Comparison of Two Topical Formulations Containing Clindamycin and Clotrimazole in Patients With Vaginal Infections

Launched by DR BHARTI DASWANI · Oct 1, 2012

Keywords

ClinConnect Summary

* This is a Randomized, Comparative, Prospective, Open label, Single center study to compare the 3 day treatment course of intravaginal soft gelatin capsule containing clindamycin and clotrimazole versus intravaginal ER tablets of clindamycin and clotrimazole in patients with vaginal discharge and clinical diagnosis of bacterial, trichomonal, candidal or mixed vaginitis with respect to efficacy and tolerability; and to study the in vitro drug release pattern of intravaginal soft gelatin capsule and intravaginal ER tablets containing clindamycin and clotrimazole.
* The study will be conducte...

Gender

FEMALE

Eligibility criteria

• Inclusion Criteria:
• • 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)
• Exclusion Criteria:
• • Post-menopausal women
• • Menstruating at diagnosis
• • Pregnancy
• • 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

Trial Officials