Bacterial VaginosisPhase 1/2NCT01020396
Bioequivalence of Metronidazole Gel, 0.75% in the Treatment of Bacterial Vaginosis
A Phase 1/2 study testing Metronidazole in people with Bacterial Vaginosis, run by Teva Pharmaceuticals USA at 37 sites in United States.
Trial summary
The purpose of this study was to demonstrate comparable efficacy, safety, and tolerability of Teva Pharmaceuticals USA's generic formulation of Metronidazole Vaginal Gel, 0.75% and 3M Pharmaceuticals' MetroGel-Vaginal® metronidazole vaginal gel, 0.75% to establish clinical equivalence in the treatment of bacterial… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Bacterial Vaginosis
- What is being tested?
- Metronidazole
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 579 participants
- Where
- 37 sitesUnited States
- Study dates
- Jan 2002to Mar 2003
- Phase
- Phase 1/2
- 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
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects must provide written informed consent prior to any study related procedures being performed.
- Female subjects must have a clinical diagnosis of bacterial vaginosis, defined as having the presence of "clue cells" > 20% of the total epithelia cells on microscopic examination of a saline "wet mount" and all of the following criteria: Off-white (milky or grey), thin, homogeneous discharge; pH of vaginal fluid > 4.7; a positive 10% KOH "whiff test".
- Subjects must be 18 years of age or older with no known medical conditions that, in the investigator's opinion, may interfere with study participation.
- Women of child bearing potential must have a negative urine pregnancy test result upon entry into the study.
- Subjects must agree to abstain from sexual intercourse throughout the first 7 days of the study. Following the first 7 days, subjects must agree to use a non-lubricated condom when engaging in sexual intercourse.
- Subjects must be willing to abstain from alcohol ingestion during the 5 day treatment period and for 1 day afterward.
- Subjects must agree to refrain from the use of intra-vaginal products throughout the study (e.g., douches, feminine deodorant sprays, spermicides, lubricated condoms, tampons, and diaphragms).
Who cannot join
- Subjects with known or suspected other infectious causes of vulvovaginitis (e.g. candidiasis, Trichomonas vaginalis, Chlamydia trachomatis, Neisseria gonorrhoeae, active Herpes simplex or human papilloma virus, or any other vaginal or vulvar condition, which in the investigator's opinion, would confound the interpretation of the clinical response).
- Subjects with a Gram's stain slide Nugent score <4.
- Subjects who received antifungal or antimicrobial therapy (systemic or intravaginal) within 14 days of randomization.
- Subjects who have taken disulfuram within 14 days or randomization.
- Subjects who have demonstrated a previous hypersensitivity reaction to metronidazole, either orally or topically administered, or any form or parabens.
- Subjects with primary or secondary immunodeficiency.
Show all 16Show fewer
- Women who will be under treatment during the study period for cervical intra-epithelial neoplasia (CIN) or cervical carcinoma.
- Subjects who are pregnant, breast feeding, or planning a pregnancy.
- Subjects who are menstruating at the time of diagnosis.
- Subjects with intrauterine devices.
- Concurrent anticoagulation therapy with coumadin or warfarin.
- Concurrent use of systemic corticosteroids or systemic antibiotics.
- Subjects with clinically significant unstable medical disorders, life threatening diseases or current malignancies.
- Subjects previously enrolled in this study.
- Subjects who have participated in another clinical trial or have taken an experimental drug within the past 30 days.
- Subjects who are unwilling or unable to comply with the requirements of the protocol.
Trial locations and contacts
37 sites in 1 country.
37 sites in 1 country
United States37 sites
Anderson Family Care
Anderson, South Carolina, 29621
Carolina OB/GYN
Anderson, South Carolina, 29621
Primary Care Associates
Anderson, South Carolina, 29621
Radiant Research
Anderson, South Carolina, 29621
Millennium Clinical Research Center, LLC
Arlington, Virginia, 22203
Kings County Hospital Center
Brooklyn, New York, 11203
SUNY Downstate Medical Center
Brooklyn, New York, 11203
Women's Health Practice
Champaign, Illinois, 61820
Chapel Hill Obstetrics and Gynecology, PA
Chapel Hill, North Carolina, 27514
Cooperfield Obstetrics and Gynecology, LLC
Concord, North Carolina, 28025
Meadowcrest Women's Center
Crystal River, Florida, 34429
Women's Health Associates, PC
Fairfax, Virginia, 22031
Office of H. Sharon Sethi
Fairfax, Virginia, 22033
Edinger Medical Group
Fountain Valley, California, 92708
Florida Medical and Research Institute, PA
Gainesville, Florida, 32607
Clinic for Women, PA
Huntsville, Alabama, 35801
Medical Affiliated Research Center, Inc.
Huntsville, Alabama, 35801
The Florida Wellcare Alliance, LC
Inverness, Florida, 34452
Wellness Center for Gyn & Osteoporosis
Inverness, Florida, 34452
Central Kentucky Research Associates, Inc.
Lexington, Kentucky, 40509
Medford Women's Clinic
Medford, Oregon, 97504
Research Memphis
Memphis, Tennessee, 38116
Phoenix Ob-Gyn Associated
Moorestown, New Jersey, 08057
Phoenix Ob-Gyn Associates
Mount Holly, New Jersey, 08060
New Orleans Institute of Clinical Investigation
New Orleans, Louisiana, 70112
Florida Medical and Research Institute, PA
Ocala, Florida, 34471
O.U. Physicians' Building
Oklahoma City, Oklahoma, 73104
The OU Medical Center
Oklahoma City, Oklahoma, 73104
University of Oklahoma Health Services Center
Oklahoma City, Oklahoma, 73104
Philadelphia Women's Research
Philadelphia, Pennsylvania, 19114
MedSource, Inc.
Richmond, Virginia, 23229
Office of Max S. Maizels, MD
Richmond, Virginia, 23229
Office of Prescott W. Prillaman, MD, PC
Richmond, Virginia, 23229
KGR, LLC
Riverdale, Georgia, 30274
Elite Medical Research, Inc.
Sellersville, Pennsylvania, 18960
Stonebridge OB/GYN Associates
Sellersville, Pennsylvania, 18960
Office of Drs. Shepard and Lugerner, PC
Washington D.C., District of Columbia, 20006
About this study
Official title: A Multi-Center, Double-Blind, Parallel Group Study Comparing the Bioequivalence of Teva Pharmaceuticals, USA's Generic Formulation of Metronidazole Vaginal Gel, 0.75% and MetroGel-Vaginal® Metronidazole Vaginal Gel, 0.75% in the Treatment of Bacterial Vaginosis
The purpose of this study was to demonstrate comparable efficacy, safety, and tolerability of Teva Pharmaceuticals USA's generic formulation of Metronidazole Vaginal Gel, 0.75% and 3M Pharmaceuticals' MetroGel-Vaginal® metronidazole vaginal gel, 0.75% to establish clinical equivalence in the treatment of bacterial vaginosis.
- Conditions
- Bacterial Vaginosis
- Being tested
- Metronidazole
- Keywords
- Bioequivalence, Metronidazole, Vaginosis
- 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.
MetronidazoleDrug
Vaginal Gel, 0.75%
MetronidazoleDrug
Also called MetroGel-Vaginal®
Vaginal Gel, 0.75%
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Metronidazole Vaginal Gel, 0.75% (Teva Pharmaceuticals, USA) Receives: Drug: Metronidazole |
| 2 | Active comparator | MetroGel-Vaginal® metronidazole vaginal gel, 0.75% (3M Pharmaceuticals) Receives: Drug: Metronidazole |
What is being measured
The primary outcome is the main question the study is designed to answer.
Therapeutic cure rate of the subject at the Test-of-Cure Visit.
Measured: Visit 3
Incidence of Adverse Effects reported throughout the study.
Measured: 29 Days
Secondary outcomes (1)
Therapeutic cure rate at the Post-Treatment Visit
Measured: Visit 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2009 (estimated)
- Study startJan 2002
- Primary completionMar 2003
- Study completionMar 2003
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.
- 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 1/2
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 579 participants (actual)
Sponsor and investigators
- Lead sponsor
- Teva Pharmaceuticals USA
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01020396
- Sponsor's protocol ID
- TCR-03
- Status last verified
- Aug 2024
- First submitted
- 24 Nov 2009
- Last updated
- 19 Aug 2024
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-Center, Double-Blind, Parallel Group Study Comparing the Bioequivalence of Teva Pharmaceuticals, USA's Generic Formulation of Metronidazole Vaginal Gel, 0.75% and MetroGel-Vaginal® Metronidazole Vaginal Gel, 0.75% in the Treatment of Bacterial Vaginosis
- ClinicalTrials.gov ID
- NCT01020396
- Acronym / sponsor ID
- TCR-03
- Conditions
- Bacterial Vaginosis
- Keywords
- Bioequivalence, Metronidazole, Vaginosis
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 579 participants (actual)
- Lead sponsor
- Teva Pharmaceuticals USAIndustry (pharma, biotech, devices)
- Study start
- Jan 2002
- Primary completion
- Mar 2003 (actual)
- Study completion
- Mar 2003 (actual)
- First posted
- 25 Nov 2009 (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.
The purpose of this study was to demonstrate comparable efficacy, safety, and tolerability of Teva Pharmaceuticals USA's generic formulation of Metronidazole Vaginal Gel, 0.75% and 3M Pharmaceuticals' MetroGel-Vaginal® metronidazole vaginal gel, 0.75% to establish clinical equivalence in the treatment of bacterial vaginosis.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: MetronidazoleMetronidazole Vaginal Gel, 0.75% (Teva Pharmaceuticals, USA) |
| 2 | Active comparator | Drug: MetronidazoleMetroGel-Vaginal® metronidazole vaginal gel, 0.75% (3M Pharmaceuticals) |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Subjects must provide written informed consent prior to any study related procedures being performed.
- Female subjects must have a clinical diagnosis of bacterial vaginosis, defined as having the presence of "clue cells" > 20% of the total epithelia cells on microscopic examination of a saline "wet mount" and all of the following criteria: Off-white (milky or grey), thin, homogeneous discharge; pH of vaginal fluid > 4.7; a positive 10% KOH "whiff test".
- Subjects must be 18 years of age or older with no known medical conditions that, in the investigator's opinion, may interfere with study participation.
- Women of child bearing potential must have a negative urine pregnancy test result upon entry into the study.
- Subjects must agree to abstain from sexual intercourse throughout the first 7 days of the study. Following the first 7 days, subjects must agree to use a non-lubricated condom when engaging in sexual intercourse.
Key exclusion criteria (16 listed)
- Subjects with known or suspected other infectious causes of vulvovaginitis (e.g. candidiasis, Trichomonas vaginalis, Chlamydia trachomatis, Neisseria gonorrhoeae, active Herpes simplex or human papilloma virus, or any other vaginal or vulvar condition, which in the investigator's opinion, would confound the interpretation of the clinical response).
- Subjects with a Gram's stain slide Nugent score <4.
- Subjects who received antifungal or antimicrobial therapy (systemic or intravaginal) within 14 days of randomization.
- Subjects who have taken disulfuram within 14 days or randomization.
- Subjects who have demonstrated a previous hypersensitivity reaction to metronidazole, either orally or topically administered, or any form or parabens.
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 |
|---|---|---|
| MetronidazoleVaginal Gel, 0.75% | Drug | 1 |
| MetronidazoleAlso: MetroGel-Vaginal®Vaginal Gel, 0.75% | Drug | 2 |
Primary outcome
Therapeutic cure rate of the subject at the Test-of-Cure Visit.
Time frame: Visit 3
Incidence of Adverse Effects reported throughout the study.
Time frame: 29 Days
1 secondary outcome
Therapeutic cure rate at the Post-Treatment Visit
Time frame: Visit 2
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 19 Aug 2024.
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.
The record lists no contact. Use the official record to reach the sponsor.
37 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Metronidazole in people with Bacterial Vaginosis, run by Teva Pharmaceuticals USA at 37 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 7 inclusion and 16 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 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 37 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Therapeutic cure rate of the subject at the Test-of-Cure Visit. (time frame: Visit 3). 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?
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 Aug 2024.