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

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

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.

Study Overview

• Status: Completed
• Conditions: Vaginal Infections
• Intervention / Treatment: Drug: ClinSupV3 -soft gelatin capsule; Drug: ClinSupV3ER- Extended release tablet

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 Type: Interventional
• Enrollment (Actual): 73
• Phase: Phase 4

Contacts and Locations

Study Locations

• India
  • Maharashtra
    • Pune, Maharashtra, India, 411001
      • BJ Govt. Medical College & Sassoon General Hospitals, Pune

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinical Response	Number of the patients showing normalization of vaginal pH to 4.5	at 8th day and 29th day after initiation of treatment
Clinical response	Number of the patients achieving improvement in scores for quantity of vaginal discharge by at least 1 unit from baseline	at 8th and 29th day after start of treatment
Clinical response	Number of the patients achieving improvement in scores for itching by at least 1 unit from baseline	at 8th day and 29th day after start of treatment

Collaborators and Investigators

• Sponsor: Dr Bharti Daswani
• Collaborators: Resilient Cosmeceuticals Pvt. Ltd, Pune
• Investigators: Principal Investigator: Bharti R Daswani, MD, PhD, BJ Govt Medical College & Sassoon General Hospitals, Pune

Study record dates

Study Major Dates

• Study Start: April 1, 2011
• Primary Completion (Actual): September 1, 2011
• Study Completion (Actual): September 1, 2011

Study Registration Dates

• First Submitted: September 29, 2012
• First Submitted That Met QC Criteria: October 1, 2012
• First Posted (Estimate): October 2, 2012

Study Record Updates

• Last Update Posted (Estimate): October 2, 2012
• Last Update Submitted That Met QC Criteria: October 1, 2012
• Last Verified: September 1, 2012

More Information

Terms related to this study

• Keywords: Candidiasis; Bacterial vaginosis; Clindamycin; Clotrimazole; Vaginal formulation; Trichomoniasis; Mixed vaginitis; Infective vaginitis
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Infections; Communicable Diseases; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents, Local; Anti-Infective Agents; Enzyme Inhibitors; Hormones, Hormone Substitutes, and Hormone Antagonists; Anti-Bacterial Agents; Cytochrome P-450 CYP3A Inhibitors; Cytochrome P-450 Enzyme Inhibitors; Protein Synthesis Inhibitors; Hormone Antagonists; Antifungal Agents; Steroid Synthesis Inhibitors; 14-alpha Demethylase Inhibitors; Cytochrome P-450 CYP2C9 Inhibitors; Clindamycin; Clindamycin palmitate; Clindamycin phosphate; Clotrimazole; Miconazole
• Other Study ID Numbers: ND1210132-34; CTRI/2011/04/001698 (Registry Identifier: Clinical Trials Registry of India)