Safety Study of Lactobacillus Administered Vaginally to Healthy Women

• Sponsor: Osel, Inc. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00537576
• Collaborator: University of California, San Francisco (Other)
• Enrollment: 12
• Location: 1
• Arms: 6
• Duration (Months): 5
• Patients Per Site Per Month: 2.4

Study Details

Study Description

Brief Summary

The purpose of this study is to compare the safety, tolerability, and acceptability of LACTIN-V (Active Ingredient: Lactobacillus crispatus CTV-05) with a matching placebo at three doses using pre-filled vaginal applicators in healthy pre-menopausal women. The study hypothesis is that LACTIN-V will be safe, tolerable, and acceptable at each dose and will not differ significantly from the placebo controls.

Condition or Disease	Intervention/Treatment	Phase
Bacterial Vaginosis	Biological: Low dose LACTIN-V applicator; Biological: Medium dose LACTIN-V applicator; Biological: High dose LACTIN-V applicator; Other: Low dose Placebo applicator; Other: Medium dose Placebo; Other: High dose Placebo applicator	Phase 1

Detailed Description

The purpose of this study is to demonstrate that LACTIN-V is safe, well tolerated, and acceptable to healthy pre-menopausal women when administered vaginally using pre-filled applicators at doses of 150 mg (5.0 x 10^{8 CFU), 300 mg (1.0 x 10}9 CFU), or 600 mg (2.0 x 10^9 CFU) daily for 5 consecutive days as compared to placebo applicators containing 150 mg, 300 mg, or 600 mg of a matching placebo formulation without Lactobacillus crispatus CTV-05.

Safety will be assessed by:

• Incidence and severity of adverse events through assessing symptoms, physical examination findings, and signs of irritation involving the external genitalia, cervix or vagina, including disruption of the epithelium and blood vessels as seen on pelvic examination and colposcopy.

• Laboratory parameters including urinalysis, a complete blood count (CBC) with differential, and chemistry panels to assess systemic effects of the study product.

Tolerability will be assessed by:

• The proportion of participants who discontinue study product use due to overt adverse events

• The proportion of participants who complete the full dosing schedule

Acceptability will be assessed by:

• Self-administered questionnaires and focus group discussions about acceptability of the study product

Study Design

• Study Type: Interventional
• Actual Enrollment: 12 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Other
• Official Title: A Phase I Study of the Safety of LACTIN-V Administered Vaginally to Healthy Women
• Study Start Date: Nov 1, 2007
• Actual Primary Completion Date: Mar 1, 2008
• Actual Study Completion Date: Apr 1, 2008

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Low dose LACTIN-V applicator Low dose LACTIN-V applicator (150 mg LACTIN-V, 5.0 x 10^8 CFU), administered vaginally once a day for 5 consecutive days	Biological: Low dose LACTIN-V applicator; Low dose LACTIN-V applicator (150 mg LACTIN-V, 5.0 x 10^8 CFU), administered vaginally once a day for 5 consecutive days; Other Names: Lactobacillus crispatus CTV-05
Experimental: Medium dose LACTIN-V applicator Medium dose LACTIN-V applicator (300 mg LACTIN-V, 1.0 x 10^9 CFU), administered vaginally once a day for 5 consecutive days	Biological: Medium dose LACTIN-V applicator; Medium dose LACTIN-V applicator (300 mg LACTIN-V, 1.0 x 10^9 CFU), administered vaginally once a day for 5 consecutive days; Other Names: Lactobacillus crispatus CTV-05
Experimental: High dose LACTIN-V applicator High dose LACTIN-V applicator (600 mg LACTIN-V, 2.0 x 10^9 CFU), administered vaginally once a day for 5 consecutive days	Biological: High dose LACTIN-V applicator; High dose LACTIN-V applicator (600 mg LACTIN-V, 2.0 x 10^9 CFU), administered vaginally once a day for 5 consecutive days; Other Names: Lactobacillus crispatus CTV-05
Placebo Comparator: Low dose Placebo applicator Low dose Placebo applicator (150 mg Placebo), administered vaginally once a day for 5 consecutive days	Other: Low dose Placebo applicator; Low dose Placebo applicator (150 mg Placebo), administered vaginally once a day for 5 consecutive days; Other Names: Control substance
Placebo Comparator: Medium dose Placebo applicator Medium dose Placebo applicator (300 mg Placebo), administered vaginally once a day for 5 consecutive days	Other: Medium dose Placebo; Medium dose Placebo applicator (300 mg Placebo), administered vaginally once a day for 5 consecutive days; Other Names: Control substance
Placebo Comparator: High dose Placebo applicator High dose Placebo applicator (600 mg Placebo), administered vaginally once a day for 5 consecutive days	Other: High dose Placebo applicator; High dose Placebo applicator (600 mg Placebo), administered vaginally once a day for 5 consecutive days; Other Names: Control substance

Outcome Measures

Primary Outcome Measures

1. Safety of LACTIN-V in Healthy Pre-menopausal Women. [35 days]

   Safety was measured by comparing the number of women experiencing adverse events of grade 3 or higher during the study.

Secondary Outcome Measures

1. Tolerability of LACTIN-V in a Pre-filled Applicator. [35 days]

   Tolerability was measured as proportion of women remaining in the study, and NOT prematurely exiting the trial due to an adverse event.

2. Acceptability of LACTIN-V in Pre-filled Applicators [35 days]

   Acceptability and overall satisfaction with the study product was measured using the response to the following question: "I would use the product again" with the following response options (strongly agree, agree, neutral, disagree, strongly disagree) Acceptability is reported as the number of women in each group who strongly agreed or agreed with the statement that they would use the product again.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 40 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• Healthy pre-menopausal women 18- 40 years of age at date of screening.

• Regular menstrual cycles (21-35 days) or amenorrheic for at least 3 months (long acting progestin contraceptives).

• Normal Pap smear collected at the screening visit.

• Previous sexual experience including vaginal intercourse.

• Previous experience of gynecological examinations.

• Currently in a mutually monogamous sexual relationship or not sexually active.

• Agree to be sexually abstinent thoughout the trial.

• Agree to abstain from the use of any other intravaginal product thoughout the trial

• Agree to use an adequate method of birth control for the duration of the study to avoid pregnancy.

Exclusion Criteria:

• Urogenital infection at screening or within the 21 days prior to screening (UTI, bacterial vaginosis, Trichomonas vaginalis, Neisseria gonorrhoeae, Chlamydia trachomatis, Treponema pallidum or Herpes simplex).

• History of recurrent genital herpes.

• Diagnosis of N. gonorrhoeae, C. trachomatis, T. pallidum or T. vaginalis on two or more occasions during the six months prior to screening.

• Pregnancy or within 2 months of last pregnancy.

• Lactation.

• Antibiotic or antifungal therapy within 30 days of enrollment visit.

• Concurrent investigational drug use within 30 days or 10 half-lives of the drug, of enrollment visit or during the study.

• Menopause.

• IUD insertion or removal, pelvic surgery, cervical cryotherapy or cervical laser within the last 3 months.

• Use of a NuvaRing® within 3 days of the screening visit or during the course of the study.

• New (less than 3 months)long-acting treatments (e.g. depot formulation including medroxyprogesterone acetate (DMPA) form of hormonal birth control). - - Diabetes or other significant disease or acute illness.

• Known HIV infection or positive HIV test at screening.

• Immunosuppressive drug within 60 days.

• Previous participation in a L. crispatus CTV-05 clinical study.

• Colposcopic findings at the enrollment visit involving significant deep disruption of the epithelium.

• Abnormal results for the pap smear at the screening visit.

• Known allergy to any component of LACTIN-V, other significant drug allergy or to latex (condoms).

• Known drug or alcohol abuse.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	San Francisco General Hospital	San Francisco	California	United States	94110

Sponsors and Collaborators

• Osel, Inc.
• University of California, San Francisco

Investigators

• Principal Investigator: Craig Cohen, MD, MPH, University of California, San Francisco

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• Click here for more information about this study: LACTIN-V phase I study

Publications

• Antonio MA, Hawes SE, Hillier SL. The identification of vaginal Lactobacillus species and the demographic and microbiologic characteristics of women colonized by these species. J Infect Dis. 1999 Dec;180(6):1950-6.
• Antonio MA, Hillier SL. DNA fingerprinting of Lactobacillus crispatus strain CTV-05 by repetitive element sequence-based PCR analysis in a pilot study of vaginal colonization. J Clin Microbiol. 2003 May;41(5):1881-7.
• Avonts D, Sercu M, Heyerick P, Vandermeeren I, Meheus A, Piot P. Incidence of uncomplicated genital infections in women using oral contraception or an intrauterine device: a prospective study. Sex Transm Dis. 1990 Jan-Mar;17(1):23-9.
• Bradshaw CS, Morton AN, Hocking J, Garland SM, Morris MB, Moss LM, Horvath LB, Kuzevska I, Fairley CK. High recurrence rates of bacterial vaginosis over the course of 12 months after oral metronidazole therapy and factors associated with recurrence. J Infect Dis. 2006 Jun 1;193(11):1478-86. Epub 2006 Apr 26.
• Bukusi EA, Cohen CR, Meier AS, Waiyaki PG, Nguti R, Njeri JN, Holmes KK. Bacterial vaginosis: risk factors among Kenyan women and their male partners. Sex Transm Dis. 2006 Jun;33(6):361-7.
• Chimura T, Funayama T, Murayama K, Numazaki M. [Ecological treatment of bacterial vaginosis]. Jpn J Antibiot. 1995 Mar;48(3):432-6. Japanese.
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• Gibney L, Macaluso M, Kirk K, Hassan MS, Schwebke J, Vermund SH, Choudhury P. Prevalence of infectious diseases in Bangladeshi women living adjacent to a truck stand: HIV/STD/hepatitis/genital tract infections. Sex Transm Infect. 2001 Oct;77(5):344-50.
• Giorgi A, Torriani S, Dellaglio F, Bo G, Stola E, Bernuzzi L. Identification of vaginal lactobacilli from asymptomatic women. Microbiologica. 1987 Oct;10(4):377-84.
• Goldenberg RL, Klebanoff MA, Nugent R, Krohn MA, Hillier S, Andrews WW. Bacterial colonization of the vagina during pregnancy in four ethnic groups. Vaginal Infections and Prematurity Study Group. Am J Obstet Gynecol. 1996 May;174(5):1618-21.
• Hawes SE, Hillier SL, Benedetti J, Stevens CE, Koutsky LA, Wolner-Hanssen P, Holmes KK. Hydrogen peroxide-producing lactobacilli and acquisition of vaginal infections. J Infect Dis. 1996 Nov;174(5):1058-63.
• Hay P. Recurrent Bacterial Vaginosis. Curr Infect Dis Rep. 2000 Dec;2(6):506-512.
• Hay PE, Lamont RF, Taylor-Robinson D, Morgan DJ, Ison C, Pearson J. Abnormal bacterial colonisation of the genital tract and subsequent preterm delivery and late miscarriage. BMJ. 1994 Jan 29;308(6924):295-8.
• Hillier SL, Kiviat NB, Hawes SE, Hasselquist MB, Hanssen PW, Eschenbach DA, Holmes KK. Role of bacterial vaginosis-associated microorganisms in endometritis. Am J Obstet Gynecol. 1996 Aug;175(2):435-41.
• Hillier SL, Krohn MA, Klebanoff SJ, Eschenbach DA. The relationship of hydrogen peroxide-producing lactobacilli to bacterial vaginosis and genital microflora in pregnant women. Obstet Gynecol. 1992 Mar;79(3):369-73.
• Hillier SL, Martius J, Krohn M, Kiviat N, Holmes KK, Eschenbach DA. A case-control study of chorioamnionic infection and histologic chorioamnionitis in prematurity. N Engl J Med. 1988 Oct 13;319(15):972-8.
• Hillier SL, Nugent RP, Eschenbach DA, Krohn MA, Gibbs RS, Martin DH, Cotch MF, Edelman R, Pastorek JG 2nd, Rao AV, et al. Association between bacterial vaginosis and preterm delivery of a low-birth-weight infant. The Vaginal Infections and Prematurity Study Group. N Engl J Med. 1995 Dec 28;333(26):1737-42.
• Hughes VL, Hillier SL. Microbiologic characteristics of Lactobacillus products used for colonization of the vagina. Obstet Gynecol. 1990 Feb;75(2):244-8.
• Jurney TH, de Ruyter H, Vigersky RA. Cushing's disease presenting as amenorrhoea with hyperprolactinaemia: report of two cases. Clin Endocrinol (Oxf). 1981 Jun;14(6):539-45.
• Kamara P, Hylton-Kong T, Brathwaite A, Del Rosario GR, Kristensen S, Patrick N, Weiss H, Figueroa PJ, Vermund SH, Jolly PE. Vaginal infections in pregnant women in Jamaica: prevalence and risk factors. Int J STD AIDS. 2000 Aug;11(8):516-20.
• Kurki T, Sivonen A, Renkonen OV, Savia E, Ylikorkala O. Bacterial vaginosis in early pregnancy and pregnancy outcome. Obstet Gynecol. 1992 Aug;80(2):173-7.
• Larsson PG, Platz-Christensen JJ, Forsum U, Påhlson C. Clue cells in predicting infections after abdominal hysterectomy. Obstet Gynecol. 1991 Mar;77(3):450-2.
• Larsson PG, Platz-Christensen JJ, Thejls H, Forsum U, Påhlson C. Incidence of pelvic inflammatory disease after first-trimester legal abortion in women with bacterial vaginosis after treatment with metronidazole: a double-blind, randomized study. Am J Obstet Gynecol. 1992 Jan;166(1 Pt 1):100-3.
• Martin HL, Richardson BA, Nyange PM, Lavreys L, Hillier SL, Chohan B, Mandaliya K, Ndinya-Achola JO, Bwayo J, Kreiss J. Vaginal lactobacilli, microbial flora, and risk of human immunodeficiency virus type 1 and sexually transmitted disease acquisition. J Infect Dis. 1999 Dec;180(6):1863-8.
• Myer L, Denny L, Telerant R, Souza Md, Wright TC Jr, Kuhn L. Bacterial vaginosis and susceptibility to HIV infection in South African women: a nested case-control study. J Infect Dis. 2005 Oct 15;192(8):1372-80. Epub 2005 Sep 9.
• Myer L, Kuhn L, Denny L, Wright TC Jr. Recurrence of symptomatic bacterial vaginosis 12 months after oral metronidazole therapy in HIV-positive and -negative women. J Infect Dis. 2006 Dec 15;194(12):1797-9.
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• Paavonen J, Teisala K, Heinonen PK, Aine R, Laine S, Lehtinen M, Miettinen A, Punnonen R, Grönroos P. Microbiological and histopathological findings in acute pelvic inflammatory disease. Br J Obstet Gynaecol. 1987 May;94(5):454-60.
• Pastore LM, Thorp JM Jr, Royce RA, Savitz DA, Jackson TP. Risk score for antenatal bacterial vaginosis: BV PIN points. J Perinatol. 2002 Mar;22(2):125-32.
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• Reid G, Burton J. Use of Lactobacillus to prevent infection by pathogenic bacteria. Microbes Infect. 2002 Mar;4(3):319-24. Review.
• Riduan JM, Hillier SL, Utomo B, Wiknjosastro G, Linnan M, Kandun N. Bacterial vaginosis and prematurity in Indonesia: association in early and late pregnancy. Am J Obstet Gynecol. 1993 Jul;169(1):175-8.
• Sewankambo N, Gray RH, Wawer MJ, Paxton L, McNaim D, Wabwire-Mangen F, Serwadda D, Li C, Kiwanuka N, Hillier SL, Rabe L, Gaydos CA, Quinn TC, Konde-Lule J. HIV-1 infection associated with abnormal vaginal flora morphology and bacterial vaginosis. Lancet. 1997 Aug 23;350(9077):546-50. Erratum in: Lancet 1997 Oct 4;350(9083):1036.
• Silver HM, Sperling RS, St Clair PJ, Gibbs RS. Evidence relating bacterial vaginosis to intraamniotic infection. Am J Obstet Gynecol. 1989 Sep;161(3):808-12.
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• Soper DE, Bump RC, Hurt WG. Bacterial vaginosis and trichomoniasis vaginitis are risk factors for cuff cellulitis after abdominal hysterectomy. Am J Obstet Gynecol. 1990 Sep;163(3):1016-21; discussion 1021-3.
• Taha TE, Hoover DR, Dallabetta GA, Kumwenda NI, Mtimavalye LA, Yang LP, Liomba GN, Broadhead RL, Chiphangwi JD, Miotti PG. Bacterial vaginosis and disturbances of vaginal flora: association with increased acquisition of HIV. AIDS. 1998 Sep 10;12(13):1699-706.
• Thomason JL, Gelbart SM, Scaglione NJ. Bacterial vaginosis: current review with indications for asymptomatic therapy. Am J Obstet Gynecol. 1991 Oct;165(4 Pt 2):1210-7. Review.
• Watts DH, Krohn MA, Hillier SL, Eschenbach DA. Bacterial vaginosis as a risk factor for post-cesarean endometritis. Obstet Gynecol. 1990 Jan;75(1):52-8.
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• Responsible Party: Osel, Inc.
• ClinicalTrials.gov Identifier: NCT00537576
• Other Study ID Numbers: LV-005
• First Posted: Oct 1, 2007
• Last Update Posted: Sep 16, 2020
• Last Verified: Apr 1, 2014

• Additional relevant MeSH terms: Vaginosis, Bacterial

Study Results

Participant Flow

Recruitment Details	Between November 2007 and January 2008, 12 participants were recruited through advertising in health centers, educational institutions, community bulletin boards and online forums.
Pre-assignment Detail	All 12 enrolled participants completed the study.

Arm/Group Title	Low Dose Applicator	Medium Dose Applicator	High Dose Applicator	Placebo Control Substance Low Dose	Placebo Control Substance Medium Dose	Placebo Control Substance High Dose
Arm/Group Description	Low dose LACTIN-V applicator (150 mg LACTIN-V, 5.0 x 10^8 CFU) and Placebo applicator (150 mg Placebo), randomized 3:1	Medium dose LACTIN-V applicator (300 mg LACTIN-V, 1.0 x 10^9 CFU) and Placebo applicator (300 mg), randomized 3:1	High dose LACTIN-V applicator (600 mg LACTIN-V, 2.0 x 10^9 CFU) and Placebo applicator (600 mg Placebo), randomized 3:1	Placebo control substance Low Dose contained a nutrient matrix of 150 mg per dose.	Placebo control substance Medium Dose contained a nutrient matrix of 300 mg per dose.	Placebo control substance High Dose contained a nutrient matrix of 600 mg per dose.
Period Title: Overall Study
STARTED	3	3	3	1	1	1
COMPLETED	3	3	3	1	1	1
NOT COMPLETED	0	0	0	0	0	0

Baseline Characteristics

Arm/Group Title	Low Dose Applicator	Medium Dose Applicator	High Dose Applicator	Placebo Control Substance Low Dose	Placebo Control Substance Medium Dose	Placebo Control Substance High Dose	Total
Arm/Group Description	Low dose LACTIN-V applicator (150 mg LACTIN-V, 5.0 x 10^8 CFU) and Placebo applicator (150 mg Placebo), randomized 3:1	Medium dose LACTIN-V applicator (300 mg LACTIN-V, 1.0 x 10^9 CFU) and Placebo applicator (300 mg), randomized 3:1	High dose LACTIN-V applicator (600 mg LACTIN-V, 2.0 x 10^9 CFU) and Placebo applicator (600 mg Placebo), randomized 3:1	Placebo control substance Low Dose contained a nutrient matrix of 150 mg per dose.	Placebo control substance Medium Dose contained a nutrient matrix of 300 mg per dose.	Placebo control substance High Dose contained a nutrient matrix of 600 mg per dose.	Total of all reporting groups
Overall Participants	3	3	3	1	1	1	12
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Between 18 and 65 years	3 100%	3 100%	3 100%	1 100%	1 100%	1 100%	12 100%
>=65 years	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	29.1 (7.0)	29.1 (7)	29.1 (7.0)	29.1 (7)	29.1 (7)	29.1 (7)	29.1 (7.0)
Sex: Female, Male (Count of Participants)
Female	3 100%	3 100%	3 100%	1 100%	1 100%	1 100%	12 100%
Male	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Region of Enrollment (participants) [Number]
United States	3 100%	3 100%	3 100%	1 100%	1 100%	1 100%	12 100%

Outcome Measures

1. Primary Outcome

Title	Safety of LACTIN-V in Healthy Pre-menopausal Women.
Description	Safety was measured by comparing the number of women experiencing adverse events of grade 3 or higher during the study.
Time Frame	35 days

Outcome Measure Data

Analysis Population Description

The analysis was per protocol. Number of participants for descriptive analysis only.

Arm/Group Title	Low Dose Applicator	Medium Dose Applicator	High Dose Applicator	Placebo Control Substance Low Dose	Placebo Control Substance Medium Dose	Placebo Control Substance High Dose
Arm/Group Description	Low dose LACTIN-V applicator (150 mg LACTIN-V, 5.0 x 10^8 CFU) and Placebo applicator (150 mg Placebo), randomized 3:1	Medium dose LACTIN-V applicator (300 mg LACTIN-V, 1.0 x 10^9 CFU) and Placebo applicator (300 mg), randomized 3:1	High dose LACTIN-V applicator (600 mg LACTIN-V, 2.0 x 10^9 CFU) and Placebo applicator (600 mg Placebo), randomized 3:1	Placebo control substance Low Dose contained a nutrient matrix of 150 mg per dose.	Placebo control substance Medium Dose contained a nutrient matrix of 300 mg per dose.	Placebo control substance High Dose contained a nutrient matrix of 600 mg per dose.
Measure Participants	3	3	3	1	1	1
Number [participants]	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%

2. Secondary Outcome

Title	Tolerability of LACTIN-V in a Pre-filled Applicator.
Description	Tolerability was measured as proportion of women remaining in the study, and NOT prematurely exiting the trial due to an adverse event.
Time Frame	35 days

Outcome Measure Data

Analysis Population Description

Analysis per Protocol. Number of participants for descriptive analysis.

Arm/Group Title	Low Dose Applicator	Medium Dose Applicator	High Dose Applicator	Placebo Control Substance Low Dose	Placebo Control Substance Medium Dose	Placebo Control Substance High Dose
Arm/Group Description	Low dose LACTIN-V applicator (150 mg LACTIN-V, 5.0 x 10^8 CFU) and Placebo applicator (150 mg Placebo), randomized 3:1	Medium dose LACTIN-V applicator (300 mg LACTIN-V, 1.0 x 10^9 CFU) and Placebo applicator (300 mg), randomized 3:1	High dose LACTIN-V applicator (600 mg LACTIN-V, 2.0 x 10^9 CFU) and Placebo applicator (600 mg Placebo), randomized 3:1	Placebo control substance Low Dose contained a nutrient matrix of 150 mg per dose.	Placebo control substance Medium Dose contained a nutrient matrix of 300 mg per dose.	Placebo control substance High Dose contained a nutrient matrix of 600 mg per dose.
Measure Participants	3	3	3	1	1	1
Number [participants]	3 100%	3 100%	3 100%	1 100%	1 100%	1 100%

3. Secondary Outcome

Title	Acceptability of LACTIN-V in Pre-filled Applicators
Description	Acceptability and overall satisfaction with the study product was measured using the response to the following question: "I would use the product again" with the following response options (strongly agree, agree, neutral, disagree, strongly disagree) Acceptability is reported as the number of women in each group who strongly agreed or agreed with the statement that they would use the product again.
Time Frame	35 days

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Low Dose Applicator	Medium Dose Applicator	High Dose Applicator	Placebo Control Substance Low Dose	Placebo Control Substance Medium Dose	Placebo Control Substance High Dose
Arm/Group Description	Low dose LACTIN-V applicator (150 mg LACTIN-V, 5.0 x 10^8 CFU) and Placebo applicator (150 mg Placebo), randomized 3:1	Medium dose LACTIN-V applicator (300 mg LACTIN-V, 1.0 x 10^9 CFU) and Placebo applicator (300 mg), randomized 3:1	High dose LACTIN-V applicator (600 mg LACTIN-V, 2.0 x 10^9 CFU) and Placebo applicator (600 mg Placebo), randomized 3:1	Placebo control substance Low Dose contained a nutrient matrix of 150 mg per dose.	Placebo control substance Medium Dose contained a nutrient matrix of 300 mg per dose.	Placebo control substance High Dose contained a nutrient matrix of 600 mg per dose.
Measure Participants	3	3	3	1	1	1
Number [participants]	3 100%	3 100%	2 66.7%	1 100%	0 0%	1 100%

Adverse Events

Arm/Group Title	Low Dose Applicator		Medium Dose Applicator		High Dose Applicator		Placebo Control Substance Low Dose		Placebo Control Substance Medium Dose		Placebo Control Substance High Dose
Arm/Group Description	Low dose LACTIN-V applicator (150 mg LACTIN-V, 5.0 x 10^8 CFU) and Placebo applicator (150 mg Placebo), randomized 3:1		Medium dose LACTIN-V applicator (300 mg LACTIN-V, 1.0 x 10^9 CFU) and Placebo applicator (300 mg), randomized 3:1		High dose LACTIN-V applicator (600 mg LACTIN-V, 2.0 x 10^9 CFU) and Placebo applicator (600 mg Placebo), randomized 3:1		Placebo control substance Low Dose contained a nutrient matrix of 150 mg per dose.		Placebo control substance Medium Dose contained a nutrient matrix of 300 mg per dose.		Placebo control substance High Dose contained a nutrient matrix of 600 mg per dose.
All Cause Mortality
	Low Dose Applicator		Medium Dose Applicator		High Dose Applicator		Placebo Control Substance Low Dose		Placebo Control Substance Medium Dose		Placebo Control Substance High Dose
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)		/ (NaN)		/ (NaN)		/ (NaN)		/ (NaN)
Serious Adverse Events
	Low Dose Applicator		Medium Dose Applicator		High Dose Applicator		Placebo Control Substance Low Dose		Placebo Control Substance Medium Dose		Placebo Control Substance High Dose
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/3 (0%)		0/3 (0%)		0/3 (0%)		0/1 (0%)		0/1 (0%)		0/1 (0%)
Other (Not Including Serious) Adverse Events
	Low Dose Applicator		Medium Dose Applicator		High Dose Applicator		Placebo Control Substance Low Dose		Placebo Control Substance Medium Dose		Placebo Control Substance High Dose
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	3/3 (100%)		3/3 (100%)		3/3 (100%)		1/1 (100%)		1/1 (100%)		1/1 (100%)
General disorders
headache	1/3 (33.3%)	1	1/3 (33.3%)	1	0/3 (0%)	0	0/1 (0%)	0	1/1 (100%)	1	0/1 (0%)	0
Reproductive system and breast disorders
vaginal discharge	1/3 (33.3%)	1	2/3 (66.7%)	2	2/3 (66.7%)	2	0/1 (0%)	0	0/1 (0%)	0	0/1 (0%)	0
Abdominal pain	1/3 (33.3%)	1	2/3 (66.7%)	2	0/3 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	1/1 (100%)	1
Metrorrhagia	0/3 (0%)	0	0/3 (0%)	0	2/3 (66.7%)	2	1/1 (100%)	1	0/1 (0%)	0	1/1 (100%)	1
Vulvovaginitis	0/3 (0%)	0	1/3 (33.3%)	1	2/3 (66.7%)	2	0/1 (0%)	0	0/1 (0%)	0	1/1 (100%)	1
vaginal odor	1/3 (33.3%)	1	2/3 (66.7%)	2	0/3 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	0/1 (0%)	0
vaginal candidiasis	0/3 (0%)	0	1/3 (33.3%)	1	1/3 (33.3%)	1	0/1 (0%)	0	1/1 (100%)	1	0/1 (0%)	0

Limitations/Caveats

[Not Specified]

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Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.