Vaginal Progesterone in the Treatment of Cervical Dysplasia Grade I and II
|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|
- 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 ]
- Change of immunohistochemically detected expression of Langerhans Cells in CIN [ Time Frame: 6 months ] [ Designated as safety issue: No ]
|Study Start Date:||August 2004|
|Study Completion Date:||April 2010|
|Primary Completion Date:||April 2009 (Final data collection date for primary outcome measure)|
- 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.
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.
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
Micronized progesterone 400mg 1x daily for 10 days/month from menstrual cycle day 16-25
Duration of treatment:
Please refer to this study by its ClinicalTrials.gov identifier: NCT00247169
|Dept OB/GYN, Med University of Vienna|
|Principal Investigator:||Lukas A Hefler, MD||Medical University of Vienna|