Status:
UNKNOWN
Efficacy and Safety of D005 Vaginal Mousse on Bacterial Vaginosis
Lead Sponsor:
PepTonic Medical AB
Collaborating Sponsors:
Key2Compliance
CPS Research
Conditions:
Bacterial Vaginosis | Vaginal | Microbiology
Eligibility:
FEMALE
18-60 years
Phase:
NA
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 conducte...
Eligibility Criteria
Inclusion
- 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
- 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 \[eDiary\]).
Key Trial Info
Start Date :
February 12 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 28 2024
Estimated Enrollment :
83 Patients enrolled
Trial Details
Trial ID
NCT04489290
Start Date
February 12 2021
End Date
February 28 2024
Last Update
October 26 2023
Active Locations (9)
Enter a location and click search to find clinical trials sorted by distance.
1
Ladulaas Kliniska Studier
Borås, Sweden
2
Hoftekliniken,
Helsingborg, Sweden
3
Qvinnolivet Praktikertjänst AB
Kungsbacka, Sweden
4
Hälsomedicinskt Center Barnmorskemottagning
Lomma, Sweden