MedTrace Logo

A Study to Compare the Efficacy and Safety of a Combination of Ketoconazole and Clindamycin Compared to Tetracycline/Amphotericin B Combination Cream for the Treatment of Bacterial Vaginosis and Vaginal Candidiasis (P08077)

NCT01293643 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 99

Last updated 2015-08-10

No results posted yet for this study

Summary

This is a study to compare the safety and efficacy of the use of a intravaginal ovule containing a combination of Ketoconazole and Clindamycin to the use of an intravaginal cream containing a combination Tetracycline and Amphotericin B for the treatment of bacterial vaginosis and/or mixed or isolated vaginal candidiasis.

Conditions

  • Vaginosis, Bacterial
  • Candidiasis, Vulvovaginal

Interventions

DRUG

100 mg clindamycin /800 mg ketoconazole vaginal ovule

1 vaginal ovule for 3 consecutive days

DRUG

100 mg tetracycline hydrochloride /50 mg amphotericin B cream

1 applicator (4 g) full of cream intravaginally for 7 to 10 days

Sponsors & Collaborators

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2010-05-31
Primary Completion
2011-01-31
Completion
2011-01-31

More Related Trials

Entities

Companies

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 NCT01293643 on ClinicalTrials.gov