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Clinical Trials/EUCTR2013-003107-19-GB
EUCTR2013-003107-19-GB
Active, not recruiting
Phase 1

Phase II clinical trial investigating the use of epigallocatechin-3-gallate (Veregen) in the treatment of vulval intraepithelial neoplasia - EPIVIN trial (v 1.0)

niversity of Birmingham0 sites26 target enrollmentApril 11, 2014

Overview

Phase
Phase 1
Intervention
Not specified
Conditions
Vulval intraepithelial neoplasia (VIN)
Sponsor
niversity of Birmingham
Enrollment
26
Status
Active, not recruiting
Last Updated
5 years ago

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
April 11, 2014
End Date
January 8, 2019
Last Updated
5 years ago
Study Type
Interventional clinical trial of medicinal product
Sex
Female

Investigators

Eligibility Criteria

Inclusion Criteria

  • \= 18 years of age, histological confirmation of usual\-type vulval intraepithelial neoplasia (VIN3\)\*, at least one lesion that can be accurately measured (using the RECIST 1\.1 criteria) in at least one dimension with longest diameter \= 20 mm, using a reliable method of contraception (excluding condoms), written informed consent to participate in the trial.
  • \*All histological material generated by this study will be assessed by Specialist Consultant in Gynaecological Pathology; 10% of biopsies will be independently reviewed by a second pathologist
  • Are the trial subjects under 18? no
  • Number of subjects for this age range: 0
  • F.1\.2 Adults (18\-64 years) yes
  • F.1\.2\.1 Number of subjects for this age range 28
  • F.1\.3 Elderly (\>\=65 years) yes
  • F.1\.3\.1 Number of subjects for this age range 28

Exclusion Criteria

  • Suspected anogenital carcinoma or those considered by the attending clinician to be at high risk of developing invasive disease; pregnant, breast feeding or trying to conceive; treated for VIN within the previous four weeks; known allergy to Veregen or any of its components; patients suffering from immunosuppressive disorder or taking immunosuppressives; unable to comply with the protocol.

Outcomes

Primary Outcomes

Not specified

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