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.
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
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
QUADRUPLE
Enrollment
12
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
San Francisco General Hospital
San Francisco, California, United States
Safety of LACTIN-V in Healthy Pre-menopausal Women.
Safety was measured by comparing the number of women experiencing adverse events of grade 3 or higher during the study.
Time frame: 35 days
Tolerability of LACTIN-V in a Pre-filled Applicator.
Tolerability was measured as proportion of women remaining in the study, and NOT prematurely exiting the trial due to an adverse event.
Time frame: 35 days
Acceptability of LACTIN-V in Pre-filled Applicators
Acceptability and overall satisfaction with the study product was measured using the response to the following question: "I would use the product again" with the following response options (strongly agree, agree, neutral, disagree, strongly disagree) Acceptability is reported as the number of women in each group who strongly agreed or agreed with the statement that they would use the product again.
Time frame: 35 days
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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