Bacterial VaginosisNCT00545181
Recurrent Bacterial Vaginosis and Vaginal Acidifying Gel Trial
A study testing Vaginal acidifying gel (RepHresh) in people with Bacterial Vaginosis, run by Indiana University at 1 site in United States.
Trial summary
Bacterial vaginosis (BV) is a common, complex clinical syndrome characterized by alterations in the normal vaginal flora. Bacterial vaginosis has been associated with a variety of adverse health outcomes including endometritis; post-abortion endometritis; nongonococcal, nonchlamydial pelvic inflammatory disease; and… Read more about this study
- Who is it for?
- Ages 18 to 50 years, women only
- Conditions the study is for
- Bacterial Vaginosis
- What is being tested?
- Vaginal acidifying gel (RepHresh)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 55 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2007to Jul 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 50 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- All women of between 18-50 years of age.
- Confirmed current diagnosis of BV using Amsel's criteria.
- Women with at least total 2 confirmed episodes of BV including most recent episode (by Amsel's criteria) within a six month period or at least total three or more in the past twelve months
Who cannot join
- Patient who received antibiotic therapy within the past two weeks.
- Patients who had co-existing gonorrhea or Chlamydia infection
- Any contraindications or sensitivity to taking the vaginal gel.
- Allergy to metronidazole
- Alcoholics or those unable to abstain from alcohol consumption.
- Pregnancy
Trial locations and contacts
1 site in 1 country.
United States1 site
Indiana University School of Medicine
Indianapolis, Indiana, 46202
About this study
Official title: Recurrent Bacterial Vaginosis (RBV): Efficiency of Metronidazole in Comparison to Metronidazole and Intravaginal Acidifying Gel: A Randomized Investigator-blinded Controlled Trial
Bacterial vaginosis (BV) is a common, complex clinical syndrome characterized by alterations in the normal vaginal flora. Bacterial vaginosis has been associated with a variety of adverse health outcomes including endometritis; post-abortion endometritis; nongonococcal, nonchlamydial pelvic inflammatory disease; and an increased risk of acquiring and transmitting HIV infection. In pregnancy, BV is associated with premature rupture of the membranes, chorioamnionitis, amniotic fluid infection, preterm labor, preterm birth, and postpartum endometritis. Several studies have documented increased postpartum complications in the newborn and infants. The etiology of BV is poorly understood but recurrence is quite common despite treatment. Documented recurrence rate of up to 30% within three months are reported. Small studies have shown that adding vaginal acidifying gel to standard antibiotic regimens may reduce recurrence rates of BV. We plan an RCT comparing standard antibiotic therapy to antibiotics plus vaginal acidifying gel. Our hypothesis is that the addition of an acidifying gel will decrease the chance of recurrence of BV within 3 months.
Read the detailed description
Women with recurrent BV will be randomly assigned to standard care of metronidazole vs metronidazole plus vaginal acidifying gel. Symptoms and presence of BV will be measured at followup.
- Conditions
- Bacterial Vaginosis
- Being tested
- Vaginal acidifying gel (RepHresh), Metronidazole control
- Keywords
- bacterial vaginosis, vaginal acidifying gel, recurrence
- 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.
Vaginal acidifying gel (RepHresh)Drug
Also called RepHresh vaginal gel.
placement of vaginal acidifying gel into vagina to restore "normal" vaginal pH.
Metronidazole controlDrug
Also called metronidazole
oral metronidazole therapy alone
| Study group | Role | What they receive |
|---|---|---|
| Metronidazole plus gel | Experimental | Receive metronidazole plus vaginal gel Receives: Drug: Vaginal acidifying gel (RepHresh) |
| Control- metronidazole alone | Active comparator | Oral Metronidazole antibiotic therapy alone Receives: Drug: Metronidazole control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recurrent Bacterial Vaginosis
Recurrence by either Amsel's or Nugent's criteria. Amsel's criteria are the presence of 3 of 4 of following: 1. homogenous gray-white vaginal discharge, 2. elevated vaginal pH >4.7, 3. presence of at least 20% of vaginal epithelial cells being clue cells on wet prep microscopy, and 4. positive amine odor test on addition of 10% KOH. Nugent's criteria is based on microscopy and bacterial scoring of lactobaccilus, gardnerella, and curved gram-variable rods. A score of at least 7 is indicative of bacterial vaginosis.
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 posted17 Oct 2007 (estimated)
- Study startSep 2007
- Primary completionJul 2009
- Study completionJul 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 Bacterial VaginosisStudies of the same condition, open and under way.
- More trials run by Indiana UniversityThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 55 participants (actual)
Sponsor and investigators
- Lead sponsor
- Indiana University
- Sponsor type
- University, hospital or other
- Investigators
- David M Haas, MD, Principal investigator, Indiana University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00545181
- Sponsor's protocol ID
- 0612-58 (Study #)
- Status last verified
- Jan 2010
- First submitted
- 15 Oct 2007
- Last updated
- 12 Jan 2010
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Recurrent Bacterial Vaginosis (RBV): Efficiency of Metronidazole in Comparison to Metronidazole and Intravaginal Acidifying Gel: A Randomized Investigator-blinded Controlled Trial
- ClinicalTrials.gov ID
- NCT00545181
- Acronym / sponsor ID
- 0612-58 (Study #)
- Conditions
- Bacterial Vaginosis
- Keywords
- bacterial vaginosis, vaginal acidifying gel, recurrence
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 55 participants (actual)
- Lead sponsor
- Indiana UniversityUniversity, hospital or other
- Study start
- Sep 2007
- Primary completion
- Jul 2009 (actual)
- Study completion
- Jul 2009 (actual)
- First posted
- 17 Oct 2007 (estimated)
- Results
- Posted 7 Jan 2010
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Bacterial vaginosis (BV) is a common, complex clinical syndrome characterized by alterations in the normal vaginal flora. Bacterial vaginosis has been associated with a variety of adverse health outcomes including endometritis; post-abortion endometritis; nongonococcal, nonchlamydial pelvic inflammatory disease; and an increased risk of acquiring and transmitting HIV infection. In pregnancy, BV is associated with premature rupture of the membranes, chorioamnionitis, amniotic fluid infection, preterm labor, preterm birth, and postpartum endometritis. Several studies have documented increased postpartum complications in the newborn and infants. The etiology of BV is poorly understood but recurrence is quite common despite treatment. Documented recurrence rate of up to 30% within three months are reported. Small studies have shown that adding vaginal acidifying gel to standard antibiotic regimens may reduce recurrence rates of BV. We plan an RCT comparing standard antibiotic therapy to antibiotics plus vaginal acidifying gel. Our hypothesis is that the addition of an acidifying gel will decrease the chance of recurrence of BV within 3 months.
Detailed description
Women with recurrent BV will be randomly assigned to standard care of metronidazole vs metronidazole plus vaginal acidifying gel. Symptoms and presence of BV will be measured at followup.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Metronidazole plus gel | Experimental | Drug: Vaginal acidifying gel (RepHresh)Receive metronidazole plus vaginal gel |
| Control- metronidazole alone | Active comparator | Drug: Metronidazole controlOral Metronidazole antibiotic therapy alone |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- All women of between 18-50 years of age.
- Confirmed current diagnosis of BV using Amsel's criteria.
- Women with at least total 2 confirmed episodes of BV including most recent episode (by Amsel's criteria) within a six month period or at least total three or more in the past twelve months
Key exclusion criteria (6 listed)
- Patient who received antibiotic therapy within the past two weeks.
- Patients who had co-existing gonorrhea or Chlamydia infection
- Any contraindications or sensitivity to taking the vaginal gel.
- Allergy to metronidazole
- Alcoholics or those unable to abstain from alcohol consumption.
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 |
|---|---|---|
| Vaginal acidifying gel (RepHresh)Also: RepHresh vaginal gel.placement of vaginal acidifying gel into vagina to restore "normal" vaginal pH. | Drug | Metronidazole plus gel |
| Metronidazole controlAlso: metronidazoleoral metronidazole therapy alone | Drug | Control- metronidazole alone |
Primary outcome
Recurrent Bacterial Vaginosis
Time frame: 3 months
Recurrence by either Amsel's or Nugent's criteria. Amsel's criteria are the presence of 3 of 4 of following: 1. homogenous gray-white vaginal discharge, 2. elevated vaginal pH >4.7, 3. presence of at least 20% of vaginal epithelial cells being clue cells on wet prep microscopy, and 4. positive amine odor test on addition of 10% KOH. Nugent's criteria is based on microscopy and bacterial scoring of lactobaccilus, gardnerella, and curved gram-variable rods. A score of at least 7 is indicative of bacterial vaginosis.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jan 2010.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Bacterial Vaginosis
Enrolling by invitationObservational study
Prevention of Vaginal Cuff Infection After Hysterectomy by Addition of Vaginal Clindamycin
Surgical Site Infection, Vaginal Cuff Cellulitis
Not yet recruitingPhase 2
WST03 Capsule Combined With Metronidazole for Bacterial Vaginosis
Bacterial Vaginosis (BV)
RecruitingPhase 1
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)
Randomized, Open-label
Not yet recruitingPhase 1
A Study to Test New Investigational Drugs (LCFA-01and LC103) for Bacterial Vaginosis (BV) Treatment
Bacterial Vaginosis
Recruiting
Multi-Gyn ActiGel Plus for Treatment of Bacterial Vaginosis
Bacterial Vaginoses
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 M Haas, MD principal investigator
Indiana University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vaginal acidifying gel (RepHresh) in people with Bacterial Vaginosis, run by Indiana University at 1 site 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 3 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 12 Jan 2010. 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 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 7 Jan 2010). 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?
Recurrent Bacterial Vaginosis (time frame: 3 months). 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 12 Jan 2010.