NCT02365389|CompletedPhase 2/3
Once Daily In-situ Forming Versus Twice-daily Conventional Metronidazole Vaginal Gels for Treatment of Bacterial Vaginosis
MNZ
Assiut University Hospital - Women Health Hospital
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MNZ
Assiut University Hospital - Women Health Hospital
Sponsor study identifier
interventional
64
0 countries
N/A
Study Start
May 2014
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
October 2014
Actual (reported)Study Completion
December 2014
Actual (reported)A previous study showed that in situ MTZ vaginal gel twice daily is more effective than the conventional vaginal gel product in sustained cure of BV( 4 weeks after treatment) (80.0% in the in-situ gel group as compared with 47.4 in the conventional gel group.The current study aims to compare the efficacy of the use of once daily in situ MTZ vaginal gel (0.8%) versus twice-daily conventional MTZ vaginal gel in treatment of BV.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 2014
Actual (reported)Click on a node to explore related trials.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
May 2014
Date type not reportedThis date has not been verified as actual or estimated.
October 2014
Actual (reported)December 2014
Actual (reported)February 15, 2015
Actual (reported)February 18, 2015
Actual (reported)Clinical improvement of vaginitis.
Therapeutic success will be defined as the presence of at least 3 signs of Amsel's criteria (Milky, homogeneous, adherent discharge; vaginal pH \> 4.5; release of fishy amine odor from vaginal fluid when mixed with 10% KOH (whiff test); and presence of \> 20 of clue cells).
6 months
Received in situ MTZ vaginal gel once daily for 5 days. Treatment in this group was offered in the form of a bottle of an aqueous liquid (100 mL of a preparation composed of 0.8% MTZ, 20% pluronic F-127, 10% pluronic F-68, and 0.01% benzalkonium chloride). Women were asked to put 5 cc of the liquid into the vagina once daily for 5 days using a graded syringe and 10-cm long soft applicator.
Group B (control group) received conventional MTZ vaginal gel (Tricho gel 0.8%, Sedico, Egypt) twice daily for 5 days, using the supplied nozzle, which applies about 5 gm of gel again in the same laying back position.
MTZ vaginal gel once daily for 5 days
Conventional MTZ vaginal gel (Tricho gel 0.8%, Sedico, Egypt) twice daily for 5 days
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
64 participants (actual enrollment reported by the registry).
First Submitted
February 15, 2015
First Posted
February 18, 2015
Study Start
May 2014
Date type not reportedThis date has not been verified as actual or estimated.
Diagnostic Accuracy By Providers Study
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Primary Completion
October 2014
Actual (reported)Study Completion
December 2014
Actual (reported)Last Updated
February 18, 2015
Record last verified: 2015-02
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Source: ClinicalTrials.gov.
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