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AV2 Antiviral Spray Versus Placebo in Human Papillomavirus Cervix Infections

NCT01654822 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2012-11-09

No results posted yet for this study

Summary

This study aims to prove that, by a one-time topical spray on the cervix, AV2-DM is an effective antiviral in reducing on short term (3 months) the human papillomavirus (HPV) infection.

* Primary endpoint: significant drop in viral load AV2-DM versus placebo
* Secondary endpoint:the number of patients with adverse events

Conditions

  • Genital Human Papilloma Virus Infection

Interventions

DRUG

topical application cervical spray

one time (2 puffs) topical application of 100µl AV2-DM antiviral spray( containing 50% AV2-DM and 50% olive oil)on the cervix

DRUG

topical spray on the cervix

one time (2 puffs) topical spray of 100 µl (90% olive oil and 10% d-limonene) on the cervix

PROCEDURE

cervical swab with Cervex-Brush-Combi at T0

PROCEDURE

cervical swab with Cervex-Brush-Combi at T1

PROCEDURE

cervical swab with Cervex-Brush-Combi at T0

PROCEDURE

cervical swab with Cervex-Brush-Combi at T1

Sponsors & Collaborators

  • Cesa Projects International

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
SINGLE_GROUP

Eligibility

Min Age
25 Years
Max Age
40 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-08-31
Primary Completion
2012-12-31
Completion
2013-01-31

Countries

  • Belgium

Study Locations

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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 NCT01654822 on ClinicalTrials.gov