lukas A Hefler, MD Medical University of Vienna
Medical University of Vienna
March 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP