Safety Study of Lactobacillus Administered Vaginally to Healthy Women

Completed · Phase 1 · Has a placebo group

Conditions studied: Bacterial Vaginosis

In brief

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.

Key facts

Study ID

NCT00537576

Run by

Osel, Inc.

People needed

12

Starts

2007-11-01

Expected to finish

2008-04-01

Last updated by the study team

2020-09-16

Who can join

Age: 18 and older, up to 40. Sex: female. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

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

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.