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Safety Study of Lactobacillus Administered Vaginally to Healthy Women

Primary Purpose

Bacterial Vaginosis

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Low dose LACTIN-V applicator
Medium dose LACTIN-V applicator
High dose LACTIN-V applicator
Low dose Placebo applicator
Medium dose Placebo
High dose Placebo applicator
Sponsored by
Osel, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Bacterial Vaginosis

Eligibility Criteria

18 Years - 40 Years (Adult)FemaleAccepts Healthy Volunteers

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.

Sites / Locations

  • San Francisco General Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm Type

Experimental

Experimental

Experimental

Placebo Comparator

Placebo Comparator

Placebo Comparator

Arm Label

Low dose LACTIN-V applicator

Medium dose LACTIN-V applicator

High dose LACTIN-V applicator

Low dose Placebo applicator

Medium dose Placebo applicator

High dose Placebo applicator

Arm Description

Low dose LACTIN-V applicator (150 mg LACTIN-V, 5.0 x 10^8 CFU), administered vaginally once a day for 5 consecutive days

Medium dose LACTIN-V applicator (300 mg LACTIN-V, 1.0 x 10^9 CFU), administered vaginally once a day for 5 consecutive days

High dose LACTIN-V applicator (600 mg LACTIN-V, 2.0 x 10^9 CFU), administered vaginally once a day for 5 consecutive days

Low dose Placebo applicator (150 mg Placebo), administered vaginally once a day for 5 consecutive days

Medium dose Placebo applicator (300 mg Placebo), administered vaginally once a day for 5 consecutive days

High dose Placebo applicator (600 mg Placebo), administered vaginally once a day for 5 consecutive days

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.

Full Information

First Posted
September 27, 2007
Last Updated
September 14, 2020
Sponsor
Osel, Inc.
Collaborators
University of California, San Francisco
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1. Study Identification

Unique Protocol Identification Number
NCT00537576
Brief Title
Safety Study of Lactobacillus Administered Vaginally to Healthy Women
Official Title
A Phase I Study of the Safety of LACTIN-V Administered Vaginally to Healthy Women
Study Type
Interventional

2. Study Status

Record Verification Date
April 2014
Overall Recruitment Status
Completed
Study Start Date
November 2007 (undefined)
Primary Completion Date
March 2008 (Actual)
Study Completion Date
April 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Osel, Inc.
Collaborators
University of California, San Francisco

4. Oversight

Data Monitoring Committee
No

5. 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.
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bacterial Vaginosis

7. Study Design

Primary Purpose
Other
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
12 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Low dose LACTIN-V applicator
Arm Type
Experimental
Arm Description
Low dose LACTIN-V applicator (150 mg LACTIN-V, 5.0 x 10^8 CFU), administered vaginally once a day for 5 consecutive days
Arm Title
Medium dose LACTIN-V applicator
Arm Type
Experimental
Arm Description
Medium dose LACTIN-V applicator (300 mg LACTIN-V, 1.0 x 10^9 CFU), administered vaginally once a day for 5 consecutive days
Arm Title
High dose LACTIN-V applicator
Arm Type
Experimental
Arm Description
High dose LACTIN-V applicator (600 mg LACTIN-V, 2.0 x 10^9 CFU), administered vaginally once a day for 5 consecutive days
Arm Title
Low dose Placebo applicator
Arm Type
Placebo Comparator
Arm Description
Low dose Placebo applicator (150 mg Placebo), administered vaginally once a day for 5 consecutive days
Arm Title
Medium dose Placebo applicator
Arm Type
Placebo Comparator
Arm Description
Medium dose Placebo applicator (300 mg Placebo), administered vaginally once a day for 5 consecutive days
Arm Title
High dose Placebo applicator
Arm Type
Placebo Comparator
Arm Description
High dose Placebo applicator (600 mg Placebo), administered vaginally once a day for 5 consecutive days
Intervention Type
Biological
Intervention Name(s)
Low dose LACTIN-V applicator
Other Intervention Name(s)
Lactobacillus crispatus CTV-05
Intervention Description
Low dose LACTIN-V applicator (150 mg LACTIN-V, 5.0 x 10^8 CFU), administered vaginally once a day for 5 consecutive days
Intervention Type
Biological
Intervention Name(s)
Medium dose LACTIN-V applicator
Other Intervention Name(s)
Lactobacillus crispatus CTV-05
Intervention Description
Medium dose LACTIN-V applicator (300 mg LACTIN-V, 1.0 x 10^9 CFU), administered vaginally once a day for 5 consecutive days
Intervention Type
Biological
Intervention Name(s)
High dose LACTIN-V applicator
Other Intervention Name(s)
Lactobacillus crispatus CTV-05
Intervention Description
High dose LACTIN-V applicator (600 mg LACTIN-V, 2.0 x 10^9 CFU), administered vaginally once a day for 5 consecutive days
Intervention Type
Other
Intervention Name(s)
Low dose Placebo applicator
Other Intervention Name(s)
Control substance
Intervention Description
Low dose Placebo applicator (150 mg Placebo), administered vaginally once a day for 5 consecutive days
Intervention Type
Other
Intervention Name(s)
Medium dose Placebo
Other Intervention Name(s)
Control substance
Intervention Description
Medium dose Placebo applicator (300 mg Placebo), administered vaginally once a day for 5 consecutive days
Intervention Type
Other
Intervention Name(s)
High dose Placebo applicator
Other Intervention Name(s)
Control substance
Intervention Description
High dose Placebo applicator (600 mg Placebo), administered vaginally once a day for 5 consecutive days
Primary Outcome Measure Information:
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
Secondary Outcome Measure Information:
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
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

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Craig Cohen, MD, MPH
Organizational Affiliation
University of California, San Francisco
Official's Role
Principal Investigator
Facility Information:
Facility Name
San Francisco General Hospital
City
San Francisco
State/Province
California
ZIP/Postal Code
94110
Country
United States

12. IPD Sharing Statement

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Links:
URL
http://www.oselinc.com
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Safety Study of Lactobacillus Administered Vaginally to Healthy Women

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