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)

A Phase 3b, Comparative and Randomized Study to Assess the Efficacy and Safety of an Intravaginal Ovule Combination of Ketoconazole and Clindamycin Compared With an Intravaginal Cream Combination of Tetracycline and Amphotericin B for the Treatment of Bacterial Vaginosis and Vaginal Candidiasis, Either Mixed or Isolated

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01293643

Enrollment

Registered

2011-02-10

Start date

2010-05-31

Completion date

2011-01-31

Last updated

2015-08-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Candidiasis, Vulvovaginal, Vaginosis, Bacterial

Brief 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.

Interventions

DRUG100 mg clindamycin /800 mg ketoconazole vaginal ovule

1 vaginal ovule for 3 consecutive days

DRUG100 mg tetracycline hydrochloride /50 mg amphotericin B cream

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 45 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Percentage of participants that obtain clinical cure	Baseline up to Day 10
Percentage of participants that obtain microbiological cure	Baseline up to Day 10

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026