Safety Study of Lactobacillus Administered Vaginally to Healthy Women
NCT ID: NCT00537576
Last Updated: 2020-09-16
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE1
12 participants
INTERVENTIONAL
2007-11-30
2008-04-30
Brief Summary
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Detailed Description
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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
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Study Design
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RANDOMIZED
PARALLEL
OTHER
QUADRUPLE
Study Groups
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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
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
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
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
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
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
Low dose Placebo applicator
Low dose Placebo applicator (150 mg Placebo), administered vaginally once a day for 5 consecutive days
Low dose Placebo applicator
Low dose Placebo applicator (150 mg Placebo), administered vaginally once a day for 5 consecutive days
Medium dose Placebo applicator
Medium dose Placebo applicator (300 mg Placebo), administered vaginally once a day for 5 consecutive days
Medium dose Placebo
Medium dose Placebo applicator (300 mg Placebo), administered vaginally once a day for 5 consecutive days
High dose Placebo applicator
High dose Placebo applicator (600 mg Placebo), administered vaginally once a day for 5 consecutive days
High dose Placebo applicator
High dose Placebo applicator (600 mg Placebo), administered vaginally once a day for 5 consecutive days
Interventions
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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
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
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
Low dose Placebo applicator
Low dose Placebo applicator (150 mg Placebo), administered vaginally once a day for 5 consecutive days
Medium dose Placebo
Medium dose Placebo applicator (300 mg Placebo), administered vaginally once a day for 5 consecutive days
High dose Placebo applicator
High dose Placebo applicator (600 mg Placebo), administered vaginally once a day for 5 consecutive days
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
40 Years
FEMALE
Yes
Sponsors
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University of California, San Francisco
OTHER
Osel, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Craig Cohen, MD, MPH
Role: PRINCIPAL_INVESTIGATOR
University of California, San Francisco
Locations
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San Francisco General Hospital
San Francisco, California, United States
Countries
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References
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Related Links
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Click here for more information about this study: LACTIN-V phase I study
Other Identifiers
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LV-005
Identifier Type: -
Identifier Source: org_study_id
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