Vaginal Progesterone in the Treatment of Cervical Dysplasia Grade I and II - Full Text View

Sponsor:	Medical University of Vienna
Information provided by:	Medical University of Vienna
ClinicalTrials.gov Identifier:	NCT00247169

Purpose

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	Intervention	Phase
Cervical Intraepithelial Neoplasia	Drug: progesterone	Phase II

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Historical Control, Single Group Assignment, Efficacy Study
Official Title:	Vaginal Progesterone in the Treatment of Cervical Dysplasia Grade I and II: A Phase II Trial

Resource links provided by NLM:

MedlinePlus related topics: Cancer

Drug Information available for: Progesterone

U.S. FDA Resources

Further study details as provided by Medical University of Vienna:

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.

Secondary Outcome Measures:

Change of immunohistochemically detected expression of Langerhans Cells in CIN

Estimated Enrollment:	40
Study Start Date:	August 2004

Intervention Details:

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

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

Eligibility

Ages Eligible for Study:	18 Years to 60 Years
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

Criteria

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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00247169

Contacts

Contact: Lukas A Hefler, MD

+43 1 40400 ext 2962

l_hefler@yahoo.com

Locations

Austria
Dept OB/GYN, Med University of Vienna	Recruiting
Vienna, Austria
Contact: Lukas A Hefler, MD +43 1 40400 2962 l_hefler@yahoo.com
Principal Investigator: Lukas A Hefler, MD

Sponsors and Collaborators

Medical University of Vienna

Investigators

Principal Investigator:

Lukas A Hefler, MD

Medical University of Vienna

More Information

No publications provided

Study ID Numbers:	UFK-HEF 4
Study First Received:	October 31, 2005
Last Updated:	February 2, 2009
ClinicalTrials.gov Identifier:	NCT00247169 History of Changes
Health Authority:	Austria: Büro des Arzneimittelbeirates des Bundesministeriums für soziale Sicherheit und Generationen

Keywords provided by Medical University of Vienna:

cervical intraepithelial neoplasia (CIN)
progesterone

Additional relevant MeSH terms:

Neoplasms by Histologic Type
Precancerous Conditions
Progesterone
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Uterine Diseases
Hormones
Pharmacologic Actions
Cervical Intraepithelial Neoplasia

Carcinoma
Genital Diseases, Female
Neoplasms
Uterine Cervical Diseases
Carcinoma in Situ
Progestins
Uterine Cervical Dysplasia
Neoplasms, Glandular and Epithelial

ClinicalTrials.gov processed this record on November 05, 2009