Study of a vaginal treatment in preventing Recurrent Vulvovaginal Candidiasis (thrush)

Phase 2

Active, not recruiting

• Conditions: Recurrent Vulvovaginal Candidiasis; Infection - Other infectious diseases; Alternative and Complementary Medicine - Other alternative and complementary medicine; Renal and Urogenital - Other renal and urogenital disorders

• Registration Number: ACTRN12620001084976
• Lead Sponsor: Griffith Univeristy

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-10-20
• Last Update Posted: 10 October 2022

Recruitment & Eligibility

• Status: Active, not recruiting
• Sex: Female
• Target Recruitment: 15

Inclusion Criteria

1.Premenopausal women
2. In good health (no serious current illness or specified chronic diseases, see exclusion criteria)
3.A history of RVVC defined as greater than or equal to 4 episodes of Vulvovaginal Candidiasis in a 12 months period as documented in patient medical records and case history, including at least one positive vaginal culture pathology report
4. Have a Sobel symptom score <3 at enrolment
5. Willing to answer questionnaires and comply with the study requirements.
6. Have a menstrual cycle between 26 and 35 days
7. Ability to apply intravaginal therapies
8. Ability to collect vaginal swabs
9. On stable medication(s) and/or Complementary medicines, other than excluded (see below), for greater than or equal to 2 months

Exclusion Criteria

1. Vaginal pH>4.5 at Eligibility screening
2. Positive SavvyCheck at Eligibility screening
3. Positive Human Chorionic gonadotropin (hCG) urinalysis test at screening (confirming pregnancy), currently pregnant and/or breastfeeding
4. Intra uterine device (hormonal or coil, ring pessary)
5. Women of child bearing potential who have not been using effective methods of contraception for 14 days prior to Baseline Appointment 1.
6. Individuals who are diagnosed with a significant chronic disease, including kidney, liver, uterine and autoimmune disease, sexually transmitted infection (except latent Herpes simplex viruses -HSV1 and HSV2), uncontrolled Diabetes (Type 1 or Type 2, HbA1c >7.5%), vulvar or vaginal medical condition (other than RVVC), pelvic inflammatory disease, recurrent urinary tract infection
7. Current cancer or a remission diagnosis in the last 12 months (Skin cancer excision without treatment not a basis for exclusion).
8. Individuals taking any medication that addresses hormones including hormone replacement therapy (except the combined OCP), antiestrogens, aromatase inhibitors or any medication of a hormonal blocking nature associated with a breast cancer diagnosis
9. Individuals taking HMG-CoA reductase inhibitors, antiretroviral or immunosuppressant medication.
10. Individuals taking antifungal, antimicrobial or anti-inflammatory medications applied for a chronic health condition (which can not be ceased)
11. Individuals using vaginal douches, taking probiotics (oral or vaginal), or complementary medicines for the management of VVC (Caprylic acid, Origanum vulgare: Oregano herb/oil, Hydrastis canadensis: Golden Seal, Saccharomyces cerevisiae, Handroanthus heptaphyllus:Pau D’arco, Allium sativum: Garlic, Pseudowintera colorata: Horopito) except for those willing and able to cease (if ceased allow a 3 week wash out)
12. Individuals who have commenced a new pharmaceutical or complementary medication < 2 months ago (and not willing or able to cease)
13. Known allergy to any of the ingredients in the formulation
14. Individuals that have participated in another clinical trial in the last 30 days

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The primary outcome is a change of recurrence and severity of RVVC. Assessed via: Sobel Symptom Score, Savvy Check rapid yeast test and vaginal swab Culture/microscopy (self swabbed) [Anytime: Ongoing, when symptoms occur during trial during the 9 months trial period]