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

Phase 4

Completed

• Conditions: Vaginal Infections
• Interventions: Drug: ClinSupV3 -soft gelatin capsule; Drug: ClinSupV3ER- Extended release tablet

• Registration Number: NCT01697826
• Lead Sponsor: Dr Bharti Daswani

Brief 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.

Detailed Description

* 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

1. absence of any clinical sign suggestive of infective vaginitis and

2. 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 \[Tolerability\].

Study Timeline

• Study Start: 2011-04
• Primary Completion: 2011-09
• Study Completion: 2011-09
• Status Verified: 2012-09
• Study First Submitted: 2012-09-29
• Study First Submitted QC: 2012-10-01
• Last Update Submitted: 2012-10-01
• Study First Posted: 2012-10-02
• Last Update Posted: 2012-10-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 73

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ClinSupV3 -soft gelatin capsule	ClinSupV3 -soft gelatin capsule	Soft gelatin capsule containing 100mg Clindamycin and 200mg clotrimazole administered per vaginally for 3 consecutive days
ClinSupV3ER- Extended release tablet	ClinSupV3ER- Extended release tablet	ER tablets containing 100mg clindamycin and 200mg clotrimazole administered per vaginally for 3 consecutive days.

Primary Outcome Measures

Name	Time	Method
Primary outcome measure for Global effectiveness	On 8th day after start of treatment	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

Secondary Outcome Measures

Name	Time	Method
Secondary outcome measures for Global effectiveness	29th day after initiation of treatment	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
Secondary outcome measures for tolerability	8th day after start of treatment	Number of patients that are able to successfully complete the 3 day treatment course without a break or experiencing intolerable side-effects

Trial Locations

Locations (1)

BJ Govt. Medical College & Sassoon General Hospitals, Pune; 🇮🇳 Pune, Maharashtra, India