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

Study Overview
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Brief Summary
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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.

Detailed Description
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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 conducted in B.J. Medical College & Sassoon General Hospitals, Pune. The study will be completed in 60 patients [30 patients in each group]. The primary outcome measure is absence of any clinical sign suggestive of infective vaginitis and a vaginal swab that is negative for bacterial, trichomonal or candidal vaginitis at 8th day after start of treatment [Effectiveness in inducing a remission]. The secondary outcome measures will be absence of any clinical sign suggestive of infective vaginitis and a vaginal swab that is negative for bacterial, trichomonal or candidal vaginitis at 29th day after start of treatment [Effectiveness in maintaining a remission] and ability to complete the 3day course without any break or experiencing intolerable side effects [Tolerability].

Official Title
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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 Vaginal Infections

Conditions
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Vaginal Infections

Intervention / Treatment
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* Drug: ClinSupV3 -soft gelatin capsule
* Drug: ClinSupV3ER- Extended release tablet


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: ClinSupV3 -soft gelatin capsule<br>Soft gelatin capsule containing 100mg Clindamycin and 200mg clotrimazole administered per vaginally for 3 consecutive days | Drug: ClinSupV3 -soft gelatin capsule<br>* 3 day treatment with intravaginal formulation containing 100mg Clindamycin and 200mg clotrimazole<br>* Other names: Clindamycin plus Clotrimazole;|
| Active Comparator: ClinSupV3ER- Extended release tablet<br>ER tablets containing 100mg clindamycin and 200mg clotrimazole administered per vaginally for 3 consecutive days. | Drug: ClinSupV3ER- Extended release tablet<br>* 3 day treatment with intravaginal formulation containing 100mg Clindamycin and 200mg Clotrimazole<br>* Other names: Clindamycin plus Clotrimazole;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Primary outcome measure for Global effectiveness | Number of patients showing resolution of clinical signs suggestive of infective vaginitis and a vaginal swab that is negative for bacterial, trichomonal or candidal vaginitis | On 8th day after start of treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Secondary outcome measures for Global effectiveness | Number of patients showing absence of clinical signs suggestive of infective vaginitis and a vaginal swab that is negative for bacterial,trichomonal or candidal vaginitis | 29th day after initiation of treatment | 
| Secondary outcome measures for tolerability | Number of patients that are able to successfully complete the 3 day treatment course without a break or experiencing intolerable side-effects | 8th day after start of treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Vaginal formulation, Bacterial vaginosis, Candidiasis, Trichomoniasis, Mixed vaginitis, Infective vaginitis, Clindamycin, Clotrimazole