Recurrent Bacterial Vaginosis and Vaginal Acidifying Gel Trial

This study has been completed.

Study NCT00545181 Information provided by Indiana University

First Received on October 15, 2007. Last Updated on January 6, 2010 History of Changes

Results First Received: December 2, 2009

Study Type:	Interventional
Study Design:	Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Single Blind (Outcomes Assessor); Primary Purpose: Treatment
Condition:	Bacterial Vaginosis
Interventions:	Drug: Vaginal acidifying gel (RepHresh) Drug: Metronidazole control

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
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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
Metronidazole + Acidifying Gel (RepHresh)	Receive metronidazole plus vaginal acidifying gel
Metronidazole Alone	Metronidazole antibiotic therapy alone

Participant Flow: Overall Study

	Metronidazole + Acidifying Gel (RepHresh)	Metronidazole Alone
STARTED	29	25
COMPLETED	29	25
NOT COMPLETED	0	0

Baseline Characteristics

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Reporting Groups

	Description
Metronidazole + Acidifying Gel (RepHresh)	Receive metronidazole plus vaginal acidifying gel
Metronidazole Alone	Metronidazole antibiotic therapy alone

Baseline Measures

	Metronidazole + Acidifying Gel (RepHresh)	Metronidazole Alone	Total
Number of Participants [units: participants]	29	25	54
Age [units: participants]
<=18 years	0	0	0
Between 18 and 65 years	29	25	54
>=65 years	0	0	0
Age [units: years] Mean ± Standard Deviation	29.8 ± 5.8	32.4 ± 6.9	31.0 ± 6.4
Gender [units: participants]
Female	29	25	54
Male	0	0	0
Region of Enrollment [units: participants]
United States	29	25	54

Outcome Measures

1. Primary:

Recurrent Bacterial Vaginosis [ Time Frame: 3 months ]

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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:

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

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
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Results Point of Contact:

Name/Title: David Haas, MD MS
Organization: Indiana University School of Medicine
phone: 3176307837
e-mail: dahaas@iupui.edu

No publications provided

Responsible Party:	David M. Haas, Indiana University School of Medicine
ClinicalTrials.gov Identifier:	NCT00545181 History of Changes
Other Study ID Numbers:	0612-58 (Study #)
Study First Received:	October 15, 2007
Results First Received:	December 2, 2009
Last Updated:	January 6, 2010
Health Authority:	United States: Institutional Review Board