COMPARATIVE CLINICAL EVALUATION OF EFFICACY AND SAFETY OF TIOCONAZOLE VAGINAL FILM VS CANESTEN V6 VAGINAL TABLET IN THE MANAGEMENT OF SYMPTOMATIC VULVOVAGINAL CANDIDIASIS IN NON-PREGNANT WOMEN - OPEN LABEL, RANDOMIZED, PARALLEL, PROSPECTIVE, MULTICENTRIC STUDY.
Overview
- Phase
- Phase 3
- Status
- Recruiting
- Sponsor
- Hetero Healthcare limited
- Enrollment
- 300
- Locations
- 10
- Primary Endpoint
- -Proportion of patients with clinical cure - defined as resolution or improvement of clinical signs and symptoms pertaining to VVC at the end of day 7 in each treatment group.
Overview
Brief Summary
| Design: Open-label, randomized, |
| parallel-group, prospective, multicentric clinical trial. |
Objectives: To evaluate the clinical efficacy and safety of Tioconazole Vaginal Film 300 mg compared to Canesten V6 Vaginal Tablet in treating symptomatic vulvovaginal candidiasis (VVC) in non-pregnant women.
Treatment Regimen
Tioconazole Vaginal Film 300 mg: Single-dose administration.
Canesten V6 Vaginal Tablet: Daily administration for 7 consecutive days.
Safety Follow-up: Conducted up to Day 14 post-treatment.
Primary Outcomes
Clinical Cure: Proportion of patients with resolution or improvement of clinical signs and symptoms of VVC at Day 7.
Mycological Cure: Proportion of patients with negative potassium hydroxide (KOH) wet mount from vaginal smear for filamentous hyphae, pseudo hyphae, or budding yeast cells at Day 7.
Therapeutic Cure: Proportion of patients achieving both clinical and mycological cure at Day 7.
Secondary Outcome
Treatment-Emergent Adverse Events (TEAEs): Incidence of adverse events occurring during the treatment period, assessed at Days 7 and 14.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Masking
- None
Eligibility Criteria
- Ages
- 18.00 Year(s) to 45.00 Year(s) (—)
- Sex
- Female
Inclusion Criteria
- •1.Women aged 18 to 45 years with clinical diagnosis of symptomatic vulvovaginal candidiasis 2.Subjects with positive baseline potassium hydroxide (KOH) wet mount from a vaginal smear revealing filamentous hyphae or pseudo hyphae or budding yeast cells 3.Presence of more than 1 vulvovaginal sign (erythema, Edema, excoriation), presence of more than 1 vulvovaginal symptom (itching or pruritus, irritation in and around vagina, burning; composite severity score of greater than 7 4.Patients with negative whiff test 5.Patients with vaginal pH less than 4.5 6.Agree to abstain from intercourse during the study period 7.Agree not to douche or use any intravaginal products during the study period 8.Willing to report response to treatment as per protocol during the study period 9.Willing to give written informed consent.
Exclusion Criteria
- •Post menopausal women
- •Menstruating at diagnosis
- •Pregnancy or nursing mothers
- •Use of intravaginal pessaries, corticosteroids, immune suppressive, immunostimulant therapy in the last 2 weeks Presence of another vaginal condition, cervical cancer
- •History of hypersensitivity to study medication, serious illness
- •Patients with uncontrolled Diabetes mellitus.
Outcomes
Primary Outcomes
-Proportion of patients with clinical cure - defined as resolution or improvement of clinical signs and symptoms pertaining to VVC at the end of day 7 in each treatment group.
Time Frame: Day 7,14
-Proportion of patients with mycological cure – negative potassium hydroxide (KOH) wet mount from vaginal smear for filamentous hyphae / pseudo hyphae or budding yeast cells at the end of day 7 in each treatment group.
Time Frame: Day 7,14
-Proportion of patients with Therapeutic cure – defined as clinical and mycological cure at end of day 7 in each treatment group.
Time Frame: Day 7,14
Secondary Outcomes
- Treatment emergent adverse events (TEAEs)(Day 7,14.)
Investigators
Dr U Shobha Jagdish Chandra
Hetero Healthcare Limited