CompletedNCT00537576Updated Sep 16, 2020Results posted

Safety Study of Lactobacillus Administered Vaginally to Healthy Women

A Phase 1 interventional study of Low dose LACTIN-V applicator and Medium dose LACTIN-V applicator in Bacterial Vaginosis, sponsored by Osel, Inc.. Completed at 1 site in United States. Open to female participants aged 18 Years to 40 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-09-16.

Sponsored by Osel, Inc. · Phase 1, Interventional, and Other

Phase: Phase 1
Study type: Interventional
Enrollment: 12
Allocation: Randomized
Ages: 18 Years to 40 Years
Sex: Female

Study 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.

Read the 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

Conditions studied

Bacterial Vaginosis

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Vaginosis, Bacterial 220

In context

Vaginosis, Bacterial

220 studies on the registry are indexed under Vaginosis, Bacterial; 36 are open to participants now.

This study's enrollment of 12 is below the median of 100 across 187 interventional studies indexed under Vaginosis, Bacterial.

Browse Vaginosis, Bacterial studies →

Lead sponsor

Osel, Inc. is the lead sponsor of 4 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years to 40 Years
Sexes eligible: 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

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.

Study design

Phase: Phase 1
Primary purpose: Other
Allocation: Randomized
Intervention model: Parallel assignment
Masking: Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment: 12 participants (actual)

Study arms

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
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
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
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
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
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

Interventions

BiologicalLow 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
Also known as: Lactobacillus crispatus CTV-05
BiologicalMedium 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
Also known as: Lactobacillus crispatus CTV-05
BiologicalHigh 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
Also known as: Lactobacillus crispatus CTV-05
OtherLow dose Placebo applicator
Low dose Placebo applicator (150 mg Placebo), administered vaginally once a day for 5 consecutive days
Also known as: Control substance
OtherMedium dose Placebo
Medium dose Placebo applicator (300 mg Placebo), administered vaginally once a day for 5 consecutive days
Also known as: Control substance
OtherHigh dose Placebo applicator
High dose Placebo applicator (600 mg Placebo), administered vaginally once a day for 5 consecutive days
Also known as: Control substance

What researchers measure

Primary outcomes

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

Secondary outcomes

Tolerability of LACTIN-V in a Pre-filled Applicator.
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
Acceptability of LACTIN-V in Pre-filled Applicators
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

Results

Posted Sep 16, 2020

Participant flow

Between November 2007 and January 2008, 12 participants were recruited through advertising in health centers, educational institutions, community bulletin boards and online forums.

Participant flow — Overall Study
Milestone	Low Dose Applicator	Medium Dose Applicator	High Dose Applicator	Placebo Control Substance Low Dose	Placebo Control Substance Medium Dose	Placebo Control Substance High Dose
Started	3	3	3	1	1	1
Completed	3	3	3	1	1	1
Not completed	0	0	0	0	0	0

Outcome measures

PrimarySafety of LACTIN-V in Healthy Pre-menopausal Women.

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

Time frame:: 35 days
Reported as:: Number · participants

Safety of LACTIN-V in Healthy Pre-menopausal Women.
participants	Low Dose Applicator	Medium Dose Applicator	High Dose Applicator	Placebo Control Substance Low Dose	Placebo Control Substance Medium Dose	Placebo Control Substance High Dose
Safety of LACTIN-V in Healthy Pre-menopausal Women.	0	0	0	0	0	0

SecondaryTolerability of LACTIN-V in a Pre-filled Applicator.

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
Reported as:: Number · participants

Tolerability of LACTIN-V in a Pre-filled Applicator.
participants	Low Dose Applicator	Medium Dose Applicator	High Dose Applicator	Placebo Control Substance Low Dose	Placebo Control Substance Medium Dose	Placebo Control Substance High Dose
Tolerability of LACTIN-V in a Pre-filled Applicator.	3	3	3	1	1	1

SecondaryAcceptability of LACTIN-V in Pre-filled Applicators

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
Reported as:: Number · participants

Acceptability of LACTIN-V in Pre-filled Applicators
participants	Low Dose Applicator	Medium Dose Applicator	High Dose Applicator	Placebo Control Substance Low Dose	Placebo Control Substance Medium Dose	Placebo Control Substance High Dose
Acceptability of LACTIN-V in Pre-filled Applicators	3	3	2	1	0	1

Adverse events

Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
Low Dose Applicator	—	0/3 (0%)	3/3 (100%)
Medium Dose Applicator	—	0/3 (0%)	3/3 (100%)
High Dose Applicator	—	0/3 (0%)	3/3 (100%)
Placebo Control Substance Low Dose	—	0/1 (0%)	1/1 (100%)
Placebo Control Substance Medium Dose	—	0/1 (0%)	1/1 (100%)
Placebo Control Substance High Dose	—	0/1 (0%)	1/1 (100%)

Most frequent other events

Most frequent other events
Event	Low Dose Applicator	Medium Dose Applicator	High Dose Applicator	Placebo Control Substance Low Dose	Placebo Control Substance Medium Dose	Placebo Control Substance High Dose
Abdominal painReproductive system and breast disorders	1/3	2/3	0/3	0/1	0/1	1/1
MetrorrhagiaReproductive system and breast disorders	0/3	0/3	2/3	1/1	0/1	1/1
VulvovaginitisReproductive system and breast disorders	0/3	1/3	2/3	0/1	0/1	1/1
headacheGeneral disorders	1/3	1/3	0/3	0/1	1/1	0/1
vaginal candidiasisReproductive system and breast disorders	0/3	1/3	1/3	0/1	1/1	0/1
vaginal dischargeReproductive system and breast disorders	1/3	2/3	2/3	0/1	0/1	0/1
vaginal odorReproductive system and breast disorders	1/3	2/3	0/3	0/1	0/1	0/1

Baseline characteristics

Age, Categorical
Age, Categorical(Participants)	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
<=18 years	0	0	0	0	0	0	0
Between 18 and 65 years	3	3	3	1	1	1	12
>=65 years	0	0	0	0	0	0	0

Age, Continuous
Age, Continuous(years)	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
Mean	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
Sex: Female, Male(Participants)	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
Female	3	3	3	1	1	1	12
Male	0	0	0	0	0	0	0

Region of Enrollment
Region of Enrollment(participants)	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
United States	3	3	3	1	1	1	12

Study locations

1 site

San Francisco General Hospital
San Francisco, California 94110, United States

References and documents

Publications

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Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Sep 16, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT00537576
Lead sponsor: Osel, Inc.
Collaborators: University of California, San Francisco
Responsible party: Sponsor
First posted: Oct 1, 2007
Start date: Nov 2007
Primary completion: Mar 2008
Completion: Apr 2008
Results posted: Sep 16, 2020
Last update: Sep 16, 2020

Study contacts

Craig Cohen, MD, MPH

principal investigator · University of California, San Francisco

Oversight

Data monitoring committee: No

View the source record on ClinicalTrials.gov ↗

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