At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase I Study of the Safety of LACTIN-V Administered Vaginally to Healthy Women
In Brief
A Phase 1 clinical trial evaluating Low dose LACTIN-V applicator, Medium dose LACTIN-V applicator, and 4 other interventions for Bacterial Vaginosis. Completed, enrolled 12 participants across 1 site.
Detailed 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.
Study Details
Timeline
Interventions
Low dose LACTIN-V applicator (150 mg LACTIN-V, 5.0 x 10\^8 CFU), administered vaginally once a day for 5 consecutive days
Medium dose LACTIN-V applicator (300 mg LACTIN-V, 1.0 x 10\^9 CFU), administered vaginally once a day for 5 consecutive days
High dose LACTIN-V applicator (600 mg LACTIN-V, 2.0 x 10\^9 CFU), administered vaginally once a day for 5 consecutive days
Low dose Placebo applicator (150 mg Placebo), administered vaginally once a day for 5 consecutive days
Medium dose Placebo applicator (300 mg Placebo), administered vaginally once a day for 5 consecutive days
High dose Placebo applicator (600 mg Placebo), administered vaginally once a day for 5 consecutive days