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Safety Study of Lactobacillus Administered Vaginally to Healthy Women

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00537576
Recruitment Status : Completed
First Posted : October 1, 2007
Results First Posted : September 16, 2020
Last Update Posted : September 16, 2020
Sponsor:
Collaborator:
University of California, San Francisco
Information provided by (Responsible Party):
Osel, Inc.

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

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Study Type : Interventional  (Clinical Trial)
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 : November 2007
Actual Primary Completion Date : March 2008
Actual Study Completion Date : April 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Safety

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 Name: 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 Name: 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 Name: 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 Name: 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 Name: 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 Name: Control substance




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.




Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00537576


Locations
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United States, California
San Francisco General Hospital
San Francisco, California, United States, 94110
Sponsors and Collaborators
Osel, Inc.
University of California, San Francisco
Investigators
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Principal Investigator: Craig Cohen, MD, MPH University of California, San Francisco
Additional Information:
Publications:

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Responsible Party: Osel, Inc.
ClinicalTrials.gov Identifier: NCT00537576    
Other Study ID Numbers: LV-005
First Posted: October 1, 2007    Key Record Dates
Results First Posted: September 16, 2020
Last Update Posted: September 16, 2020
Last Verified: April 2014
Additional relevant MeSH terms:
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Vaginosis, Bacterial
Vaginal Diseases
Bacterial Infections
Bacterial Infections and Mycoses
Infections
Vaginitis