Ignite Creation Date:
2024-05-05 @ 12:07 PM
Last Modification Date:
2024-10-26 @ 9:20 AM
Study NCT ID:
NCT00247169
Status:
COMPLETED
Last Update Posted:
2012-03-09
First Post:
2005-10-31
Brief Title:
Vaginal Progesterone in the Treatment of Cervical Dysplasia Grade I and II
Sponsor:
Medical University of Vienna
Organization:
Medical University of Vienna
Study Overview
Official Title:
Vaginal Progesterone in the Treatment of Cervical Dysplasia Grade I and II A Phase II Trial
Status:
COMPLETED
Status Verified Date:
2012-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 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 ie 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 daysmonth 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 ie 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 patients compliance
Medication
Micronized progesterone 400mg 1x daily for 10 daysmonth from menstrual cycle day 16-25
Duration of treatment
6 months
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 ie 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 daysmonth 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 ie 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 patients compliance
Medication
Micronized progesterone 400mg 1x daily for 10 daysmonth from menstrual cycle day 16-25
Duration of treatment
6 months
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None