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

NCT01697826 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 73

Last updated 2012-10-02

No results posted yet for this study

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.

Conditions

  • Vaginal Infections

Interventions

DRUG

ClinSupV3 -soft gelatin capsule

3 day treatment with intravaginal formulation containing 100mg Clindamycin and 200mg clotrimazole

DRUG

ClinSupV3ER- Extended release tablet

3 day treatment with intravaginal formulation containing 100mg Clindamycin and 200mg Clotrimazole

Sponsors & Collaborators

  • Resilient Cosmeceuticals Pvt. Ltd, Pune

    collaborator UNKNOWN
  • Dr Bharti Daswani

    lead INDIV

Principal Investigators

  • Bharti R Daswani, MD, PhD · BJ Govt Medical College & Sassoon General Hospitals, Pune

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-04-30
Primary Completion
2011-09-30
Completion
2011-09-30

Countries

  • India

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01697826 on ClinicalTrials.gov