Vaginal Progesterone in the Treatment of Cervical Dysplasia Grade I and II
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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 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Vaginal Progesterone in the Treatment of Cervical Dysplasia Grade I and II: A Phase II Trial |
- 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 ] [ Designated as safety issue: No ]
- Change of immunohistochemically detected expression of Langerhans Cells in CIN [ Time Frame: 6 months ] [ Designated as safety issue: No ]
| Enrollment: | 40 |
| Study Start Date: | August 2004 |
| Study Completion Date: | April 2010 |
| Primary Completion Date: | April 2009 (Final data collection date for primary outcome measure) |
-
Drug: progesterone
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 |
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 More Information
No publications provided
| Responsible Party: | LHefler, Assoc Professor, Medical University of Vienna |
| ClinicalTrials.gov Identifier: | NCT00247169 History of Changes |
| Other Study ID Numbers: | UFK-HEF 4 |
| Study First Received: | October 31, 2005 |
| Last Updated: | March 8, 2012 |
| 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 Uterine Cervical Dysplasia Cervical Intraepithelial Neoplasia Carcinoma in Situ Precancerous Conditions Uterine Cervical Diseases Uterine Diseases Genital Diseases, Female Carcinoma |
Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Progesterone Progestins Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 19, 2013