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Clinical Trials/EUCTR2015-003356-51-SE
EUCTR2015-003356-51-SE
Active, not recruiting
Phase 1

A single-centre, open-label, single-arm, Phase I/II study to investigate the effect of a hydrogen peroxide foam on clinical signs and symptoms and the vaginal flora in patients with bacterial vaginosis

Zelmic AB0 sites30 target enrollmentAugust 14, 2015
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ConditionsBacterial vaginosisMedDRA version: 18.1Level: PTClassification code 10004055Term: Bacterial vaginosisSystem Organ Class: 10021881 - Infections and infestationsTherapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]

Overview

Phase
Phase 1
Intervention
Not specified
Conditions
Bacterial vaginosis
Sponsor
Zelmic AB
Enrollment
30
Status
Active, not recruiting
Last Updated
8 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
August 14, 2015
End Date
TBD
Last Updated
8 years ago
Study Type
Interventional clinical trial of medicinal product
Sex
Female

Investigators

Sponsor
Zelmic AB

Eligibility Criteria

Inclusion Criteria

  • •1\) Willing and able to provide informed consent
  • •3\) Age \=18 years
  • •4\) BV, as defined by the following criteria (Amsel criteria):
  • •a. pH of vaginal fluid greater than 4\.5
  • •and at least two of the following criteria:
  • •b. Positive amine test
  • •c. Presence of clue cells
  • •d. Presence of characteristic, homogenous vaginal discharge
  • •5\) Regular menstruation cycle
  • •6\) Using adequate contraceptive measures

Exclusion Criteria

  • •1\) Hypersensitivity or allergy to the IMP (investigational medical product) or to chemically related products
  • •2\) Current use of a copper intrauterine device
  • •3\) Currently pregnant or intending to become pregnant within 1 month after treatment
  • •4\) Antibiotic treatment within 2 weeks before treatment
  • •5\) Signs of infection requiring specific antibiotic treatment
  • •6\) Immunosuppression, including HIV1 or 2 infection
  • •7\) Vaginal or cervical ulcer or cancer

Outcomes

Primary Outcomes

Not specified

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