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Sponsored by: |
PhotoCure |
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Information provided by: | PhotoCure |
ClinicalTrials.gov Identifier: | NCT00369018 |
The study will determine the best drug (MAL or HAL) dosage for photodynamic therapy of cervical precancerous lesions (dysplasia) in women that are referred for conisation (surgery).
Condition | Intervention | Phase |
---|---|---|
Cervical Dysplasia |
Drug: methyl aminolevulinate (MAL) and hexaminolevulinate (HAL) |
Phase I Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Active Control, Parallel Assignment, Efficacy Study |
Official Title: | Methyl Aminolevulinate (MAL) and Hexaminolevulinate (HAL) Photodynamic Therapy (PDT)of Cervical Intraepithelial Lesions (SIL) - a Double-Blind Dose-Finding Study |
Estimated Enrollment: | 96 |
Study Start Date: | August 2006 |
Estimated Study Completion Date: | July 2009 |
Estimated Primary Completion Date: | July 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
MAL 3: Active Comparator |
Drug: methyl aminolevulinate (MAL) and hexaminolevulinate (HAL)
MAL 1.2M, HAL 10mM and HAL 40mM solutions for 3 and 12 hours application
|
MAL 12: Active Comparator |
Drug: methyl aminolevulinate (MAL) and hexaminolevulinate (HAL)
MAL 1.2M, HAL 10mM and HAL 40mM solutions for 3 and 12 hours application
|
HAL 10, 3: Active Comparator |
Drug: methyl aminolevulinate (MAL) and hexaminolevulinate (HAL)
MAL 1.2M, HAL 10mM and HAL 40mM solutions for 3 and 12 hours application
|
HAL 10, 12: Active Comparator |
Drug: methyl aminolevulinate (MAL) and hexaminolevulinate (HAL)
MAL 1.2M, HAL 10mM and HAL 40mM solutions for 3 and 12 hours application
|
HAL 40, 3: Active Comparator |
Drug: methyl aminolevulinate (MAL) and hexaminolevulinate (HAL)
MAL 1.2M, HAL 10mM and HAL 40mM solutions for 3 and 12 hours application
|
HAL 40, 12: Active Comparator |
Drug: methyl aminolevulinate (MAL) and hexaminolevulinate (HAL)
MAL 1.2M, HAL 10mM and HAL 40mM solutions for 3 and 12 hours application
|
Surgery (conisation) of precancerous cervical lesions (dysplasia) increase the risk of preterm deliveries in young women. Photodynamic therapy (PDT) is a selective, tissue preserving method that may become a good treatment option for these patients.
This study will explore topical application of methyl aminolevulinate (MAL) and hexaminolevulinate (HAL) of the cervix for photodynamic therapy using red light (630 nm). Different doses of MAL and HAL will be used with different application time, followed by illumination.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Germany | |
Medizinische Hochschule Hannover, Department of Obstetrics and Gynecology | |
Hannover, Germany, 30625 | |
Norway | |
Ullevål University Hospital, Department of Obstetrics and Gynecology | |
Oslo, Norway, 0407 |
Principal Investigator: | Peter Hillemanns, Md PhD | Hannover Medical School |
Study ID Numbers: | PC CE101/06 |
Study First Received: | August 28, 2006 |
Last Updated: | January 15, 2009 |
ClinicalTrials.gov Identifier: | NCT00369018 History of Changes |
Health Authority: | Norway: Norwegian Medicines Agency; Germany: Federal Institute for Drugs and Medical Devices |
photodynamic therapy methyl aminolevulinate hexaminolevulinate dose-finding cervical dysplasia |
Precancerous Conditions Methyl 5-aminolevulinate Uterine Diseases Cervical Intraepithelial Neoplasia Carcinoma Aminolevulinic Acid Genital Diseases, Female |
Signs and Symptoms Uterine Cervical Diseases Photosensitizing Agents Radiation-Sensitizing Agents Carcinoma in Situ Uterine Cervical Dysplasia Neoplasms, Glandular and Epithelial |
Neoplasms by Histologic Type Precancerous Conditions Physiological Effects of Drugs Methyl 5-aminolevulinate Uterine Diseases Pharmacologic Actions Cervical Intraepithelial Neoplasia Carcinoma Aminolevulinic Acid Genital Diseases, Female |
Photosensitizing Agents Neoplasms Uterine Cervical Diseases Radiation-Sensitizing Agents Therapeutic Uses Carcinoma in Situ Dermatologic Agents Uterine Cervical Dysplasia Neoplasms, Glandular and Epithelial |