Prevention of Persistence of Bacterial Vaginosis

Bacterial Vaginosis Clinical Trial

Official title:

Prevention of Persistence of Bacterial Vaginosis: The Effects of High Dose Intravaginal Metronidazole

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00741845
• Other study ID #: Embil-2008Peru
• Status: Terminated
• Phase: Phase 3
• First received: August 25, 2008
• Last updated: March 5, 2012
• Start date: June 2008

Study information

• Verified date: March 2012
• Source: Embil Pharmaceutical Co. Ltd
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 117
• Est. primary completion date: June 2009
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

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

Related Conditions & MeSH terms

• Bacterial Vaginosis
• Vaginal Diseases
• Vaginosis, Bacterial

Intervention

Drug:
• intravaginal metronidazole
high dose intravaginal metronidazole 750mg (with or without miconazole) to be compared to low dose intravaginal metronidazole 37.5mg

Locations

Country	Name	City	State
Peru	Cayetano Heredia Hospital	Lima	Urb Ingenieria

Sponsors (1)

Lead Sponsor	Collaborator
Embil Pharmaceutical Co. Ltd

Country where clinical trial is conducted

Peru, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The specific aim of this study is to compare the rate of persistence of BV in non-pregnant women randomized to one of three different schemes of intravaginal metronidazole given nightly for 5 nights		28 days after therapy initiation