NCT00537576

Safety Study of Lactobacillus Administered Vaginally to Healthy Women

A Phase I Study of the Safety of LACTIN-V Administered Vaginally to Healthy Women

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 12 (actual)
• Sponsor: Osel, Inc. · Industry
• Sex: Female
• Age: 18 Years – 40 Years
• Healthy volunteers: Accepted

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.

Detailed description

The purpose of this study is to demonstrate that LACTIN-V is safe, well tolerated, and acceptable to healthy pre-menopausal women when administered vaginally using pre-filled applicators at doses of 150 mg (5.0 x 10\^8 CFU), 300 mg (1.0 x 10\^9 CFU), or 600 mg (2.0 x 10\^9 CFU) daily for 5 consecutive days as compared to placebo applicators containing 150 mg, 300 mg, or 600 mg of a matching placebo formulation without Lactobacillus crispatus CTV-05. 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

• Bacterial Vaginosis

Interventions

Type	Name	Description
BIOLOGICAL	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
BIOLOGICAL	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
BIOLOGICAL	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
OTHER	Low dose Placebo applicator	Low dose Placebo applicator (150 mg Placebo), administered vaginally once a day for 5 consecutive days
OTHER	Medium dose Placebo	Medium dose Placebo applicator (300 mg Placebo), administered vaginally once a day for 5 consecutive days
OTHER	High dose Placebo applicator	High dose Placebo applicator (600 mg Placebo), administered vaginally once a day for 5 consecutive days

Timeline

• Start date: 2007-11-01
• Primary completion: 2008-03-01
• Completion: 2008-04-01
• First posted: 2007-10-01
• Last updated: 2020-09-16
• Results posted: 2020-09-16

Locations

1 site across 1 country: United States