PIVA01 a Medical Device trial for the treatment of Bacterial Vaginosis
Research type
Research Study
Full title
A randomised, double-blind, and placebo-controlled Post Market Clinical Follow-Up (PMCF) investigation to investigate the clinical performance of a medical device on clinical signs and symptoms, and the vaginal environment in patients with bacterial vaginosis
IRAS ID
288648
Contact name
Christina Lloyd
Contact email
Clinicaltrials.gov Identifier
Duration of Study in the UK
1 years, 3 months, 30 days
Research summary
Research Summary
Bacterial vaginosis is the most common vaginal infection among women of reproductive age and caused by a disruption in the balance of bacteria inside the vagina. The infection can cause vaginal discomfort such as increased vaginal discharge, vaginal itching and a bad odour.
There are several medications for bacterial vaginosis, but most of them contain antibiotics and although they work well in the short term, the infection commonly recurs and there is a potential risk for impaired vaginal flora and developing antibiotic resistance.
The purpose of the study is to investigate if the D005 vaginal mousse is effective and safe to use. To find out, we put women into two groups and give one group the D005 vaginal mousse and give one group an identical looking vaginal mousse but with a different formulation (called placebo). The results are compared to see if one is better. To try to make sure the groups are the same to start with, each woman is put into a group by chance. This is known as a randomised trial.
The study involves self-treatment with the D005 vaginal mousse or the placebo for 7 days, gynaecological examinations, vaginal swab samples, self-performed pH tests and completion of an electronic diary (eDiary) using a free mobile phone application (mobile app).
The treatment that will be evaluated, the D005 vaginal mousse, consists of a white mousse packed in a 75 mL can, closed with a cap and with a flexible re-usable vaginal applicator. The mousse mainly contains lipids (monoglycerides), lactic acid and water. During treatment, the mousse will expand, fill the entire vagina and stick to the mucosal surface (i.e. the walls of the vagina). The effect of the mousse is initiated by the contact with the vaginal mucosa and the vaginal fluid. The mousse melts at body temperature and releases the compounds. Through its method of application and the physical form of the product, it should reach all parts of the vagina and create an environment that will restore the healthy conditions.
To find out if the treatment with D005 vaginal mousse is effective, it will be given to women who have a confirmed diagnosis of bacterial vaginosis. The study will also find out if the treatment is safe and how you as a user experience the treatment.
A total of 96 women in the UK will participate in the study and all will be treated with a vaginal mousse either D005 vaginal mousse or placebo.Summary of Results
Thank you to Study Participants.
Study title
A randomised, double-blind, and placebo-controlled Post Market Clinical Follow-Up (PMCF) investigation to investigate the clinical performance of a medical device on clinical signs and symptoms, and the vaginal environment in patients with bacterial vaginosisWho carried out the research?
This clinical investigation was sponsored by Pharmiva AB (now Peptonic Medical, Peptonic Medical AB and Pharmiva AB were merged 21st of November 2023 and were thereafter called Peptonic Medical AB) and conducted at the following sites:01 CPS Research, Glasgow, United Kingdom
02 Kvinnokliniken, Danderyds Sjukhus, Stockholm
03 Ondrasek Läkarmottagning, Sundsvall
04 Hälsomedicinskt Center, Lomma
05 Norrlands Universitetssjukhus, Umeå
06 Qvinnolivet, Kungsbacka
08 2Heal Medical, Stockholm
09 Hoftekliniken, Helsingborg
Two sites (07 Ladulaas Kliniska studier, Borås and 10 Citymottagningen för Sexuell Hälsa, Stockholm) were included in the application to EC in Sweden and planned to be part of the investigation but where however never initiated.
Clinical monitoring, Data Management and SAE reporting services were provided by K2C.
Biostatistics services were provided by SDS Life Science AB.Where and when the study took place
See above for list of sites. The date of first randomised subject was 12 Feb 2021 and Date of last subject completed was 25 Aug 2023What public involvement there was in the study
165 subjects were consented and screened for the study participation, 65 were included and received treatment, 47 completed the study procedures while 18 discontinued the study. These subjects were involved as a result of having bacterial vaginosis.Why was the research needed?
The goal of this study was to assess the effectiveness of D005 vaginal mousse on bacterial vaginosisWhat were the main questions studied?
Primary objective was to study the effect of D005 vaginal mousse on bacterial vaginosis (BV) as determined by the proportion of subjects experiencing clinical cure at Visit 2*.
Secondary objectives were to evaluate the effect of D005 vaginal mousse based on the proportion with clinical cure at Visit 3, the proportion of subjects with modified Hay/Ison < grade III* (Visit 2 and Visit 3) and the “composite endpoint” (at Visit 2 and Visit 3). To evaluate the effect of D005 vaginal mousse based on the absence of clue cells*. And also to study the safety of D005 vaginal mousse used as a multi-dose medical device applied once daily for 7 consecutive days.Who participated in the study?
165 subjects were consented and screened for the study participation, 65 were included and received treatment, 47 completed the study procedures while 18 discontinued the study. These subjects were involved as a result of having bacterial vaginosis.What treatments or interventions did the participants take/receive?
The investigational medical device, D005 vaginal mousse, was a class IIa device for local treatment and prevention of BV. The main components of the mousse were water, lipids (monoglycerides) and lactic acid. The mousse was packed in a hand-held can with a re-usable vaginal applicator.What medical problems (adverse reactions) did the participants have?
No serious adverse events were reported during the investigation. The most common AEs, as well as ADEs, in the D005 vaginal mousse group included Vulvovaginal burning sensation, Vaginal haemorrhage and Vulvovaginal pruritus. All detect AEs were expected; thus, the overall conclusion is that there are no safety concerns with the use of the IMD.What happened during the study?
The participants were asked to use the mousse once daily, every evening immediately before bedtime, over a 7-day period. Each dose contained approximately 5 g mousse. The mousse had to be used as instructed with one administration in the vagina each time. All instructions of how to use the investigational medical device were given to the subjects from qualified site investigational staff on the first visit. A written instruction sheet (Instructions for use)(1) was handed out to the participants along with the device.What were the results of the study?
The intended purpose of this treatment was to treat Bacterial Vaginosis. The mousse was intended to rapidly relieve common symptoms of BV such as discharge, unpleasant odour and irritation. Through the study, the analysis determined through the Hay/Ison criteria (Grade 3 is Bacterial Vaginosis, Grade 1 is normal flora) that 50% of patients had <Grade 3 for the single dose arm of the study and 83.3% of patients had <Grade 3 for the triple dose arm of the study. Furthermore, a rapid symptom relief was demonstrated together with a significant release of lactobacillus that was correlated with a decrease in BV associated bacterium.The overall conclusion is that the performance and safety was confirmed.
Where can I learn more about this study?
https://eur03.safelinks.protection.outlook.com/?url=https%3A%2F%2Fu2790089.ct.sendgrid.net%2Fls%2Fclick%3Fupn%3DXv3JSvJ-2B3M71ppf7N9agbRehJ-2Fi4xyo44sEgJVCl5BdbU-2B04DcG1GGZRJWvJyZEf7QfWFPTNZHD3utJR-2FvOJ4pHesxRXxoMakpinOeWxRZpYKCtjmrnDQ-2Fw2eYFLebMVcn5DLnutpMX0Rj82G1mCGQ-3D-3Da1L-_E1aO2-2BZlVOSJJV-2FajQqskegTd6IRomHYTi-2Fbt8SH3YJQbqiMgAchCWi22wxOzeJvkpt6E1NvW9Tnb8UuT2HlSfR1TBvcXTbdkmD2ZMlgLa0uyeWim21Xql-2F-2Bj-2FMnMCqoPx0q61RSJY-2B-2FlPO875zZ05-2BKwCPbMStXbceJYRHH4vbWBnYrdGUQAeGEBVNUONiYP1Ab9BfW-2BUWNFONK0JnaSQ-3D-3D&data=05%7C02%7Capprovals%40hra.nhs.uk%7C78fd4ddbd839407c39f908dc225de3f2%7C8e1f0acad87d4f20939e36243d574267%7C0%7C0%7C638423033873391453%7CUnknown%7CTWFpbGZsb3d8eyJWIjoiMC4wLjAwMDAiLCJQIjoiV2luMzIiLCJBTiI6Ik1haWwiLCJXVCI6Mn0%3D%7C0%7C%7C%7C&sdata=i%2FIcSDmiaj%2FBV2nCdQOIaw1Ev1iOFfBCUwhU3cJARn0%3D&reserved=0REC name
East of Scotland Research Ethics Service REC 1
REC reference
20/ES/0104
Date of REC Opinion
20 Nov 2020
REC opinion
Further Information Favourable Opinion