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Clinical Trials/EUCTR2013-002918-12-HU
EUCTR2013-002918-12-HU
Active, not recruiting
Phase 1

Randomized, prospective, double blind clinical study to evaluate the effectiveness, dosage and safety of lactobacillus vaccine for management of bacterial vaginosis in a non-selected patient population - LATVAC

Amvac Kft0 sitesAugust 6, 2013
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ConditionsBacterial vaginosis (Nugent score 4 or above)Therapeutic area: Diseases [C] - Female diseases of the urinary and reproductive systems and pregancy complications [C13]
DrugsGynevac suspension for injection

Overview

Phase
Phase 1
Intervention
Not specified
Conditions
Bacterial vaginosis (Nugent score 4 or above)
Sponsor
Amvac Kft
Status
Active, not recruiting
Last Updated
9 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
August 6, 2013
End Date
TBD
Last Updated
9 years ago
Study Type
Interventional clinical trial of medicinal product
Sex
Female

Investigators

Sponsor
Amvac Kft

Eligibility Criteria

Inclusion Criteria

  • •1\.18 years or above
  • •2\.Mentally competent
  • •3\.Written informed consent
  • •4\.Being able to comply with the protocol
  • •Are the trial subjects under 18? no
  • •Number of subjects for this age range:
  • •F.1\.2 Adults (18\-64 years) yes
  • •F.1\.2\.1 Number of subjects for this age range 400
  • •F.1\.3 Elderly (\>\=65 years) no
  • •F.1\.3\.1 Number of subjects for this age range

Exclusion Criteria

  • •1\.Hypersensitivity to formaldehyde, or any other of the components of Gynevac
  • •3\.Acute infectious disease
  • •4\.Immunosuppression
  • •5\.Acute polyarthritis
  • •6\.Serious cardiac, liver or kidney diseases
  • •7\.Abnormalities of the blood circulation or of the hemopoetic system
  • •8\.Ongoing antibiotic treatment
  • •9\.Use of any investigational drug within 30 days of V0
  • •10\. No former antibiotic treatment for any reasons in 14 days before study entry

Outcomes

Primary Outcomes

Not specified

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