Bacterial VaginosisNCT07247851
Title of the Protocol: Combined Use of Vaginal Clindamycin Cream and Oral Metronidazole Versus Oral Metronidazole
A study testing Clindamycin Phosphate in people with Bacterial Vaginosis, run by Ain Shams Maternity Hospital at 1 site in Egypt.
Trial summary
Bacterial vaginosis (BV) constitutes a gynecological condition characterized by an alteration of the vaginal microenvironment and more specifically an alteration of the normal Lactobacillus-dominated vaginal flora, to a flora that includes a variety of facultative and obligatory anaerobic bacteria; this alteration… Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Bacterial Vaginosis
- What is being tested?
- Clindamycin Phosphate
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteEgypt
- Study dates
- 10 Jan 2024to 10 Jun 2024
- Phase
- Interventional
- 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 to 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Women aged ≥ 18 years with a clinical diagnosis and laboratory diagnosis as (cervical smear \& high vaginal swab) of bacterial vaginosis.
- Diagnosed with Bacterial vaginosis the Amsel scoring system which requires 3 criteria of 4 criteria for diagnosis.:
- The presence of homogeneous, thin, greyish white vaginal discharge.
- Vaginal pH over 4.5.
- Positive whiff-amine test (the presence of a fishy odor following addition of KOH to the vaginal sample).
- More than 20% clue cells/high power field on a wet mount of vaginal secretions.
Who cannot join
- Other types of infections based on history and clinical examination as candida vaginitis (itching with cottage cheese whitish discharge, Trichomonas vaginalis (with yellowish green offensive discharge) and any sexually transmitted disease (STDs) as gonorrhea(watery creamy greenish discharge, pain on micturation)syphilis(appearance of shung-kur ulcer, painless sore), chlamydia(abnormal discharge from vagina, burning sensation on peeing, abnormal discharge from penis) or genital herpes (tingling, burning, itching around genitals on both parteners).
- Pregnant and lactating females
- Any contraindication or hypersensitivity to metronidazole use
- Use of other antibiotics or systemic antifungal agents within the previous 2 weeks or planned use within 2 weeks
- Use of topical vaginal antibiotics, antifungals or acidifying products recently or planned within 2 weeks
- Atrophic vaginitis
- Using IUD as contraceptive method because IUD is a risk factor for infection
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Title of the Protocol: Combined Use of Vaginal Clindamycin Cream and Oral Metronidazole Versus Oral Metronidazole in Treatment of Bacterial Vagionosis: A Randomized Controlled Clinical Trial
Bacterial vaginosis (BV) constitutes a gynecological condition characterized by an alteration of the vaginal microenvironment and more specifically an alteration of the normal Lactobacillus-dominated vaginal flora, to a flora that includes a variety of facultative and obligatory anaerobic bacteria; this alteration causes offensive smelling vaginal discharge, leading to significant psychological distress and a reduction in quality of life and may be associated with adverse outcomes following a gynecological/obstetrical surgical intervention, such as an increased risk of post-operative infections after pelvic surgery.
It has been observed in 29% of reproductive-age individuals in the United States, and the prevalence of BV varies with race and ethnicity
Read the detailed description
Bacterial vaginosis (BV) constitutes a gynecological condition characterized by an alteration of the vaginal microenvironment and more specifically an alteration of the normal Lactobacillus-dominated vaginal flora, to a flora that includes a variety of facultative and obligatory anaerobic bacteria
symptoms in cases of symptomatic BV include an elevated vaginal pH, grey-white milky vaginal discharge, itching, and a "fishy" odor. moreover, It is well known that unfavorable outcomes of early pregnancy including premature rupture of membranes (PROM), chorioamnionitis, preterm delivery, spontaneous abortion, and low birth weight can be exacerbated by BV during pregnancy.
Aside from the evaluation of clinical symptoms, the gold standard for the confirmation of BV diagnosis is the Nugent score based on Gram staining and observing the number of lactobacilli and other morphotypes (different shapes of gardenerellavaginalis, prevotella species, and mobiluncus) which are scored between 0 and 10, where scores 7-10 show BV. However, traditional assessment using Nugent scoring typically requires more time, resources, and expertise, which can impact its use in a clinical setting. The preferred alternative in practice is the Amsel scoring or a Gram stain.
The Amsel scoring system is simple to use and is based on four predefined criteria: (I) the presence of homogeneous, thin, greyish white vaginal discharge, (II) a vaginal pH over 4.5, (III) a positive whiff-amine test, and (IV) >20% clue cells/high power field on a wet mount of vaginal secretions. Yet, important diagnostic tools for BV are the phase contrast microscope and a trained user.
Oral divided dose metronidazole is the most widely used therapy and serves as the standard of care for bacterial vaginosis. Despite its favorable pharmacodynamics, recurrence rates of BV are high, 69-80% within 12 months. The causes of recurrence are still not known, whether from development of a treatment resistant bacterial biofilm on the vaginal mucosa, reinfection from a sexual partner, or host factors leading to failure to re-establish the normal vaginal flora.Two-thirds of cases complain from bacterial vaginosis recurrence within a year of treatment.
Metronidazole treatment is also associated with side effects which can limit acceptability and adherence. Patients also dislike taking multiple courses of antibiotics and are concerned that they may acquire resistant bacteria. Preventing and reducing antimicrobial resistance is also a public health priority through improving antibiotic stewardship including a reduction in antibiotic use. The limited efficacy of current treatment for bacterial vaginosis and a need to reduce antibiotic exposure highlight the need for alternative therapies.
Clindamycin phosphate was approved by the united states (U.S) Food and Drug Administration (FDA) in 2021 for the treatment of bacterial vaginosis. It is unique among bacterial vaginosis treatments in that it is a thermosetting bioadhesive intravaginal cream formulated with 2% clindamycin phosphate designed to release the active ingredient for an extended period of time. Reduced leakage should result in better user compliance, and, because clindamycin is more effective with increased exposure time, the increased retention time is supposed to result in higher cure rates
- Conditions
- Bacterial Vaginosis
- Being tested
- Clindamycin Phosphate
- Medical subject headings
- Vaginosis, Bacterial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Clindamycin PhosphateDrug
Also called Metronidazole
comparing the efficacy of the combined use of vaginal clindamycin cream and oral metronidazole in comparison to oral metronidazole alone for bacterial vaginosis treatment.
| Study group | Role | What they receive |
|---|---|---|
| Group A (Clindamycine with Metronidazole) | Active comparator | About 50 female patients used Vaginal Clindamycin vaginal cream: 2% and Oral Metronidazole tablets in the treatment of Bacterial Vaginosis Receives: Drug: Clindamycin Phosphate |
| Group B (Metronidazole) | Active comparator | About 50 female patients used Metronidazole tables in the treatment of Bacterial Vaginosis Receives: Drug: Clindamycin Phosphate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bacterial Vaginosis treatment
Assessment of the female patients whom suffering from Bacterial Vaginosis by Complete history description to changes of discharge odour and symptoms of vulvovaginitis as itching. and efficacy of both medications (reliving symptoms of BV as discharge \& odour) .
Measured: At 2 weeks and through 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2025
- Study start10 Jan 2024
- Primary completion1 Jun 2024
- Study completion10 Jun 2024
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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams Maternity Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rania Gamal Anwar Elskaan, Ain Shams Maternity Hospital
- Investigators
- Laila Aly Farid, Professor, Study chair, Obstetrics and Gynecology, Faculty of Medicine, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07247851
- Sponsor's protocol ID
- Bacterial Vagionos
- Status last verified
- Jan 2024
- First submitted
- 18 Nov 2025
- Last updated
- 25 Nov 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 25 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Title of the Protocol: Combined Use of Vaginal Clindamycin Cream and Oral Metronidazole Versus Oral Metronidazole in Treatment of Bacterial Vagionosis: A Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT07247851
- Acronym / sponsor ID
- Bacterial Vagionos
- Conditions
- Bacterial Vaginosis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Ain Shams Maternity HospitalUniversity, hospital or other
- Study start
- 10 Jan 2024 (actual)
- Primary completion
- 1 Jun 2024 (actual)
- Study completion
- 10 Jun 2024 (actual)
- First posted
- 25 Nov 2025 (actual)
- 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.
Bacterial vaginosis (BV) constitutes a gynecological condition characterized by an alteration of the vaginal microenvironment and more specifically an alteration of the normal Lactobacillus-dominated vaginal flora, to a flora that includes a variety of facultative and obligatory anaerobic bacteria; this alteration causes offensive smelling vaginal discharge, leading to significant psychological distress and a reduction in quality of life and may be associated with adverse outcomes following a gynecological/obstetrical surgical intervention, such as an increased risk of post-operative infections after pelvic surgery.
It has been observed in 29% of reproductive-age individuals in the United States, and the prevalence of BV varies with race and ethnicity
Detailed description
Bacterial vaginosis (BV) constitutes a gynecological condition characterized by an alteration of the vaginal microenvironment and more specifically an alteration of the normal Lactobacillus-dominated vaginal flora, to a flora that includes a variety of facultative and obligatory anaerobic bacteria
symptoms in cases of symptomatic BV include an elevated vaginal pH, grey-white milky vaginal discharge, itching, and a "fishy" odor. moreover, It is well known that unfavorable outcomes of early pregnancy including premature rupture of membranes (PROM), chorioamnionitis, preterm delivery, spontaneous abortion, and low birth weight can be exacerbated by BV during pregnancy.
Aside from the evaluation of clinical symptoms, the gold standard for the confirmation of BV diagnosis is the Nugent score based on Gram staining and observing the number of lactobacilli and other morphotypes (different shapes of gardenerellavaginalis, prevotella species, and mobiluncus) which are scored between 0 and 10, where scores 7-10 show BV. However, traditional assessment using Nugent scoring typically requires more time, resources, and expertise, which can impact its use in a clinical setting. The preferred alternative in practice is the Amsel scoring or a Gram stain.
The Amsel scoring system is simple to use and is based on four predefined criteria: (I) the presence of homogeneous, thin, greyish white vaginal discharge, (II) a vaginal pH over 4.5, (III) a positive whiff-amine test, and (IV) >20% clue cells/high power field on a wet mount of vaginal secretions. Yet, important diagnostic tools for BV are the phase contrast microscope and a trained user.
Oral divided dose metronidazole is the most widely used therapy and serves as the standard of care for bacterial vaginosis. Despite its favorable pharmacodynamics, recurrence rates of BV are high, 69-80% within 12 months. The causes of recurrence are still not known, whether from development of a treatment resistant bacterial biofilm on the vaginal mucosa, reinfection from a sexual partner, or host factors leading to failure to re-establish the normal vaginal flora.Two-thirds of cases complain from bacterial vaginosis recurrence within a year of treatment.
Metronidazole treatment is also associated with side effects which can limit acceptability and adherence. Patients also dislike taking multiple courses of antibiotics and are concerned that they may acquire resistant bacteria. Preventing and reducing antimicrobial resistance is also a public health priority through improving antibiotic stewardship including a reduction in antibiotic use. The limited efficacy of current treatment for bacterial vaginosis and a need to reduce antibiotic exposure highlight the need for alternative therapies.
Clindamycin phosphate was approved by the united states (U.S) Food and Drug Administration (FDA) in 2021 for the treatment of bacterial vaginosis. It is unique among bacterial vaginosis treatments in that it is a thermosetting bioadhesive intravaginal cream formulated with 2% clindamycin phosphate designed to release the active ingredient for an extended period of time. Reduced leakage should result in better user compliance, and, because clindamycin is more effective with increased exposure time, the increased retention time is supposed to result in higher cure rates
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A (Clindamycine with Metronidazole) | Active comparator | Drug: Clindamycin PhosphateAbout 50 female patients used Vaginal Clindamycin vaginal cream: 2% and Oral Metronidazole tablets in the treatment of Bacterial Vaginosis |
| Group B (Metronidazole) | Active comparator | Drug: Clindamycin PhosphateAbout 50 female patients used Metronidazole tables in the treatment of Bacterial Vaginosis |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Women aged ≥ 18 years with a clinical diagnosis and laboratory diagnosis as (cervical smear \& high vaginal swab) of bacterial vaginosis.
- Diagnosed with Bacterial vaginosis the Amsel scoring system which requires 3 criteria of 4 criteria for diagnosis.:
- The presence of homogeneous, thin, greyish white vaginal discharge.
- Vaginal pH over 4.5.
- Positive whiff-amine test (the presence of a fishy odor following addition of KOH to the vaginal sample).
Key exclusion criteria (7 listed)
- Other types of infections based on history and clinical examination as candida vaginitis (itching with cottage cheese whitish discharge, Trichomonas vaginalis (with yellowish green offensive discharge) and any sexually transmitted disease (STDs) as gonorrhea(watery creamy greenish discharge, pain on micturation)syphilis(appearance of shung-kur ulcer, painless sore), chlamydia(abnormal discharge from vagina, burning sensation on peeing, abnormal discharge from penis) or genital herpes (tingling, burning, itching around genitals on both parteners).
- Pregnant and lactating females
- Any contraindication or hypersensitivity to metronidazole use
- Use of other antibiotics or systemic antifungal agents within the previous 2 weeks or planned use within 2 weeks
- Use of topical vaginal antibiotics, antifungals or acidifying products recently or planned within 2 weeks
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 |
|---|---|---|
| Clindamycin PhosphateAlso: Metronidazolecomparing the efficacy of the combined use of vaginal clindamycin cream and oral metronidazole in comparison to oral metronidazole alone for bacterial vaginosis treatment. | Drug | Group A (Clindamycine with Metronidazole), Group B (Metronidazole) |
Primary outcome
Bacterial Vaginosis treatment
Time frame: At 2 weeks and through 6 months
Assessment of the female patients whom suffering from Bacterial Vaginosis by Complete history description to changes of discharge odour and symptoms of vulvovaginitis as itching. and efficacy of both medications (reliving symptoms of BV as discharge \& odour) .
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 25 Nov 2025.
- Individual participant dataSharing planned: Undecided
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.
Laila Aly Farid, Professor study chair
Obstetrics and Gynecology, Faculty of Medicine, Ain Shams 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 Clindamycin Phosphate in people with Bacterial Vaginosis, run by Ain Shams Maternity Hospital at 1 site in Egypt.
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 6 inclusion and 7 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 25 Nov 2025. 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 Egypt. 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?
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?
Bacterial Vaginosis treatment (time frame: At 2 weeks and through 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 25 Nov 2025.