VaginitisPhase 2/3MNZNCT02365389
Once Daily In-situ Forming Versus Twice-daily Conventional Metronidazole Vaginal Gels for Treatment of Bacterial Vaginosis
A Phase 2/3 study testing MTZ vaginal gel and Conventional MTZ vaginal gel in people with Vaginitis, run by Assiut University.
Trial summary
A previous study showed that in situ MTZ vaginal gel twice daily is more effective than the conventional vaginal gel product in sustained cure of BV( 4 weeks after treatment) (80.0% in the in-situ gel group as compared with 47.4 in the conventional gel group.The current study aims to compare the efficacy of the use of… Read more about this study
- Who is it for?
- Ages 20 to 40 years, women only
- Conditions the study is for
- Vaginitis
- What is being tested?
- MTZ vaginal gel and Conventional MTZ vaginal gel
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- No sites listed yet
- Study dates
- May 2014to Dec 2014
- Phase
- Phase 2/3
- 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 20 to 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Women with proven diagnosis of bacterial vaginosis infection from the Outpatient Gynecological Clinic in Women Health Center Assiut University.
Who cannot join
- Women refusal to participate in the study.
- Pregnant and nursing Women.
- Anticipation of difficulty of subsequent communication with the woman.
About this study
Official title: Assiut University Hospital - Women Health Hospital
A previous study showed that in situ MTZ vaginal gel twice daily is more effective than the conventional vaginal gel product in sustained cure of BV( 4 weeks after treatment) (80.0% in the in-situ gel group as compared with 47.4 in the conventional gel group.The current study aims to compare the efficacy of the use of once daily in situ MTZ vaginal gel (0.8%) versus twice-daily conventional MTZ vaginal gel in treatment of BV.
Read the detailed description
Bacterial vaginosis (BV) is one of the most frequently diagnosed infections in women attending genitourinary clinics. As 50% of cases of BV are asymptomatic, the true prevalence of this condition in the community is uncertain.Metronidazole (MTZ) is considered the drug of choice for the treatment of BV. It can be given either orally or locally. Formulations for the local administration of the drug include gels and suppositories.
The acceptance of suppositories is lower than the oral administration of the drug as they might cause irritation and thus affecting the patient's compliance. Moreover, the mode of administration of MTZ does not have a significant difference in the eradication of the pathogenic bacteria .
Among the metronidazole gels and lactic acid gels, for local application, lactic acid gels have been found to be more efficient and safer. The recurrence of BV is less common in patients treated with lactic acid gel when compared with patients treated with metronidazole gels. This may be attributed to the inhibition in the growth of the lactobacilli when MTZ is used for the treatment and depends on the concentration of the lactobacilli .
Intravaginal deliveries of MTZ for the treatment of BV have shown that there was an improvement in the clinical symptoms of the patients within 21-30 days of the starting of the treatment. Unfortunately, the vagina was not recolonized with lactobacilli within the stated period . The use of formulation consisting policarbophil-carbopol and lactic acid-chitosan mucoadhesive vaginal gels has also been reported and both of them have been found to be safe .
Cure rates following intravaginal treatment with MTZ account for 80-90% at the end of treatment and one month after the end of therapy. However, three months after the end of therapy the rate of relapses can overcome 30%. Persistence of an adherent bacterial biofilm, containing mostly Gardenerlla vaginalis is the main reason for failure of BV treatment .
Suppressive treatment with MTZ gel has been investigated with variable results . Moreover, long-term treatment with MTZ is not recommended because of the high incidence of gastrointestinal adverse reactions, the risk of peripheral neuropathy, and Candida super infection.
Although the patients are known to tolerate gels better than suppositories or ointments, the direct application of gels into the diseased sites of vagina might be difficult as well as improper. Therefore, vaginal therapy would be significantly improved if an intravaginally administered drug can retain at the site of administration for prolonged time .
The in situ forming hydrogel is a stimuli sensitive hydrogel that exists as an aqueous solution before administration. When exposed to external physical stimuli like heat, it undergoes reversible volume-phase transition, then immediately turned into standing gels after its contact with the mucosa .Recently, in situ gel drug delivery system has been investigated as a more convenient dosage form of topical applications. It's easy to be applied into the vagina with accurate dosing of liquid before turning to gel with even spreading. It had been tried before and proved effectiveness, safety and tolerance .
- Conditions
- Vaginitis
- Being tested
- MTZ vaginal gel, Conventional MTZ vaginal gel
- Medical subject headings
- Vaginitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MTZ vaginal gelDrug
MTZ vaginal gel once daily for 5 days
Conventional MTZ vaginal gelDrug
Conventional MTZ vaginal gel (Tricho gel 0.8%, Sedico, Egypt) twice daily for 5 days
| Study group | Role | What they receive |
|---|---|---|
| Group A received in situ MTZ vaginal gel | Active comparator | Received in situ MTZ vaginal gel once daily for 5 days. Treatment in this group was offered in the form of a bottle of an aqueous liquid (100 mL of a preparation composed of 0.8% MTZ, 20% pluronic F-127, 10% pluronic F-68, and 0.01% benzalkonium chloride). Women were asked to put 5 cc of the liquid into the vagina once daily for 5 days using a graded syringe and 10-cm long soft applicator. Receives: Drug: MTZ vaginal gel |
| Group B received conventional MTZ vaginal gel | Active comparator | Group B (control group) received conventional MTZ vaginal gel (Tricho gel 0.8%, Sedico, Egypt) twice daily for 5 days, using the supplied nozzle, which applies about 5 gm of gel again in the same laying back position. Receives: Drug: Conventional MTZ vaginal gel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical improvement of vaginitis.
Therapeutic success will be defined as the presence of at least 3 signs of Amsel's criteria (Milky, homogeneous, adherent discharge; vaginal pH > 4.5; release of fishy amine odor from vaginal fluid when mixed with 10% KOH (whiff test); and presence of > 20 of clue cells).
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2015 (estimated)
- Study startMay 2014
- Primary completionOct 2014
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for VaginitisStudies of the same condition, open and under way.
- More trials run by Assiut 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Omar Mamdouh Shaaban, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02365389
- Sponsor's protocol ID
- Vaginal gell
- Acronym
- MNZ
- Status last verified
- Feb 2015
- First submitted
- 15 Feb 2015
- Last updated
- 18 Feb 2015
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assiut University Hospital - Women Health Hospital
- ClinicalTrials.gov ID
- NCT02365389
- Acronym / sponsor ID
- MNZ / Vaginal gell
- Conditions
- Vaginitis
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- May 2014
- Primary completion
- Oct 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 18 Feb 2015 (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.
A previous study showed that in situ MTZ vaginal gel twice daily is more effective than the conventional vaginal gel product in sustained cure of BV( 4 weeks after treatment) (80.0% in the in-situ gel group as compared with 47.4 in the conventional gel group.The current study aims to compare the efficacy of the use of once daily in situ MTZ vaginal gel (0.8%) versus twice-daily conventional MTZ vaginal gel in treatment of BV.
Detailed description
Bacterial vaginosis (BV) is one of the most frequently diagnosed infections in women attending genitourinary clinics. As 50% of cases of BV are asymptomatic, the true prevalence of this condition in the community is uncertain.Metronidazole (MTZ) is considered the drug of choice for the treatment of BV. It can be given either orally or locally. Formulations for the local administration of the drug include gels and suppositories.
The acceptance of suppositories is lower than the oral administration of the drug as they might cause irritation and thus affecting the patient's compliance. Moreover, the mode of administration of MTZ does not have a significant difference in the eradication of the pathogenic bacteria .
Among the metronidazole gels and lactic acid gels, for local application, lactic acid gels have been found to be more efficient and safer. The recurrence of BV is less common in patients treated with lactic acid gel when compared with patients treated with metronidazole gels. This may be attributed to the inhibition in the growth of the lactobacilli when MTZ is used for the treatment and depends on the concentration of the lactobacilli .
Intravaginal deliveries of MTZ for the treatment of BV have shown that there was an improvement in the clinical symptoms of the patients within 21-30 days of the starting of the treatment. Unfortunately, the vagina was not recolonized with lactobacilli within the stated period . The use of formulation consisting policarbophil-carbopol and lactic acid-chitosan mucoadhesive vaginal gels has also been reported and both of them have been found to be safe .
Cure rates following intravaginal treatment with MTZ account for 80-90% at the end of treatment and one month after the end of therapy. However, three months after the end of therapy the rate of relapses can overcome 30%. Persistence of an adherent bacterial biofilm, containing mostly Gardenerlla vaginalis is the main reason for failure of BV treatment .
Suppressive treatment with MTZ gel has been investigated with variable results . Moreover, long-term treatment with MTZ is not recommended because of the high incidence of gastrointestinal adverse reactions, the risk of peripheral neuropathy, and Candida super infection.
Although the patients are known to tolerate gels better than suppositories or ointments, the direct application of gels into the diseased sites of vagina might be difficult as well as improper. Therefore, vaginal therapy would be significantly improved if an intravaginally administered drug can retain at the site of administration for prolonged time .
The in situ forming hydrogel is a stimuli sensitive hydrogel that exists as an aqueous solution before administration. When exposed to external physical stimuli like heat, it undergoes reversible volume-phase transition, then immediately turned into standing gels after its contact with the mucosa .Recently, in situ gel drug delivery system has been investigated as a more convenient dosage form of topical applications. It's easy to be applied into the vagina with accurate dosing of liquid before turning to gel with even spreading. It had been tried before and proved effectiveness, safety and tolerance .
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A received in situ MTZ vaginal gel | Active comparator | Drug: MTZ vaginal gelReceived in situ MTZ vaginal gel once daily for 5 days. Treatment in this group was offered in the form of a bottle of an aqueous liquid (100 mL of a preparation composed of 0.8% MTZ, 20% pluronic F-127, 10% pluronic F-68, and 0.01% benzalkonium chloride). Women were asked to put 5 cc of the liquid into the vagina once daily for 5 days using a graded syringe and 10-cm long soft applicator. |
| Group B received conventional MTZ vaginal gel | Active comparator | Drug: Conventional MTZ vaginal gelGroup B (control group) received conventional MTZ vaginal gel (Tricho gel 0.8%, Sedico, Egypt) twice daily for 5 days, using the supplied nozzle, which applies about 5 gm of gel again in the same laying back position. |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Women with proven diagnosis of bacterial vaginosis infection from the Outpatient Gynecological Clinic in Women Health Center Assiut University.
Key exclusion criteria (3 listed)
- Women refusal to participate in the study.
- Pregnant and nursing Women.
- Anticipation of difficulty of subsequent communication with the woman.
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 |
|---|---|---|
| MTZ vaginal gelMTZ vaginal gel once daily for 5 days | Drug | Group A received in situ MTZ vaginal gel |
| Conventional MTZ vaginal gelConventional MTZ vaginal gel (Tricho gel 0.8%, Sedico, Egypt) twice daily for 5 days | Drug | Group B received conventional MTZ vaginal gel |
Primary outcome
Clinical improvement of vaginitis.
Time frame: 6 months
Therapeutic success will be defined as the presence of at least 3 signs of Amsel's criteria (Milky, homogeneous, adherent discharge; vaginal pH > 4.5; release of fishy amine odor from vaginal fluid when mixed with 10% KOH (whiff test); and presence of > 20 of clue cells).
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 18 Feb 2015.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing MTZ vaginal gel and Conventional MTZ vaginal gel in people with Vaginitis, run by Assiut University.
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 1 inclusion and 3 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 18 Feb 2015. Status can change between updates, so confirm with the study contact before making plans.
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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Clinical improvement of vaginitis. (time frame: 6 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 18 Feb 2015; AzTrials last refreshed its copy on 8 Nov 2026.