Comparison of Two Topical Formulations Containing Clindamycin and Clotrimazole in Patients With V… (NCT01697826) | Clinical Trial Compass
CompletedPhase 4
Comparison of Two Topical Formulations Containing Clindamycin and Clotrimazole in Patients With Vaginal Infections
India73 participantsStarted 2011-04
Plain-language 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.
Who can participate
Age range
18 Years – 65 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.