Vaginal CandidiasisNCT05012852
Evaluation of VagiVitalAC for Treatment of Candida Vulvovaginitis
A study testing VagiVitalAC in people with Vaginal Candidiasis and Vulvovaginal Candidiasis, run by PepTonic Medical AB at 1 site in Sweden.
Trial summary
Candidiasis is an infection caused by a yeast (a type of fungus) called Candida. Candidiasis in the vagina is commonly called a "vaginal yeast infection." Another names for this infection is "vaginal candidiasis". Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Vaginal Candidiasis, Vulvovaginal Candidiasis, Candidal Vulvovaginitis
- What is being tested?
- VagiVitalAC
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 126 participants
- Where
- 1 siteSweden
- Study dates
- Sep 2021to Jun 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Be a female, 18 years or older.
- Signed informed consent form.
- Women with earlier recurrent verified vaginal candidiasis.
- Has seeked treatment for suspected fungal infection.
- Be judged by an investigator as having an ongoing vulvovaginal candidiasis.
- If of child-bearing potential, willing to use a reliable method of contraception during the duration of the study. The following methods of contraception are considered reliable: an intrauterine device or any of the following hormonal contraceptives: contraceptive pills, implants, transdermal patches, vaginal ring, injections with prolonged release. A woman is considered of childbearing potential (WOCBP), i.e. fertile, following menarche and until becoming post-menopausal unless permanently sterile. Permanent sterilisation methods include hysterectomy, bilateral salpingectomy and bilateral oophorectomy. A postmenopausal state is defined as no menses for 12 months without an alternative medical cause.
- Be in general good health, as judged by an investigator.
Who cannot join
- Be currently hospitalized.
- First time with a vulvovaginal candidiasis infection.
- Have a history of ongoing cardiovascular, hepatic, renal, pulmonary, hematologic, gastrointestinal, endocrine, immunologic, dermatologic, neurologic, psychological, or musculoskeletal disease or disorder that is clinically significant in the opinion of the Principal Investigator or Sub-Investigator.
- Have a history of undiagnosed vaginal bleeding.
- Have an ongoing urogenital infection at the screening visit, other than vulvovaginal candidiasis.
- Any contraindication to the gel (VagiVitalAC) therapy and allergy to the use of any components of the investigational device.
Show all 14Show fewer
- Pregnant, as determined by urine pregnancy test.
- Have been giving birth during the last 30 days.
- Have a history of drug and/or alcohol abuse within one year of start of study.
- Patient who are currently menstruating or anticipate they will start menstruating within 7 days of starting using the investigational device.
- Have used any intravaginal or systemic antifungal medication within the previous 7 days or had used any intravaginal product such as a spermicide, medicated douche or feminine spray within two days before the start of the study.
- Current treatment for any medical condition that include systemic antimycotics or immunosuppressive drugs.
- Have any reason, which in the opinion of the Principal Investigator would prevent the patient from safely participating in the study or complying with protocol requirements.
- Have participated in another clinical trial within 30 days prior to screening, have received an investigational drug within one month prior to the initial dose of the investigational medical device, or be likely to participate in another clinical trial or receive another investigational medication during the study.
Trial locations and contacts
1 site in 1 country.
Sweden1 site, 1 recruiting
- Recruiting
Karolinska University Hospital
Huddinge
Aino Fianu Jonasson, MD, PhD
Aino Fianu Jonasson, MD, PhD
About this study
Official title: A Two-part Study; Consisting of a Pilot Part Followed by a Randomized, Parallel Group Part; Comparing Topically Applied Novel Gel Containing Lactic Acid With no Treatment on Women With Candida Vulvovaginitis
Candidiasis is an infection caused by a yeast (a type of fungus) called Candida. Candidiasis in the vagina is commonly called a "vaginal yeast infection." Another names for this infection is "vaginal candidiasis". The symptoms of vaginal candidiasis include: Vaginal itching or soreness, Pain during sexual intercourse, Pain or discomfort when urinating and Abnormal vaginal discharge. VagiVitalAC is a modified version of the existing gel VagiVital, formulated to act as a treatment for fungal infections.
This clinical investigation is a two-part study consisting of a pilot part followed by a randomized part. The aim of the pilot part is to evaluate if VagiVitalAC is able to cure the vulvovaginal candidiasis in at least 70% of the patients after 7 days treatment. If the proportion of cured patients is at least 70 %, the next part, the randomized part, will be performed. In the randomized part, the treatment efficacy and safety of VagiVitalAC on candida vulvovaginitis will be evaluated by comparing a treatment group with a control group receiving no treatment.
- Being tested
- VagiVitalAC
- Medical subject headings
- Candidiasis, Vulvovaginal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VagiVitalACDevice
In the Pilot part, the single intervention used is VagiVitalAC treatment for 30 days. In the randomized part, patients in the Interventional arm are treated with VagiVital AC for up to 90 days.
| Study group | Role | What they receive |
|---|---|---|
| VagiVitalAC | Experimental | Not described Receives: Device: VagiVitalAC |
| No treatment | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Presence or not of candida fungi in the vaginal culture after 7 days treatment
Measured: Day 7
Secondary outcomes (16)
Presence or not of candida fungi in the vaginal culture after 30 days treatment
Measured: Day 30
For patients with initial treatment effect (i.e., no presence of candida fungi in the vaginal culture) after 7 days treatment, relapse at day 30, after continued treatment
Measured: Day 30
Change in self-reported vulvovaginal symptoms (vaginal itching/burning and/or soreness and/or vaginal discharge and/or pain during sexual intercourse) after 7 days treatment compared to baseline (patient's own experience)
Measured: Day 7
Change in self-reported vulvovaginal symptoms after 7 days treatment compared with baseline (patient's own experience), that has been self-identified by the patient as being the most bothersome to her
Measured: Day 7
Change in self-reported vulvovaginal symptoms (vaginal itching/burning and/or soreness and/or vaginal discharge and/or pain during sexual intercourse) after 30 days treatment compared to baseline (patient's own experience)
Measured: Day 30
Change in self-reported vulvovaginal symptoms after 30 days treatment (patient's own experience), that has been self-identified by the patient at baseline as being the most bothersome to her
Measured: Day 30
Frequency of Adverse events Adverse Events (AEs)/Serious Adverse Events (SAEs)/Device Deficiencies (DDs)/Adverse Device Effects (ADEs)/Serious Adverse Device Effects (SADEs) at 7 days
Measured: Day 7
Frequency of Adverse events AEs/SAEs/DDs/ADEs/SADEs at 30 days
Measured: Day 30
Presence or not of candida fungi in the vaginal culture after 90 days treatment.
Only applicable for randomized part
Measured: Day 90
For patients with initial treatment effect by VagiVitalAC (i.e. no presence of candida fungi in the vaginal culture) after 7 and 30 days treatment, relapse at day 90, after continued treatment.
Only applicable for randomized part
Measured: Day 90
Change in self-reported vulvovaginal symptoms after 7 days treatment compared to baseline, Investigational device group compared to comparator group (patient's own experience).
Only applicable for randomized part
Measured: Day 7
Change in self-reported vulvovaginal symptoms after 7 days treatment, Investigational device group compared to comparator group (patient's own experience), that has been self-identified by the patient at baseline as being the most bothersome to her.
Only applicable for randomized part
Measured: Day 7
Change in self-reported vulvovaginal symptoms (vaginal itching/burning and/or soreness and/or vaginal discharge and/or pain during sexual intercourse) after 90 days treatment compared to baseline (patient's own experience).
Only applicable for randomized part
Measured: Day 90
Change in self-reported vulvovaginal symptoms after 90 days treatment (patient's own experience), that has been self-identified by the patient at baseline as being the most bothersome to her.
Only applicable for randomized part
Measured: Day 90
Frequency of Adverse events AEs/SAEs/DDs/ADEs/SADEs at 7 days, Investigational device group compared to comparator group
Only applicable for randomized part
Measured: Day 7
Frequency of Adverse events AEs/SAEs/DDs/ADEs/SADEs at 90 days.
Only applicable for randomized part
Measured: Day 90
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2021
- Study startSep 2021 (estimated)
- Primary completionFeb 2022 (estimated)
- Study completionJun 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vaginal CandidiasisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- An single group pilot sub-study followed by a randomized, parallel, controlled sub-study. In the randomized part, the non cured patients in the control goup are given an option to change to active treatment after 7 days.
- Masking
- None (open label)
- Enrolment
- 126 participants (estimated)
Sponsor and investigators
- Lead sponsor
- PepTonic Medical AB
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- StatCons, Karolinska Trial Alliance
- Responsible party
- Sponsor
- Investigators
- Aino Fianu Jonasson, MD, PhD, Principal investigator, Karolinska University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05012852
- Sponsor's protocol ID
- VagiPep102
- Other IDs
- CIV-21-06-037087
- Status last verified
- Sep 2021
- First submitted
- 4 Aug 2021
- Last updated
- 23 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Two-part Study; Consisting of a Pilot Part Followed by a Randomized, Parallel Group Part; Comparing Topically Applied Novel Gel Containing Lactic Acid With no Treatment on Women With Candida Vulvovaginitis
- ClinicalTrials.gov ID
- NCT05012852
- Acronym / sponsor ID
- VagiPep102
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 126 participants (estimated)
- Lead sponsor
- PepTonic Medical ABIndustry (pharma, biotech, devices)
- Collaborators
- StatCons, Karolinska Trial Alliance
- Study start
- Sep 2021 (estimated)
- Primary completion
- Feb 2022 (estimated)
- Study completion
- Jun 2022 (estimated)
- First posted
- 19 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Candidiasis is an infection caused by a yeast (a type of fungus) called Candida. Candidiasis in the vagina is commonly called a "vaginal yeast infection." Another names for this infection is "vaginal candidiasis". The symptoms of vaginal candidiasis include: Vaginal itching or soreness, Pain during sexual intercourse, Pain or discomfort when urinating and Abnormal vaginal discharge. VagiVitalAC is a modified version of the existing gel VagiVital, formulated to act as a treatment for fungal infections.
This clinical investigation is a two-part study consisting of a pilot part followed by a randomized part. The aim of the pilot part is to evaluate if VagiVitalAC is able to cure the vulvovaginal candidiasis in at least 70% of the patients after 7 days treatment. If the proportion of cured patients is at least 70 %, the next part, the randomized part, will be performed. In the randomized part, the treatment efficacy and safety of VagiVitalAC on candida vulvovaginitis will be evaluated by comparing a treatment group with a control group receiving no treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- An single group pilot sub-study followed by a randomized, parallel, controlled sub-study. In the randomized part, the non cured patients in the control goup are given an option to change to active treatment after 7 days.
| Arm | Type | Receives |
|---|---|---|
| VagiVitalAC | Experimental | Device: VagiVitalAC |
| No treatment | No intervention | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Be a female, 18 years or older.
- Signed informed consent form.
- Women with earlier recurrent verified vaginal candidiasis.
- Has seeked treatment for suspected fungal infection.
- Be judged by an investigator as having an ongoing vulvovaginal candidiasis.
Key exclusion criteria (14 listed)
- Be currently hospitalized.
- First time with a vulvovaginal candidiasis infection.
- Have a history of ongoing cardiovascular, hepatic, renal, pulmonary, hematologic, gastrointestinal, endocrine, immunologic, dermatologic, neurologic, psychological, or musculoskeletal disease or disorder that is clinically significant in the opinion of the Principal Investigator or Sub-Investigator.
- Have a history of undiagnosed vaginal bleeding.
- Have an ongoing urogenital infection at the screening visit, other than vulvovaginal candidiasis.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VagiVitalACIn the Pilot part, the single intervention used is VagiVitalAC treatment for 30 days. In the randomized part, patients in the Interventional arm are treated with VagiVital AC for up to 90 days. | Device | VagiVitalAC |
Primary outcome
Presence or not of candida fungi in the vaginal culture after 7 days treatment
Time frame: Day 7
16 secondary outcomes
Presence or not of candida fungi in the vaginal culture after 30 days treatment
Time frame: Day 30
For patients with initial treatment effect (i.e., no presence of candida fungi in the vaginal culture) after 7 days treatment, relapse at day 30, after continued treatment
Time frame: Day 30
Change in self-reported vulvovaginal symptoms (vaginal itching/burning and/or soreness and/or vaginal discharge and/or pain during sexual intercourse) after 7 days treatment compared to baseline (patient's own experience)
Time frame: Day 7
Change in self-reported vulvovaginal symptoms after 7 days treatment compared with baseline (patient's own experience), that has been self-identified by the patient as being the most bothersome to her
Time frame: Day 7
Change in self-reported vulvovaginal symptoms (vaginal itching/burning and/or soreness and/or vaginal discharge and/or pain during sexual intercourse) after 30 days treatment compared to baseline (patient's own experience)
Time frame: Day 30
Change in self-reported vulvovaginal symptoms after 30 days treatment (patient's own experience), that has been self-identified by the patient at baseline as being the most bothersome to her
Time frame: Day 30
Frequency of Adverse events Adverse Events (AEs)/Serious Adverse Events (SAEs)/Device Deficiencies (DDs)/Adverse Device Effects (ADEs)/Serious Adverse Device Effects (SADEs) at 7 days
Time frame: Day 7
Frequency of Adverse events AEs/SAEs/DDs/ADEs/SADEs at 30 days
Time frame: Day 30
Presence or not of candida fungi in the vaginal culture after 90 days treatment.
Time frame: Day 90
For patients with initial treatment effect by VagiVitalAC (i.e. no presence of candida fungi in the vaginal culture) after 7 and 30 days treatment, relapse at day 90, after continued treatment.
Time frame: Day 90
Change in self-reported vulvovaginal symptoms after 7 days treatment compared to baseline, Investigational device group compared to comparator group (patient's own experience).
Time frame: Day 7
Change in self-reported vulvovaginal symptoms after 7 days treatment, Investigational device group compared to comparator group (patient's own experience), that has been self-identified by the patient at baseline as being the most bothersome to her.
Time frame: Day 7
Change in self-reported vulvovaginal symptoms (vaginal itching/burning and/or soreness and/or vaginal discharge and/or pain during sexual intercourse) after 90 days treatment compared to baseline (patient's own experience).
Time frame: Day 90
Change in self-reported vulvovaginal symptoms after 90 days treatment (patient's own experience), that has been self-identified by the patient at baseline as being the most bothersome to her.
Time frame: Day 90
Frequency of Adverse events AEs/SAEs/DDs/ADEs/SADEs at 7 days, Investigational device group compared to comparator group
Time frame: Day 7
Frequency of Adverse events AEs/SAEs/DDs/ADEs/SADEs at 90 days.
Time frame: Day 90
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Aino Fianu Jonasson, MD, PhD principal investigator
Karolinska University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing VagiVitalAC in people with Vaginal Candidiasis and Vulvovaginal Candidiasis, run by PepTonic Medical AB at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Dan Markusson (+46104750800, registrator@etikprovning.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Presence or not of candida fungi in the vaginal culture after 7 days treatment (time frame: Day 7). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Sep 2021.