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

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 Overview

• Status: Active, not recruiting
• Conditions: Bacterial Vaginosis | Vaginal | Microbiology
• Intervention / Treatment: Other: Placebo; Device: D005 Vaginal Mousse

• Study Type: Interventional
• Enrollment (Estimated): 83
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Sweden
  • Borås, Sweden
    • Ladulaas Kliniska Studier
  • Helsingborg, Sweden
    • Hoftekliniken,
  • Kungsbacka, Sweden
    • Qvinnolivet Praktikertjänst AB
  • Lomma, Sweden
    • Hälsomedicinskt Center Barnmorskemottagning
  • Stockholm, Sweden
    • 2Heal Medical
  • Stockholm, Sweden
    • Kvinnokliniken, Danderyds Sjukhus
  • Sundsvall, Sweden
    • Ondrasek Läkarmottagning
  • Umeå, Sweden
    • Gynekologisk mottagning Centrum för Obstetrik och gynekologi Norrlands Universitetssjukhus
• United Kingdom
  • Scottland
    • Glasgow, Scottland, United Kingdom, G20 0XA
      • CPS Research

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 60 years (Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Other: Placebo; Placebo
Experimental: D005 Vaginal Mousse	Device: D005 Vaginal Mousse; D005 Vaginal Mousse is class IIa medical device for treatment of Bacterial Vaginosis.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinical cure rate	Clinical cure at Visit 2, defined as absence of all of the following 3 Amsel criteria: Off-white (milky or gray), thin, homogeneous discharge.; The presence of clue cells greater than 20% of the total epithelial cells on microscopic examination.; 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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinical cure rate	Clinical cure at Visit 3, defined as absence of all of the following 3 Amsel criteria: Off-white (milky or gray), thin, homogeneous discharge.; The presence of clue cells greater than 20% of the total epithelial cells on microscopic examination.; A fishy odour (i.e., a positive whiff test) of the vaginal discharge with the addition of a drop of KOH.	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
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	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	23 to 28 days after last dosing
pH of the vaginal fluid during treatment		Day 1-7
pH of the vaginal fluid at Visit 2		1 to 3 days after last dosing
pH of the vaginal fluid at Visit 3		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.		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.		1 to 3 days + 23 to 28 days after last dosing

Collaborators and Investigators

• Sponsor: Pharmiva AB
• Collaborators: CPS Research; Scandinavian Development Services AB; Key2Compliance AB

Study record dates

Study Major Dates

• Study Start (Actual): February 12, 2021
• Primary Completion (Actual): October 4, 2023
• Study Completion (Estimated): February 28, 2024

Study Registration Dates

• First Submitted: July 24, 2020
• First Submitted That Met QC Criteria: July 24, 2020
• First Posted (Actual): July 28, 2020

Study Record Updates

• Last Update Posted (Actual): October 26, 2023
• Last Update Submitted That Met QC Criteria: October 24, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Keywords: women's health; bakteriell vaginos
• Additional Relevant MeSH Terms: Infections; Bacterial Infections; Bacterial Infections and Mycoses; Vaginitis; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Genital Diseases, Female; Vaginal Diseases; Vaginosis, Bacterial
• Other Study ID Numbers: Piva01

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No