A Study to Find the Effect of Clotrimazole vaginal film

COMPARATIVE CLINICAL EVALUATION OF EFFICACY AND SAFETY OF CLOTRIMAZOLE VAGINAL FILM VS CANESTEN V6 VAGINAL TABLET IN THE MANAGEMENT OF SYMPTOMATIC VULVOVAGINAL CANDIDIASIS IN NON PREGNANT WOMEN - OPEN LABEL, RANDOMIZED, COMPARATIVE, PARALLEL, PROSPECTIVE, MULTICENTRIC STUDY

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2022/12/048230

Enrollment

300

Registered

2022-12-19

Start date

Unknown

Completion date

Unknown

Last updated

2024-03-04

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

Conditions

Health Condition 1: N899- Noninflammatory disorder of vagina, unspecified

Interventions

Intervention1: Clotrimazole vaginal film: Dose: Two clotrimazole vaginal films (50mg each) Route of administration: Intravaginally Frequency: Two films during night time for 7days. Control Intervent

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 / pseudo hyphae or budding yeast cells. 3. Presence of > 1 vulvovaginal sign (erythema, edema, excoriation), presence of > 1 vulvovaginal symptom (itching / pruritus, irritation in and around vagina, burning); composite severity score of > 6. 4. Patients with negative whiff test. 5. Patients with vaginal pH 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, immune suppressive therapy in the last 2 weeks. 5. Presence of another vaginal condition, cervical cancer. 6. H/O hypersensitivity to study medication, serious illness.

Design outcomes

Primary

Measure	Time frame
- Proportion of patients with clinical cure - defined as complete resolution of 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 3,7,14	—

Measure

Time frame

- Proportion of patients with clinical cure - defined as complete resolution of 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 3,7,14

—

Secondary

Measure	Time frame
Treatment Emergent Adverse EventsTimepoint: Day 3, 7, 14	—

Countries

India

Contacts

Public ContactMr P Narender reddy

Hetero Healthcare Limited

shobhaudutha@gmail.com9704416425

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026