Efficacy and Safety of D005 Vaginal Mousse on Bacterial Vaginosis

Not Applicable

Active, not recruiting

• Conditions: Bacterial Vaginosis | Vaginal | Microbiology
• Interventions: Device: D005 Vaginal Mousse; Other: Placebo

• Registration Number: NCT04489290
• Lead Sponsor: Pharmiva AB

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-07-24
• Study First Submitted QC: 2020-07-24
• Study First Posted: 2020-07-28
• Study Start: 2021-02-12
• Status Verified: 2023-10
• Primary Completion: 2023-10-04
• Last Update Submitted: 2023-10-24
• Last Update Posted: 2023-10-26
• Study Completion: 2024-02-28

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: Female
• Target Recruitment: 83

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]).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
D005 Vaginal Mousse	D005 Vaginal Mousse	-
Placebo	Placebo	-

Primary Outcome Measures

Name	Time	Method
Clinical cure rate	1 to 3 days after last dosing	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).

Secondary Outcome Measures

Name	Time	Method
Modified Hay/Ison <grade III at Visit 3	23 to 28 days after last dosing
Clinical cure + 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
pH of the vaginal fluid during treatment	Day 1-7
Subject-reported experiences and symptoms of vaginal malodour, discharge or itch during treatment, at Visit 2	1 to 3 days after last dosing	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
Subject-reported experiences and symptoms of vaginal malodour, discharge or itch during treatment, at Visit 3	23 to 28 days after last dosing	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
pH of the vaginal fluid at Visit 2	1 to 3 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.	1 to 3 days + 23 to 28 days after last dosing
Clinical cure rate	23 to 28 days after last dosing	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.
pH of the vaginal fluid at Visit 3	23 to 28 days after last dosing
Modified Hay/Ison <grade III at Visit 2	1 to 3 days after last dosing
Total absence of clue cells (0%) of the total epithelial cells on microscopic examination at Visit 2 and Visit 3.	1 to 3 days + 23 to 28 days after last dosing

Trial Locations

Locations (9)

Kvinnokliniken, Danderyds Sjukhus; 🇸🇪 Stockholm, Sweden

Hoftekliniken,; 🇸🇪 Helsingborg, Sweden

Hälsomedicinskt Center Barnmorskemottagning; 🇸🇪 Lomma, Sweden

CPS Research; 🇬🇧 Glasgow, Scottland, United Kingdom

Gynekologisk mottagning Centrum för Obstetrik och gynekologi Norrlands Universitetssjukhus; 🇸🇪 Umeå, Sweden

Ondrasek Läkarmottagning; 🇸🇪 Sundsvall, Sweden

Qvinnolivet Praktikertjänst AB; 🇸🇪 Kungsbacka, Sweden

2Heal Medical; 🇸🇪 Stockholm, Sweden

Ladulaas Kliniska Studier; 🇸🇪 Borås, Sweden