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A Dose-finding Study of MAL and HAL Photodynamic Therapy of Cervical Premalignant Lesions.

NCT00369018 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 96

Last updated 2010-11-30

No results posted yet for this study

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).

Conditions

  • Cervical Dysplasia

Interventions

DRUG

methyl aminolevulinate (MAL) and hexaminolevulinate (HAL)

MAL 1.2M, HAL 10mM and HAL 40mM solutions for 3 and 12 hours application

Sponsors & Collaborators

  • Photocure

    lead INDUSTRY

Principal Investigators

  • Peter Hillemanns, Md PhD · Hannover Medical School

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-08-31
Primary Completion
2009-07-31
Completion
2009-07-31

Countries

  • Germany
  • Norway

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00369018 on ClinicalTrials.gov