Status:
COMPLETED
A Dose-finding Study of MAL and HAL Photodynamic Therapy of Cervical Premalignant Lesions.
Lead Sponsor:
Photocure
Conditions:
Cervical Dysplasia
Eligibility:
FEMALE
18+ years
Phase:
PHASE1
PHASE2
Brief Summary
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).
Detailed Description
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 b...
Eligibility Criteria
Inclusion
- Positive histology of CIN 1-3
Exclusion
- Patients with endocervical lesions
- Patients with AGUS
- Patients with invasive disease
- Patients with porphyria
- Patients sensitive to MAL and HAL
Key Trial Info
Start Date :
August 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2009
Estimated Enrollment :
96 Patients enrolled
Trial Details
Trial ID
NCT00369018
Start Date
August 1 2006
End Date
July 1 2009
Last Update
November 30 2010
Active Locations (2)
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1
Medizinische Hochschule Hannover, Department of Obstetrics and Gynecology
Hanover, Germany, 30625
2
Ullevål University Hospital, Department of Obstetrics and Gynecology
Oslo, Norway, 0407