Bacterial VaginosisPhase 2/3TBVAPNCT01471457
Trial of Trimosan Gel Effect on Pessary-associated Bacterial Vaginosis
A Phase 2/3 study testing Trimo-San gel in people with Bacterial Vaginosis, run by University of New Mexico at 2 sites in United States.
Trial summary
The primary objective of this prospective, randomized, controlled study is to assess the effect of Trimo-San vaginal gel on the rate of bacterial vaginosis in women who use pessaries. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Bacterial Vaginosis
- What is being tested?
- Trimo-San gel
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 184 participants
- Where
- 2 sitesUnited States
- Study dates
- Sep 2009to Sep 2014
- Phase
- Phase 2/3
- 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 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Female
- Indications for initiation of pessary use and planning to be fitted for and wear a pessary
Who cannot join
- Male
- Already using a pessary or have used in the last year
- History of recurrent or chronic bacterial vaginosis with > 2 episodes per year or symptoms reported for > 6 months out of last year
- Active known vaginal infection (symptomatic and/or untreated) or completion of treatment for BV or cervical/vaginal infection within one week of recruitment
- History of active vaginal ulcerative disease (active ulcers from atrophy, herpes symptoms at recruitment, or HSV with > 2 outbreaks per year or last outbreak < 1 month ago)
- Chronic antibiotic use for indications not listed above
Trial locations and contacts
2 sites in 1 country.
United States2 sites
University of New Mexico
Albuquerque, New Mexico, 87131
Washington Hospital Center
Washington D.C., District of Columbia, 20010
About this study
Official title: The Use of Trimo-San Gel for the Prevention of Pessary-associated Bacterial Vaginosis
The primary objective of this prospective, randomized, controlled study is to assess the effect of Trimo-San vaginal gel on the rate of bacterial vaginosis in women who use pessaries. Women being fitted for a pessary for the first time or not wearing a pessary for >1 year are recruited in to the study and randomized to using Trimo-San gel daily or not using Trimo-San gel. The investigators use two objective measures of bacterial vaginosis (OSOM BV blue and gram stain) and subjective questionnaires regarding the presence and effect of vaginal symptoms on the pessary user prior to pessary fitting and at 3 months post pessary fitting. The investigators hypothesize that Trimo-San gel with not significantly affect the rate of bacterial vaginosis in pessary wearers as measures by OSOM BV blue and Gram stain, but will have a positive effect on the subjective symptoms experienced by women wearing pessaries.
Read the detailed description
The study population will consist of women who will be fitted for and initiate use of a pessary for relief of pelvic organ prolapse and/or urinary symptoms.
All patients scheduled for pessary fitting/initiation who meet the above inclusion criteria will be asked to participate in the study. They are randomized using opaque envelopes pulled sequentially, which were made originally from a blocked design, stratified to women removing the pessary daily themselves and women not removing the pessary daily themselves. Prior to pessary fitting all women in the study answer a brief questionnaire about their vaginal symptoms. Subjects undergo a vaginal swab for OSOM BV Blue (copyright by Genzyme, SekiSui) and Gram stain testing for Nugent's criteria the presence of bacterial vaginosis. Women are then fitted with and instructed on use of a pessary in the standard fashion by a trained physician at at the study sites.
Women will be randomized to either standard pessary care or to use of TrimoSan gel twice a week (half applicator) to the vagina either with applicator or applying half applicator amount to the surface of the pessary before insertion. If women are using additional vaginal medications such as Premarin this information will be collected but not change their randomization and they will continue to use other indicated vaginal medications as they did before participation in the study (per clinical judgement).
At 2 weeks and 3 month after pessary initiation the patients are seen for an office visit. At both the 2 week and 3 month visit they have repeat testing for bacterial vaginosis using vaginal swab for OSOM BV Blue (copyright by Genzyme) and Gram stain testing. At both the 2 week and 3 month visits they will also answer a questionnaire about their vaginal symptoms and the effect of these symptoms on their distress and lifestyle. This questionnaire is similar to the baseline questionnaire answered before initiation of pessary use, and will include questions about whether these symptoms have changed since initiation of their pessary. At the University of New Mexico site, information is also being collected on sexual function using the PISQ-IR questionnaire and on body image using the modified Body Image Scale at baseline, 2 weeks, and 3 months. At this particular site women will also answer questions about their management of the pessary (e.g. if they take it out for intercourse) surrounding sexual activity.
The recruitment goal for this study is 150 women, with 75 in each group. This was calculated to detect a significant difference in the rate of bacterial vaginosis between the control and study groups (α=0.05), and assuming baseline of bacterial vaginosis to be approximately 10% in the population and increased to 30% by hypothetical risk factors, the sample size needed for each group is 62 for a power of 80%. Assuming a 15% dropout rate after recruitment, we plan to randomize at least 75 patients to the control group and 75 patients to the study group for a total of at least 150 patients. 60 women were recruited for this study at the initial site of Washington Hospital Center in Washington, D.C. This study site closed in June 2012. In January 2013 the study opened at University of New Mexico in Albuquerque, NM. The study is currently opening and running at University of New Mexico with the recruitment goal of 90 women at this institution.
The primary outcome measure will be rate of bacterial vaginosis in the study population, to be compared between the control (non Trimo-San using) and study (Trimo-San using) groups. As part of this analysis, we will also compare the rate of bacterial vaginosis in the control and study groups before and after pessary initiation. Secondary outcomes will include:
- Change in vaginal symptoms as assessed by questionnaire before and after initiation of pessary use
- Change in level of worry or distress about vaginal symptoms as assessed by questionnaire before and after initiation of pessary use.
- Change in vaginal symptoms or distress about these symptoms as assessed by questionnaire based on use or non-use of Trimo-San gel.
- Describe the management of women of their pessary surrounding sexual activity (University of New Mexico only)
- Change in body image or sexual function associated with initiation of the pessary or use of TrimoSan gel (University of New Mexico only)
- Conditions
- Bacterial Vaginosis
- Being tested
- Trimo-San gel
- Keywords
- bacterial, vaginosis, pessary, discharge
- Medical subject headings
- Vaginosis, Bacterial, Vaginal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Trimo-San gelDrug
Pessary wearers are instructed to apply one fingertip (approx 1 tablespoon) of Trimo-San gel inside the vagina or to the pessary (for women removing and cleaning pessary before reinsertion after cleaning) once nightly
| Study group | Role | What they receive |
|---|---|---|
| Trimo-San group | Experimental | Pessary wearers are instructed to apply one fingertip (approx 1 tablespoon) of Trimo-San gel inside the vagina or to the pessary (for women removing and cleaning pessary before reinsertion after cleaning) once nightly Receives: Drug: Trimo-San gel |
| Control group | No intervention | Pessary wearers are informed on standard care of pessary, which includes topical estrogen application if they are using. Pessary wearers do not use Trimo-San gel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Patients With Bacterial Vaginosis at 3 Months
The primary outcome is the rate of bacterial vaginosis after pessary fitting as measured by OSOM BV blue (Genzyme) and gram stain, measured in women using and women not using Trimo-San gel after pessary fitting, at 3 months, with the denominator being the number of women having a gram stain at the 3 months time point in each group
Measured: 3 months
Secondary outcomes (1)
Participants With Any Bothersome Vaginal Symptom at 3 Months
Vaginal symptoms and effect of vaginal symptoms on pessary wearers measured before and after pessary fitting by questionnaire based on verified vaginal symptoms questionnaire at 3 months, with the denominator being the number of women completing the questionnaire at the 3 months time point in each group
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Nov 2011 (estimated)
- Study startSep 2009
- Primary completionSep 2014
- Study completionSep 2014
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.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for Bacterial VaginosisStudies 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 2/3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 184 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of New Mexico
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Kate V Meriwether, MD, Principal investigator, University of New Mexico
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01471457
- Sponsor's protocol ID
- 2009-028
- Acronym
- TBVAP
- Status last verified
- Apr 2020
- First submitted
- 10 Nov 2011
- Last updated
- 22 Apr 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Alnaif B, Drutz HP. Bacterial vaginosis increases in pessary users. Int Urogynecol J Pelvic Floor Dysfunct. 2000;11(4):219-22; discussion 222-3. doi: 10.1007/pl00004026.
PubMed 11005473Eschenbach DA, Hillier S, Critchlow C, Stevens C, DeRouen T, Holmes KK. Diagnosis and clinical manifestations of bacterial vaginosis. Am J Obstet Gynecol. 1988 Apr;158(4):819-28. doi: 10.1016/0002-9378(88)90078-6.
PubMed 3259075Landers DV, Wiesenfeld HC, Heine RP, Krohn MA, Hillier SL. Predictive value of the clinical diagnosis of lower genital tract infection in women. Am J Obstet Gynecol. 2004 Apr;190(4):1004-10. doi: 10.1016/j.ajog.2004.02.015.
PubMed 15118630Powers K, Lazarou G, Wang A, LaCombe J, Bensinger G, Greston WM, Mikhail MS. Pessary use in advanced pelvic organ prolapse. Int Urogynecol J Pelvic Floor Dysfunct. 2006 Feb;17(2):160-4. doi: 10.1007/s00192-005-1311-8. Epub 2005 May 10.
PubMed 15883856Myziuk L, Romanowski B, Johnson SC. BVBlue test for diagnosis of bacterial vaginosis. J Clin Microbiol. 2003 May;41(5):1925-8. doi: 10.1128/JCM.41.5.1925-1928.2003.
PubMed 12734228Bradshaw CS, Morton AN, Garland SM, Horvath LB, Kuzevska I, Fairley CK. Evaluation of a point-of-care test, BVBlue, and clinical and laboratory criteria for diagnosis of bacterial vaginosis. J Clin Microbiol. 2005 Mar;43(3):1304-8. doi: 10.1128/JCM.43.3.1304-1308.2005.
PubMed 15750100Forsum U, Hallen A, Larsson PG. Bacterial vaginosis--a laboratory and clinical diagnostics enigma. APMIS. 2005 Mar;113(3):153-61. doi: 10.1111/j.1600-0463.2005.apm1130301.x.
PubMed 15799757Bugge C, Adams EJ, Gopinath D, Stewart F, Dembinsky M, Sobiesuo P, Kearney R. Pessaries (mechanical devices) for managing pelvic organ prolapse in women. Cochrane Database Syst Rev. 2020 Nov 18;11(11):CD004010. doi: 10.1002/14651858.CD004010.pub4.
PubMed 33207004Gupta A, Cox C, Dunivan GC, Gaskins JT, Rogers RG, Iglesia CB, Meriwether KV. Desire for Continued Pessary Use Among Women of Hispanic and Non-Hispanic Ethnic Backgrounds for Pelvic Floor Disorders. Female Pelvic Med Reconstr Surg. 2019 Mar/Apr;25(2):172-177. doi: 10.1097/SPV.0000000000000652.
PubMed 30807423Fregosi NJ, Hobson DTG, Kinman CL, Gaskins JT, Stewart JR, Meriwether KV. Changes in the Vaginal Microenvironment as Related to Frequency of Pessary Removal. Female Pelvic Med Reconstr Surg. 2018 Mar/Apr;24(2):166-171. doi: 10.1097/SPV.0000000000000520.
PubMed 29474292Meriwether KV, Rogers RG, Craig E, Peterson SD, Gutman RE, Iglesia CB. The effect of hydroxyquinoline-based gel on pessary-associated bacterial vaginosis: a multicenter randomized controlled trial. Am J Obstet Gynecol. 2015 Nov;213(5):729.e1-9. doi: 10.1016/j.ajog.2015.04.032. Epub 2015 Apr 30.
PubMed 25935783
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Use of Trimo-San Gel for the Prevention of Pessary-associated Bacterial Vaginosis
- ClinicalTrials.gov ID
- NCT01471457
- Acronym / sponsor ID
- TBVAP / 2009-028
- Conditions
- Bacterial Vaginosis
- Keywords
- bacterial, vaginosis, pessary, discharge
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 184 participants (actual)
- Lead sponsor
- University of New MexicoUniversity, hospital or other
- Study start
- Sep 2009
- Primary completion
- Sep 2014 (actual)
- Study completion
- Sep 2014 (actual)
- First posted
- 15 Nov 2011 (estimated)
- Results
- Posted 22 Apr 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary objective of this prospective, randomized, controlled study is to assess the effect of Trimo-San vaginal gel on the rate of bacterial vaginosis in women who use pessaries. Women being fitted for a pessary for the first time or not wearing a pessary for >1 year are recruited in to the study and randomized to using Trimo-San gel daily or not using Trimo-San gel. The investigators use two objective measures of bacterial vaginosis (OSOM BV blue and gram stain) and subjective questionnaires regarding the presence and effect of vaginal symptoms on the pessary user prior to pessary fitting and at 3 months post pessary fitting. The investigators hypothesize that Trimo-San gel with not significantly affect the rate of bacterial vaginosis in pessary wearers as measures by OSOM BV blue and Gram stain, but will have a positive effect on the subjective symptoms experienced by women wearing pessaries.
Detailed description
The study population will consist of women who will be fitted for and initiate use of a pessary for relief of pelvic organ prolapse and/or urinary symptoms.
All patients scheduled for pessary fitting/initiation who meet the above inclusion criteria will be asked to participate in the study. They are randomized using opaque envelopes pulled sequentially, which were made originally from a blocked design, stratified to women removing the pessary daily themselves and women not removing the pessary daily themselves. Prior to pessary fitting all women in the study answer a brief questionnaire about their vaginal symptoms. Subjects undergo a vaginal swab for OSOM BV Blue (copyright by Genzyme, SekiSui) and Gram stain testing for Nugent's criteria the presence of bacterial vaginosis. Women are then fitted with and instructed on use of a pessary in the standard fashion by a trained physician at at the study sites.
Women will be randomized to either standard pessary care or to use of TrimoSan gel twice a week (half applicator) to the vagina either with applicator or applying half applicator amount to the surface of the pessary before insertion. If women are using additional vaginal medications such as Premarin this information will be collected but not change their randomization and they will continue to use other indicated vaginal medications as they did before participation in the study (per clinical judgement).
At 2 weeks and 3 month after pessary initiation the patients are seen for an office visit. At both the 2 week and 3 month visit they have repeat testing for bacterial vaginosis using vaginal swab for OSOM BV Blue (copyright by Genzyme) and Gram stain testing. At both the 2 week and 3 month visits they will also answer a questionnaire about their vaginal symptoms and the effect of these symptoms on their distress and lifestyle. This questionnaire is similar to the baseline questionnaire answered before initiation of pessary use, and will include questions about whether these symptoms have changed since initiation of their pessary. At the University of New Mexico site, information is also being collected on sexual function using the PISQ-IR questionnaire and on body image using the modified Body Image Scale at baseline, 2 weeks, and 3 months. At this particular site women will also answer questions about their management of the pessary (e.g. if they take it out for intercourse) surrounding sexual activity.
The recruitment goal for this study is 150 women, with 75 in each group. This was calculated to detect a significant difference in the rate of bacterial vaginosis between the control and study groups (α=0.05), and assuming baseline of bacterial vaginosis to be approximately 10% in the population and increased to 30% by hypothetical risk factors, the sample size needed for each group is 62 for a power of 80%. Assuming a 15% dropout rate after recruitment, we plan to randomize at least 75 patients to the control group and 75 patients to the study group for a total of at least 150 patients. 60 women were recruited for this study at the initial site of Washington Hospital Center in Washington, D.C. This study site closed in June 2012. In January 2013 the study opened at University of New Mexico in Albuquerque, NM. The study is currently opening and running at University of New Mexico with the recruitment goal of 90 women at this institution.
The primary outcome measure will be rate of bacterial vaginosis in the study population, to be compared between the control (non Trimo-San using) and study (Trimo-San using) groups. As part of this analysis, we will also compare the rate of bacterial vaginosis in the control and study groups before and after pessary initiation. Secondary outcomes will include:
- Change in vaginal symptoms as assessed by questionnaire before and after initiation of pessary use
- Change in level of worry or distress about vaginal symptoms as assessed by questionnaire before and after initiation of pessary use.
- Change in vaginal symptoms or distress about these symptoms as assessed by questionnaire based on use or non-use of Trimo-San gel.
- Describe the management of women of their pessary surrounding sexual activity (University of New Mexico only)
- Change in body image or sexual function associated with initiation of the pessary or use of TrimoSan gel (University of New Mexico only)
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Trimo-San group | Experimental | Drug: Trimo-San gelPessary wearers are instructed to apply one fingertip (approx 1 tablespoon) of Trimo-San gel inside the vagina or to the pessary (for women removing and cleaning pessary before reinsertion after cleaning) once nightly |
| Control group | No intervention | –Pessary wearers are informed on standard care of pessary, which includes topical estrogen application if they are using. Pessary wearers do not use Trimo-San gel |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Female
- Indications for initiation of pessary use and planning to be fitted for and wear a pessary
Key exclusion criteria (6 listed)
- Male
- Already using a pessary or have used in the last year
- History of recurrent or chronic bacterial vaginosis with > 2 episodes per year or symptoms reported for > 6 months out of last year
- Active known vaginal infection (symptomatic and/or untreated) or completion of treatment for BV or cervical/vaginal infection within one week of recruitment
- History of active vaginal ulcerative disease (active ulcers from atrophy, herpes symptoms at recruitment, or HSV with > 2 outbreaks per year or last outbreak < 1 month ago)
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 |
|---|---|---|
| Trimo-San gelPessary wearers are instructed to apply one fingertip (approx 1 tablespoon) of Trimo-San gel inside the vagina or to the pessary (for women removing and cleaning pessary before reinsertion after cleaning) once nightly | Drug | Trimo-San group |
Primary outcome
Number of Patients With Bacterial Vaginosis at 3 Months
Time frame: 3 months
The primary outcome is the rate of bacterial vaginosis after pessary fitting as measured by OSOM BV blue (Genzyme) and gram stain, measured in women using and women not using Trimo-San gel after pessary fitting, at 3 months, with the denominator being the number of women having a gram stain at the 3 months time point in each group
1 secondary outcome
Participants With Any Bothersome Vaginal Symptom at 3 Months
Time frame: 3 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Apr 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 11005473Alnaif B, Drutz HP. Bacterial vaginosis increases in pessary users. Int Urogynecol J Pelvic Floor Dysfunct. 2000;11(4):219-22; discussion 222-3. doi: 10.1007/pl00004026.
- Background: PubMed 3259075Eschenbach DA, Hillier S, Critchlow C, Stevens C, DeRouen T, Holmes KK. Diagnosis and clinical manifestations of bacterial vaginosis. Am J Obstet Gynecol. 1988 Apr;158(4):819-28. doi: 10.1016/0002-9378(88)90078-6.
- Background: PubMed 15118630Landers DV, Wiesenfeld HC, Heine RP, Krohn MA, Hillier SL. Predictive value of the clinical diagnosis of lower genital tract infection in women. Am J Obstet Gynecol. 2004 Apr;190(4):1004-10. doi: 10.1016/j.ajog.2004.02.015.
- Background: PubMed 15883856Powers K, Lazarou G, Wang A, LaCombe J, Bensinger G, Greston WM, Mikhail MS. Pessary use in advanced pelvic organ prolapse. Int Urogynecol J Pelvic Floor Dysfunct. 2006 Feb;17(2):160-4. doi: 10.1007/s00192-005-1311-8. Epub 2005 May 10.
- Background: PubMed 12734228Myziuk L, Romanowski B, Johnson SC. BVBlue test for diagnosis of bacterial vaginosis. J Clin Microbiol. 2003 May;41(5):1925-8. doi: 10.1128/JCM.41.5.1925-1928.2003.
- Background: PubMed 15750100Bradshaw CS, Morton AN, Garland SM, Horvath LB, Kuzevska I, Fairley CK. Evaluation of a point-of-care test, BVBlue, and clinical and laboratory criteria for diagnosis of bacterial vaginosis. J Clin Microbiol. 2005 Mar;43(3):1304-8. doi: 10.1128/JCM.43.3.1304-1308.2005.
- Background: PubMed 15799757Forsum U, Hallen A, Larsson PG. Bacterial vaginosis--a laboratory and clinical diagnostics enigma. APMIS. 2005 Mar;113(3):153-61. doi: 10.1111/j.1600-0463.2005.apm1130301.x.
- Derived from this study: PubMed 33207004Bugge C, Adams EJ, Gopinath D, Stewart F, Dembinsky M, Sobiesuo P, Kearney R. Pessaries (mechanical devices) for managing pelvic organ prolapse in women. Cochrane Database Syst Rev. 2020 Nov 18;11(11):CD004010. doi: 10.1002/14651858.CD004010.pub4.
- Derived from this study: PubMed 30807423Gupta A, Cox C, Dunivan GC, Gaskins JT, Rogers RG, Iglesia CB, Meriwether KV. Desire for Continued Pessary Use Among Women of Hispanic and Non-Hispanic Ethnic Backgrounds for Pelvic Floor Disorders. Female Pelvic Med Reconstr Surg. 2019 Mar/Apr;25(2):172-177. doi: 10.1097/SPV.0000000000000652.
- Derived from this study: PubMed 29474292Fregosi NJ, Hobson DTG, Kinman CL, Gaskins JT, Stewart JR, Meriwether KV. Changes in the Vaginal Microenvironment as Related to Frequency of Pessary Removal. Female Pelvic Med Reconstr Surg. 2018 Mar/Apr;24(2):166-171. doi: 10.1097/SPV.0000000000000520.
- Derived from this study: PubMed 25935783Meriwether KV, Rogers RG, Craig E, Peterson SD, Gutman RE, Iglesia CB. The effect of hydroxyquinoline-based gel on pessary-associated bacterial vaginosis: a multicenter randomized controlled trial. Am J Obstet Gynecol. 2015 Nov;213(5):729.e1-9. doi: 10.1016/j.ajog.2015.04.032. Epub 2015 Apr 30.
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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.
Kate V Meriwether, MD principal investigator
University of New Mexico
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Trimo-San gel in people with Bacterial Vaginosis, run by University of New Mexico 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 2 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 22 Apr 2020. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 22 Apr 2020). 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?
Number of Patients With Bacterial Vaginosis at 3 Months (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01471457, which also lists 11 linked publications.
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 22 Apr 2020.