drugset / Trial / NCT02010593
Safety and Pharmacokinetics of Dapivirine Vaginal Ring in Post-menopausal Women
Phase 2
Completed
96 enrolled
International Partnership for Microbicides, Inc.
National Institute of Allergy and Infectious Diseases (NIAID) · collab
RandomizedParallel-groupDouble-blindPrevention
Summary
This study will evaluate the safety of the dapivirine vaginal ring when inserts once every 4 weeks in postmenopausal women over 12 weeks of product use.
Timeline
- Start
- 2013-12
- Primary completion
- 2015-04
- Completion
- 2015-04
Publications
- Shapley-Quinn MK, Laborde N, Luecke E, Hoesley C, Salata RA, Johnson S, Nel A, Soto-Torres L, Chen BA, van der Straten A. Acceptability of the Dapivirine Vaginal Ring in Postmenopausal US Women. AIDS Patient Care STDS. 2022 Mar;36(3):97-105. doi: 10.1089/apc.2022.0002.
- Chen BA, Zhang J, Gundacker HM, Hendrix CW, Hoesley CJ, Salata RA, Dezzutti CS, van der Straten A, Hall WB, Jacobson CE, Johnson S, McGowan I, Nel AM, Soto-Torres L, Marzinke MA; MTN-024/IPM 031 Protocol Team for the Microbicide Trials Network. Phase 2a Safety, Pharmacokinetics, and Acceptability of Dapivirine Vaginal Rings in US Postmenopausal Women. Clin Infect Dis. 2019 Mar 19;68(7):1144-1151. doi: 10.1093/cid/ciy654.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | dapivirine | Small molecule | 25 mg | — |