Vaginal MicrofloraNCT00913523
Clinical Evaluation of Effects of an Investigational Tampon on Vaginal Microflora
A study testing Experimental - Tampon with GML in people with Vaginal Microflora, run by Johnson & Johnson Consumer and Personal Products Worldwide at 2 sites in United States.
Trial summary
Subjects will be using investigational or control tampons during their menstrual period but these tampons are not intended to prevent, treat or diagnose an infection or other disease condition. A total 450 women will participate in this study at two study sites. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Vaginal Microflora
- What is being tested?
- Experimental - Tampon with GML
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 482 participants
- Where
- 2 sitesUnited States
- Study dates
- Jan 2009to Aug 2009
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- normal healthy women
- 18-45 years of age
- regular 21- to 35-day menstrual cycles with at least 5 days of bleeding, or at least 3 days of bleeding if they are using hormonal contraception
- used tampons as their principal mode of menstrual sanitary protection for at least the previous 6 months
- willing to not change their feminine care or hygiene practices during their participation in the study (except as directed by the protocol and instructions for participants)
Who cannot join
- signs or symptoms of clinically significant vulvovaginal infection or vaginosis
- history of recurrent urinary tract or vulvovaginal infection
- abnormal vaginal discharge of any etiology
- use of a systemic, vaginal, or perineal antibiotic, antifungal, anti-infective, or immunosuppressant medication or any experimental drug or medical device within the 30 days preceding the Screening/Baseline Visit
- history of treatment for Toxic Shock Syndrome (TSS) or a suspicion of having had TSS
- other clinical issues or history (per protocol) that would make participation in the trial inappropriate
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Hill Top Research
Scottsdale, Arizona, 85251
Hill Top Research
St. Petersburg, Florida, 33710
About this study
Official title: Vaginal Lactobacillus and Other Key Microflora During and After Menses in Women Using Tampons Containing Glycerol Monolaurate (GML) and Women Using Tampons Without GML
Subjects will be using investigational or control tampons during their menstrual period but these tampons are not intended to prevent, treat or diagnose an infection or other disease condition. A total 450 women will participate in this study at two study sites. Subjects will be randomly assigned to one of three tampon groups. The first group will test an experimental test tampon containing glycerol monolaurate (GML) on the cover. The second group will test an identical tampon, but without GML. The third group will not be issued study tampons but will be instructed to use their normal tampon brand. This study is intended to determine whether the effects of GML observed in the laboratory can be demonstrated in healthy menstruating women.
Read the detailed description
Subjects will be using investigational or control tampons during their menstrual period but these tampons are not intended to prevent, treat or diagnose an infection or other disease condition. This study will be a randomized, single-blinded, multi-center study of women using Tampons with GML, Tampons without GML or the Tampons Normally Used for one menstrual period. Subjects will undergo Baseline microflora evaluations taken from the vaginal walls 5-10 days following their menstrual period (Baseline evaluation). Subjects will be randomly assigned to use one of the three study products during their next menstrual period. Microflora will be re-evaluated in samples taken from the tampons and from the vaginal walls during use of the study tampons, and from vaginal walls soon after the end of the menstrual period. Evaluations of microflora will be done by quantitative cultures of tampons and vaginal swabs, and also by Nugent scoring of the vaginal swabs. Staphylococcal α-hemolysin and TSST-1 will be analyzed in extracts of the study tampons from subjects found to be colonized with S. aureus. Vaginal pH will be measured, using electronic meters, at each clinic visit. All samples (tampons and vaginal swabs) will be analyzed at a central microbiology laboratory. Extracts of tampons found to contain S. aureus will be forwarded to another central laboratory for the toxin assays. Personnel in the central laboratories will be blinded to the group assignment (study product) for each subject until completion of the study.
- Conditions
- Vaginal Microflora
- Being tested
- Experimental - Tampon with GML, Sham Control - Tampons without GML
- Keywords
- tampons, Glycerol Monolaurate, vaginal microflora, microbes, Vaginal Tampon
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Experimental - Tampon with GMLDevice
Also called Not yet marketed
Regular and Super Tampon with Glycerol Monolaurate (GML) added to the cover
Sham Control - Tampons without GMLDevice
Also called Tampons with no GML
There is no intervention associated with these arms - they are sham controls.
| Study group | Role | What they receive |
|---|---|---|
| Tampon with GML | Experimental | Regular and Super Tampon with GML added to the cover Receives: Device: Experimental - Tampon with GML |
| Tampon without GML | Sham comparator | Regular and Super Tampon without GML Receives: Device: Sham Control - Tampons without GML |
| Tampon Normally Used | Sham comparator | Type and Size of Tampon Normally Used by Subjects Receives: Device: Sham Control - Tampons without GML |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Subjects Showing Unfavorable Changes in Primary Microflora
Percentage of subjects showing unfavorable changes of at least 1-log in lactobacilli (decrease), C. albicans (increase), or G. vaginalis (increase)
Measured: Mid-Cycle Baseline to Mid-Menstrual Samples
Secondary outcomes (5)
Percentage of Subjects Showing Unfavorable Changes in Primary Microflora
Percentage of subjects showing unfavorable changes of at least 1-log in lactobacilli (decrease), C. albicans (increase), or G. vaginalis (increase)
Measured: Mid-Cycle Baseline to Post-Menstrual Samples
Percentage of Subjects With Selected Microflora in Tampons
Percentage of subjects with selected relevant microorganisms in tampons during menses
Measured: During Menses
Abundance of Selected Microflora in Tampons
Abundance of selected relevant microorganisms in tampons during menses, in log10 colony forming units (CFU) per gram of menstrual fluid add-on to the tampon, in subjects who had detectable counts of the microorganism.
Measured: During Menses
Changes in Nugent Score
Percentage of subjects who showed a change in Nugent score from a score of </= 3 to a score of >/= 4.
Measured: Mid-Cycle Baseline to Mid-Menstrual Samples
Changes in Nugent Score
Percentage of subjects who showed a change in Nugent score from a score of </= 3 to a score of >/= 4.
Measured: Mid-Cycle Baseline to Post-Menstrual Samples
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2009 (estimated)
- Study startJan 2009
- Primary completionAug 2009
- Study completionAug 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Vaginal MicrofloraStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 482 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johnson & Johnson Consumer and Personal Products Worldwide
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- David J Chase, PhD, Study director, Johnson & Johnson Consumer and Personal Products Worldwide
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00913523
- Sponsor's protocol ID
- 2007-101
- Status last verified
- Aug 2011
- First submitted
- 3 Jun 2009
- Last updated
- 23 Aug 2011
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Aug 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vaginal Lactobacillus and Other Key Microflora During and After Menses in Women Using Tampons Containing Glycerol Monolaurate (GML) and Women Using Tampons Without GML
- ClinicalTrials.gov ID
- NCT00913523
- Acronym / sponsor ID
- 2007-101
- Conditions
- Vaginal Microflora
- Keywords
- tampons, Glycerol Monolaurate, vaginal microflora, microbes, Vaginal Tampon
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 482 participants (actual)
- Lead sponsor
- Johnson & Johnson Consumer and Personal Products WorldwideIndustry (pharma, biotech, devices)
- Study start
- Jan 2009
- Primary completion
- Aug 2009 (actual)
- Study completion
- Aug 2009 (actual)
- First posted
- 4 Jun 2009 (estimated)
- Results
- Posted 6 May 2011
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Subjects will be using investigational or control tampons during their menstrual period but these tampons are not intended to prevent, treat or diagnose an infection or other disease condition. A total 450 women will participate in this study at two study sites. Subjects will be randomly assigned to one of three tampon groups. The first group will test an experimental test tampon containing glycerol monolaurate (GML) on the cover. The second group will test an identical tampon, but without GML. The third group will not be issued study tampons but will be instructed to use their normal tampon brand. This study is intended to determine whether the effects of GML observed in the laboratory can be demonstrated in healthy menstruating women.
Detailed description
Subjects will be using investigational or control tampons during their menstrual period but these tampons are not intended to prevent, treat or diagnose an infection or other disease condition. This study will be a randomized, single-blinded, multi-center study of women using Tampons with GML, Tampons without GML or the Tampons Normally Used for one menstrual period. Subjects will undergo Baseline microflora evaluations taken from the vaginal walls 5-10 days following their menstrual period (Baseline evaluation). Subjects will be randomly assigned to use one of the three study products during their next menstrual period. Microflora will be re-evaluated in samples taken from the tampons and from the vaginal walls during use of the study tampons, and from vaginal walls soon after the end of the menstrual period. Evaluations of microflora will be done by quantitative cultures of tampons and vaginal swabs, and also by Nugent scoring of the vaginal swabs. Staphylococcal α-hemolysin and TSST-1 will be analyzed in extracts of the study tampons from subjects found to be colonized with S. aureus. Vaginal pH will be measured, using electronic meters, at each clinic visit. All samples (tampons and vaginal swabs) will be analyzed at a central microbiology laboratory. Extracts of tampons found to contain S. aureus will be forwarded to another central laboratory for the toxin assays. Personnel in the central laboratories will be blinded to the group assignment (study product) for each subject until completion of the study.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Tampon with GML | Experimental | Device: Experimental - Tampon with GMLRegular and Super Tampon with GML added to the cover |
| Tampon without GML | Sham comparator | Device: Sham Control - Tampons without GMLRegular and Super Tampon without GML |
| Tampon Normally Used | Sham comparator | Device: Sham Control - Tampons without GMLType and Size of Tampon Normally Used by Subjects |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- normal healthy women
- 18-45 years of age
- regular 21- to 35-day menstrual cycles with at least 5 days of bleeding, or at least 3 days of bleeding if they are using hormonal contraception
- used tampons as their principal mode of menstrual sanitary protection for at least the previous 6 months
- willing to not change their feminine care or hygiene practices during their participation in the study (except as directed by the protocol and instructions for participants)
Key exclusion criteria (6 listed)
- signs or symptoms of clinically significant vulvovaginal infection or vaginosis
- history of recurrent urinary tract or vulvovaginal infection
- abnormal vaginal discharge of any etiology
- use of a systemic, vaginal, or perineal antibiotic, antifungal, anti-infective, or immunosuppressant medication or any experimental drug or medical device within the 30 days preceding the Screening/Baseline Visit
- history of treatment for Toxic Shock Syndrome (TSS) or a suspicion of having had TSS
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Experimental - Tampon with GMLAlso: Not yet marketedRegular and Super Tampon with Glycerol Monolaurate (GML) added to the cover | Device | Tampon with GML |
| Sham Control - Tampons without GMLAlso: Tampons with no GMLThere is no intervention associated with these arms - they are sham controls. | Device | Tampon Normally Used, Tampon without GML |
Primary outcome
Percentage of Subjects Showing Unfavorable Changes in Primary Microflora
Time frame: Mid-Cycle Baseline to Mid-Menstrual Samples
Percentage of subjects showing unfavorable changes of at least 1-log in lactobacilli (decrease), C. albicans (increase), or G. vaginalis (increase)
5 secondary outcomes
Percentage of Subjects Showing Unfavorable Changes in Primary Microflora
Time frame: Mid-Cycle Baseline to Post-Menstrual Samples
Percentage of Subjects With Selected Microflora in Tampons
Time frame: During Menses
Abundance of Selected Microflora in Tampons
Time frame: During Menses
Changes in Nugent Score
Time frame: Mid-Cycle Baseline to Mid-Menstrual Samples
Changes in Nugent Score
Time frame: Mid-Cycle Baseline to Post-Menstrual Samples
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Aug 2011.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David J Chase, PhD study director
Johnson & Johnson Consumer and Personal Products Worldwide
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Experimental - Tampon with GML in people with Vaginal Microflora, run by Johnson & Johnson Consumer and Personal Products Worldwide at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Aug 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 6 May 2011). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Subjects Showing Unfavorable Changes in Primary Microflora (time frame: Mid-Cycle Baseline to Mid-Menstrual Samples). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Aug 2011.