deltatrials
Completed PHASE4 INTERVENTIONAL 1-arm 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

Sponsor: Lupin Research Inc

Conditions Bacterial Vaginoses
Interventions Secnidazole
Updated 7 times since 2019 Last updated: Dec 16, 2020 Started: Nov 28, 2018 Primary completion: Nov 5, 2020 Completion: Nov 5, 2020
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

This PHASE4 trial investigates Bacterial Vaginoses and is currently completed. Lupin Research Inc leads this study, which shows 7 recorded versions since 2018 — indicating limited longitudinal coverage. Longitudinal tracking of infectious disease trials helps identify durability of treatment effects.

Status Flow

~Jun 2019 – ~Sep 2019 · 3 months · monthly snapshotRecruiting~Sep 2019 – ~May 2020 · 8 months · monthly snapshotRecruiting~May 2020 – ~Nov 2020 · 6 months · monthly snapshotRecruiting~Nov 2020 – ~Jan 2021 · 2 months · monthly snapshotRecruiting~Jan 2021 – ~Jul 2024 · 42 months · monthly snapshotCompleted~Jul 2024 – ~Sep 2024 · 2 months · monthly snapshotCompleted~Sep 2024 – present · 22 months · monthly snapshotCompleted

Change History

7 versions recorded

  1. Sep 2024 — Present [monthly]

    Completed PHASE4

  2. Jul 2024 — Sep 2024 [monthly]

    Completed PHASE4

  3. Jan 2021 — Jul 2024 [monthly]

    Completed PHASE4

    Status: Recruiting → Completed

  4. Nov 2020 — Jan 2021 [monthly]

    Recruiting PHASE4

  5. May 2020 — Nov 2020 [monthly]

    Recruiting PHASE4

▶ Show 2 earlier versions

  1. Sep 2019 — May 2020 [monthly]

    Recruiting PHASE4

  2. Jun 2019 — Sep 2019 [monthly]

    Recruiting PHASE4

    First recorded

Nov 2018

Trial started

Per CT.gov start date — pre-dates our first snapshot

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:
  • Lupin Research Inc
Data source: Lupin Research Inc

For direct contact, visit the study record on ClinicalTrials.gov .

Study Locations