An interventional study of D005 Vaginal Mousse and Placebo in Bacterial Vaginosis | Vaginal | Microbiology, sponsored by Pharmiva AB. Active, not recruiting at 9 sites in 2 countries. Open to female participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2023-10-26.
Sponsored by Pharmiva AB · Not applicable, Interventional, and Treatment
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.
220 studies on the registry are indexed under Vaginosis, Bacterial; 36 are open to participants now.
This study's planned enrollment of 83 is below the median of 100 across 187 interventional studies indexed under Vaginosis, Bacterial.
Browse Vaginosis, Bacterial studies →Pharmiva AB is the lead sponsor of 2 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Bacterial vaginosis, as defined by the following criteria (Amsel criteria):
Exclusion Criteria:
Device: D005 Vaginal Mousse
Other: Placebo
D005 Vaginal Mousse is class IIa medical device for treatment of Bacterial Vaginosis.
Placebo
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
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
This study is active, not recruiting, as verified in Oct 2023. You cannot join it, but the record below documents what was studied.
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Pharmiva AB