Efficacy and Safety of D005 Vaginal Mousse on Bacterial Vaginosis
A Randomised, Double-blind, and Placebo-controlled Post Market Clinical Follow-Up Investigation to Investigate the Clinical Performance of a Medical Device on Clinical Signs and Symptoms, and the Vaginal Environment in Patients With Bacterial Vaginosis
1 other identifier
interventional
83
2 countries
9
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Feb 2021
Typical duration for not_applicable
9 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 24, 2020
CompletedFirst Posted
Study publicly available on registry
July 28, 2020
CompletedStudy Start
First participant enrolled
February 12, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 4, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
February 28, 2024
CompletedOctober 26, 2023
October 1, 2023
2.6 years
July 24, 2020
October 24, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Clinical cure rate
Clinical cure at Visit 2, defined as absence of all of the following 3 Amsel criteria: 1. Off-white (milky or gray), thin, homogeneous discharge. 2. The presence of clue cells greater than 20% of the total epithelial cells on microscopic examination. 3. A fishy odour (i.e., a positive whiff test) of the vaginal discharge with the addition of a drop of potassium hydroxide (KOH).
1 to 3 days after last dosing
Secondary Outcomes (12)
Clinical cure rate
23 to 28 days after last dosing
Modified Hay/Ison <grade III at Visit 2
1 to 3 days after last dosing
Modified Hay/Ison <grade III at Visit 3
23 to 28 days after last dosing
Clinical cure + Modified Hay/Ison <grade III at Visit 2
1 to 3 days after last dosing
Clinical cure + Modified Hay/Ison <grade III at Visit 3
23 to 28 days after last dosing
- +7 more secondary outcomes
Study Arms (2)
D005 Vaginal Mousse
EXPERIMENTALPlacebo
PLACEBO COMPARATORInterventions
D005 Vaginal Mousse is class IIa medical device for treatment of Bacterial Vaginosis.
Eligibility Criteria
You may qualify if:
- Willingness and ability to provide informed consent
- Female in fertile age
- Age ≥18 years
- Bacterial vaginosis, as defined by the following criteria (Amsel criteria):
- A fishy odour (i.e., a positive whiff test) of the vaginal discharge with the addition of a drop of potassium hydroxide (KOH)
- Presence of clue cells (≥20%)
- Off-white (milky or gray), thin, homogeneous discharge
- Refrain from using any intravaginal products during the investigation period
- Refrain from sexual intercourse during treatment. Refrain from sexual intercourse or use a condom during rest of the investigation period to Visit 3.
You may not qualify if:
- Hypersensitivity or allergy to the investigational devices or to chemically related products
- Current use of an intrauterine device.
- Current pregnancy or intention to become pregnant within 1 month after treatment
- Antibiotic treatment within 2 weeks before treatment
- Signs of other infections (such as chlamydia, gonorrhoea, trichomonas, candida, HSV or HPV) requiring specific antibiotic, antifungal or other treatment at screening.
- Immunosuppression therapy (Allergy medications allowed) at the discretion of the PI
- Existing or suspected vaginal or cervical cancer or ulcer
- Unprotected vaginal sex within 24 hours prior to Visit 1
- 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 \[eDiary\]).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- PepTonic Medical ABlead
- Key2Compliancecollaborator
- CPS Researchcollaborator
- Scandinavian Development Services ABcollaborator
Study Sites (9)
Ladulaas Kliniska Studier
Borås, Sweden
Hoftekliniken,
Helsingborg, Sweden
Qvinnolivet Praktikertjänst AB
Kungsbacka, Sweden
Hälsomedicinskt Center Barnmorskemottagning
Lomma, Sweden
2Heal Medical
Stockholm, Sweden
Kvinnokliniken, Danderyds Sjukhus
Stockholm, Sweden
Ondrasek Läkarmottagning
Sundsvall, Sweden
Gynekologisk mottagning Centrum för Obstetrik och gynekologi Norrlands Universitetssjukhus
Umeå, Sweden
CPS Research
Glasgow, Scottland, G20 0XA, United Kingdom
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 24, 2020
First Posted
July 28, 2020
Study Start
February 12, 2021
Primary Completion
October 4, 2023
Study Completion
February 28, 2024
Last Updated
October 26, 2023
Record last verified: 2023-10