Clinical Evaluation of Effects of an Investigational Tampon on Vaginal Microflora

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Johnson & Johnson Consumer and Personal Products Worldwide

ClinicalTrials.gov Identifier:

NCT00913523

First received: June 3, 2009

Last updated: August 19, 2011

Last verified: August 2011

History of Changes

Results First Received: April 12, 2011

Study Type:	Interventional
Study Design:	Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Single Blind (Outcomes Assessor)
Condition:	Vaginal Microflora
Interventions:	Device: Experimental - Tampon with GML Device: Sham Control - Tampons without GML

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
Tampon With GML	Regular and Super Tampon with GML added to the cover
Tampon Without GML	Regular and Super Tampon without GML added to the cover
Tampon Normally Used	Type and Size of Tampon Normally Used by Subjects

Participant Flow: Overall Study

	Tampon With GML	Tampon Without GML	Tampon Normally Used
STARTED	162	159	161
COMPLETED	144	143	147
NOT COMPLETED	18	16	14
Withdrawal by Subject	3	2	2
Lost to Follow-up	1	1	1
Adverse Event	1	0	0
Protocol Violation	5	8	8
Pregnancy	1	3	0
Inadequate Number of Tampons Used	7	2	3

Baseline Characteristics

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Reporting Groups

	Description
Tampon With GML	Regular and Super Tampon with GML added to the cover
Tampon Without GML	Regular and Super Tampon without GML added to the cover
Tampon Normally Used	Type and Size of Tampon Normally Used by Subjects
Total	Total of all reporting groups

Baseline Measures

	Tampon With GML	Tampon Without GML	Tampon Normally Used	Total
Number of Participants [units: participants]	162	159	161	482
Age, Customized [units: Participants]
<18 years	0	0	0	0
18 to 64 years, inclusive	162	159	161	482
>=65 years	0	0	0	0
Gender, Customized [units: participants]
Female	162	159	161	482
Race/Ethnicity, Customized [units: Participants]
Hispanic or Latino (H/L)	18	15	13	46
Not Hispanic or Latino	140	142	148	430
Native Hawaiian/Other Pacific Islander (NH/OPI)	4	1	0	5
H/L & NH/OPI	0	1	0	1
Race/Ethnicity, Customized [units: Participants]
American Indian or Alaska Native	1	0	2	3
Asian	2	2	3	7
Black or African American	17	12	21	50
White	141	138	133	412
Unknown or Not Reported	1	7	2	10
Region of Enrollment [units: participants]
United States	162	159	161	482
Weight 39-169 kg, inclusive [units: Participants]	162	159	161	482
Height 143-148 cm, inclusive [units: Participants]	162	159	161	482
Body Mass Index 15-54, inclusive [units: Participants]	162	159	161	482
Average Cycle 17-35 Days, inclusive ^[1] [units: Participants]	162	159	161	482
Average Flow 3-10 Days, inclusive ^[2] [units: Participants]
Less than 3 Days	0	0	0	0
3 to 10 Days, inclusive	162	159	161	482
More than 10 Days	0	0	0	0
Number of Pregnancies Less than 14 [units: Participants]	162	159	161	482
Years of Tampon Use [units: Participants]
Less than 1 Year	0	0	1	1
1 Year	1	1	0	2
2 to 34 Years, inclusive	161	158	160	479

[1]	Average Days per Cycle in the past 4-6 months
[2]	Average Days of Flow in the past 4-6 months

Outcome Measures

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1. Primary:

Percentage of Subjects Showing Unfavorable Changes in Primary Microflora [ Time Frame: Mid-Cycle Baseline to Mid-Menstrual Samples ]

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2. Secondary:

Percentage of Subjects Showing Unfavorable Changes in Primary Microflora [ Time Frame: Mid-Cycle Baseline to Post-Menstrual Samples ]

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3. Secondary:

Percentage of Subjects With Selected Microflora in Tampons [ Time Frame: During Menses ]

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4. Secondary:

Abundance of Selected Microflora in Tampons [ Time Frame: During Menses ]

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5. Secondary:

Changes in Nugent Score [ Time Frame: Mid-Cycle Baseline to Mid-Menstrual Samples ]

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6. Secondary:

Changes in Nugent Score [ Time Frame: Mid-Cycle Baseline to Post-Menstrual Samples ]

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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 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.

The agreement is:

	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed. Restriction Description: No paper that incorporates Sponsor Confidential Information will be submitted for publication without Sponsor's prior written consent. The Institution will provide Sponsor with at least sixty (60) days for review of a manuscript, and if requested in writing, the Institution and Principal Investigators will withhold such publication for up to an additional sixty (60) days to allow for filing of a patent application.

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: Joyce Hauze, RPS Senior Specialist, Clinical Research Operations
Organization: Johnson & Johnson Consumer and Personal Products Worldwide
phone: 928-277-0715
e-mail: jhauze@its.jnj.com

No publications provided

Responsible Party:	Johnson & Johnson Consumer and Personal Products Worldwide
ClinicalTrials.gov Identifier:	NCT00913523 History of Changes
Other Study ID Numbers:	2007-101
Study First Received:	June 3, 2009
Results First Received:	April 12, 2011
Last Updated:	August 19, 2011
Health Authority:	United States: Institutional Review Board

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