Safety, Tolerability, and Acceptability Study of Intravaginal Administration of LABTHERA-001 Capsules in Healthy Women
NCT ID: NCT05587283
Last Updated: 2023-03-09
Study Results
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Basic Information
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UNKNOWN
PHASE1
24 participants
INTERVENTIONAL
2022-11-02
2023-05-31
Brief Summary
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Detailed Description
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The main goals of this study are 1. to determine whether LABTHERA-001 is safe and well tolerated in healthy adult women. And 2. to investigate the acceptability of the LABTHERA-001 capsule or matching placebo by completing a satisfaction evaluation questionnaire.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
OTHER
QUADRUPLE
Study Groups
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Low dose LABTHERA-001 capsule
Low dose LABTHERA-001 capsule (0.2 x 10\^9 CFU), administered intravaginally once a day for 7 consecutive days.
Experimental: Low dose LABTHERA-001 capsule
Low dose LABTHERA-001 capsule, 0.2 x 10\^9 CFU/capsule with excipients.
Medium dose LABTHERA-001 capsule
Medium dose LABTHERA-001 capsule (1 x 10\^9 CFU), administered intravaginally once a day for 7 consecutive days.
Experimental: Medium dose LABTHERA-001 capsule
Medium dose LABTHERA-001 capsule, 1 x 10\^9 CFU/capsule with excipients.
High dose LABTHERA-001 capsule
High dose LABTHERA-001 capsule (5 x 10\^9 CFU), administered intravaginally once a day for 7 consecutive days.
Experimental: High dose LABTHERA-001 capsule
High dose LABTHERA-001 capsule, 5 x 10\^9 CFU/capsule with excipients.
Low dose Placebo capsule
Low dose Placebo (excipients of the study drug) capsule administered intravaginally once a day for 7 consecutive days.
Placebo Comparator: Low dose Placebo capsule
Medium dose Placebo capsule, filled with excipients; Lactose, and magnesium stearate.
Medium dose Placebo capsule
Medium dose Placebo capsule (excipients of the study drug) administered intravaginally once a day for 7 consecutive days.
Placebo Comparator: Medium dose Placebo capsule
Medium dose Placebo capsule, filled with excipients; Lactose, and magnesium stearate.
High dose Placebo capsule
High dose Placebo capsule (excipients of the study drug) administered intravaginally once a day for 7 consecutive days.
Placebo Comparator: High dose Placebo capsule
High dose Placebo capsule, filled with excipients; Lactose, and magnesium stearate.
Interventions
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Experimental: Low dose LABTHERA-001 capsule
Low dose LABTHERA-001 capsule, 0.2 x 10\^9 CFU/capsule with excipients.
Experimental: Medium dose LABTHERA-001 capsule
Medium dose LABTHERA-001 capsule, 1 x 10\^9 CFU/capsule with excipients.
Experimental: High dose LABTHERA-001 capsule
High dose LABTHERA-001 capsule, 5 x 10\^9 CFU/capsule with excipients.
Placebo Comparator: Low dose Placebo capsule
Medium dose Placebo capsule, filled with excipients; Lactose, and magnesium stearate.
Placebo Comparator: Medium dose Placebo capsule
Medium dose Placebo capsule, filled with excipients; Lactose, and magnesium stearate.
Placebo Comparator: High dose Placebo capsule
High dose Placebo capsule, filled with excipients; Lactose, and magnesium stearate.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Agrees to maintain her contraceptive method during the clinical trial if she has regular menstrual cycles (21-35 days) or has had amenorrhea for more than 12 weeks before the Screening Visit due to continued use of long-acting progestin or oral contraceptives.
3. Confirmed normal cervical screen test (CST) performed at the Screening Visit
4. Has had sexual experiences that included vaginal intercourse
5. Has experienced gynecological examinations previously
6. Agrees to discontinue the use of the following during the clinical trial period (Screening Visit to End of study visit or early termination visit):
* products for vaginal insertion (e.g., tampons, menstrual cups, etc.)
* Other vaginal products (e.g., contraceptive creams, vaginal cleaners, lubricants, etc.)
7. Agrees to be sexually abstinent from 72 hours before the Day 1 visit until the first study visit after final administration of IP (nominally the Day 9 visit).
8. Agrees to continue to use the following highly effective contraceptive methods during the clinical trial period and for at least 30 days after the final dose of study treatment, if woman of child-bearing potential (has experienced menarche and is not permanently sterile or postmenopausal):
* Female: combined (estrogen and progestogen containing) hormonal/ contraception associated with inhibition of ovulation (oral or transdermal), progestogen-only hormonal contraception associated with inhibition of ovulation (oral, injectable, implantable), intrauterine device (IUD; if inserted more than 12 weeks before the Screening visit), intrauterine hormone-releasing system (IUS), bilateral tubal occlusion, vasectomized partner, sexual abstinence
* Male partner: 'Vasectomy,' 'condom'
9. Able and willing to insert a hard capsule into her vagina
10. Able and willing to answer questions about her health status and sexual life
11. Able and willing to undergo vaginal and cervical examinations by the Investigator
12. Agrees and can comply with the planned clinical trial procedures after receiving a full explanation and voluntarily decides to participate and gives written informed consent
Exclusion Criteria
• Urinary tract infection, bacterial vaginosis, candida vaginitis, trichomonas vaginalis, Neisseria gonorrhoeae, chlamydia trachomatis, treponema pallidum, herpes simplex
2. History of recurrent genital herpes
3. Has the following diagnosed urogenital infections, or had two or more clinically significant urogenital infections within 24 weeks before the Screening Visit, at the discretion of the Investigator:
• \[Gonococcus, chlamydia trachomatis, syphilis treponema, trichomonas vaginitis, candida vaginitis, etc.\]
4. Has vaginitis symptoms (abnormal vaginal discharge, itching, burning sensation, etc.) at Screening or pre-dose at the Day 1 visit, or between the Screening and Day 1 visits.
5. Is pregnant, lactating, within eight weeks of childbirth, or is planning pregnancy within 60 days of the last dose of IP.
6. Is menopausal, defined as being amenorrhoeic for at least 12 months without an alternative cause.
7. Has had an intrauterine device (IUD) inserted within 12 weeks before the Screening Visit
8. Underwent pelvic surgery within 12 weeks before the Screening Visit
9. Received cervical cryotherapy or cervical laser treatment within 12 weeks before the Screening Visit
10. Started to use long-acting hormonal contraceptives within 12 weeks before the Screening Visit \[e.g., DMPA (depot formulation including medroxyprogesterone acetate)\] (However, participants who have continuously used the contraceptive for more than 12 weeks can be enrolled at the discretion of the Investigator.)
11. Has a clinically significant medical history or current medical condition as assessed by the Investigator including but not limited to the cardiovascular system, respiratory system, kidney, endocrine system, hematology, digestive system, central nervous system, psychiatric disorder, or infectious disease, that may affect the safety evaluation of the investigational product or jeopardize the individual's involvement in the study. History of any cancer (including non-melanoma skin cancer) is exclusionary.
12. Positive test for SARS-CoV-2 (COVID-19) during the Screening period and pre-dose at the Day 1 visit (may be re-screened when eligible).
13. Positive diagnosis of human immunodeficiency virus (HIV), hepatitis B or C at the Screening Visit
14. Confirmed to have severe damage to the vaginal epithelium in the physical examination at the Screening Visit
15. Used immunosuppressants within four weeks before the Screening Visit
16. Used antibiotics or antifungals within three days before the Screening Visit (However, enrollment is possible if the individual agrees to a washout period equivalent to three times or more the half-life of the corresponding drugs as of the randomization date.)
17. History of hypersensitivity reactions to the components of the study drug or history of other serious drug hypersensitivity reactions, at the discretion of the Investigator
18. History of or current drug or alcohol abuse; or tests positive to urine drug screen or alcohol breath test at the Screening or Day 1 visits; or does not agree to abstain from alcohol 24 hours before each study visit and to consume no more than 10 standard drinks per week with no more than 4 standard drinks on any one day at any other time during their participation in the study. One standard drink contains 10 g alcohol. Urine drug screen may be repeated once only at the discretion of the Investigator.
19. Current tobacco smoker; or smoked more than one pack of cigarettes (or tobacco equivalent) per day for more than 10 years; or uses nicotine-replacement therapy (including vaping); or does not agree to abstain from using tobacco or nicotine-containing products during the study.
20. Received other investigational products within four weeks before the Screening Visit
21. Received COVID-19 vaccination or any other vaccination within 8 weeks before the first dose of IP, and/or is planning or scheduled to be vaccinated (including COVID-19 initial, second or booster dose) during the study period up to the final follow-up visit.
22. Judged by the Investigator to be unsuitable for participation in this clinical trial.
18 Years
45 Years
FEMALE
Yes
Sponsors
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ATOGEN AUSTRALIA PTY LTD
UNKNOWN
AtoGen Co. Ltd
INDUSTRY
Responsible Party
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Principal Investigators
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Christopher Argent, Dr.
Role: PRINCIPAL_INVESTIGATOR
Scientia Clinical Research Ltd
Locations
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Scientia Clinical Research
Randwick, New South Wales, Australia
Countries
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Central Contacts
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Facility Contacts
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References
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Mastromarino P, Vitali B, Mosca L. Bacterial vaginosis: a review on clinical trials with probiotics. New Microbiol. 2013 Jul;36(3):229-38. Epub 2013 Jun 30.
Kenyon C, Colebunders R, Crucitti T. The global epidemiology of bacterial vaginosis: a systematic review. Am J Obstet Gynecol. 2013 Dec;209(6):505-23. doi: 10.1016/j.ajog.2013.05.006. Epub 2013 May 6.
Workowski KA, Bachmann LH, Chan PA, Johnston CM, Muzny CA, Park I, Reno H, Zenilman JM, Bolan GA. Sexually Transmitted Infections Treatment Guidelines, 2021. MMWR Recomm Rep. 2021 Jul 23;70(4):1-187. doi: 10.15585/mmwr.rr7004a1.
Vicariotto F, Mogna L, Del Piano M. Effectiveness of the two microorganisms Lactobacillus fermentum LF15 and Lactobacillus plantarum LP01, formulated in slow-release vaginal tablets, in women affected by bacterial vaginosis: a pilot study. J Clin Gastroenterol. 2014 Nov-Dec;48 Suppl 1:S106-12. doi: 10.1097/MCG.0000000000000226.
De Seta F, Parazzini F, De Leo R, Banco R, Maso GP, De Santo D, Sartore A, Stabile G, Inglese S, Tonon M, Restaino S. Lactobacillus plantarum P17630 for preventing Candida vaginitis recurrence: a retrospective comparative study. Eur J Obstet Gynecol Reprod Biol. 2014 Nov;182:136-9. doi: 10.1016/j.ejogrb.2014.09.018. Epub 2014 Sep 17.
Strus M, Chmielarczyk A, Kochan P, Adamski P, Chelmicki Z, Chelmicki A, Palucha A, Heczko PB. Studies on the effects of probiotic Lactobacillus mixture given orally on vaginal and rectal colonization and on parameters of vaginal health in women with intermediate vaginal flora. Eur J Obstet Gynecol Reprod Biol. 2012 Aug;163(2):210-5. doi: 10.1016/j.ejogrb.2012.05.001. Epub 2012 Jun 19.
Hemalatha R, Mastromarino P, Ramalaxmi BA, Balakrishna NV, Sesikeran B. Effectiveness of vaginal tablets containing lactobacilli versus pH tablets on vaginal health and inflammatory cytokines: a randomized, double-blind study. Eur J Clin Microbiol Infect Dis. 2012 Nov;31(11):3097-105. doi: 10.1007/s10096-012-1671-1. Epub 2012 Jul 10.
Other Identifiers
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LT-001
Identifier Type: -
Identifier Source: org_study_id
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