Bacterial VaginosisNCT00542074
Bacterial Vaginosis; A Randomized Trial to Reduce Recurrence
A study testing hygienic information plus 62% ethyl alcohol in emollient gel and hygienic information in people with Bacterial Vaginosis, run by University of Washington at 1 site in Kenya.
Trial summary
Randomized controlled trial (RCT) to evaluate the effectiveness of applying Purell® (62% ethyl alcohol in emollient gel) to the penis of male partners of women diagnosed with BV for preventing BV recurrence after treatment. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bacterial Vaginosis
- What is being tested?
- hygienic information plus 62% ethyl alcohol in emollient gel and hygienic information
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 223 participants
- Where
- 1 siteKenya
- Study dates
- Jun 2003to Aug 2005
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Vaginal symptoms
- Nugent score > 6 for vaginal fluid gram stain
- Woman and her male partner both interested in study participation
- Woman able to return for follow-up visits
- Woman able to provide detailed contact information for tracing
Who cannot join
- Either male or female partner not recruited within 24 hours of the other
Trial locations and contacts
1 site in 1 country.
Kenya1 site
Nairobi City Council STI referral clinic (Special Treatment Clinic)
Nairobi
About this study
Randomized controlled trial (RCT) to evaluate the effectiveness of applying Purell® (62% ethyl alcohol in emollient gel) to the penis of male partners of women diagnosed with BV for preventing BV recurrence after treatment.
- Conditions
- Bacterial Vaginosis
- Being tested
- hygienic information plus 62% ethyl alcohol in emollient gel, hygienic information
- Keywords
- Bacterial vaginosis, recurrence, male factor
- Medical subject headings
- Vaginosis, Bacterial, Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
hygienic information plus 62% ethyl alcohol in emollient gelOther
Also called Purell® (GOJO Healthcare Inc., Akron, OH)
The male partner in each couple was asked to apply Purell® to his penis at least daily, and immediately prior to and following intercourse. Couples received a brochure with information on control of STI and good hygienic practices. Brochures for intervention and control arms were similar except the intervention arm brochure provided information on how to use the study product (Purell®).
hygienic informationOther
Couples received a brochure with information on control of STI and good hygienic practices.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Other: hygienic information plus 62% ethyl alcohol in emollient gel |
| 2 | Active comparator | Not described Receives: Other: hygienic information |
What is being measured
The primary outcome is the main question the study is designed to answer.
bacterial vaginosis by Nugent's score
Measured: up to 2 months following treatment
Secondary outcomes (1)
presence of lactobacillus by culture
Measured: 2 months following treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2007 (estimated)
- Study startJun 2003
- Study completionAug 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bacterial VaginosisStudies of the same condition, open and under way.
- More trials run by University of WashingtonThe sponsor's other registered studies.
- 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
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Care provider, Investigator, Outcomes assessor
- Enrolment
- 223 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Washington
- Sponsor type
- University, hospital or other
- Collaborators
- Fogarty International Center of the National Institute of Health, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), National Institute of Allergy and Infectious Diseases (NIAID)
- Investigators
- King K. Holmes, MD, PhD, Principal investigator, University of Washington
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00542074
- Sponsor's protocol ID
- 01-9276-001
- Other IDs
- R03TW005820, HD 40540-04, P30AI027757
- Status last verified
- Oct 2007
- First submitted
- 8 Oct 2007
- Last updated
- 31 Oct 2007
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Oct 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bacterial Vaginosis; A Randomized Trial to Reduce Recurrence
- ClinicalTrials.gov ID
- NCT00542074
- Acronym / sponsor ID
- 01-9276-001
- Conditions
- Bacterial Vaginosis
- Keywords
- Bacterial vaginosis, recurrence, male factor
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 223 participants (actual)
- Lead sponsor
- University of WashingtonUniversity, hospital or other
- Collaborators
- Fogarty International Center of the National Institute of Health, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), National Institute of Allergy and Infectious Diseases (NIAID)
- Study start
- Jun 2003
- Study completion
- Aug 2005 (actual)
- First posted
- 10 Oct 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Randomized controlled trial (RCT) to evaluate the effectiveness of applying Purell® (62% ethyl alcohol in emollient gel) to the penis of male partners of women diagnosed with BV for preventing BV recurrence after treatment.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Other: hygienic information plus 62% ethyl alcohol in emollient gel |
| 2 | Active comparator | Other: hygienic information |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Vaginal symptoms
- Nugent score > 6 for vaginal fluid gram stain
- Woman and her male partner both interested in study participation
- Woman able to return for follow-up visits
- Woman able to provide detailed contact information for tracing
Key exclusion criteria (1 listed)
- Either male or female partner not recruited within 24 hours of the other
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 |
|---|---|---|
| hygienic information plus 62% ethyl alcohol in emollient gelAlso: Purell® (GOJO Healthcare Inc., Akron, OH)The male partner in each couple was asked to apply Purell® to his penis at least daily, and immediately prior to and following intercourse. Couples received a brochure with information on control of STI and good hygienic practices. Brochures for intervention and control arms were similar except the intervention arm brochure provided information on how to use the study product (Purell®). | Other | 1 |
| hygienic informationCouples received a brochure with information on control of STI and good hygienic practices. | Other | 2 |
Primary outcome
bacterial vaginosis by Nugent's score
Time frame: up to 2 months following treatment
1 secondary outcome
presence of lactobacillus by culture
Time frame: 2 months following treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Oct 2007.
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WST03 Capsule Combined With Metronidazole for Bacterial Vaginosis
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A Randomized, Multicenter, Open-label, Active-controlled Phase Ib Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of Multiple Intravaginal Doses of GenSci142 in Patients With Bacterial Vaginosis (BV)
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Recruiting
Multi-Gyn ActiGel Plus for Treatment of Bacterial Vaginosis
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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.
King K. Holmes, MD, PhD principal investigator
University of Washington
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing hygienic information plus 62% ethyl alcohol in emollient gel and hygienic information in people with Bacterial Vaginosis, run by University of Washington at 1 site in Kenya.
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 1 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 31 Oct 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Kenya. 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
bacterial vaginosis by Nugent's score (time frame: up to 2 months following treatment). 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 31 Oct 2007; AzTrials last refreshed its copy on 1 Nov 2026.