Prevention of Persistence of Bacterial Vaginosis

Embil Pharmaceutical

Status and phase: Terminated; Phase 3

Conditions: Bacterial Vaginosis

Treatments: Drug: intravaginal metronidazole

Study type: Interventional

Funder types: Industry

Identifiers

NCT00741845

Embil-2008Peru

Details and patient eligibility

About

This purpose of this study will be to conduct a double-blind, randomized, controlled clinical trial to determine the association between intravaginal high dose metronidazole (750mg), intravaginal high dose metronidazole combined with an antifungal agent(750mg metronidazole + 200mg miconazole) and low dose (37.5mg) intravaginal metronidazole, with the rate of persistent bacterial vaginosis.

Enrollment: 117 patients

Sex: Female

Ages: 18 to 40 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• women 18-40 yrs old
• abnormal vaginal discharge or malodor
• positive QuickVue test
• positive KOH whiff test
• Positive finding of clue cells greater than or equal to 20% on wet mount
• Able to give informed consent
• willing to abstain from alcohol during the 5 day therapy and 1 day following

Exclusion criteria

• immunocompromised women
• symptomatic VVC
• pregnancy or positive pregnancy test
• menstruating or breastfeeding women
• other oral or vaginal antifungal or antimicrobial drugs w/in past 2 wks
• women with MPC, PID

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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117 participants in 3 patient groups

1

Active Comparator group

Description:

intravaginal metronidazole 750mg + 200mg miconazole

Treatment:

Drug: intravaginal metronidazole

2

Active Comparator group

Description:

intravaginal metronidazole 750mg

Treatment:

Drug: intravaginal metronidazole

3

Active Comparator group

Description:

intravaginal metronidazole 37.5mg

Treatment:

Drug: intravaginal metronidazole