Vaginosis, BacterialMAT072017NCT04171947
Vaginal Ovule With Flavonoid Tea Extract for the Correction of Imbalance in the Vaginal Environment
A study testing Matuzalem ovule in people with Vaginosis, Bacterial and Vaginal Flora Imbalance, run by Value Outcomes Ltd. at 14 sites in Czechia.
Trial summary
Randomized, blinded vehicle-controlled multicenter clinical trial (MAT072017) to determine the effect of vaginal ovules containing 2 mg of the tea extract Matuzalem on the subjective symptoms (5-point scale pruritus (itching), dolor (pain), rubor (redness), fluor (discharge), and fetor (odor)), and objective symptoms… Read more about this study
- Who is it for?
- Ages 18 to 55 years, women only
- Conditions the study is for
- Vaginosis, Bacterial, Vaginal Flora Imbalance
- What is being tested?
- Matuzalem ovule
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 274 participants
- Where
- 14 sitesCzechia
- Study dates
- 4 Dec 2017to 9 May 2018
- 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 55 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- premenopausal participants
- disturbed vaginal environment
- not in need of antibiotic or antimycotic treatment
- participants were citizens of the Czech Republic
- age between 18 and 55 years
- either a vaginal pH > 4.5 or/and vaginal discomfort
- able to follow the prescribed regimen
- informed consents prior to any intervention, including diagnostic procedures.
Who cannot join
- no vaginal bleeding of unknown aetiology
- hypersensitivity
- pregnancy
- lactation
- period during enrollment
- antibiotics in the previous 30 days
Show all 12Show fewer
- treated with any products with similar indication
- acute urogenital infection
- diabetes mellitus
- advanced oncologic disease
- participant to other trial
- Nugent score above 6
Trial locations and contacts
14 sites in 1 country.
14 sites in 1 country
Czechia14 sites
Centrum ambulantní gynekologie a primární péče, s.r.o.
Brno, Czech Republic, 60200
MUDr. Milan Kučera. s.r.o.
Kladno, Czech Republic, 27201
MUDr. Eva Novotná - FEMCARE s.r.o.
Odolena Voda, Czech Republic, 25070
OB/GYN Associates, s.r.o.
Prague, Czech Republic, 11000
MediStar s.r.o.
Prague, Czech Republic, 12000
MUDr. Michal Jelšík
Prague, Czech Republic, 12800
Gyn Por Ivf MUDr. Samer Asad s.r.o.
Prague, Czech Republic, 147000
Mediva s.r.o.
Prague, Czech Republic, 15500
GYNEKOLOGIE Studentský dům s.r.o.
Prague, Czech Republic, 16000
LEVRET s.r.o.
Prague, Czech Republic, 16000
T.B. Gyn s.r.o.
Prague, Czech Republic, 16100
Gynelav s.r.o.
Prague, Czech Republic, 16500
GYNEDAN s.r.o.
Prague, Czech Republic
MUDr.Tereza Šmrhová-Kovács
Tábor, Czech Republic, 39003
About this study
Official title: Medical Device Matuzalem Flavonoid Tea Extract Vaginal Ovule for the Correction of the Imbalance in the Vaginal Environment- Prospective, Multicentric, Two-arm, Randomized, Vehicle-controlled, Blinded, Comparative Clinical Trial
Randomized, blinded vehicle-controlled multicenter clinical trial (MAT072017) to determine the effect of vaginal ovules containing 2 mg of the tea extract Matuzalem on the subjective symptoms (5-point scale pruritus (itching), dolor (pain), rubor (redness), fluor (discharge), and fetor (odor)), and objective symptoms (pH, Nugent score) of bacterial vaginosis. An ovule containing only the vehicle (polyethylene glycol 3000 S) was used as a control. The study was blinded from the perspective of the subject, investigator, laboratory personnel and data analyst.
Read the detailed description
The objective was to determine whether vaginal ovule with tea extract once-daily for 5-7 days improves symptoms of intermediate vaginal flora and prevents the development of bacterial vaginosis.
Composite primary endpoint designed as a drop in the Nugent score, vaginal pH, or improvement of subjective symptoms was compared between the active and vehicle (polyethylene-glycol) arm after 7 days of application and following 7 days after the application.
Secondary outcome measures were (1) Correction of the vaginal environment (as previously defined) 7 days after the completion of the prescribed 7-day regimen (day 14); (2) change in each parameter separately; (3) change in individual subjective symptoms, (4) exploratory analysis of the microbial environment at each subject visit.
The study was approved and supervised by the National authority and Ethics committee and prospectively registered in the Czech national medical device trial registry RZPRO and the European medical device trial registry EUDAMED.
- Conditions
- Vaginosis, Bacterial, Vaginal Flora Imbalance
- Being tested
- Matuzalem ovule, Vehicle ovule
- Keywords
- Tea, Polyphenols, Nugent score, Antioxidants, Vaginal pH, complementary medicine
- Medical subject headings
- Vaginosis, Bacterial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Matuzalem ovuleDevice
vaginal ovule with 2 mg tea extract
Vehicle ovuleDevice
polyethylene glycol vaginal ovule
| Study group | Role | What they receive |
|---|---|---|
| Matuzalem | Experimental | Tea extract vaginal ovule daily for 7 consecutive days Receives: Device: Matuzalem ovule |
| Vehicle | Sham comparator | Polyethylene glycol vaginal ovule daily for 7 consecutive days Receives: Device: Vehicle ovule |
What is being measured
The primary outcome is the main question the study is designed to answer.
Composite endpoint (vaginal pH, Nugent score, subjective symptoms via questionnaire) after treatment completion
Correction of the vaginal environment after 7 days of once-daily application of the ovule was defined as: a drop-in Nugent score to < 4 and/or a drop in vaginal pH to < 4.5, or a subjective improvement in at least 2 symptoms by at least 2 points on a 5-point scale in patients whose baseline pH was < 4.5 and NS < 4. Subjective symptoms: Pruritus, dolor, rubor, fluor and fetor reported by the patient on 5-point scale (0=no problem to 4=severe problem)
Measured: following 7 days of the ovule daily application
Secondary outcomes (39)
Composite endpoint (vaginal pH, Nugent score, subjective symptoms via questionnaire) after 7 days since treatment completion
Correction of the vaginal environment after 7 days after treatment completion defined as: a drop-in NS to < 4 and/or a drop in vaginal pH to < 4.5, or a subjective improvement in at least 2 symptoms by at least 2 points on a 5-point scale in patients whose baseline pH was < 4.5 and NS < 4. Subjective symptoms: Pruritus, dolor, rubor, fluor and fetor reported by the patient on 5-point scale (0=no problem to 4=severe problem)
Measured: 7 days after the completion of the 7-day treatment
Change in the pH alone after treatment completion
Correction of the pH measured via pH strips
Measured: following 7 days of the ovule daily application
Change in the Nugent score alone after treatment completion
Nugent score determined under 1000x magnification
Measured: following 7 days of the ovule daily application
Change in the subjective symptoms (questionnaire) after treatment completion
Pruritus, dolor, rubor, fluor and fetor reported by the patient on 5-point scale (0=no problem to 4=severe problem)
Measured: following 7 days of the ovule daily application
Change in the pH alone after 7 days since treatment completion
Correction of the pH measured via pH strips
Measured: 7 days after the completion of the 7-day treatment
Change in the Nugent score alone 7 days after treatment completion
Nugent score determined under 1000x magnification
Measured: 7 days after the completion of the 7-day treatment
Change in the subjective symptoms (questionnaire) 7 days after treatment completion
Pruritus, dolor, rubor, fluor and fetor reported by the patient on 5-point scale (0=no problem to 4=severe problem)
Measured: 7 days after the completion of the 7-day treatment
Exploratory analysis of the microbial environment after treatment completion: squamous epithelial cells
Quantification of: squamous epithelial cells under 1000x magnification
Measured: following 7 days of the ovule daily application
Exploratory analysis of the microbial environment after 7 days after treatment completion: squamous epithelial cells
Quantification of: squamous epithelial cells under 1000x magnification
Measured: 7 days after the completion of the 7-day treatment
Exploratory analysis of the microbial environment after treatment completion: clue cells
Quantification of clue cells under 1000x magnification
Measured: following 7 days of the ovule daily application
Exploratory analysis of the microbial environment after 7 days after treatment completion: clue cells
Quantification of clue cells under 1000x magnification
Measured: 7 days after the completion of the 7-day treatment
Exploratory analysis of the microbial environment after treatment completion: mixed flora
Quantification of mixed flora under 1000x magnification
Measured: following 7 days of the ovule daily application
Exploratory analysis of the microbial environment after 7 days after treatment completion: mixed flora
Quantification of mixed flora under 1000x magnification
Measured: 7 days after the completion of the 7-day treatment
Exploratory analysis of the microbial environment after treatment completion: yeast as pseudomycelia
Quantification of yeast as pseudomycelia under 1000x magnification
Measured: following 7 days of the ovule daily application
Exploratory analysis of the microbial environment after 7 days after treatment completion: yeast as pseudomycelia
Quantification of yeast as pseudomycelia under 1000x magnification
Measured: 7 days after the completion of the 7-day treatment
Exploratory analysis of the microbial environment after treatment completion: Gram negative diplococci
Quantification of: Gram negative diplococci under 1000x magnification
Measured: following 7 days of the ovule daily application
Exploratory analysis of the microbial environment after 7 days after treatment completion: Gram negative diplococci
Quantification of: Gram negative diplococci under 1000x magnification
Measured: 7 days after the completion of the 7-day treatment
Exploratory analysis of the microbial environment after treatment completion: fibrous Lactobacillus
Quantification of: fibrous Lactobacillus under 1000x magnification
Measured: following 7 days of the ovule daily application
Exploratory analysis of the microbial environment after 7 days after treatment completion: fibrous Lactobacillus
Quantification of: fibrous Lactobacillus under 1000x magnification
Measured: 7 days after the completion of the 7-day treatment
Exploratory analysis of the microbial environment after treatment completion: Gardnerella
Quantification of: Gardnerella under 1000x magnification
Measured: following 7 days of the ovule daily application
Exploratory analysis of the microbial environment after 7 days after treatment completion: Gardnerella
Quantification of: Gardnerella under 1000x magnification
Measured: 7 days after the completion of the 7-day treatment
Exploratory analysis of the microbial environment after treatment completion: spirochetes
Quantification of: spirochetes under 1000x magnification
Measured: following 7 days of the ovule daily application
Exploratory analysis of the microbial environment after 7 days after treatment completion: spirochetes
Quantification of: spirochetes under 1000x magnification
Measured: 7 days after the completion of the 7-day treatment
Exploratory analysis of the microbial environment after treatment completion: parabasal epithelial cells
Quantification of: parabasal epithelial cells under 1000x magnification
Measured: following 7 days of the ovule daily application
Exploratory analysis of the microbial environment after 7 days after treatment completion: parabasal epithelial cells
Quantification of: parabasal epithelial cells under 1000x magnification
Measured: 7 days after the completion of the 7-day treatment
Exploratory analysis of the microbial environment after treatment completion: leukocytes
Quantification of: leukocytes under 1000x magnification
Measured: following 7 days of the ovule daily application
Exploratory analysis of the microbial environment after 7 days after treatment completion: leukocytes
Quantification of: leukocytes under 1000x magnification
Measured: 7 days after the completion of the 7-day treatment
Exploratory analysis of the microbial environment after treatment completion: yeast as blastospores
Quantification of: yeast as blastospores under 1000x magnification
Measured: following 7 days of the ovule daily application
Exploratory analysis of the microbial environment after 7 days after treatment completion: yeast as blastospores
Quantification of: yeast as blastospores under 1000x magnification
Measured: 7 days after the completion of the 7-day treatment
Exploratory analysis of the microbial environment after treatment completion: Gram pos. cocci in chains
Quantification of: Gram pos. cocci in chains under 1000x magnification
Measured: following 7 days of the ovule daily application
Exploratory analysis of the microbial environment after 7 days after treatment completion: Gram pos. cocci in chains
Quantification of: Gram pos. cocci in chains under 1000x magnification
Measured: 7 days after the completion of the 7-day treatment
Exploratory analysis of the microbial environment after treatment completion: Lactobacillus
Quantification of: Lactobacillus under 1000x magnification
Measured: following 7 days of the ovule daily application
Exploratory analysis of the microbial environment after 7 days after treatment completion: Lactobacillus
Quantification of: Lactobacillus under 1000x magnification
Measured: 7 days after the completion of the 7-day treatment
Exploratory analysis of the microbial environment after treatment completion: Mobilincus
Quantification of: Mobilincus under 1000x magnification
Measured: following 7 days of the ovule daily application
Exploratory analysis of the microbial environment after 7 days after treatment completion: Mobilincus
Quantification of: Mobilincus under 1000x magnification
Measured: 7 days after the completion of the 7-day treatment
Exploratory analysis of the microbial environment after treatment completion: Leptotrichia
Quantification of: Leptotrichia under 1000x magnification
Measured: following 7 days of the ovule daily application
Exploratory analysis of the microbial environment after 7 days after treatment completion: Leptotrichia
Quantification of: Leptotrichia under 1000x magnification
Measured: 7 days after the completion of the 7-day treatment
Exploratory analysis of the microbial environment after treatment completion: Trichomonas vaginalis
Quantification of: Trichomonas vaginalis under 1000 magnification
Measured: following 7 days of the ovule daily application
Exploratory analysis of the microbial environment after 7 days after treatment completion: Trichomonas vaginalis
Quantification of: Trichomonas vaginalis under 1000 magnification
Measured: 7 days after the completion of the 7-day treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2019
- Study start4 Dec 2017
- Primary completion9 May 2018
- Study completion9 May 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vaginosis, BacterialStudies 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
- Model description
- vehicle-controlled two-arm
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 274 participants (actual)
Sponsor and investigators
- Lead sponsor
- Value Outcomes Ltd.
- Sponsor type
- University, hospital or other
- Collaborators
- Matuzalem.com-cz, s.r.o.
- Responsible party
- Sponsor
- Investigators
- Tomáš Doležal, MD et PhD, Study director, Value Outcomes Ltd.Luboš Chadim, MVDr, Study chair, Matuzalem.com-cz, s.r.o.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04171947
- Sponsor's protocol ID
- MAT072017
- Acronym
- MAT072017
- Status last verified
- Nov 2019
- First submitted
- 13 Nov 2019
- Last updated
- 21 Nov 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Secondary analyses in progress
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Medical Device Matuzalem Flavonoid Tea Extract Vaginal Ovule for the Correction of the Imbalance in the Vaginal Environment- Prospective, Multicentric, Two-arm, Randomized, Vehicle-controlled, Blinded, Comparative Clinical Trial
- ClinicalTrials.gov ID
- NCT04171947
- Acronym / sponsor ID
- MAT072017 / MAT072017
- Conditions
- Vaginosis, Bacterial, Vaginal Flora Imbalance
- Keywords
- Tea, Polyphenols, Nugent score, Antioxidants, Vaginal pH, complementary medicine
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 274 participants (actual)
- Lead sponsor
- Value Outcomes Ltd.University, hospital or other
- Collaborators
- Matuzalem.com-cz, s.r.o.
- Study start
- 4 Dec 2017 (actual)
- Primary completion
- 9 May 2018 (actual)
- Study completion
- 9 May 2018 (actual)
- First posted
- 21 Nov 2019 (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.
Randomized, blinded vehicle-controlled multicenter clinical trial (MAT072017) to determine the effect of vaginal ovules containing 2 mg of the tea extract Matuzalem on the subjective symptoms (5-point scale pruritus (itching), dolor (pain), rubor (redness), fluor (discharge), and fetor (odor)), and objective symptoms (pH, Nugent score) of bacterial vaginosis. An ovule containing only the vehicle (polyethylene glycol 3000 S) was used as a control. The study was blinded from the perspective of the subject, investigator, laboratory personnel and data analyst.
Detailed description
The objective was to determine whether vaginal ovule with tea extract once-daily for 5-7 days improves symptoms of intermediate vaginal flora and prevents the development of bacterial vaginosis.
Composite primary endpoint designed as a drop in the Nugent score, vaginal pH, or improvement of subjective symptoms was compared between the active and vehicle (polyethylene-glycol) arm after 7 days of application and following 7 days after the application.
Secondary outcome measures were (1) Correction of the vaginal environment (as previously defined) 7 days after the completion of the prescribed 7-day regimen (day 14); (2) change in each parameter separately; (3) change in individual subjective symptoms, (4) exploratory analysis of the microbial environment at each subject visit.
The study was approved and supervised by the National authority and Ethics committee and prospectively registered in the Czech national medical device trial registry RZPRO and the European medical device trial registry EUDAMED.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- vehicle-controlled two-arm
| Arm | Type | Receives |
|---|---|---|
| Matuzalem | Experimental | Device: Matuzalem ovuleTea extract vaginal ovule daily for 7 consecutive days |
| Vehicle | Sham comparator | Device: Vehicle ovulePolyethylene glycol vaginal ovule daily for 7 consecutive days |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- premenopausal participants
- disturbed vaginal environment
- not in need of antibiotic or antimycotic treatment
- participants were citizens of the Czech Republic
- age between 18 and 55 years
Key exclusion criteria (12 listed)
- no vaginal bleeding of unknown aetiology
- hypersensitivity
- pregnancy
- lactation
- period during enrollment
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 |
|---|---|---|
| Matuzalem ovulevaginal ovule with 2 mg tea extract | Device | Matuzalem |
| Vehicle ovulepolyethylene glycol vaginal ovule | Device | Vehicle |
Primary outcome
Composite endpoint (vaginal pH, Nugent score, subjective symptoms via questionnaire) after treatment completion
Time frame: following 7 days of the ovule daily application
Correction of the vaginal environment after 7 days of once-daily application of the ovule was defined as: a drop-in Nugent score to < 4 and/or a drop in vaginal pH to < 4.5, or a subjective improvement in at least 2 symptoms by at least 2 points on a 5-point scale in patients whose baseline pH was < 4.5 and NS < 4. Subjective symptoms: Pruritus, dolor, rubor, fluor and fetor reported by the patient on 5-point scale (0=no problem to 4=severe problem)
39 secondary outcomes
Composite endpoint (vaginal pH, Nugent score, subjective symptoms via questionnaire) after 7 days since treatment completion
Time frame: 7 days after the completion of the 7-day treatment
Change in the pH alone after treatment completion
Time frame: following 7 days of the ovule daily application
Change in the Nugent score alone after treatment completion
Time frame: following 7 days of the ovule daily application
Change in the subjective symptoms (questionnaire) after treatment completion
Time frame: following 7 days of the ovule daily application
Change in the pH alone after 7 days since treatment completion
Time frame: 7 days after the completion of the 7-day treatment
Change in the Nugent score alone 7 days after treatment completion
Time frame: 7 days after the completion of the 7-day treatment
Change in the subjective symptoms (questionnaire) 7 days after treatment completion
Time frame: 7 days after the completion of the 7-day treatment
Exploratory analysis of the microbial environment after treatment completion: squamous epithelial cells
Time frame: following 7 days of the ovule daily application
Exploratory analysis of the microbial environment after 7 days after treatment completion: squamous epithelial cells
Time frame: 7 days after the completion of the 7-day treatment
Exploratory analysis of the microbial environment after treatment completion: clue cells
Time frame: following 7 days of the ovule daily application
Exploratory analysis of the microbial environment after 7 days after treatment completion: clue cells
Time frame: 7 days after the completion of the 7-day treatment
Exploratory analysis of the microbial environment after treatment completion: mixed flora
Time frame: following 7 days of the ovule daily application
Exploratory analysis of the microbial environment after 7 days after treatment completion: mixed flora
Time frame: 7 days after the completion of the 7-day treatment
Exploratory analysis of the microbial environment after treatment completion: yeast as pseudomycelia
Time frame: following 7 days of the ovule daily application
Exploratory analysis of the microbial environment after 7 days after treatment completion: yeast as pseudomycelia
Time frame: 7 days after the completion of the 7-day treatment
Exploratory analysis of the microbial environment after treatment completion: Gram negative diplococci
Time frame: following 7 days of the ovule daily application
Exploratory analysis of the microbial environment after 7 days after treatment completion: Gram negative diplococci
Time frame: 7 days after the completion of the 7-day treatment
Exploratory analysis of the microbial environment after treatment completion: fibrous Lactobacillus
Time frame: following 7 days of the ovule daily application
Exploratory analysis of the microbial environment after 7 days after treatment completion: fibrous Lactobacillus
Time frame: 7 days after the completion of the 7-day treatment
Exploratory analysis of the microbial environment after treatment completion: Gardnerella
Time frame: following 7 days of the ovule daily application
Exploratory analysis of the microbial environment after 7 days after treatment completion: Gardnerella
Time frame: 7 days after the completion of the 7-day treatment
Exploratory analysis of the microbial environment after treatment completion: spirochetes
Time frame: following 7 days of the ovule daily application
Exploratory analysis of the microbial environment after 7 days after treatment completion: spirochetes
Time frame: 7 days after the completion of the 7-day treatment
Exploratory analysis of the microbial environment after treatment completion: parabasal epithelial cells
Time frame: following 7 days of the ovule daily application
Exploratory analysis of the microbial environment after 7 days after treatment completion: parabasal epithelial cells
Time frame: 7 days after the completion of the 7-day treatment
Exploratory analysis of the microbial environment after treatment completion: leukocytes
Time frame: following 7 days of the ovule daily application
Exploratory analysis of the microbial environment after 7 days after treatment completion: leukocytes
Time frame: 7 days after the completion of the 7-day treatment
Exploratory analysis of the microbial environment after treatment completion: yeast as blastospores
Time frame: following 7 days of the ovule daily application
Exploratory analysis of the microbial environment after 7 days after treatment completion: yeast as blastospores
Time frame: 7 days after the completion of the 7-day treatment
Exploratory analysis of the microbial environment after treatment completion: Gram pos. cocci in chains
Time frame: following 7 days of the ovule daily application
Exploratory analysis of the microbial environment after 7 days after treatment completion: Gram pos. cocci in chains
Time frame: 7 days after the completion of the 7-day treatment
Exploratory analysis of the microbial environment after treatment completion: Lactobacillus
Time frame: following 7 days of the ovule daily application
Exploratory analysis of the microbial environment after 7 days after treatment completion: Lactobacillus
Time frame: 7 days after the completion of the 7-day treatment
Exploratory analysis of the microbial environment after treatment completion: Mobilincus
Time frame: following 7 days of the ovule daily application
Exploratory analysis of the microbial environment after 7 days after treatment completion: Mobilincus
Time frame: 7 days after the completion of the 7-day treatment
Exploratory analysis of the microbial environment after treatment completion: Leptotrichia
Time frame: following 7 days of the ovule daily application
Exploratory analysis of the microbial environment after 7 days after treatment completion: Leptotrichia
Time frame: 7 days after the completion of the 7-day treatment
Exploratory analysis of the microbial environment after treatment completion: Trichomonas vaginalis
Time frame: following 7 days of the ovule daily application
Exploratory analysis of the microbial environment after 7 days after treatment completion: Trichomonas vaginalis
Time frame: 7 days after the completion of the 7-day treatment
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 21 Nov 2019.
- Individual participant dataSharing planned: No. Secondary analyses in progress
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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.
Tomáš Doležal, MD et PhD study director
Value Outcomes Ltd.
Luboš Chadim, MVDr study chair
Matuzalem.com-cz, s.r.o.
14 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Matuzalem ovule in people with Vaginosis, Bacterial and Vaginal Flora Imbalance, run by Value Outcomes Ltd. at 14 sites in Czechia.
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 8 inclusion and 12 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 21 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 sites in Czechia. 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. Some participants in this study may receive a placebo. 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?
Composite endpoint (vaginal pH, Nugent score, subjective symptoms via questionnaire) after treatment completion (time frame: following 7 days of the ovule daily application). 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 21 Nov 2019.