Safety Study of Lactobacillus Administered Vaginally to Healthy Women

This study has been completed.
Sponsor:
Collaborator:
University of California, San Francisco
Information provided by:
Osel, Inc.
ClinicalTrials.gov Identifier:
NCT00537576
First received: September 27, 2007
Last updated: May 6, 2009
Last verified: June 2008
  Purpose

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.


Condition Intervention Phase
Bacterial Vaginosis
Drug: LACTIN-V
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Official Title: A Phase I Study of the Safety of LACTIN-V Administered Vaginally to Healthy Women

Resource links provided by NLM:


Further study details as provided by Osel, Inc.:

Primary Outcome Measures:
  • Safety of a modified formulation of L. crispatus, LACTIN-V, administered as a powder via a pre-filled vaginal applicator, in healthy pre-menopausal women. [ Time Frame: 35 days ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Tolerability and acceptability of LACTIN-V in a pre-filled applicator. [ Time Frame: 35 days ] [ Designated as safety issue: No ]

Enrollment: 12
Study Start Date: November 2007
Study Completion Date: April 2008
Primary Completion Date: March 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
5.0 x 10^8 cfu/dose LACTIN-V
Drug: LACTIN-V
Arm 1: 5.0 x 10^8 cfu/dose 1x/day x 5 days total intravaginal. Arm 2: 1.0 x 10^9 cfu/dose 1x/day x 5 days total intravaginal. Arm 3: 2.0 x 10^9 cfu/dose 1x/day x 5 days total intravaginal. Arm 4: placebo 1x/day x 5 days total intravaginal.
Experimental: 2
1.0 x 10^9 cfu/dose LACTIN-V
Drug: LACTIN-V
Arm 1: 5.0 x 10^8 cfu/dose 1x/day x 5 days total intravaginal. Arm 2: 1.0 x 10^9 cfu/dose 1x/day x 5 days total intravaginal. Arm 3: 2.0 x 10^9 cfu/dose 1x/day x 5 days total intravaginal. Arm 4: placebo 1x/day x 5 days total intravaginal.
Experimental: 3
2.0 x 10^9 cfu/dose LACTIN-V
Drug: LACTIN-V
Arm 1: 5.0 x 10^8 cfu/dose 1x/day x 5 days total intravaginal. Arm 2: 1.0 x 10^9 cfu/dose 1x/day x 5 days total intravaginal. Arm 3: 2.0 x 10^9 cfu/dose 1x/day x 5 days total intravaginal. Arm 4: placebo 1x/day x 5 days total intravaginal.
Placebo Comparator: 4
Placebo
Drug: LACTIN-V
Arm 1: 5.0 x 10^8 cfu/dose 1x/day x 5 days total intravaginal. Arm 2: 1.0 x 10^9 cfu/dose 1x/day x 5 days total intravaginal. Arm 3: 2.0 x 10^9 cfu/dose 1x/day x 5 days total intravaginal. Arm 4: placebo 1x/day x 5 days total intravaginal.

Detailed Description:

The purpose of this study is to demonstrate that the new formulation of L. crispatus CTV-05 (LACTIN-V) is safe and well tolerated in healthy pre-menopausal women when administered vaginally via a pre-filled applicator at a dose of 5.0 x 10^8, 1.0 x 10^9 or 2.0 x 10^9 cfu/dose daily for 5 consecutive days as compared to a placebo control substance containing maltodextrin and a preservation matrix. 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.

The study will also evaluate the tolerability and acceptability of LACTIN-V in a pre-filled applicator by:

  • The proportion of participants who discontinue study product use due to overt adverse events
  • The proportion of participants who adhere to the complete dosing schedule
  • Self-administered questionnaires and focus group discussions about acceptability of the study product
  Eligibility

Ages Eligible for Study:   18 Years to 40 Years
Genders 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 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00537576

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

Publications:

Responsible Party: Peter Lee, MD, Osel, Inc.
ClinicalTrials.gov Identifier: NCT00537576     History of Changes
Other Study ID Numbers: LV-005
Study First Received: September 27, 2007
Last Updated: May 6, 2009
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Vaginosis, Bacterial
Bacterial Infections
Vaginitis
Vaginal Diseases
Genital Diseases, Female

ClinicalTrials.gov processed this record on August 27, 2014