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


Phase 2
18 Years
60 Years
Not Enrolling
Female
Cervical Intraepithelial Neoplasia

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Trial Information

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


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.

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


Inclusion Criteria:



1. Histological evidence of CIN I and II

2. Transformation zone and lesion margins fully visible

3. Compliant subject

4. Safe contraception

5. Negative pregnancy test

Exclusion Criteria:

Lesion related

1. CIN III, (micro)-Invasive Cancer

2. Endocervical lesion, upper margin of lesion not visible on colposcopy

3. Non-compliance of patient

4. PAP V

Drug related

1. Age > 60

2. Hypersensitivity to progesterone or any component of the formulation

3. Thrombophlebitis

4. Undiagnosed vaginal bleeding

5. Carcinoma of the breast

6. Cerebral apoplexy

7. Severe liver dysfunction

8. Pregnancy

9. Depression

10. Diabetes

11. Epilepsy

12. Migraine

13. Renal dysfunction

14. Asthma

15. HIV infection

16. Hepatitis B or C

17. Concurrent use of anticoagulants

18. Uncontrolled hypertension (> 160/90 mmHg)

19. Breast cancer in personal history

20. Concurrent hormonal therapy including OC

Clinical laboratory related

1. Hemoglobin < 11 g/dl

2. Leukocytes < 4,0 x 109/L

3. Platelet count < 100 x 109/L

4. Serum bilirubin > 2 x above upper cut-off value

5. Serum GOT > 2 x above upper cut-off value

6. Serum GPT > 2 x above upper cut-off value

7. Serum alkaline phosphatase > 2 x above upper cut-off value

8. Serum creatinine > 2 x above cut-off value

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

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.

Outcome Time Frame:

6 months

Safety Issue:

No

Principal Investigator

Lukas A Hefler, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Medical University of Vienna

Authority:

Austria: Büro des Arzneimittelbeirates des Bundesministeriums für soziale Sicherheit und Generationen

Study ID:

UFK-HEF 4

NCT ID:

NCT00247169

Start Date:

August 2004

Completion Date:

April 2010

Related Keywords:

  • Cervical Intraepithelial Neoplasia
  • cervical intraepithelial neoplasia (CIN)
  • progesterone
  • Neoplasms
  • Uterine Cervical Dysplasia
  • Cervical Intraepithelial Neoplasia
  • Carcinoma in Situ

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