Vaginal Progesterone in the Treatment of Cervical Dysplasia Grade I and II: A Phase II Trial
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.
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:
Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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.
Lukas A Hefler, MD
Medical University of Vienna
Austria: Büro des Arzneimittelbeirates des Bundesministeriums für soziale Sicherheit und Generationen