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

• Status: Completed
• Trial end date: 2011-09-01
• Target enrollment: 0
• Participant gender: Female

Summary

Randomized, Parallel Group, Active Controlled Trial to compare effectiveness and tolerability of 2 different vaginal formulations containing 200mg clotrimazole and clindamycin phosphate equivalent to 100mg clindamycin for 3 days in women clinically diagnosed to have infective vaginitis.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Dr Bharti Daswani
• Collaborator: Resilient Cosmeceuticals Pvt. Ltd, Pune
• Treatments: Clindamycin; Clindamycin palmitate; Clindamycin phosphate; Clotrimazole; Miconazole

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