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

Phase 1

• Conditions: Bacterial vaginosis; MedDRA version: 18.1Level: PTClassification code 10004055Term: Bacterial vaginosisSystem Organ Class: 10021881 - Infections and infestations; Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]

• Registration Number: EUCTR2015-003356-51-SE
• Lead Sponsor: Zelmic AB

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2015-08-14
• Last Update Posted: 30 October 2017

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Female
• Target Recruitment: 30

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

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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<br>• 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<br>;Timepoint(s) of evaluation of this end point: After the first post-treatment menstruation

Secondary Outcome Measures

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