Evaluation of VagiVitalAC for Treatment of Candida Vulvovaginitis

This is an interventional treatment trial for Vaginal Candidiasis Read More

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.