A study of the effect of hydrogen peroxide foam in patients with bacterial vaginosis

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

Status

Active, not recruiting

Phases

Phase 1Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2015-003356-51-SE

Enrollment

Registered

2015-08-14

Start date

2015-10-15

Completion date

Unknown

Last updated

2017-10-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bacterial vaginosis MedDRA version: 18.1 Level: PT Classification code 10004055 Term: Bacterial vaginosis System Organ Class: 10021881 - Infections and infestations

Interventions

Product Name: Cleargonal Pharmaceutical Form: Vaginal foam INN or Proposed INN: hydrogen peroxide CAS Number: 7722-84-1 Other descriptive name: HYDROGEN PEROXIDE Concentration unit: % (W/W) percent we

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) Willing and able to provide informed consent 2) Female 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 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 30 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range 0

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
Main Objective: The primary objective is to study the effect of Cleargonal on BV.;Secondary Objective: The secondary objective is to study the safety of Cleargonal used as a multiple-dose vaginal application.;Primary end point(s): • Change in Hay/Ison grade between Visit 1 and after the first post-treatment menstruation • Percentage of patients who show an improvement in Hay/Ison grade from “BV” to “Normal” between Visit 1 and after the first post-treatment menstruation ;Timepoint(s) of evaluation of this end point: After the first post-treatment menstruation	—

Measure

Time frame

Main Objective: The primary objective is to study the effect of Cleargonal on BV.;Secondary Objective: The secondary objective is to study the safety of Cleargonal used as a multiple-dose vaginal application.;Primary end point(s): • Change in Hay/Ison grade between Visit 1 and after the first post-treatment menstruation • Percentage of patients who show an improvement in Hay/Ison grade from “BV” to “Normal” between Visit 1 and after the first post-treatment menstruation ;Timepoint(s) of evaluation of this end point: After the first post-treatment menstruation

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Secondary

Measure	Time frame
Secondary end point(s): • Change in Hay/Ison grade between Visit 1 and the end of the first week post-final treatment • Change in patient-reported symptoms between Visit 1 and Visit 2 • Change in patient-reported symptoms between Visit 1 and Visit 3 • Change in vaginal pH between Visit 1 and the end of the first week post-final treatment • Change in vaginal pH between Visit 1 and after the first post-treatment menstruation • Changes in the vaginal flora during the first week after treatment • Changes in the vaginal flora between Visit 1 and after the first post-treatment menstruation • Patient perceptions of treatment • Number and type of AEs during the study period;Timepoint(s) of evaluation of this end point: see above	—

Measure

Time frame

Secondary end point(s): • Change in Hay/Ison grade between Visit 1 and the end of the first week post-final treatment • Change in patient-reported symptoms between Visit 1 and Visit 2 • Change in patient-reported symptoms between Visit 1 and Visit 3 • Change in vaginal pH between Visit 1 and the end of the first week post-final treatment • Change in vaginal pH between Visit 1 and after the first post-treatment menstruation • Changes in the vaginal flora during the first week after treatment • Changes in the vaginal flora between Visit 1 and after the first post-treatment menstruation • Patient perceptions of treatment • Number and type of AEs during the study period;Timepoint(s) of evaluation of this end point: see above

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Countries

Sweden

Contacts

Public ContactÅke Lindahl

Zelmic AB

al@zelmic.se+4670880 46 86

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026