Health Condition 1: N771- Vaginitis, vulvitis and vulvovaginitis in diseases classified elsewhere
Conditions
Interventions
Intervention1: LABTHERA-001 Intravaginal Capsule: Group A: LABTHERA-001 Capsule : 6Ã?10 to the power of 9 CFU Once daily at night for 7 consecutive days
followed by twice a week at night for 3 weeks.
Sponsors
Atogen Co., Ltd.
Eligibility
Inclusion criteria
Inclusion criteria: 1. Non-pregnant, non-breastfeeding females between the ages of 20 and 45 years, inclusive willing to participate in study and provide written informed consent. 2. Women of childbearing potential must agree to practice reliable contraception for the 28-day period before enrollment through 30 days following treatment. 3. Agree to abstain from sexual intercourse 24 hours before each visit and 6 hours after IP insertion and agrees to follow medically acceptable method of contraception. 4. Presenting with signs of Bacterial Vaginosis (as per Amsel Criteria). 5. Vaginal specimen should have a Nugent score of greater than or equal to 4 6. Women who are currently not menstruating or expected not to have menstruation within 17 days from screening 7. Able to understand and comply with planned study procedures 8. Willing to abstain from insertion of tampons, douches, or other intravaginal medications or objects during study 9. Negative serum or urine pregnancy test 10. Provide written informed consent before initiation of any study procedures and be available for all study visits 11. No known history of HIV 12. Have a refrigerator to store the investigational product
Exclusion criteria
Exclusion criteria: 1)Potential participants who are pregnant or breastfeeding, or if of child-bearing potential unwilling to practice acceptable means of birth control or abstinence during the study 2)Patients with vaginal, vulvar, or genitourinary condition that, according to the Investigators 14)Any other condition that in the opinion of the investigator does not justify the patientâ??s participation in the study judgement, may confound the interpretation of clinical response based on Liquid Based Cytology 3)Patients with a history of regional enteritis, ulcerative colitis, or a history of C. difficile associated diarrhea 4)Patients with known current drug or alcohol abuse that could impact study compliance 5)Mixed vaginal infections, including bacterial vaginosis and trichomoniasis or coexistent infections with genital herpes and cervicitis based on Liquid Based Cytology 6)Self-reported abnormal Papanicolaou smear (grade 3 or more) in the preceding 12 months 7)History of diabetes mellitus 8)Immunocompromised patients, including those with human immunodeficiency virus seropositivity or with clinically diagnosed acquired immunodeficiency syndrome or its related complex as per HIV test 9)Patients who had taken oral or intravenous antifungal agents within 4weeks or used topical vaginal antifungal drugs within 1 week before enrollment 10)Terminally ill patients or patients with severe cardiac (creatine kinase values >3 X upper limit of normal laboratory values), hepatic (AST, ALT values >3 X upper limit of normal laboratory values) renal (creatinine > 2mg/dl) or history of cerebrovascular disease, malignancy, chronic uncontrolled systemic disease e.g., hypertension, collagen disorders, etc. or any other serious medical illness. 11)Patients with known sensitivity to any of the active or inactive ingredients in the study drug 12)Patients with a history of any severe acute or chronic medical or psychiatric condition or laboratory abnormality that could increase the risk associated with trial participation or study treatment administration or could interfere with the interpretation of trial results and, in the judgment of the Investigator, would make the patient inappropriate for entry into the trial. 13)Patients who have participated in a new drug study in the past 3 months
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Reduction in Amsel Criteria 2. Reduction in Nugent Score 3. Microbiome restoration through vaginal specimen 4. LABTHERA-001 colonization through qPCRTimepoint: 1. Visit 1,2,3,4,5,6 and 7 2. Visit 1,2,3,4,5,6 and 7 3. Visit 1,2,3,4,5,6 and 7 4. Visit 1,2,3,4,5,6 and 7 | — |
Secondary
| Measure | Time frame |
|---|---|
| Acceptability of treatment a. Proportion of participants who comply with the complete dose regimen in each study arm as assessed by subject reporting through diary card b. Self-administered questionnaire about acceptability of the study product in each study arm Timepoint: Visit 1,2,3,4 and 5;Improvement in self-reported vaginal signs and symptoms will be assessed for vaginal itch, vaginal burning, itch of external genitals, burning of external genitals, vaginal discharge, urination disorder and painful intercourse on a scale of 0 to 10 (0: absence of signs and symptoms & 10: maximum discomfort)Timepoint: Visit 1,2,3,4,5,6 and 7;Number of negative Bacterial vaginosisTimepoint: Visit 1,2,3,4,5,6 and 7;Number of positive Bacterial VaginosisTimepoint: Visit 1,2,3,4,5,6 and 7 ;Tolerability of treatment:Tolerability will be assessed by proportion of participants who discontinue investigational product early in each study arm due to local adverse events (local adverse events includes signs and symptoms of vaginal origin) Timepoint: Visit 1,2,3,4 and 5 | — |
Countries
India
Contacts
Public ContactSubham Dutta
Syncorp Health Pvt Ltd
Outcome results
None listed