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

Hetero Healthcare Limited0 个研究点目标入组 300 人开始时间: 待定最近更新: 2024年3月4日

试验速览

暂无简介。

•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 < 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

•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.

发起方

Hetero Healthcare Limited