CTRI/2011/04/001698
Completed
Phase 4
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 sites60 target enrollmentTBD
Overview
- Phase
- Phase 4
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Bharti Daswani
- Enrollment
- 60
- Status
- Completed
- Last Updated
- 4 years ago
Overview
Brief Summary
No summary available.
Investigators
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
- •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
Outcomes
Primary Outcomes
Not specified
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