Efficacy and Safety of D005 Vaginal Mousse on Bacterial Vaginosis

Pharmiva

Status: Active, not recruiting

Conditions: Bacterial Vaginosis | Vaginal | Microbiology

Treatments: Device: D005 Vaginal Mousse; Other: Placebo

Study type: Interventional

Funder types: Industry; Other

Identifiers

NCT04489290

Piva01

Details and patient eligibility

About

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.

Enrollment: 83 estimated patients

Sex: Female

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

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]).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

83 participants in 2 patient groups, including a placebo group

D005 Vaginal Mousse

Experimental group

Treatment:

Device: D005 Vaginal Mousse

Placebo

Placebo Comparator group

Treatment:

Other: Placebo