Clinical trial NCT04489290: Efficacy and Safety of D005 Vaginal Mousse on Bacterial Vaginosis
Official title: 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
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Bacterial Vaginosis &#X7C; Vaginal &#X7C; Microbiology
Keywords: women's health
bakteriell vaginos
Lead sponsor: PepTonic Medical AB
Sponsor class: INDUSTRY
Collaborators: name: Key2Compliance
name: CPS Research
name: Scandinavian Development Services AB
First posted: 2020-07-28
Enrollment: 83
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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 \[eDiary\]).

Primary outcomes:
measure: Clinical cure rate
timeFrame: 1 to 3 days after last dosing
Secondary outcomes:
measure: Clinical cure rate
timeFrame: 23 to 28 days after last dosing
measure: Modified Hay/Ison <grade III at Visit 2
timeFrame: 1 to 3 days after last dosing
measure: Modified Hay/Ison <grade III at Visit 3
timeFrame: 23 to 28 days after last dosing
measure: Clinical cure + Modified Hay/Ison <grade III at Visit 2
timeFrame: 1 to 3 days after last dosing
measure: Clinical cure + Modified Hay/Ison <grade III at Visit 3
timeFrame: 23 to 28 days after last dosing
measure: Subject-reported experiences and symptoms of vaginal malodour, discharge or itch during treatment, at Visit 2
timeFrame: 1 to 3 days after last dosing
measure: Subject-reported experiences and symptoms of vaginal malodour, discharge or itch during treatment, at Visit 3
timeFrame: 23 to 28 days after last dosing
measure: pH of the vaginal fluid during treatment
timeFrame: Day 1-7
measure: pH of the vaginal fluid at Visit 2
timeFrame: 1 to 3 days after last dosing
measure: pH of the vaginal fluid at Visit 3
timeFrame: 23 to 28 days after last dosing
measure: Absence of clue cells greater than 20 % of the total epithelial cells on microscopic examination at Visit 2 and Visit 3.
timeFrame: 1 to 3 days + 23 to 28 days after last dosing
measure: Total absence of clue cells (0%) of the total epithelial cells on microscopic examination at Visit 2 and Visit 3.
timeFrame: 1 to 3 days + 23 to 28 days after last dosing
Other outcomes:
Locations:
city: Borås
country: Sweden
facility: Ladulaas Kliniska Studier
city: Helsingborg
country: Sweden
facility: Hoftekliniken,
city: Kungsbacka
country: Sweden
facility: Qvinnolivet Praktikertjänst AB
city: Lomma
country: Sweden
facility: Hälsomedicinskt Center Barnmorskemottagning
city: Stockholm
country: Sweden
facility: 2Heal Medical
city: Stockholm
country: Sweden
facility: Kvinnokliniken, Danderyds Sjukhus
city: Sundsvall
country: Sweden
facility: Ondrasek Läkarmottagning
city: Umeå
country: Sweden
facility: Gynekologisk mottagning Centrum för Obstetrik och gynekologi Norrlands Universitetssjukhus
city: Glasgow
country: United Kingdom
facility: CPS Research
state: Scottland
Study officials:
References: