Candidiasis, VulvovaginalPhase 1COMPRIGELNCT02730494
Study Evaluating the Optimal Dosage for Equivalence Between Lcr Regenerans® Capsules and Tablets (Lactobacillus Rhamnosus Lcr35®) on the Vaginal Flora Colonisation
A Phase 1 study testing Lcr Regenerans® vaginal capsules and Lcr Regenerans® vaginal tablet in people with Candidiasis, Vulvovaginal, run by Biose at 1 site in France.
Trial summary
The primary objective of this study is to study the vaginal flora colonisation equivalence between the tablet and capsule dosage forms of a treatment with Lcr Regenerans® between D0 (V1) and Dend of treatment. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Candidiasis, Vulvovaginal
- What is being tested?
- Lcr Regenerans® vaginal capsules and Lcr Regenerans® vaginal tablet
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteFrance
- Study dates
- Jul 2015to Jan 2018
- Phase
- Phase 1
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Relating to the condition:
- Clinically healthy women
- Relating to the population:
- Adult women
- Women of child-bearing age: with a negative urine pregnancy test and using a method of contraception deemed effective by the investigator(excluding spermicides) throughout the trial
- Women who can be treated with the study product immediately after the inclusion visit for a duration of 21 consecutive days without interruption by her next menstrual period.
- Women who can speak and read French and having been informed about the study and having voluntarily signed an Informed Consent Form
- Women registered with a social insurance scheme
Who cannot join
- Relating to the condition or the gynaecological field:
- Presence of a presumed or proven gynaecological bacterial or viral infection, whether treated or not during the month preceding inclusion.
- Presence of an existing gynaecological condition that could interfere with the assessment of the trial treatment (severe cervical dysplasia or carcinoma in situ, invasive carcinoma, intra-epithelial cervical neoplasia, squamous intra-epithelial lesions etc.)
- Relating to the treatments:
- Systemic antifungals or antibiotics during the month preceding the inclusion visit.
- Use of probiotics (see list in 16.2) during the month preceding the inclusion visit.
Show all 21Show fewer
- Use of prebiotics (acidifying agents) - (see list in 16.2) during the 15 days preceding the inclusion visit.
- Allergy to one of the active ingredients or one of the excipients in the products.
- Relating to the population:
- Women unable to comply with the constraints of the protocol.
- Breastfeeding women.
- Post-menopausal women.
- Women whose menstrual bleeding lasts longer than 8 days per month.
- Women having participated in a clinical study in the 3 months preceding inclusion in this protocol.
- Women with a severe acute or chronic condition deemed by the investigator as being incompatible with participation in the trial or a serious infection which could be life-threatening in the short term.
- Immunosuppressed women.
- Women with a previous condition which, according to the investigator, is likely to interfere with the study results or expose the female volunteer to additional risk.
- Women with linguistic (not speaking or writing French) or psychological inability to understand and sign the informed consent form.
- Women deprived of her liberty through an administrative or judicial decision or subject to a guardianship order.
- Women likely not to comply with the treatment.
- Women who cannot be contacted in the case of emergency.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Study Evaluating the Optimal Dosage for Equivalence Between a Tablet and Capsule Dosage Form of an Intravaginal Treatment With Total Freeze-dried Culture of Lcr Regenerans® (Lactobacillus Rhamnosus Lcr35®) on Vaginal Flora Colonisation in Healthy Women.
The primary objective of this study is to study the vaginal flora colonisation equivalence between the tablet and capsule dosage forms of a treatment with Lcr Regenerans® between D0 (V1) and Dend of treatment.
Read the detailed description
The healthy vaginal microbiota is mainly colonised by strains of Lactobacillus which play an important role in defence against vaginal infections. The intravaginal use of probiotic strains stimulating the recolonisation of the endogenous vaginal microbiota and capable of inhibiting the growth of pathogens such as Candida albicans appears to be an interesting alternative to prevent recurrences of VVC. Recently, longitudinal studies have revealed that the vaginal microbiota is relatively stable and that the main cause of disturbance to the stability of the vaginal microbiota is over short menstruation periods. However, the use of antimicrobial agents induces severe disturbances with disappearance of certain endogenous species over several weeks. These results suggest that antimicrobial treatments severely affect the vaginal flora and that probiotics are therefore recommended to help re-establish a vaginal microbiota after this treatment.
For this, a sufficient direct local supply must be provided. The general data from studying the vaginal microbiota reveal that in the healthy woman, the concentration of Lactobacilli is greater than or equal to 107 CFU/ml of vaginal secretion. During capsule administration, all the Lactobacilli are immediately released into the vaginal cavity. The natural vaginal secretions, estimated to be an average of 0.51 ml/day, result in daily elimination of around 107 to 108 CFU and therefore generates very rapid elimination of this supply which requires daily administrations.
The objective of this clinical trial is to prove that the two dosage forms, capsule administered daily and tablet administered at a certain dosage, enable equivalent local provision of a concentration which is greater than or equal to 10e7 CFU (this concentration ensures the establishment of a sufficiently large bacterial population to enable efficacy of the product).
Therefore, the optimal dosage of the Lcr Regenerans® tablet to be administered and which will be equivalent to the daily administration of the Lcr Regenerans® capsule will be determined during this trial. To do this, 3 different dosages of the Lcr Regenerans® tablet, corresponding to or encompassing the time during which the tablet provides continuous release and presence of the strain in the in vitro model, will be compared to that of the Lcr Regenerans® capsule. For this reason, the frequencies of administration for the Lcr Regenerans® tablet will be 3, 4 or 5 days.
- Conditions
- Candidiasis, Vulvovaginal
- Being tested
- Lcr Regenerans® vaginal capsules, Lcr Regenerans® vaginal tablet
- Keywords
- mycosis, Candidiasis, Lcr35®, Lcr Regenerans®
- Medical subject headings
- Candidiasis, Vulvovaginal, Mycoses, Candidiasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lcr Regenerans® vaginal capsulesDevice
Also called GYNOPHILUS Capsules
Lcr Regenerans® vaginal tabletDevice
Also called GYNOPHILUS Tablet
| Study group | Role | What they receive |
|---|---|---|
| Lcr Regenerans® vaginal capsule | Active comparator | Name: Lcr Regenerans® containing at least 10e7 CFU per intravaginal capsule. 1 vaginal capsule per day Receives: Device: Lcr Regenerans® vaginal capsules |
| Lcr Regenerans® vaginal tablet every 3 days | Experimental | Lcr Regenerans® containing at least 10e7 CFU per intravaginal table. One vaginal tablet every 3 days Receives: Device: Lcr Regenerans® vaginal tablet |
| Lcr Regenerans® vaginal tablet every 4 days | Experimental | Lcr Regenerans® containing at least 10e7 CFU per intravaginal table. One vaginal tablet every 4 days Receives: Device: Lcr Regenerans® vaginal tablet |
| Lcr Regenerans® vaginal tablet every 5 days | Experimental | Lcr Regenerans® containing at least 10e7 CFU per intravaginal table. One vaginal tablet every 5 days Receives: Device: Lcr Regenerans® vaginal tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measure the vaginal flora equivalence between the tablet and the capsule dosage forms of a treatment with Lcr Regenerans® between D0 (V1) and Dend of treatment.
Measured: 21 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2016 (estimated)
- Study startJul 2015
- Primary completionJan 2016
- Study completionJan 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Candidiasis, VulvovaginalStudies 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
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Biose
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Yann Dr LENGLET, Principal investigator, Hospital center Jacques LACARIN of VICHY
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02730494
- Sponsor's protocol ID
- PRO_2014-01
- Other IDs
- 2014-001746-21, 2014
- Acronym
- COMPRIGEL
- Status last verified
- Feb 2018
- First submitted
- 1 Apr 2016
- Last updated
- 5 Feb 2018
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study Evaluating the Optimal Dosage for Equivalence Between a Tablet and Capsule Dosage Form of an Intravaginal Treatment With Total Freeze-dried Culture of Lcr Regenerans® (Lactobacillus Rhamnosus Lcr35®) on Vaginal Flora Colonisation in Healthy Women.
- ClinicalTrials.gov ID
- NCT02730494
- Acronym / sponsor ID
- COMPRIGEL / PRO_2014-01
- Conditions
- Candidiasis, Vulvovaginal
- Keywords
- mycosis, Candidiasis, Lcr35®, Lcr Regenerans®
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- BioseIndustry (pharma, biotech, devices)
- Study start
- Jul 2015
- Primary completion
- Jan 2016 (actual)
- Study completion
- Jan 2018 (actual)
- First posted
- 6 Apr 2016 (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 primary objective of this study is to study the vaginal flora colonisation equivalence between the tablet and capsule dosage forms of a treatment with Lcr Regenerans® between D0 (V1) and Dend of treatment.
Detailed description
The healthy vaginal microbiota is mainly colonised by strains of Lactobacillus which play an important role in defence against vaginal infections. The intravaginal use of probiotic strains stimulating the recolonisation of the endogenous vaginal microbiota and capable of inhibiting the growth of pathogens such as Candida albicans appears to be an interesting alternative to prevent recurrences of VVC. Recently, longitudinal studies have revealed that the vaginal microbiota is relatively stable and that the main cause of disturbance to the stability of the vaginal microbiota is over short menstruation periods. However, the use of antimicrobial agents induces severe disturbances with disappearance of certain endogenous species over several weeks. These results suggest that antimicrobial treatments severely affect the vaginal flora and that probiotics are therefore recommended to help re-establish a vaginal microbiota after this treatment.
For this, a sufficient direct local supply must be provided. The general data from studying the vaginal microbiota reveal that in the healthy woman, the concentration of Lactobacilli is greater than or equal to 107 CFU/ml of vaginal secretion. During capsule administration, all the Lactobacilli are immediately released into the vaginal cavity. The natural vaginal secretions, estimated to be an average of 0.51 ml/day, result in daily elimination of around 107 to 108 CFU and therefore generates very rapid elimination of this supply which requires daily administrations.
The objective of this clinical trial is to prove that the two dosage forms, capsule administered daily and tablet administered at a certain dosage, enable equivalent local provision of a concentration which is greater than or equal to 10e7 CFU (this concentration ensures the establishment of a sufficiently large bacterial population to enable efficacy of the product).
Therefore, the optimal dosage of the Lcr Regenerans® tablet to be administered and which will be equivalent to the daily administration of the Lcr Regenerans® capsule will be determined during this trial. To do this, 3 different dosages of the Lcr Regenerans® tablet, corresponding to or encompassing the time during which the tablet provides continuous release and presence of the strain in the in vitro model, will be compared to that of the Lcr Regenerans® capsule. For this reason, the frequencies of administration for the Lcr Regenerans® tablet will be 3, 4 or 5 days.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Lcr Regenerans® vaginal capsule | Active comparator | Device: Lcr Regenerans® vaginal capsulesName: Lcr Regenerans® containing at least 10e7 CFU per intravaginal capsule. 1 vaginal capsule per day |
| Lcr Regenerans® vaginal tablet every 3 days | Experimental | Device: Lcr Regenerans® vaginal tabletLcr Regenerans® containing at least 10e7 CFU per intravaginal table. One vaginal tablet every 3 days |
| Lcr Regenerans® vaginal tablet every 4 days | Experimental | Device: Lcr Regenerans® vaginal tabletLcr Regenerans® containing at least 10e7 CFU per intravaginal table. One vaginal tablet every 4 days |
| Lcr Regenerans® vaginal tablet every 5 days | Experimental | Device: Lcr Regenerans® vaginal tabletLcr Regenerans® containing at least 10e7 CFU per intravaginal table. One vaginal tablet every 5 days |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Clinically healthy women
- Adult women
- Women of child-bearing age: with a negative urine pregnancy test and using a method of contraception deemed effective by the investigator(excluding spermicides) throughout the trial
- Women who can be treated with the study product immediately after the inclusion visit for a duration of 21 consecutive days without interruption by her next menstrual period.
- Women who can speak and read French and having been informed about the study and having voluntarily signed an Informed Consent Form
Key exclusion criteria (21 listed)
- Relating to the condition or the gynaecological field:
- Presence of a presumed or proven gynaecological bacterial or viral infection, whether treated or not during the month preceding inclusion.
- Presence of an existing gynaecological condition that could interfere with the assessment of the trial treatment (severe cervical dysplasia or carcinoma in situ, invasive carcinoma, intra-epithelial cervical neoplasia, squamous intra-epithelial lesions etc.)
- Systemic antifungals or antibiotics during the month preceding the inclusion visit.
- Use of probiotics (see list in 16.2) during the month preceding the inclusion visit.
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 |
|---|---|---|
| Lcr Regenerans® vaginal capsulesAlso: GYNOPHILUS Capsules | Device | Lcr Regenerans® vaginal capsule |
| Lcr Regenerans® vaginal tabletAlso: GYNOPHILUS Tablet | Device | Lcr Regenerans® vaginal tablet every 3 days, Lcr Regenerans® vaginal tablet every 4 days, Lcr Regenerans® vaginal tablet every 5 days |
Primary outcome
Measure the vaginal flora equivalence between the tablet and the capsule dosage forms of a treatment with Lcr Regenerans® between D0 (V1) and Dend of treatment.
Time frame: 21 days
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 5 Feb 2018.
Related trials for Candidiasis, Vulvovaginal
Recruiting
Multi-Gyn FemiTotal for the Treatment and Prevention of Vulvovaginal Candidiasis Symptoms and Bacterial Vaginosis
Bacterial Vaginosis, Vaginal Candidiasis
RecruitingObservational study
Safety of Pregnant Subjects Exposed to Ibrexafungerp Including Infant Outcomes
Vulvovaginitis, Candidal, Vulvovaginal Candidiasis
Active, not recruitingObservational study
Comparative Performance of a Vaginal Yeast Test
Vulvovaginal Candidiasis
Active, not recruitingObservational study
DeVEnIR: Defining Vulvovaginal Candidiasis - Elements of Infection and Remedy
Vulvovaginal Candidiasis
Not yet recruiting
Photobiomodulation for Vaginal Dysfunctions: Home-Based vs Outpatient Treatment
Genitourinary Syndrome of Menopause (GSM), Bacterial Vaginosis
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.
Yann Dr LENGLET principal investigator
Hospital center Jacques LACARIN of VICHY
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Lcr Regenerans® vaginal capsules and Lcr Regenerans® vaginal tablet in people with Candidiasis, Vulvovaginal, run by Biose at 1 site in France.
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 21 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 5 Feb 2018. 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 France. 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 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.
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?
Measure the vaginal flora equivalence between the tablet and the capsule dosage forms of a treatment with Lcr Regenerans® between D0 (V1) and Dend of treatment. (time frame: 21 days). 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 5 Feb 2018; AzTrials last refreshed its copy on 30 Oct 2026.