Asymptomatic Bacterial Vaginosis and Herpes Simplex Virus Type 2 (BV/HSV-2) Shedding Study - Study Results

Asymptomatic Bacterial Vaginosis and Herpes Simplex Virus Type 2 (BV/HSV-2) Shedding Study (MASH)

This study has been completed.

Study NCT00464542 Information provided by University of Pittsburgh

First Received on April 19, 2007. Last Updated on August 31, 2011 History of Changes

Results First Received: March 22, 2011

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized; Endpoint Classification: Efficacy Study; Intervention Model: Single Group Assignment; Masking: Open Label; Primary Purpose: Treatment
Condition:	Bacterial Vaginosis
Intervention:	Drug: Metronidazole

Participant Flow

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Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Twelve HSV-2 seropositive women with asymptomatic BV were enrolled. Two of these women were lost to follow-up within 2 weeks of enrollment. A third woman was lost to follow-up after initiating metronidazole therapy at study midpoint.

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups

	Description
MASH Cohort	This cohort consisted of women who were seropositive for Herpes Simplex Virus type 2 (HSV-2)and who had asymptomatic bacterial vaginosis as assessed by Amsel's criteria at enrollment

Participant Flow for 2 periods

Period 1: Pre-treatment

	MASH Cohort
STARTED	12
COMPLETED	10
NOT COMPLETED	2
Withdrawal by Subject	2

Period 2: Post-treatment

	MASH Cohort
STARTED	10
COMPLETED	10
NOT COMPLETED	0

Baseline Characteristics

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Reporting Groups

	Description
MASH Cohort	This cohort consisted of women who were seropositive for Herpes Simplex Virus type 2 (HSV-2)and who had asymptomatic bacterial vaginosis as assessed by Amsel's criteria at enrollment

Baseline Measures

	MASH Cohort
Number of Participants [units: participants]	12
Age [units: participants]
<=18 years	0
Between 18 and 65 years	12
>=65 years	0
Age [units: years] Mean ± Standard Deviation	24 ± 2.5
Gender [units: participants]
Female	12
Male	0
Region of Enrollment [units: participants]
United States	12

Outcome Measures

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1. Primary:

Number of Participants With Bacterial Vaginosis Recurrence [ Time Frame: 30 days after cessation of metronidazole therapy ]

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2. Secondary:

Median Time to Bacterial Vaginosis During the 30 Days After Cessation of Metronidazole Therapy [ Time Frame: 30 days after cessation of metronidazole therapy ]

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Serious Adverse Events

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Other Adverse Events

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More Information

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Certain Agreements:

All Principal Investigators ARE employed by the organization sponsoring the study.

Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
Inadequate controls (study would have been improved by inclusion of women without herpes simplex virus type 2 infection) to better determine the strength of the association between recalcitrance of BV and HSV-2 infection.

Results Point of Contact:

Name/Title: Thomas Cherpes
Organization: University of Pittsburgh
phone: 412 692 5930
e-mail: cherpestl@upmc.edu

No publications provided

Responsible Party:	Thomas L. Cherpes, MD, University of Pittsburgh
ClinicalTrials.gov Identifier:	NCT00464542 History of Changes
Other Study ID Numbers:	PRO07030124
Study First Received:	April 19, 2007
Results First Received:	March 22, 2011
Last Updated:	August 31, 2011
Health Authority:	United States: Institutional Review Board