Clinical Trial: Vaginal Progesterone in the Treatment of Cervical Dysplasia Grade I and II

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Vaginal Progesterone in the Treatment of Cervical Dysplasia Grade I and II: A Phase II Trial

Brief 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 Summary:

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.

Sponsor: Medical University of Vienna

Current Primary Outcome: 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 ]

Original Primary Outcome: 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.

Current Secondary Outcome: Change of immunohistochemically detected expression of Langerhans Cells in CIN [ Time Frame: 6 months ]

Original Secondary Outcome: Change of immunohistochemically detected expression of Langerhans Cells in CIN

Information By: Medical University of Vienna

Dates:
Date Received: October 31, 2005
Date Started: August 2004
Date Completion:
Last Updated: March 8, 2012
Last Verified: March 2012