NCT03937869

Evaluate the Safety of a Single Oral Dose of Solosec™ (Secnidazole) 2g for the Treatment of Adolescent Girls With BV

A Multi-Center, Open-Label Study to Evaluate the Safety of a Single Oral Dose of Solosec™ (Secnidazole) 2g Oral Granules for the Treatment of Adolescent Girls With Bacterial Vaginosis

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: Lupin Research Inc · Industry
• Sex: Female
• Age: 12 Years – 17 Years
• Healthy volunteers: Accepted

Summary

A multi-center, open-label study to evaluate the treatment of one oral dose of 2g Solosec™ (Secnidazole) in adolescent girls with BV

Detailed description

This is a multi-center, open-label study to evaluate the safety of Solosec in adolescent girls with bacterial vaginosis. Approximately 40 patients will be enrolled. Patients determined to be eligible at the Baseline Visit (Day 1) will receive a single oral dose of Solosec™ granules (containing 2 grams of secnidazole) on Day 1. Patients will return to the site once between Days 7-14 for a "test of cure" (TOC) Visit. A follow-up telephone call will be performed at Days 21-30 to assess the continued clinical response to treatment and adverse events.

Conditions

• Bacterial Vaginoses

Interventions

Type	Name	Description
DRUG	Secnidazole	One dose

Timeline

• Start date: 2018-11-28
• Primary completion: 2020-11-05
• Completion: 2020-11-05
• First posted: 2019-05-06
• Last updated: 2020-12-19

Locations

9 sites across 1 country: United States

Regulatory

• FDA-regulated drug study