Phase I Study of HAL Formulations Applied to the Cervix in Healthy Volunteers - Full Text View

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

This study has been terminated.

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

Drug Information available for: Hexyl 5-aminolevulinate

U.S. FDA Resources

Study Type:	Observational
Study Design:	Prospective
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

Locations

Norway
Riks-Radium University Hospital
Oslo, Norway

Sponsors and Collaborators

PhotoCure

Investigators

Principal Investigator:

Claes G Tropé, MD PhD

Riks-Radium University Hospital

More Information

Study ID Numbers:	PC CE102/07
Study First Received:	July 3, 2007
Last Updated:	January 15, 2009
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 January 16, 2009