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
  Purpose

The investigators 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
Drug: progesterone
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Vaginal Progesterone in the Treatment of Cervical Dysplasia Grade I and II: A Phase II Trial

Resource links provided by NLM:


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. [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change of immunohistochemically detected expression of Langerhans Cells in CIN [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Enrollment: 40
Study Start Date: August 2004
Study Completion Date: April 2010
Primary Completion Date: April 2009 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: progesterone
    Micronized progesterone 400mg 1x daily for 10 days/month from menstrual cycle day 16-25
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

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

Locations
Austria
Dept OB/GYN, Med University of Vienna
Vienna, Austria
Sponsors and Collaborators
Medical University of Vienna
Investigators
Principal Investigator: Lukas A Hefler, MD Medical University of Vienna
  More Information

No publications provided

Responsible Party: LHefler, Assoc Professor, Medical University of Vienna
ClinicalTrials.gov Identifier: NCT00247169     History of Changes
Other Study ID Numbers: UFK-HEF 4
Study First Received: October 31, 2005
Last Updated: March 8, 2012
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

Additional relevant MeSH terms:
Neoplasms
Uterine Cervical Dysplasia
Cervical Intraepithelial Neoplasia
Carcinoma in Situ
Precancerous Conditions
Uterine Cervical Diseases
Uterine Diseases
Genital Diseases, Female
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Progesterone
Progestins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 16, 2014