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Phase I Study of HAL Formulations Applied to the Cervix in Healthy Volunteers

This study is not yet open for participant recruitment.
Verified by PhotoCure, July 2007

Sponsored by: PhotoCure
Information provided by: PhotoCure
ClinicalTrials.gov Identifier: NCT00496171
  Purpose

The purpose of the study is to determine the most effective formulation of HAL for release of hexaminolevulinate to the cervical epithelium at different doses.


Condition
Healthy

ChemIDplus related topics:   Hexyl 5-aminolevulinate   

U.S. FDA Resources

Study Type:   Observational
Study Design:   Natural History, Cross-Sectional, Defined Population, Prospective Study
Official Title:   A Phase I Hexaminolevulinate (HAL) Dose-Finding Study Applying Different Formulations to the Cervix in Healthy Volunteers
  Eligibility
Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes

Criteria

Inclusion Criteria:

  • Healthy, pre-menopausal female volunteers

Exclusion Criteria:

  • Acute or chronic disease which could influence the study results
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00496171

Contacts
Contact: Claes G Tropé, MD PhD     +4722934000     c.g.trope@medisin.uio.no    

Locations
Norway
Riks-Radium University Hospital     Not yet recruiting
      Oslo, Norway
      Sub-Investigator: Kern Janne, MD PhD            
      Sub-Investigator: Gunnar Kristensen, MD PhD            
      Sub-Investigator: Even Angell-Petersen, MSc PhD            

Sponsors and Collaborators
PhotoCure

Investigators
Principal Investigator:     Claes G Tropé, MD PhD     Riks-Radium University Hospital    
  More Information


Study ID Numbers:   PC CE102/07
First Received:   July 3, 2007
Last Updated:   July 3, 2007
ClinicalTrials.gov Identifier:   NCT00496171
Health Authority:   Norway: Norwegian Medicines Agency;   Norway: The National Committees for Research Ethics in Norway

Study placed in the following topic categories:
Signs and Symptoms
Healthy

ClinicalTrials.gov processed this record on October 06, 2008




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