Who is sponsoring NCT02766023?

NCT02766023 is sponsored by National Institute of Allergy and Infectious Diseases (NIAID).

What condition does NCT02766023 study?

NCT02766023 studies Bacterial Vaginosis.

What drugs are being tested in NCT02766023?

Interventions: Lactobacillus crispatus CTV-05, Metronidazole, Placebo.

What is the status of NCT02766023?

NCT02766023 is currently COMPLETED.

Last reviewed 2020-03-04 · How we verify

LACTIN-V Study for Recurrent Bacterial Vaginosis

NCT02766023 PHASE2 COMPLETED Results posted

This Phase 2b trial is designed to provide a screening evaluation for the hypothesis that, following a 5-day treatment with MetroGel® to treat BV, L. crispatus CTV-05 (LACTIN-V, Osel, Inc.) administered at 2 x 10\^9 cfu/dose using a vaginal applicator reduces the 12-week incidence of BV recurrence when compared to placebo. The primary objectives of this study are: 1) To estimate the efficacy of repeated doses of LACTIN-V (2 x 10\^9 cfu/dose) as compared to placebo in preventing BV recurrence by 12 weeks following treatment of BV with MetroGel vaginal gel (MetroGel). 2) To assess the safety of LACTIN-V over 24 weeks by comparing the incidence of AEs between individuals randomized to LACTIN-V or placebo.

Details

Lead sponsor	National Institute of Allergy and Infectious Diseases (NIAID)
Phase	PHASE2
Status	COMPLETED
Enrolment	228
Start date	Fri Jun 03 2016 00:00:00 GMT+0000 (Coordinated Universal Time)
Completion	Mon Feb 11 2019 00:00:00 GMT+0000 (Coordinated Universal Time)

Conditions

Bacterial Vaginosis

Interventions

Lactobacillus crispatus CTV-05
Metronidazole
Placebo

Countries

United States