Efficacy and Safety of D005 Vaginal Mousse on Bacterial Vaginosis

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

83 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-02-12

Study Completion Date

2024-02-28

Brief Summary

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This is a randomised, double-blind clinical investigation to evaluate the efficacy and safety of D005 vaginal mousse compared to placebo, in women with bacterial vaginosis.

The study will be conducted at one site in Scotland, United Kingdom and at six different sites in Sweden. The study population will consist of approximately 83 female subjects.

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Detailed Description

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Conditions

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Bacterial Vaginosis &#X7C; Vaginal &#X7C; Microbiology

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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D005 Vaginal Mousse

Group Type EXPERIMENTAL

D005 Vaginal Mousse

Intervention Type DEVICE

D005 Vaginal Mousse is class IIa medical device for treatment of Bacterial Vaginosis.

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

Placebo

Interventions

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D005 Vaginal Mousse

D005 Vaginal Mousse is class IIa medical device for treatment of Bacterial Vaginosis.

Intervention Type DEVICE

Placebo

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

1. Willingness and ability to provide informed consent
2. Female in fertile age
3. Age ≥18 years
4. Bacterial vaginosis, as defined by the following criteria (Amsel criteria):

1. A fishy odour (i.e., a positive whiff test) of the vaginal discharge with the addition of a drop of potassium hydroxide (KOH)
2. Presence of clue cells (≥20%)
3. Off-white (milky or gray), thin, homogeneous discharge
5. Refrain from using any intravaginal products during the investigation period
6. Refrain from sexual intercourse during treatment. Refrain from sexual intercourse or use a condom during rest of the investigation period to Visit 3.

Exclusion Criteria

1. Hypersensitivity or allergy to the investigational devices or to chemically related products
2. Current use of an intrauterine device.
3. Current pregnancy or intention to become pregnant within 1 month after treatment
4. Antibiotic treatment within 2 weeks before treatment
5. Signs of other infections (such as chlamydia, gonorrhoea, trichomonas, candida, HSV or HPV) requiring specific antibiotic, antifungal or other treatment at screening.
6. Immunosuppression therapy (Allergy medications allowed) at the discretion of the PI
7. Existing or suspected vaginal or cervical cancer or ulcer
8. Unprotected vaginal sex within 24 hours prior to Visit 1
9. Be identified by the Investigator as inappropriate from a medical or compliance perspective to participate in this investigation (e.g. hysterectomised or inability to report daily using smartphone/computer \[eDiary\]).

Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No