Ignite Creation Date:
2025-12-24 @ 11:13 PM
Ignite Modification Date:
2026-02-25 @ 4:13 PM
Study NCT ID:
NCT00247169
Status:
COMPLETED
Last Update Posted:
2012-03-09
First Post:
2005-10-31
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Vaginal Progesterone in the Treatment of Cervical Dysplasia Grade I and II
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002578', 'term': 'Uterine Cervical Dysplasia'}], 'ancestors': [{'id': 'D011230', 'term': 'Precancerous Conditions'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D002577', 'term': 'Uterine Cervical Diseases'}, {'id': 'D014591', 'term': 'Uterine Diseases'}, {'id': 'D005831', 'term': 'Genital Diseases, Female'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D000091662', 'term': 'Genital Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D011374', 'term': 'Progesterone'}], 'ancestors': [{'id': 'D011282', 'term': 'Pregnenediones'}, {'id': 'D011283', 'term': 'Pregnenes'}, {'id': 'D011278', 'term': 'Pregnanes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D003339', 'term': 'Corpus Luteum Hormones'}, {'id': 'D042341', 'term': 'Gonadal Hormones'}, {'id': 'D006728', 'term': 'Hormones'}, {'id': 'D006730', 'term': 'Hormones, Hormone Substitutes, and Hormone Antagonists'}, {'id': 'D045167', 'term': 'Progesterone Congeners'}, {'id': 'D012739', 'term': 'Gonadal Steroid Hormones'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2004-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-03', 'completionDateStruct': {'date': '2010-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-03-08', 'studyFirstSubmitDate': '2005-10-31', 'studyFirstSubmitQcDate': '2005-10-31', 'lastUpdatePostDateStruct': {'date': '2012-03-09', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2005-11-01', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'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.', 'timeFrame': '6 months'}], 'secondaryOutcomes': [{'measure': 'Change of immunohistochemically detected expression of Langerhans Cells in CIN', 'timeFrame': '6 months'}]}, 'conditionsModule': {'keywords': ['cervical intraepithelial neoplasia (CIN)', 'progesterone'], 'conditions': ['Cervical Intraepithelial Neoplasia']}, 'descriptionModule': {'briefSummary': 'The investigators want to test whether treatment with a natural progesterone intravaginally increases the cure rate of cervical intraepithelial neoplasia grade I and II.', 'detailedDescription': "Background:\n\n1. 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.\n2. There is no accepted treatment strategy of low grade CIN, i.e., CIN I and II, than await spontaneous regression.\n\nThus, vaginal progesterone is expected to increase the regression rate of cervical dysplasia grade I and II.\n\nOutcome parameters:\n\nPrimary outcome parameters:\n\nTo 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.\n\nSecondary outcome parameters:\n\nChange of immunohistochemically detected expression of LCs in CIN.\n\nMethods:\n\nProspective 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.\n\nDiagnosis and main inclusion criteria:\n\nCIN I and II diagnosed by punch biopsy, lesion fully visible, otherwise healthy subjects \\< 60 years, no history of breast cancer, patient's compliance\n\nMedication:\n\nMicronized progesterone 400mg 1x daily for 10 days/month from menstrual cycle day 16-25\n\nDuration of treatment:\n\n6 months"}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Histological evidence of CIN I and II\n2. Transformation zone and lesion margins fully visible\n3. Compliant subject\n4. Safe contraception\n5. Negative pregnancy test\n\nExclusion Criteria:\n\nLesion related\n\n1. CIN III, (micro)-Invasive Cancer\n2. Endocervical lesion, upper margin of lesion not visible on colposcopy\n3. Non-compliance of patient\n4. PAP V\n\nDrug related\n\n1. Age \\> 60\n2. Hypersensitivity to progesterone or any component of the formulation\n3. Thrombophlebitis\n4. Undiagnosed vaginal bleeding\n5. Carcinoma of the breast\n6. Cerebral apoplexy\n7. Severe liver dysfunction\n8. Pregnancy\n9. Depression\n10. Diabetes\n11. Epilepsy\n12. Migraine\n13. Renal dysfunction\n14. Asthma\n15. HIV infection\n16. Hepatitis B or C\n17. Concurrent use of anticoagulants\n18. Uncontrolled hypertension (\\> 160/90 mmHg)\n19. Breast cancer in personal history\n20. Concurrent hormonal therapy including OC\n\nClinical laboratory related\n\n1. Hemoglobin \\< 11 g/dl\n2. Leukocytes \\< 4,0 x 109/L\n3. Platelet count \\< 100 x 109/L\n4. Serum bilirubin \\> 2 x above upper cut-off value\n5. Serum GOT \\> 2 x above upper cut-off value\n6. Serum GPT \\> 2 x above upper cut-off value\n7. Serum alkaline phosphatase \\> 2 x above upper cut-off value\n8. Serum creatinine \\> 2 x above cut-off value'}, 'identificationModule': {'nctId': 'NCT00247169', 'briefTitle': 'Vaginal Progesterone in the Treatment of Cervical Dysplasia Grade I and II', 'organization': {'class': 'OTHER', 'fullName': 'Medical University of Vienna'}, 'officialTitle': 'Vaginal Progesterone in the Treatment of Cervical Dysplasia Grade I and II: A Phase II Trial', 'orgStudyIdInfo': {'id': 'UFK-HEF 4'}}, 'armsInterventionsModule': {'interventions': [{'name': 'progesterone', 'type': 'DRUG', 'description': 'Micronized progesterone 400mg 1x daily for 10 days/month from menstrual cycle day 16-25'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Vienna', 'country': 'Austria', 'facility': 'Dept OB/GYN, Med University of Vienna', 'geoPoint': {'lat': 48.20849, 'lon': 16.37208}}], 'overallOfficials': [{'name': 'Lukas A Hefler, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Medical University of Vienna'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Medical University of Vienna', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assoc Professor', 'investigatorFullName': 'LHefler', 'investigatorAffiliation': 'Medical University of Vienna'}}}}