Vaginal progesterone in the treatment of cervical dysplasia grade I: A phase II trial

Abstract

5174 Background: Cervical intraepithelial neoplasia (CIN) grade I is a frequent HPV associated disease. The development of CIN was linked to a decrease of apoptosis and Langerhans’ cell (LC) count in the cervical epithelium, as well as to an increase in the expression of various adhesion molecules. Preliminary studies show that vaginally administered progesterone locally increases apoptosis and the number of LCs, and decreases the expression of various adhesion molecules. We hypothesized that vaginal progesterone increases the regression rate of CIN I. Methods: We are performing a prospective, non-randomized, open phase II trial with vaginal progesterone as treatment of CIN I. As of 12/5/2004, 18 patients are receiving 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. A total of 40 patients will be included in the study. Regression rates are compared with 40 controls managed expectantly. Results: Of the 40 controls, 14 lesions regressed within a mean observation time of 194 days. HPV status at inclusion (p=0.01), but not age, number of sexual partners, parity, smoking habits, use of contraceptive devices, and social status were associated with the regression rate. During the study period, 23 women were screened and asked to participate. Of those, only 5 refused to participate. Of the 18 progesterone treated women, already 6 had their 3-month examination. Regression was ascertained in 2 women during a mean follow-up of 103 (SD=11.1) days. Patients’ compliance is excellent, no side effects were noted. As of 12/05/04, we did not ascertain any statistical difference between women with and without progesterone treatment due to the low number of women enrolled in the active treatment arm to date. Conclusions: Vaginal progesterone is a well-established treatment option in gynecology. In women with CIN I, the participation rate and compliance is high and no side effects of the applied treatment were reproted. We expect to present more comprehensive data on the efficacy of vaginal progesterone with respect to CIN I regression rates in a few months. No significant financial relationships to disclose.