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

This study is currently recruiting participants.
Verified by Medical University of Vienna, October 2005

Sponsored by: Medical University of Vienna
Information provided by: Medical University of Vienna
ClinicalTrials.gov Identifier: NCT00247169
  Purpose

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


Condition Intervention Phase
Cervical Intraepithelial Neoplasia (CIN)
Drug: progesterone
Phase II

MedlinePlus related topics:   Cancer   

ChemIDplus related topics:   Progesterone   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Non-Randomized, Open Label, Historical Control, Single Group Assignment, Efficacy Study
Official Title:   Vaginal Progesterone in the Treatment of Cervical Dysplasia Grade I and II: A Phase II Trial

Further study details as provided by Medical University of Vienna:

Primary Outcome Measures:
  • 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 Measures:
  • Change of immunohistochemically detected expression of Langerhans Cells in CIN

Estimated Enrollment:   40
Study Start Date:   August 2004

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

  Eligibility
Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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

  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00247169

Contacts
Contact: Lukas A Hefler, MD     +43 1 40400 ext 2962     l_hefler@yahoo.com    

Locations
Austria
Dept OB/GYN, Med University of Vienna     Recruiting
      Vienna, Austria
      Contact: Lukas A Hefler, MD     +43 1 40400 2962     l_hefler@yahoo.com    
      Principal Investigator: Lukas A Hefler, MD            

Sponsors and Collaborators
Medical University of Vienna

Investigators
Principal Investigator:     Lukas A Hefler, MD     Medical University of Vienna    
  More Information

Study ID Numbers:   UFK-HEF 4
First Received:   October 31, 2005
Last Updated:   December 15, 2005
ClinicalTrials.gov Identifier:   NCT00247169
Health Authority:   Austria: Büro des Arzneimittelbeirates des Bundesministeriums für soziale Sicherheit und Generationen

Keywords provided by Medical University of Vienna:
cervical intraepithelial neoplasia (CIN)  
progesterone  

Study placed in the following topic categories:
Genital Diseases, Female
Uterine Cervical Diseases
Progesterone
Precancerous Conditions
Cervical intraepithelial neoplasia
Carcinoma in Situ
Uterine Diseases
Uterine Cervical Dysplasia
Neoplasms, Glandular and Epithelial
Carcinoma
Cervical Intraepithelial Neoplasia

Additional relevant MeSH terms:
Neoplasms
Neoplasms by Histologic Type
Progestins
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Hormones
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 05, 2008




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