- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00247169
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
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Background:
- 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.
- 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
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
-
-
-
Vienna, Austria
- Dept OB/GYN, Med University of Vienna
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Histological evidence of CIN I and II
- Transformation zone and lesion margins fully visible
- Compliant subject
- Safe contraception
- Negative pregnancy test
Exclusion Criteria:
Lesion related
- CIN III, (micro)-Invasive Cancer
- Endocervical lesion, upper margin of lesion not visible on colposcopy
- Non-compliance of patient
- PAP V
Drug related
- Age > 60
- Hypersensitivity to progesterone or any component of the formulation
- Thrombophlebitis
- Undiagnosed vaginal bleeding
- Carcinoma of the breast
- Cerebral apoplexy
- Severe liver dysfunction
- Pregnancy
- Depression
- Diabetes
- Epilepsy
- Migraine
- Renal dysfunction
- Asthma
- HIV infection
- Hepatitis B or C
- Concurrent use of anticoagulants
- Uncontrolled hypertension (> 160/90 mmHg)
- Breast cancer in personal history
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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
|
6 months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Change of immunohistochemically detected expression of Langerhans Cells in CIN
Time Frame: 6 months
|
6 months
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Lukas A Hefler, MD, Medical University of Vienna
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Neoplasms by Histologic Type
- Carcinoma
- Neoplasms, Glandular and Epithelial
- Uterine Cervical Diseases
- Uterine Diseases
- Precancerous Conditions
- Carcinoma in Situ
- Neoplasms
- Cervical Intraepithelial Neoplasia
- Uterine Cervical Dysplasia
- Physiological Effects of Drugs
- Hormones
- Hormones, Hormone Substitutes, and Hormone Antagonists
- Progestins
- Progesterone
Other Study ID Numbers
- UFK-HEF 4
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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