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

Pharmiva AB9 sites in 2 countries83 target enrollmentFebruary 12, 2021

ConditionsBacterial Vaginosis &#X7C; Vaginal &#X7C; Microbiology

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Bacterial Vaginosis &#X7C; Vaginal &#X7C; Microbiology
Sponsor: Pharmiva AB
Enrollment: 83
Locations: 9
Primary Endpoint: Clinical cure rate
Status: Active, not recruiting
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

February 12, 2021

End Date

February 28, 2024

Last Updated

2 years ago

Study Type

Interventional

Study Design

Parallel

Sex

Female

Investigators

Sponsor

Pharmiva AB

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Willingness and ability to provide informed consent
•Female in fertile age
•Age ≥18 years
•Bacterial vaginosis, as defined by the following criteria (Amsel criteria):
•A fishy odour (i.e., a positive whiff test) of the vaginal discharge with the addition of a drop of potassium hydroxide (KOH)
•Presence of clue cells (≥20%)
•Off-white (milky or gray), thin, homogeneous 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.
•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 therapy (Allergy medications allowed) at the discretion of the PI
•Existing or suspected vaginal or cervical cancer or ulcer
•Unprotected vaginal sex within 24 hours prior to Visit 1
•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 \[eDiary\]).

Outcomes

Primary Outcomes

Clinical cure rate

Time Frame: 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 Outcomes

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)
Subject-reported experiences and symptoms of vaginal malodour, discharge or itch during treatment, at Visit 3(23 to 28 days after last dosing)
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)
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)