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Efficacy and Safety of D005 Vaginal Mousse on Bacterial Vaginosis

Primary Purpose

Bacterial Vaginoses

Status
Unknown status
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
D005 Vaginal Mousse
Placebo
Sponsored by
Pharmiva AB
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Bacterial Vaginoses

Eligibility Criteria

16 Years - 60 Years (Child, Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  1. Willingness and ability to provide informed consent
  2. Female in fertile age
  3. Age ≥16 years
  4. Nugent score ≥7

  5. Bacterial vaginosis, as defined by the following criteria (Amsel criteria):

    1. pH of vaginal fluid >4.5
    2. Positive amine test
    3. Presence of clue cells
    4. Presence of characteristic, homogenous vaginal discharge
  6. Refrain from using any intravaginal products during the investigation period
  7. 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. Irregular menstruation cycle (21-35 days considered normal). Note that women with amenorrhea are considered eligible.
  4. Current pregnancy or intention to become pregnant within 1 month after treatment
  5. Antibiotic treatment within 2 weeks before treatment
  6. Signs of other infections (such as chlamydia, gonorrhoea, trichomonas, candida, HSV or HPV) requiring specific antibiotic, antifungal or other treatment at screening.
  7. Immunosuppression
  8. Existing or suspected vaginal or cervical cancer or ulcer 9 Unprotected vaginal sex within 24 hours prior to Visit 1

10. Be identified by the Investigator as inappropriate to participate in this investigation

Sites / Locations

  • CPS ResearchRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

D005 Vaginal Mousse

Placebo

Arm Description

Outcomes

Primary Outcome Measures

Clinical cure rate
Clinical cure 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.

Secondary Outcome Measures

Clinical cure rate
Clinical cure 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.
Nugent score <4
Nugent score <4
Clinical cure + Nugent score <4
Clinical cure + Nugent score <4
Subject-reported experiences and symptoms of vaginal malodour, discharge or itch during treatment
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
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
pH of the vaginal fluid
pH of the vaginal fluid
Absence of clue cells
Absence of clue cells

Full Information

First Posted
July 24, 2020
Last Updated
September 2, 2021
Sponsor
Pharmiva AB
Collaborators
LINK Medical Research AB, CPS Research, Scandinavian Development Services AB
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1. Study Identification

Unique Protocol Identification Number
NCT04489290
Brief Title
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 in Patients With Bacterial Vaginosis
Study Type
Interventional

2. Study Status

Record Verification Date
September 2021
Overall Recruitment Status
Unknown status
Study Start Date
February 12, 2021 (Actual)
Primary Completion Date
April 30, 2022 (Anticipated)
Study Completion Date
June 15, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Pharmiva AB
Collaborators
LINK Medical Research AB, CPS Research, Scandinavian Development Services AB

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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. The study population will consist of approximately 96 female subjects.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bacterial Vaginoses

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
96 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
D005 Vaginal Mousse
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Device
Intervention Name(s)
D005 Vaginal Mousse
Intervention Description
D005 Vaginal Mousse is class IIa medical device for treatment of Bacterial Vaginosis.
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
Placebo
Primary Outcome Measure Information:
Title
Clinical cure rate
Description
Clinical cure 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.
Time Frame
23 to 28 days after last dosing
Secondary Outcome Measure Information:
Title
Clinical cure rate
Description
Clinical cure 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.
Time Frame
1 to 3 days after last dosing
Title
Nugent score <4
Time Frame
1 to 3 days after last dosing
Title
Nugent score <4
Time Frame
23 to 28 days after last dosing
Title
Clinical cure + Nugent score <4
Time Frame
1 to 3 days after last dosing
Title
Clinical cure + Nugent score <4
Time Frame
23 to 28 days after last dosing
Title
Subject-reported experiences and symptoms of vaginal malodour, discharge or itch during treatment
Description
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
Title
Subject-reported experiences and symptoms of vaginal malodour, discharge or itch during treatment
Description
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
Title
pH of the vaginal fluid
Time Frame
Day 1-7
Title
pH of the vaginal fluid
Time Frame
1 to 3 days after last dosing
Title
pH of the vaginal fluid
Time Frame
23 to 28 days after last dosing
Title
Absence of clue cells
Time Frame
1 to 3 days after last dosing
Title
Absence of clue cells
Time Frame
23 to 28 days after last dosing

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Willingness and ability to provide informed consent Female in fertile age Age ≥16 years Nugent score ≥7 Bacterial vaginosis, as defined by the following criteria (Amsel criteria): pH of vaginal fluid >4.5 Positive amine test Presence of clue cells Presence of characteristic, homogenous vaginal discharge Refrain from using any intravaginal products during the investigation period 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: Hypersensitivity or allergy to the investigational devices or to chemically related products Current use of an intrauterine device Irregular menstruation cycle (21-35 days considered normal). Note that women with amenorrhea are considered eligible. Current pregnancy or intention to become pregnant within 1 month after treatment Antibiotic treatment within 2 weeks before treatment Signs of other infections (such as chlamydia, gonorrhoea, trichomonas, candida, HSV or HPV) requiring specific antibiotic, antifungal or other treatment at screening. Immunosuppression Existing or suspected vaginal or cervical cancer or ulcer 9 Unprotected vaginal sex within 24 hours prior to Visit 1 10. Be identified by the Investigator as inappropriate to participate in this investigation
Facility Information:
Facility Name
CPS Research
City
Glasgow
State/Province
Scottland
ZIP/Postal Code
G20 0XA
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gordon Crawford, DR
Phone
+44 141 946 7888
Email
gordon.crawford@cpsresearch.co.uk

12. IPD Sharing Statement

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Efficacy and Safety of D005 Vaginal Mousse on Bacterial Vaginosis

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