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)

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

99 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-05-31

Study Completion Date

2011-01-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Vaginosis, Bacterial Candidiasis, Vulvovaginal

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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clindamycin/ketoconazole combination

Group Type EXPERIMENTAL

100 mg clindamycin /800 mg ketoconazole vaginal ovule

Intervention Type DRUG

1 vaginal ovule for 3 consecutive days

tetracycline hydrochloride/amphotericin B combination

Group Type ACTIVE_COMPARATOR

100 mg tetracycline hydrochloride /50 mg amphotericin B cream

Intervention Type DRUG

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

Interventions

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100 mg clindamycin /800 mg ketoconazole vaginal ovule

1 vaginal ovule for 3 consecutive days

Intervention Type DRUG

100 mg tetracycline hydrochloride /50 mg amphotericin B cream

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

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Diagnosis of vaginal candidiasis
* No Trichomonas vaginalis or any other protozoa
* No clinical evidences of infection by Neisseria gonorrhoeae, Chlamydia trachomatis, or viral infections

Exclusion Criteria

* Known sensitivity to the formula components
* Pregnant or nursing patients
* Any gynecological condition contraindicating the use of vaginal ovule or cream.
* Use of any other local or systemic bactericidal, anti-protozoa or antifungal agent within the 2 weeks prior to the study start or during it
* Presence of other sexually transmitted diseases (except from Candidal vaginitis).
* History of recurrent candidiasis (≥4 episodes per year)
* Use of intra-uterine device, spermicides, or diaphragms
* Has metabolic or immune disorder
* Has abnormal uterine bleeding

Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No