NCT02730494

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
34

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Jul 2015

Typical duration for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2015

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2016

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

April 1, 2016

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 6, 2016

Completed
1.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2018

Completed
Last Updated

February 5, 2018

Status Verified

February 1, 2018

Enrollment Period

6 months

First QC Date

April 1, 2016

Last Update Submit

February 1, 2018

Conditions

Candidiasis, Vulvovaginal

Keywords

mycosisCandidiasisLcr35®Lcr Regenerans®

Outcome Measures

Primary Outcomes (1)

  • 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.

    21 days

Study Arms (4)

Lcr Regenerans® vaginal capsule

ACTIVE COMPARATOR

Name: Lcr Regenerans® containing at least 10e7 CFU per intravaginal capsule. 1 vaginal capsule per day

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

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

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

Device: Lcr Regenerans® vaginal tablet

Interventions

Lcr Regenerans® vaginal capsulesDEVICE
Also known as: GYNOPHILUS Capsules
Lcr Regenerans® vaginal capsule
Lcr Regenerans® vaginal tabletDEVICE
Also known as: GYNOPHILUS Tablet
Lcr Regenerans® vaginal tablet every 3 daysLcr Regenerans® vaginal tablet every 4 daysLcr Regenerans® vaginal tablet every 5 days

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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 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

You may not qualify if:

  • Relating to the condition or the gynaecological field:
  • 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:
  • 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 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.
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

BIOSE

Aurillac, 15000, France

Location

MeSH Terms

Conditions

Candidiasis, VulvovaginalMycosesCandidiasis

Condition Hierarchy (Ancestors)

Bacterial Infections and MycosesInfectionsVulvovaginitisVaginitisVaginal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesVulvitisVulvar DiseasesGenital Diseases

Study Officials

  • Yann Dr LENGLET

    Hospital center Jacques LACARIN of VICHY

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 1, 2016

First Posted

April 6, 2016

Study Start

July 1, 2015

Primary Completion

January 1, 2016

Study Completion

January 1, 2018

Last Updated

February 5, 2018

Record last verified: 2018-02

Locations

FR(1)