|
Main
|
|
Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
|
Register:
|
ClinicalTrials.gov |
|
Last refreshed on:
|
19 October 2017 |
|
Main ID: |
NCT00708942 |
|
Date of registration:
|
01/07/2008 |
|
Prospective Registration:
|
Yes |
|
Primary sponsor: |
|
|
Public title:
|
Hexaminolevulinate (HAL) Photodynamic Therapy (PDT) of Cervical Intraepithelial Neoplasia (CIN) Grade 1
|
|
Scientific title:
|
A Randomized Phase II Study of Hexaminolevulinate (HAL) Photodynamic Therapy (PDT) in Patients With Low-grade Cervical Intraepithelial Neoplasia (CIN1) |
|
Date of first enrolment:
|
January 2009 |
|
Target sample size:
|
83 |
|
Recruitment status: |
Terminated |
|
URL:
|
https://clinicaltrials.gov/show/NCT00708942 |
|
Study type:
|
Interventional |
|
Study design:
|
|
|
Phase:
|
Phase 2
|
|
|
Countries of recruitment
|
|
France
|
Germany
|
Norway
|
United States
| | | | |
|
Contacts
|
|
Name:
|
Peter Hillemanns, MD, PhD |
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
Medizinische Hochschule Hannover, Hannover, Germany |
| | |
|
Key inclusion & exclusion criteria
|
Inclusion Criteria:
- Satisfactory colposcopy examination
- Negative endocervical canal by colposcopy
- Ectocervical CIN1 as verified by local pathologist (biopsy).
- Colposcopical visible lesion at visit 2, before photoactivation
- Written Informed Consent signed
- Age 18 or above
Exclusion Criteria:
- Previous treatment of CIN or invasive disease or suspicion of either micro-invasive or
invasive disease
- Malignant cells on cytology or histology
- Atypical glandular cells (AGC) or adenocarcinoma in situ (AIS) on cytology
- Suspicion of endocervical disease on colposcopy
- Current pelvic inflammatory disease, cervicitis, or other gynecological infection as
per colposcopy and clinical examination
- Known or suspected porphyria
- Known allergy to hexaminolevulinate or similar compounds (e.g. methyl aminolevulinate
or aminolevulinic acid)
- Use of heart pacemaker
- Pregnancy
- Nursing
- Childbirth or miscarriage within six weeks of enrolment - Known
- Participation in other "competitive" clinical studies either concurrently or within
the last 30 days
- Risk of poor protocol compliance
- Not willing to use adequate birth control from screening until last PDT
- Subject is the investigator or any sub-investigator, research assistant, pharmacist,
study coordinator, other staff or relative thereof directly involved in the conduct of
the protocol.
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Female
|
|
Health Condition(s) or Problem(s) studied
|
|
Cervical Intraepithelial Neoplasia
|
|
Intervention(s)
|
|
Drug: Hexaminolevulinate (HAL)
|
|
Drug: Placebo
|
|
Primary Outcome(s)
|
|
Complete Response Rate
[Time Frame: 6 month]
|
|
Secondary Outcome(s)
|
|
Incidence of Patients With Adverse Events
[Time Frame: 3 months]
|
|
Eradication of HPV
[Time Frame: 6 months]
|
|
Secondary ID(s)
|
|
PC CE201/08
|
|
Source(s) of Monetary Support
|
|
Please refer to primary and secondary sponsors
|
|