Safety Study of Lactobacillus Administered Vaginally to Healthy Women

• Status: Completed
• Trial end date: 0000-00-00
• Target enrollment: 12
• Participant gender: Female

Summary

The purpose of this study is to evaluate the safety, tolerability and acceptability of a new formulation of Lactobacillus crispatus, strain CTV-05 (LACTIN-V) in healthy pre-menopausal women. Osel, Inc. proposes that this new formulation will be safe and well-tolerated in healthy pre-menopausal women.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Osel, Inc.
• Collaborator: University of California, San Francisco
• Last Updated: 2009-05-06

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 due to use of a long acting progestin or continuous use of oral contraceptives.

• Subject is willing to insert pre-filled vaginal applicators.

• Subject is willing to be asked questions about personal medical health and sexual history.

• Normal Pap smear collected at the screening visit.

• Vaginal and cervical anatomy that in the opinion of the Investigator lends itself easily to colposcopy.

• Capable of providing informed consent and reading English.

• 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 72 hours prior to Visit 1 (enrollment) until Visit 3 (Day 14).

• Agree to abstain from the use of any other intravaginal product (i.e., contraceptive creams, gels, foams, sponges, lubricants, douches, etc.) throughout the trial period, from the time of screening until Day 35.

• Agree to not use tampons throughout the trial period, from the time of screening until Day 35.

• Agree to use an adequate method of birth control for the duration of the study to avoid pregnancy. Acceptable methods include a history of tubal ligation, male partner with a vasectomy, a steroidal contraceptive (oral, patch, injectable or implantable), IUD (Paragard or Mirena), use of condoms or abstinence.

Exclusion Criteria:

• Urogenital infection at screening or within the 21 days prior to screening. This includes urinary tract infection, bacterial vaginosis, Trichomonas vaginalis, Neisseria gonorrhoeae, Chlamydia trachomatis, Treponema pallidum or Herpes simplex. Subjects may be re-screened at least 21 days after the respective antibiotic or antifungal therapies have been completed.

• 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 (all subjects will have a urine pregnancy test prior to enrollment).

• Lactation.

• Antibiotic or antifungal therapy within 30 days of enrollment visit (vaginal or systemic).

• Investigational drug use within 30 days or 10 half-lives of the drug, whichever is longer, of enrollment visit. Planned investigational drug while participating in this study.

• Menopause.

• IUD insertion or removal within the last 3 months.

• Pelvic surgery within the last 3 months.

• 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 long-acting treatments (e.g. depot formulation including medroxyprogesterone acetate (DMPA) form of hormonal birth control). Subjects may be enrolled if stable (> 3months) on existing therapy as determined by the Principal Investigator.

• Diabetes or other significant disease or acute illness that in the Investigator's assessment could complicate the evaluation.

• 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).

• Unavailable for follow-up visits.

• Known drug or alcohol abuse.

• At enrollment, have any social or medical condition (e.g., neurological, gastrointestinal, renal, hepatic, cardiovascular, pulmonary, metabolic, endocrine, hematological, genitourinary or other major disorder), or psychiatric illness (e.g., depression, schizophrenia) that, in the opinion of the Investigator, would preclude provision of informed consent, make participation in the study unsafe, complicate interpretation of study outcome data, or otherwise interfere with achieving the study objectives.