A Study to find the Effect of Tioconazole Vaginal Film

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.

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2025/10/095909

Enrollment

300

Registered

2025-10-10

Start date

Unknown

Completion date

Unknown

Last updated

2026-09-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: B373- Candidiasis of vulva and vagina

Interventions

Intervention1: Tioconazole Vaginal film: Dose: 300mg vaginal film Route of administration: intravaginal Frequency: One Tioconazole vaginal film (300mg) intravaginally during nighttime for One day. C

Eligibility

Inclusion criteria

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

Exclusion criteria: 1. Post menopausal women 2. Menstruating at diagnosis 3. Pregnancy or nursing mothers 4. Use of intravaginal pessaries, corticosteroids, immune suppressive, immunostimulant therapy in the last 2 weeks Presence of another vaginal condition, cervical cancer 6. History of hypersensitivity to study medication, serious illness 7. Patients with uncontrolled Diabetes mellitus

Design outcomes

Primary

Measure	Time frame
-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. -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. -Proportion of patients with Therapeutic cure defined as clinical and mycological cure at end of day 7 in each treatment group. Timepoint: Day 7,14	—

Measure

Time frame

-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. -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. -Proportion of patients with Therapeutic cure defined as clinical and mycological cure at end of day 7 in each treatment group. Timepoint: Day 7,14

—

Secondary

Measure	Time frame
Treatment emergent adverse events (TEAEs)Timepoint: Day 7,14.	—

Countries

India

Contacts

Public ContactDr U Shobha Jagdish Chandra

Hetero Healthcare Limited

shobhaudutha@gmail.com9704416425

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Sep 19, 2026