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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: Medical University of Vienna · Academic / Other
• Sex: Female
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

Summary

The investigators want to test whether treatment with a natural progesterone intravaginally increases the cure rate of cervical intraepithelial neoplasia grade I and II.

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

Conditions

• Cervical Intraepithelial Neoplasia

Interventions

Type	Name	Description
DRUG	progesterone	Micronized progesterone 400mg 1x daily for 10 days/month from menstrual cycle day 16-25

Timeline

• Start date: 2004-08-01
• Primary completion: 2009-04-01
• Completion: 2010-04-01
• First posted: 2005-11-01
• Last updated: 2012-03-09

Locations

1 site across 1 country: Austria