PK Study of 90-Day Use of Vaginal Rings Containing Dapivirine and Levonorgestrel

Phase 1 Completed 25 enrolled International Partnership for Microbicides, Inc. Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) · collab National Institute of Allergy and Infectious Diseases (NIAID) · collab National Institute of Mental Health (NIMH) · collab National Institutes of Health (NIH) · collab

RandomizedParallel-groupOpen-labelOther

Summary

This is a Phase I single-center, two-arm, open-label, randomized study in healthy HIV-negative women to evaluate the pharmacokinetics, safety, and bleeding patterns associated with 90-day use of matrix vaginal rings containing 200 mg Dapivirine and 320 mg Levonorgestrel.

Timeline

Start: 2018-07-17
Primary completion: 2019-08-30
Completion: 2019-10-07

Publications

Friedland BA, Gundacker H, Achilles SL, Chen BA, Hoesley C, Richardson BA, Kelly CW, Piper J, Johnson S, Devlin B, Steytler J, Kleinbeck K, Dangi B, Friend C, Song M, Mensch B, van der Straten A, Jacobson C, Hendrix CW, Brown J, Blithe D, Hiller SL; MTN-030/IPM 041 and MTN-044/IPM 053/CCN019 Protocol Teams for the Microbicide Trials Network and the Contraceptive Clinical Trials Network. 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. PLoS One. 2025 Jan 14;20(1):e0312957. doi: 10.1371/journal.pone.0312957. eCollection 2025.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Levonorgestrel	Small molecule	320 mg	Other
Subject	dapivirine	Small molecule	200 mg	Other

Indications

No indication recorded.