Phase 1
N=12
Safety Study of Lactobacillus Administered Vaginally to Healthy Women
Bacterial Vaginosis
Bottom Line
View on ClinicalTrials.gov: NCT00537576 ↗Enrolled (actual)
12
Serious AEs
0.0%
Results posted
Sep 2020
Primary outcome: Primary: Safety of LACTIN-V in Healthy Pre-menopausal Women. — 0; 0; 0; 0 participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 1
- Interventions
- Low dose LACTIN-V applicator (Biological); Medium dose LACTIN-V applicator (Biological); High dose LACTIN-V applicator (Biological); Low dose Placebo applicator (Other); Medium dose Placebo (Other); High dose Placebo applicator (Other)
- Age
- Adult · 18+ yrs
- Sex
- Female
- Sponsor
- Osel, Inc.
- Primary completion
- Mar 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Safety of LACTIN-V in Healthy Pre-menopausal Women. |
0; 0; 0; 0; 0; 0 | — |
| SECONDARY Tolerability of LACTIN-V in a Pre-filled Applicator. |
3; 3; 3; 1; 1; 1 | — |
| SECONDARY Acceptability of LACTIN-V in Pre-filled Applicators |
3; 3; 2; 1; 0; 1 | — |
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.
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.
Data sourced from ClinicalTrials.gov (NCT00537576). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.