A Comparative Open Labeled Clinical Study to Evaluate the Efficacy and Tolerability of Two different Intravaginal Formulations Containing a Combination of Clindamycin and Clotrimazole in Patients of Bacterial, Trichomonal, Candidial and Mixed Vaginal Infections

Bharti Daswani0 个研究点目标入组 60 人开始时间: 待定最近更新: 2021年11月24日

试验速览

暂无简介。

•Women with symptoms of vaginal discharge and/or odor and a clinical diagnosis of vaginitis of infective origin [based on symptoms and signs on per speculum examination]
•Age at least 18 years
•Capable of giving written informed consent
•Agree to no intercourse for 8 days from the day of start of treatment
•Agree not to douche or use any intravaginal products during the study period (including tampons, medications and devices)

•Post-menopausal women
•Menstruating at diagnosis
•Any antifungal or antibiotic use 14 days prior to enrolment
•Use of oral or intravaginal antibiotics within the past 2 weeks
•Immunosuppressive drug within 4 months
•Presence of vaginal / vulval ulcer
•Presence of any other vulval, vaginal or medical condition, including cervical neoplasia/ treatment that might confound treatment response
•Inability to keep return appointments
•History of hypersensitivity to clotrimazole, clindamycin or lincomycin
•History of regional enteritis, ulcerative colitis or ?antibiotic associated? colitis
•Significant disease or acute illness that in the Investigators assessment could complicate the evaluation
•Intrauterine Device

发起方

Bharti Daswani