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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
83
D005 Vaginal Mousse is class IIa medical device for treatment of Bacterial Vaginosis.
Placebo
Ladulaas Kliniska Studier
Borås, Sweden
Hoftekliniken,
Helsingborg, Sweden
Qvinnolivet Praktikertjänst AB
Kungsbacka, Sweden
Hälsomedicinskt Center Barnmorskemottagning
Lomma, Sweden
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).
Time frame: 1 to 3 days after last dosing
Clinical cure rate
Clinical cure at Visit 3, 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 KOH.
Time frame: 23 to 28 days after last dosing
Modified Hay/Ison <grade III at Visit 2
Time frame: 1 to 3 days after last dosing
Modified Hay/Ison <grade III at Visit 3
Time frame: 23 to 28 days after last dosing
Clinical cure + Modified Hay/Ison <grade III at Visit 2
Time frame: 1 to 3 days after last dosing
Clinical cure + Modified Hay/Ison <grade III at Visit 3
Time frame: 23 to 28 days after last dosing
Subject-reported experiences and symptoms of vaginal malodour, discharge or itch during treatment, at Visit 2
Vaginal malodour, discharge and itch will be graded as the following: Vaginal malodour 0 = normal, 1 = mild, 2 = moderate, 3 = severe Discharge 0 = normal, 1 = mild, 2 = moderate Itch 0 = normal, 1 = mild, 2 = moderate, 3 = severe
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
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, United Kingdom
Time frame: 1 to 3 days after last dosing
Subject-reported experiences and symptoms of vaginal malodour, discharge or itch during treatment, at Visit 3
Vaginal malodour, discharge and itch will be graded as the following: Vaginal malodour 0 = normal, 1 = mild, 2 = moderate, 3 = severe Discharge 0 = normal, 1 = mild, 2 = moderate Itch 0 = normal, 1 = mild, 2 = moderate, 3 = severe
Time frame: 23 to 28 days after last dosing
pH of the vaginal fluid during treatment
Time frame: Day 1-7
pH of the vaginal fluid at Visit 2
Time frame: 1 to 3 days after last dosing
pH of the vaginal fluid at Visit 3
Time frame: 23 to 28 days after last dosing
Absence of clue cells greater than 20 % of the total epithelial cells on microscopic examination at Visit 2 and Visit 3.
Time frame: 1 to 3 days + 23 to 28 days after last dosing
Total absence of clue cells (0%) of the total epithelial cells on microscopic examination at Visit 2 and Visit 3.
Time frame: 1 to 3 days + 23 to 28 days after last dosing