Bacterial VaginosisPhase 4MASHNCT00464542
Asymptomatic Bacterial Vaginosis and Herpes Simplex Virus Type 2 (BV/HSV-2) Shedding Study
A Phase 4 study testing Metronidazole in people with Bacterial Vaginosis, run by University of Pittsburgh at 2 sites in United States.
Trial summary
This investigation assessed the effects of asymptomatic BV on daily genital tract shedding of HSV-2 by determining shedding frequency before and after treatment of asymptomatic BV. Read more about this study
- Who is it for?
- Ages 18 to 26 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Bacterial Vaginosis
- What is being tested?
- Metronidazole
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 2 sitesUnited States
- Study dates
- Dec 2007to Mar 2010
- Phase
- Phase 4
- 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 26 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Women 18-26 years old of age
- Only those women who deny symptoms of vaginal discharge and odor but who meet Amsel and Gram stain criteria for the diagnosis of BV will be eligible
- Amsel criteria (3 of the following 4 conditions) (10):
- Homogenous vaginal discharge
- Vaginal pH > 4.5
- Positive amine (sniff) test
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- Presence of clue cells in the vaginal fluid
- Gram stain criteria (11):
- Score: 0-3; classification: normal; vaginal bacteria morphotype: Lactobacillus predominant
- Score: 4-6; classification: intermediate; vaginal bacteria morphotype: Lactobacilli reduced
- Score: 7-10; classification: BV; vaginal bacteria morphotype: Lactobacillus replaced by Gardnerella and anaerobes
- Eligible women will need to test positive for HSV-2 type-specific antibodies. Determination of HSV-2 serostatus will be determined by a point-of-care type-specific immunoassay kit.
- Patients capable of providing written informed consent
- Patients willing to refrain from the use of intravaginal products (i.e., contraceptive creams, gels, foams, sponges, lubricants, douches, etc.) during the study period
- Patients willing to refrain from the use of any systemic or topical genital antiviral medication during the study period
- Patients willing and capable of cooperating to the extent and degree required by this protocol
Who cannot join
- HSV-2 seronegativity (as determined by the point-of-care immunoassay)
- Pregnancy (all women will receive a pregnancy test prior to enrollment) or those women currently not practicing an effective method of birth control
- Current Chlamydia trachomatis, Neisseria gonorrhea, or Trichomonas vaginalis infection
- Use of prescriptive antiviral treatment for presumed HSV reactivation within the 14 days prior to enrollment
- Use of systemic antimicrobials within the past 14 days
- History of hypersensitivity or inability to tolerate systemic metronidazole therapy
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- Nursing mother
- Patients with intrauterine devices
- Unwillingness to refrain from initiation of antiviral medication during study period
- Unwillingness to refrain from use of douche products during study period
- Unwillingness to refrain from the ingestion of any alcoholic beverages during the one-week course of oral metronidazole therapy
Trial locations and contacts
2 sites in 1 country.
United States2 sites
University of Pittsburgh
Pittsburgh, Pennsylvania, 15213
University of Pittsburgh, Magee Womens Hospital
Pittsburgh, Pennsylvania, 15237
About this study
Official title: Asymptomatic Bacterial Vaginosis and Herpes Simplex Virus Type 2 Shedding
This investigation assessed the effects of asymptomatic BV on daily genital tract shedding of HSV-2 by determining shedding frequency before and after treatment of asymptomatic BV.
Read the detailed description
An important contributor to the epidemic spread of herpes simplex virus type 2 (HSV-2) is its high frequency of asymptomatic shedding in the genital tract, as transmission usually occurs during these periods of subclinical reactivation of the virus. Therefore, an improved understanding of the risk factors associated with HSV-2 shedding is needed.
Preliminary data suggests that bacterial vaginosis (BV) may be associated with increased genital tract shedding of HSV-2. As BV is the most common cause of vaginal symptoms in reproductive age women, even modest associations with genital tract shedding of HSV-2 would result in substantial attributable risks for transmission of the virus.
This study assessed the effects of asymptomatic BV on daily genital tract shedding of HSV-2 by determining shedding frequency before and after treatment of asymptomatic BV. Twelve HSV-2 seropositive women with asymptomatic BV were enrolled. These women were instructed to self-collect daily swab specimens for HSV-2 deoxyribonucleic acid (DNA) polymerase chain reaction (PCR) analysis from the lower genital tract for one month. At the end of the one month follow-up visit, each participant completed a one week course of oral metronidazole for treatment of BV. This was followed by daily home collection of genital tract swab specimens for an additional one month.
- Conditions
- Bacterial Vaginosis
- Being tested
- Metronidazole
- Keywords
- herpes simplex virus
- Medical subject headings
- Vaginosis, Bacterial, Herpes Simplex
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MetronidazoleDrug
Also called Flagyl
500 mg, taken by mouth, two times a day, 7 days
| Study group | Role | What they receive |
|---|---|---|
| Metronidazole | Other | Observational before and after treatment Drug: Metronidazole 500 mg, taken by mouth, two times a day, 7 days Receives: Drug: Metronidazole |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Bacterial Vaginosis Recurrence
Bacterial vaginosis, defined as any vaginal smear with a Nugent score of 7-10 during the 30 day period following cessation of metronidazole therapy.
Measured: 30 days after cessation of metronidazole therapy
Secondary outcomes (1)
Median Time to Bacterial Vaginosis During the 30 Days After Cessation of Metronidazole Therapy
The time by which half of the participants were diagnosed with bacterial vaginosis, defined as any vaginal smear with a Nugent score of 7-10 during the 30 day period following cessation of metronidazole therapy
Measured: 30 days after cessation of metronidazole therapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Apr 2007 (estimated)
- Study startDec 2007
- Primary completionMar 2010
- Study completionMar 2010
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 University of PittsburghThe 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 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pittsburgh
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Thomas L Cherpes, Principal investigator, Univerisity of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00464542
- Sponsor's protocol ID
- PRO07030124
- Acronym
- MASH
- Status last verified
- Apr 2017
- First submitted
- 19 Apr 2007
- Last updated
- 11 May 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Asymptomatic Bacterial Vaginosis and Herpes Simplex Virus Type 2 Shedding
- ClinicalTrials.gov ID
- NCT00464542
- Acronym / sponsor ID
- MASH / PRO07030124
- Conditions
- Bacterial Vaginosis
- Keywords
- herpes simplex virus
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- University of PittsburghUniversity, hospital or other
- Study start
- Dec 2007
- Primary completion
- Mar 2010 (actual)
- Study completion
- Mar 2010 (actual)
- First posted
- 23 Apr 2007 (estimated)
- Results
- Posted 4 Oct 2011
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This investigation assessed the effects of asymptomatic BV on daily genital tract shedding of HSV-2 by determining shedding frequency before and after treatment of asymptomatic BV.
Detailed description
An important contributor to the epidemic spread of herpes simplex virus type 2 (HSV-2) is its high frequency of asymptomatic shedding in the genital tract, as transmission usually occurs during these periods of subclinical reactivation of the virus. Therefore, an improved understanding of the risk factors associated with HSV-2 shedding is needed.
Preliminary data suggests that bacterial vaginosis (BV) may be associated with increased genital tract shedding of HSV-2. As BV is the most common cause of vaginal symptoms in reproductive age women, even modest associations with genital tract shedding of HSV-2 would result in substantial attributable risks for transmission of the virus.
This study assessed the effects of asymptomatic BV on daily genital tract shedding of HSV-2 by determining shedding frequency before and after treatment of asymptomatic BV. Twelve HSV-2 seropositive women with asymptomatic BV were enrolled. These women were instructed to self-collect daily swab specimens for HSV-2 deoxyribonucleic acid (DNA) polymerase chain reaction (PCR) analysis from the lower genital tract for one month. At the end of the one month follow-up visit, each participant completed a one week course of oral metronidazole for treatment of BV. This was followed by daily home collection of genital tract swab specimens for an additional one month.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Metronidazole | Other | Drug: MetronidazoleObservational before and after treatment Drug: Metronidazole 500 mg, taken by mouth, two times a day, 7 days |
Who may qualify
- Ages
- 18 to 26 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (16 listed)
- Women 18-26 years old of age
- Only those women who deny symptoms of vaginal discharge and odor but who meet Amsel and Gram stain criteria for the diagnosis of BV will be eligible
- Amsel criteria (3 of the following 4 conditions) (10):
- Homogenous vaginal discharge
- Vaginal pH > 4.5
Key exclusion criteria (11 listed)
- HSV-2 seronegativity (as determined by the point-of-care immunoassay)
- Pregnancy (all women will receive a pregnancy test prior to enrollment) or those women currently not practicing an effective method of birth control
- Current Chlamydia trachomatis, Neisseria gonorrhea, or Trichomonas vaginalis infection
- Use of prescriptive antiviral treatment for presumed HSV reactivation within the 14 days prior to enrollment
- Use of systemic antimicrobials within the past 14 days
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 |
|---|---|---|
| MetronidazoleAlso: Flagyl500 mg, taken by mouth, two times a day, 7 days | Drug | Metronidazole |
Primary outcome
Number of Participants With Bacterial Vaginosis Recurrence
Time frame: 30 days after cessation of metronidazole therapy
Bacterial vaginosis, defined as any vaginal smear with a Nugent score of 7-10 during the 30 day period following cessation of metronidazole therapy.
1 secondary outcome
Median Time to Bacterial Vaginosis During the 30 Days After Cessation of Metronidazole Therapy
Time frame: 30 days after cessation of metronidazole therapy
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
Related trials for Bacterial Vaginosis
Enrolling by invitationObservational study
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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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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.
Thomas L Cherpes principal investigator
Univerisity of Pittsburgh
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Metronidazole in people with Bacterial Vaginosis, run by University of Pittsburgh 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 16 inclusion and 11 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 11 May 2017. 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 phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 4 Oct 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?
Number of Participants With Bacterial Vaginosis Recurrence (time frame: 30 days after cessation of metronidazole therapy). 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 11 May 2017.