Evaluation of VagiVitalAC for Treatment of Candida Vulvovaginitis

NCT ID: NCT05012852

Last Updated: 2021-09-23

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 126 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-09-30
• Study Completion Date: 2022-06-30

Brief 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". 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.

Conditions

Vaginal Candidiasis; Vulvovaginal Candidiasis; Candidal Vulvovaginitis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

VagiVitalAC

Group Type: EXPERIMENTAL

VagiVitalAC

Intervention Type: DEVICE

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.

No treatment

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

VagiVitalAC

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.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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.
• 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

StatCons

UNKNOWN

Sponsor Role: collaborator

Karolinska Trial Alliance

INDUSTRY

Sponsor Role: collaborator

PepTonic Medical AB

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Aino Fianu Jonasson, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Karolinska University Hospital

Locations

Karolinska University Hospital

Huddinge, , Sweden

Site Status: RECRUITING

Countries

Sweden

Central Contacts

Dan Markusson

Role: CONTACT

registrator@etikprovning.se

+46104750800

Facility Contacts

Aino Fianu Jonasson, MD, PhD

Role: primary

Other Identifiers

CIV-21-06-037087

Identifier Type: REGISTRY

Identifier Source: secondary_id

VagiPep102

Identifier Type: -

Identifier Source: org_study_id