None listed
Conditions
Brief summary
Recurrent Vulvovaginal Candidiasis (RVVC) is a dermatological and sexual health disorder impacting 5-10% of the female population. The management of RVVC often requires ongoing drug management called maintenance therapy. Even with maintenance regimes, up to 57% of women may experience a relapse of symptoms within 3-6 months of therapy completion. The ongoing and recurrent symptom presentations associated with RVVC have significant impacts on health status and quality of life, as well as pose an economic burden. The proposed trial will assess whether "Intravaginal Combination Therapy of Acetic and Lactic Acid" (ICTALA) is effective and well-tolerated for the prevention of RVVC. ICTALA will be utilised to ultimately provide an intervention that can reduce antimicrobial drug usage and decrease relapse.
Interventions
A 1.9gm pessary that contains 3% Acetic and 2% lactic acid in gelatin forms the investigational medicinal product. Intravaginal Combination Therapy of Acetic and Lactic Acid (ICTALA)
One ICTALA pessary, applied for 7 days following menstruation (from day 10-17 of menstrual cycle). Administration repeated every month for 6 months.
Particpant compliance:
At appointment 2 and 3 IMP compliance will be checked:
Study intervention use will be recorded, and any returned medication will be counted as
A 1.9gm pessary that contains 3% Acetic and 2% lactic acid in gelatin forms the investigational medicinal product. Intravaginal Combination Therapy of Acetic and Lactic Acid (ICTALA) One ICTALA pessary, applied for 7 days following menstruation (from day 10-17 of menstrual cycle). Administration repeated every month for 6 months. Particpant compliance: At appointment 2 and 3 IMP compliance will be checked: Study intervention use will be recorded, and any returned medication will be counted as a measure of compliance. Any participant with less than 60% compliance will be withdrawn. Confirmation of recurrence and treatment. Participants with confirmed recurrence will be instructed to seek 150mg oral fluconazole from their local pharmacy for treatment. Participants will be reimbursed for treatment cost. Microbiome assessment (Subset of participants) A subset of local Queensland participants will have the option to provide additional consent to provide vaginal swabs (self swabbed) for next generation sequencing microbiome analysis (fungal and bacterial). Participants self vaginal swab at Baseline, appointment 2 (3 months) and appointment 3 (6 months). Hormonal blood draw (Subset of participants-Estradiol, FSH, LH, Progesterone): A subset of local Queensland participants who have provided additional consent to vaginal microbiome analysis will also be asked to provide consent to a blood draw at a local pathology centre for hormonal analysis. Participants attend the blood draw at Baseline, appointment 2 (3 months) and appointment 3 (6 months).
Sponsors
Griffith Univeristy
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Prevention
Masking
Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to 60 Years
Healthy volunteers
No
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
Outcome results
None listed