Bacterial VaginosisCONRADBVNCT01347632

Study of How Bacterial Vaginosis and Its Treatment Affects Cervical and Vaginal Tissue

A study testing Metronidazole in people with Bacterial Vaginosis and Vaginal Discharge, run by CONRAD at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

This is a research study to determine whether bacterial vaginosis (BV) changes the cervico-vaginal tissue (skin covering the cervix and vagina) and makes women at higher risk for getting HIV (Human Immunodeficiency Virus). Read more about this study

Who is it for?: Ages 18 to 50 years, women onlyHealthy volunteers can take part
Conditions the study is for: Bacterial Vaginosis, Vaginal Discharge
What is being tested?: Metronidazole
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 35 participants
Where: 1 siteUnited States
Study dates: Apr 2011to Dec 2011
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
Healthy volunteers accepted
Adult

Who may be able to join

Be of age 18 - 50 years-old, inclusive;
Have a current BV infection (Nugent score 7 - 10) or intermediate vaginal flora (Nugent score 4 - 6), as diagnosed by Nugent score in the clinic (with later validation of the Nugent score by a blinded separate laboratory);63
Regular menses with the last 2 menses 21-35 days apart;
Willing and able to comply with study procedures, including the use of oral treatment for BV.

Who cannot join

Contraindications to the use of oral metronidazole including:
Daily alcohol consumption and be unable or unwilling to abstain from alcohol while taking metronidazole tablets;
Known hypersensitivity to oral metronidazole;
Chronic immune suppression (including, but not limited to chronic steroid use, chronic anti-fungal use, Diabetes Mellitus, organ transplant);
An abnormal Pap smear documented in the past 12 months defined as:
ASC-US without a normal repeat Pap smear at least 6 months later;

Show all 23Show fewer

ASC-US with positive reflex high-risk HPV testing (ASC-US/HPV+), low grade squamous epithelial lesion or high grade squamous intraepithelial lesion, ASC-H, atypical glandular cells, or malignant cells;
It has been less than 3 months since the patient's last Depo medroxyprogesterone acetate (DMPA) injection and she has not had 2 normal, spontaneous menses since last using DMPA;
Use of any other hormonal contraceptive method within past 2 months (oral, transdermal, transvaginal, implant, or hormonal intrauterine device);
Use of oral or vaginal antibiotics or anti-fungals in the last 14 days;
Surgery or biopsy of the vulva, vagina, or cervix within the past 30 days;
History of hysterectomy;
Pregnancy within the past 3 months;
Current breastfeeding;
HIV-1 sero-positivity in the participant (by history or buccal HIV-1 swab) or her current sexual partner(s);
Current use of anti-viral suppression medications for Herpes Simplex Virus (HSV) (a history of HSV without active lesions is permitted);
Current active sexually transmitted infection (STI);
Presence of vaginal semen in the last 48 hours, per patient's report or as detected by prostate specific antigen (PSA) test;
Use of douches, vaginal products or anything in the vagina in the past 48 hours;
Current presence of vulvar, anal and or vaginal genital warts;
Current tobacco use (any amount)
Other conditions that, in the opinion of the investigator, would constitute contraindications to participation in the study or would compromise ability to comply with the study protocol, such as any major chronic illness including cancer, serious autoimmune disease or a major psychiatric disorder not under good control; and
Current participation in any other drug or device study, or any study which, in the opinion of the investigator, would jeopardize interpretation of results of this study.

Trial locations and contacts

1 site in 1 country.

United States1 site

Eastern Virginia Medical School CONRAD Clinical Research Center
Norfolk, Virginia, 23507

Other trials in United States

About this study

Official title: Prospective Evaluation of the Impact of Bacterial Vaginosis and Its Treatment on Mucosal Susceptibility to HIV-1 Infection and Endpoints of Cervico-Vaginal Safety

BV is a vaginal infection that develops when there is an imbalance in the normal bacteria found in a woman's vagina. It is the most common cause of vaginal discharge among women of child-bearing age. BV infections potentially harm the safety of the tissue surrounding the cervico-vaginal region. When the cervico-vaginal tissue is not well protected, the risk of acquiring HIV from an infected partner might increase significantly. Studies have shown that HIV is more common in women with BV than in women with normal vaginal bacteria.

Treatment of BV typically involves the use of antibiotics. Antibiotics kill harmful bacteria and provide a temporary relief from the symptoms caused by the infection. Women participating in this study will use the generic antibiotic metronidazole, also known as Flagyl. The Center for Disease Control and Prevention (CDC) recommends Flagyl for the treatment of BV.

The study will evaluate HIV infection and safety of cervico-vaginal tissue in women at 3 different time periods:

During a BV infection
Approximately 1 week after completing a 7-day course of metronidazole therapy
Approximately 1 month after completing the 7-day course of metronidazole therapy

You will not come in contact with HIV during this study - only your samples (after we have removed them from your vagina/cervix) come in contact with HIV.

Read the detailed description

WHY ARE YOU BEING ASKED TO TAKE PART?

You are being asked to participate in this research project because you are a female between the ages of 18-50 and you think you might have a current BV infection; your menstrual cycle is regular and your last two periods were 21-35 days apart; you are willing comply with the procedures done at 3 study visits; and you are willing to take metronidazole for 7 days.

This study includes only people who voluntarily choose to take part. Please take your time to make your decision and feel free to ask any questions you might have.

WHAT ARE SOME IMPORTANT DETAILS ABOUT THIS STUDY?

Up to approximately 80 women are expected to take part in the study at this local site. There are no other study sites participating in the study. You will have three scheduled visits to the clinic. Your participation in the study will last for approximately 2 months.

WHEN SHOULD YOU NOT TAKE PART?

You should not take part in this study if you:

Drink alcohol on a daily basis and are unwilling to abstain from alcohol while taking metronidazole.
Have a known allergy to metronidazole.
Have chronic immune suppression (including, but not limited to, chronic steroid use, chronic anti-fungal use, Diabetes Mellitus, organ transplant).
Had an abnormal documented Pap smear in the past 12 months.
Had your last Depo medroxyprogesterone acetate (DMPA) injection less than 3 months ago and you have not had 2 normal menses since then.
Used any hormonal contraceptive method within the past 2 months.
Used oral or vaginal antibiotics or anti-fungals in the last 14 days.
Had surgery or biopsy of the vulva, vagina, or cervix within 30 days.
Had a hysterectomy.
Were pregnant within the past 3 months.
Are currently breastfeeding.
Are HIV-1 positive, or your current sexual partner(s) is.
Use daily anti-viral suppression medications for Herpes Simplex Virus (HSV).
Believe you currently have a sexually transmitted infection.
Used a douche or other vaginal products or put anything in your vagina in the past 48 hours; have a current presence of vulvar, anal and or vaginal genital warts.
Have had vaginal intercourse with a male partner within the last 48 hours.
Current tobacco use.
Are currently participating in another research study.

Conditions: Bacterial Vaginosis, Vaginal Discharge
Being tested: Metronidazole
Keywords: Bacterial Vaginosis, Vaginal discharge, Vaginal infections
Medical subject headings: Vaginosis, Bacterial, Vaginal Discharge, Vaginitis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

MetronidazoleDrug
Also called Flagyl
All participants had BV at baseline. They all received metronidazole 500 mg po BID for 7 days

Study groups in NCT01347632
Study group	Role	What they receive
BV pre treatment	Other	Open Label Study. All participants had BV and took metronidazole 500 mg po BID for 7 days. Receives: Drug: Metronidazole

What is being measured

The primary outcome is the main question the study is designed to answer.

p24 Antigen Production in Tissue
The study will evaluate HIV infection and safety of cervico-vaginal tissue in women at 3 different time periods:
1. During a BV infection
2. Approximately 1 week after completing a 7-day course of metronidazole therapy
3. Approximately 1 month after completing the 7-day course of metronidazole therapy
Each of the 33 participants were sampled at baseline (during BV infection), approximately 1 week after treatment and approximately 1 month after treatment. p 24 antigen data was not evaluable in this study due to the fact that the samples were frozen prior to laboratory analyses, which damaged the samples. No data were collected.
Measured: 6 weeks
p24 Antigen Production at Baseline Versus After Treatment With Metronidazole
p 24 antigen data was not evaluable in this study due to the fact that the samples were frozen prior to laboratory analyses.
Measured: 30 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Apr 2011Dec 2011

First posted4 May 2011 (estimated)
Study startApr 2011
Primary completionDec 2011
Study completionDec 2011

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 (1)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 N/A
Primary purpose: Prevention
Allocation: Not applicable
Intervention model: Single group
Model description: Open Label
Masking: None (open label)
Enrolment: 35 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01347632
Sponsor's protocol ID: D11115
Acronym: CONRADBV
Status last verified: Nov 2017
First submitted: 15 Apr 2011
Last updated: 19 Dec 2017
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
Individual data sharing: No: Cohort data will be published but not IPD

Publications

Gustin AT, Thurman AR, Chandra N, Schifanella L, Alcaide M, Fichorova R, Doncel GF, Gale M Jr, Klatt NR. Recurrent bacterial vaginosis following metronidazole treatment is associated with microbiota richness at diagnosis. Am J Obstet Gynecol. 2022 Feb;226(2):225.e1-225.e15. doi: 10.1016/j.ajog.2021.09.018. Epub 2021 Sep 22.
PubMed 34560047

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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

All Bacterial Vaginosis trials

Study at a glance

From the registry record, last updated by the sponsor on 19 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Prospective Evaluation of the Impact of Bacterial Vaginosis and Its Treatment on Mucosal Susceptibility to HIV-1 Infection and Endpoints of Cervico-Vaginal Safety
ClinicalTrials.gov ID: NCT01347632
Acronym / sponsor ID: CONRADBV / D11115
Conditions: Bacterial Vaginosis, Vaginal Discharge
Keywords: Bacterial Vaginosis, Vaginal discharge, Vaginal infections
Study type: Interventional
Recruitment status: Completed
Enrolment: 35 participants (actual)
Lead sponsor: CONRADUniversity, hospital or other
Collaborators: Dartmouth-Hitchcock Medical Center
Study start: Apr 2011
Primary completion: Dec 2011 (actual)
Study completion: Dec 2011 (actual)
First posted: 4 May 2011 (estimated)
Results: Posted 26 Aug 2014

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

The study will evaluate HIV infection and safety of cervico-vaginal tissue in women at 3 different time periods:

During a BV infection
Approximately 1 week after completing a 7-day course of metronidazole therapy
Approximately 1 month after completing the 7-day course of metronidazole therapy

You will not come in contact with HIV during this study - only your samples (after we have removed them from your vagina/cervix) come in contact with HIV.

Detailed description

WHY ARE YOU BEING ASKED TO TAKE PART?

This study includes only people who voluntarily choose to take part. Please take your time to make your decision and feel free to ask any questions you might have.

WHAT ARE SOME IMPORTANT DETAILS ABOUT THIS STUDY?

WHEN SHOULD YOU NOT TAKE PART?

You should not take part in this study if you:

Drink alcohol on a daily basis and are unwilling to abstain from alcohol while taking metronidazole.
Have a known allergy to metronidazole.
Have chronic immune suppression (including, but not limited to, chronic steroid use, chronic anti-fungal use, Diabetes Mellitus, organ transplant).
Had an abnormal documented Pap smear in the past 12 months.
Had your last Depo medroxyprogesterone acetate (DMPA) injection less than 3 months ago and you have not had 2 normal menses since then.
Used any hormonal contraceptive method within the past 2 months.
Used oral or vaginal antibiotics or anti-fungals in the last 14 days.
Had surgery or biopsy of the vulva, vagina, or cervix within 30 days.
Had a hysterectomy.
Were pregnant within the past 3 months.
Are currently breastfeeding.
Are HIV-1 positive, or your current sexual partner(s) is.
Use daily anti-viral suppression medications for Herpes Simplex Virus (HSV).
Believe you currently have a sexually transmitted infection.
Used a douche or other vaginal products or put anything in your vagina in the past 48 hours; have a current presence of vulvar, anal and or vaginal genital warts.
Have had vaginal intercourse with a male partner within the last 48 hours.
Current tobacco use.
Are currently participating in another research study.

Study design

Primary purpose: Prevention
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1
Model description: Open Label

Arm	Type	Receives
BV pre treatment	Other	Drug: MetronidazoleOpen Label Study. All participants had BV and took metronidazole 500 mg po BID for 7 days.

Who may qualify

Ages: 18 to 50 years
Sex: Female only
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (4 listed)

Be of age 18 - 50 years-old, inclusive;
Have a current BV infection (Nugent score 7 - 10) or intermediate vaginal flora (Nugent score 4 - 6), as diagnosed by Nugent score in the clinic (with later validation of the Nugent score by a blinded separate laboratory);63
Regular menses with the last 2 menses 21-35 days apart;
Willing and able to comply with study procedures, including the use of oral treatment for BV.

Key exclusion criteria (23 listed)

Contraindications to the use of oral metronidazole including:
Chronic immune suppression (including, but not limited to chronic steroid use, chronic anti-fungal use, Diabetes Mellitus, organ transplant);
An abnormal Pap smear documented in the past 12 months defined as:
It has been less than 3 months since the patient's last Depo medroxyprogesterone acetate (DMPA) injection and she has not had 2 normal, spontaneous menses since last using DMPA;
Use of any other hormonal contraceptive method within past 2 months (oral, transdermal, transvaginal, implant, or hormonal intrauterine device);

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: FlagylAll participants had BV at baseline. They all received metronidazole 500 mg po BID for 7 days	Drug	BV pre treatment

Primary outcome

p24 Antigen Production in Tissue
Time frame: 6 weeks
The study will evaluate HIV infection and safety of cervico-vaginal tissue in women at 3 different time periods: 1. During a BV infection 2. Approximately 1 week after completing a 7-day course of metronidazole therapy 3. Approximately 1 month after completing the 7-day course of metronidazole therapy Each of the 33 participants were sampled at baseline (during BV infection), approximately 1 week after treatment and approximately 1 month after treatment. p 24 antigen data was not evaluable in this study due to the fact that the samples were frozen prior to laboratory analyses, which damaged the samples. No data were collected.
p24 Antigen Production at Baseline Versus After Treatment With Metronidazole
Time frame: 30 days
p 24 antigen data was not evaluable in this study due to the fact that the samples were frozen prior to laboratory analyses.

Results and safety

Results posted to the registry on 26 Aug 2014, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Metronidazole	35	33

Primary outcome: p24 Antigen Production in Tissue

Time frame: 6 weeks

Primary outcome: p24 Antigen Production at Baseline Versus After Treatment With Metronidazole

Time frame: 30 days

Adverse events

Time frame: 1 year. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Metronidazole	0 of 35 (0%)	2 of 35 (5.7%)	Not reported

Limitations and caveats (from the sponsor): There were no serious adverse events related to product or procedures.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2017.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 34560047Gustin AT, Thurman AR, Chandra N, Schifanella L, Alcaide M, Fichorova R, Doncel GF, Gale M Jr, Klatt NR. Recurrent bacterial vaginosis following metronidazole treatment is associated with microbiota richness at diagnosis. Am J Obstet Gynecol. 2022 Feb;226(2):225.e1-225.e15. doi: 10.1016/j.ajog.2021.09.018. Epub 2021 Sep 22.
CONRAD Reproductive HealthLink provided by the sponsor.
Individual participant dataSharing planned: No. Cohort data will be published but not IPD

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.

Andrea R Thurman, MD principal investigator

CONRAD Eastern Virginia Medical School

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Metronidazole in people with Bacterial Vaginosis and Vaginal Discharge, run by CONRAD 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 4 inclusion and 23 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 19 Dec 2017. 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 26 Aug 2014). 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?

p24 Antigen Production in Tissue (time frame: 6 weeks). The study lists 2 primary outcomes in all. 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 NCT01347632, which also lists 1 linked publication.

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 19 Dec 2017.