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Hexaminolevulinate (HAL) Photodynamic Therapy (PDT) of Cervical Intraepithelial Neoplasia (CIN) Grade 1

NCT00708942 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 83

Last updated 2013-04-24

Study results available
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Summary

The study will examine the effect of HAL vs placebo photodynamic therapy of low-grade cervical precancerous lesions (dysplasia) in women.

Conditions

  • Cervical Intraepithelial Neoplasia

Interventions

DRUG

Hexaminolevulinate (HAL)

Drug: hexaminolevulinate (HAL) Suppository HAL 100 mg for 3-7 hours application

DRUG

Placebo

Placebo suppository, for 3-7 hours application

DRUG

Hexaminolevulinate (HAL)

Drug: hexaminolevulinate (HAL) Ointment HAL 100 mg for 5 hours application

DRUG

Placebo

Placebo ointment for 5 hours application

Sponsors & Collaborators

  • Photocure

    lead INDUSTRY

Principal Investigators

  • Peter Hillemanns, MD, PhD · Medizinische Hochschule Hannover, Hannover, Germany

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-01-31
Primary Completion
2012-01-31
Completion
2012-01-31

Countries

  • France
  • Germany
  • Norway

Study Locations

More Related Trials

Entities

Drugs

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 NCT00708942 on ClinicalTrials.gov