ClinicalTrials.gg
Status unknownNCT00889356Updated Apr 28, 2009

Evaluate Efficacy, Tolerability & Safety of Combination of Clindamycin and Ketoconazole for the Treatment of Mixed-Type Vaginosis, Bacterial Vaginosis and Candidiasis

A Phase 3 interventional study of Clindamycin 100mg and Ketoconazole 400mg and Tetracycline 100mg and Amphotericin B 50mg in Candidiasis and Bacterial Vaginosis, sponsored by Zodiac Produtos Farmaceuticos S.A.. Status unknown at 1 site in Brazil. Open to female participants aged 18 Years to 50 Years. Per ClinicalTrials.gov, last updated 2009-04-28.

Sponsored by Zodiac Produtos Farmaceuticos S.A. · Phase 3, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Apr 2009), so the status shown — last known as Not yet recruiting — may be out of date.
Phase
Phase 3
Study type
Interventional
Enrollment
160
Allocation
Randomized
Ages
18 Years to 50 Years
Sex
Female
01

Study summary

The purpose of this study is to determine the Efficacy, Tolerability \& Safety of Combination of Clindamycin 100mg and Ketoconazole 400mg in Vaginal Capsules, used for 7 consecutive days in patients with Mixed-Type Vaginosis compared to Combination of Tetracycline 100mg and Amphotericin B 50mg in Vaginal Cream.

02

Conditions studied

  • Candidiasis
  • Bacterial Vaginosis
03

In context

Candidiasis

270 studies on the registry are indexed under Candidiasis; 20 are open to participants now.

This study's planned enrollment of 160 is above the median of 99 across 191 interventional studies indexed under Candidiasis.

Browse Candidiasis studies →

Lead sponsor

Zodiac Produtos Farmaceuticos S.A. is the lead sponsor of 7 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 50 Years
Sexes eligible
Female
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Mixed-type vaginosis
  • Bacterial vaginosis
  • Candidiasis

Exclusion criteria

Exclusion Criteria:

  • Pregnancy
  • Vaginal bleeding
  • History of recurrent vaginosis
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
160 participants (estimated)

Study arms

  • Experimental
    Clindamycin 100mg and Ketoconazole 400mg

    Drug: Clindamycin 100mg and Ketoconazole 400mg

  • Active comparator
    Tetracycline 100mg and Amphotericin B 50mg

    Drug: Tetracycline 100mg and Amphotericin B 50mg

Interventions

  • DrugClindamycin 100mg and Ketoconazole 400mg

    Drug page: Clindamycin

    1 vaginal capsule once a day at night

  • DrugTetracycline 100mg and Amphotericin B 50mg

    Drug page: Tetracycline

    One full applicator, once a day at night

06

What researchers measure

Primary outcomes

  1. Efficacy based on cure rate evaluated by clinical and laboratory criteria.

    Time frame: 7 days

Secondary outcomes

  1. Tolerability based on adverse events reports and patient's information

    Time frame: 7 days

  2. Safety based on adverse events reports and laboratory criterion

    Time frame: 7 days

07

Study locations

1 site
  • Vox Femina
    Jundiaí, São Paulo, Brazil
    • Rogerio Bonassi Machado, MD · Contact
    • Rogerio Bonassi Machado, MD · Principal investigator
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 28, 2009, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00889356
Lead sponsor
Zodiac Produtos Farmaceuticos S.A.
First posted
Apr 28, 2009
Start date
Sep 2009
Primary completion
Mar 2010 (estimated)
Completion
Mar 2010 (estimated)
Last update
Apr 28, 2009

Study contacts

Rogerio Bonassi Machado, MD
Contact
rogeriobonassi@terra.com.br
+55 11 4521-6466
Paula Fabrini, MD
Contact
+55 11 4521-6466
Rogerio Bonassi Machado, MD
principal investigator · CRM Regional Council of Medicine

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Apr 2009. You cannot join it, but the record below documents what was studied.

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Discussion

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Studies of the drug tested here: Clindamycin

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