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NCT02855346: DAP/LNG

PK and Safety Study of Vaginal Rings Containing Dapivirine and Levonorgestrel

Completed Phase 1 Last updated 22 May 2018
What this trial tests

Phase 1 trial testing 200 mg of DPV + 320 mg LNG in HIV Prevention in 24 participants. Completed in 18 August 2017.

Timeline
3 May 2017
Primary endpoint
18 August 2017
18 August 2017

Quick facts

Lead sponsorInternational Partnership for Microbicides, Inc.
PhasePhase 1
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designsingle group
Maskingnone
Primary purposeprevention
Enrollment24
Start date3 May 2017
Primary completion18 August 2017
Estimated completion18 August 2017
Sites2 locations across United States

Drugs / interventions tested

Conditions studied

Sponsor

International Partnership for Microbicides, Inc. — full company profile →

Who can join

Adults 18 to 45, female only, with HIV Prevention. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

PK and Safety Study of Vaginal Ring Containing Dapivirine and Levonorgestrel

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Acceptability of a dapivirine levonorgestrel vaginal ring in two Phase 1 trials (MTN-030/IPM 041 and MTN-044/IPM 053/CCN019): Implications for multipurpose prevention technology development.
    Friedland BA, Gundacker H, Achilles SL, Chen BA, et al · · 2025 · cited 4× · PMID 39808648 · DOI 10.1371/journal.pone.0312957
  2. Phase 1 randomized trials to assess safety, pharmacokinetics, and vaginal bleeding associated with use of extended duration dapivirine and levonorgestrel vaginal rings.
    Achilles SL, Kelly CW, Hoesley CJ, Blithe DL, et al · · 2024 · cited 4× · PMID 38838028 · DOI 10.1371/journal.pone.0304552

Verify or expand the search:

Other recruiting trials for HIV Prevention

Currently open trials in the same condition.

Other International Partnership for Microbicides, Inc. trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02855346.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing