Safety Study of Lactobacillus Administered Vaginally to Healthy Women

September 14, 2020 updated by: Osel, Inc.

A Phase I Study of the Safety of LACTIN-V Administered Vaginally to Healthy Women

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

12

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 40 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Osel, Inc.

Collaborators

University of California, San Francisco

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2007

Primary Completion (Actual)

March 1, 2008

Study Completion (Actual)

April 1, 2008

Study Registration Dates

First Submitted

September 27, 2007

First Submitted That Met QC Criteria

September 27, 2007

First Posted (Estimate)

October 1, 2007

Study Record Updates

Last Update Posted (Actual)

September 16, 2020

Last Update Submitted That Met QC Criteria

September 14, 2020

Last Verified

April 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LV-005

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Bacterial Vaginosis

Clinical Trials on Low dose LACTIN-V applicator

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Montenegro

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe