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

Sponsor

Medical University of Vienna (Other)

Overall Status

Completed

CT.gov ID

NCT00247169

Collaborator

(none)

Enrollment

Location

Duration (Months)

0.6

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Cervical Intraepithelial Neoplasia	Drug: progesterone	Phase 2

Detailed Description

Background:

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.
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

Study Design

Study Type:

Interventional

Actual Enrollment :

40 participants

Allocation:

Non-Randomized

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Aug 1, 2004

Actual Primary Completion Date :

Apr 1, 2009

Actual Study Completion Date :

Apr 1, 2010

Outcome Measures

Primary Outcome Measures

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. [6 months]

Secondary Outcome Measures

Change of immunohistochemically detected expression of Langerhans Cells in CIN [6 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 60 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Inclusion Criteria:

Histological evidence of CIN I and II
Transformation zone and lesion margins fully visible
Compliant subject
Safe contraception
Negative pregnancy test

Exclusion Criteria:

Lesion related

CIN III, (micro)-Invasive Cancer
Endocervical lesion, upper margin of lesion not visible on colposcopy
Non-compliance of patient
PAP V

Drug related

Age > 60
Hypersensitivity to progesterone or any component of the formulation
Thrombophlebitis
Undiagnosed vaginal bleeding
Carcinoma of the breast
Cerebral apoplexy
Severe liver dysfunction
Pregnancy
Depression
Diabetes
Epilepsy
Migraine
Renal dysfunction
Asthma
HIV infection
Hepatitis B or C
Concurrent use of anticoagulants
Uncontrolled hypertension (> 160/90 mmHg)
Breast cancer in personal history
Concurrent hormonal therapy including OC

Clinical laboratory related

Hemoglobin < 11 g/dl
Leukocytes < 4,0 x 109/L
Platelet count < 100 x 109/L
Serum bilirubin > 2 x above upper cut-off value
Serum GOT > 2 x above upper cut-off value
Serum GPT > 2 x above upper cut-off value
Serum alkaline phosphatase > 2 x above upper cut-off value
Serum creatinine > 2 x above cut-off value

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Dept OB/GYN, Med University of Vienna	Vienna		Austria

Sponsors and Collaborators

Medical University of Vienna

Investigators

Principal Investigator: Lukas A Hefler, MD, Medical University of Vienna

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

LHefler, Assoc Professor, Medical University of Vienna

ClinicalTrials.gov Identifier:

NCT00247169

Other Study ID Numbers:

UFK-HEF 4

First Posted:

Nov 1, 2005

Last Update Posted:

Mar 9, 2012

Last Verified:

Mar 1, 2012

Keywords provided by LHefler, Assoc Professor, Medical University of Vienna

cervical intraepithelial neoplasia (CIN)

progesterone

Additional relevant MeSH terms:

Neoplasms

Cervical Intraepithelial Neoplasia

Uterine Cervical Dysplasia

Progesterone

Study Results

No Results Posted as of Mar 9, 2012