PK and Safety Study of Vaginal Rings Containing Dapivirine and Levonorgestrel
NCT ID: NCT02855346
Last Updated: 2018-05-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
24 participants
INTERVENTIONAL
2017-05-03
2017-08-18
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
SINGLE_GROUP
PREVENTION
NONE
Study Groups
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200 mg of DPV
Each participant will receive a VR containing either 200 mg DPV or 200 mg DPV + 320 mg LNG. Participants will be randomized in a 1:1 ratio. The VR should be worn for approximately 14 consecutive days +/-1 day. The ring will be removed by the participant (or clinician/designee, if necessary) at the Product Use End Visit (PUEV)/Early Termination Visit. The participant will be followed for approximately 2 days following VR removal
200 mg of DPV + 320 mg LNG
DPV VR, containing 200 mg DPV
200 mg of DPV + 320 mg LNG
Each participant will receive a VR containing either 200 mg DPV or 200 mg DPV + 320 mg LNG. Participants will be randomized in a 1:1 ratio. The VR should be worn for approximately 14 consecutive days +/-1 day. The ring will be removed by the participant (or clinician/designee, if necessary) at the Product Use End Visit (PUEV)/Early Termination Visit. The participant will be followed for approximately 2 days following VR removal
200 mg of DPV
DPV-LNG VR, containing 200 mg of DPV + 320 mg LNG
Interventions
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200 mg of DPV + 320 mg LNG
DPV VR, containing 200 mg DPV
200 mg of DPV
DPV-LNG VR, containing 200 mg of DPV + 320 mg LNG
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
18 Years
45 Years
FEMALE
Yes
Sponsors
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National Institutes of Health (NIH)
NIH
International Partnership for Microbicides, Inc.
INDUSTRY
Responsible Party
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Locations
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University of Alabama Hospital
Birmingham, Alabama, United States
Magee Women's Hospital of UPMC
Pittsburgh, Pennsylvania, United States
Countries
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References
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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.
Other Identifiers
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5UM1 A1068633
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
MTN-030/IPM 041
Identifier Type: -
Identifier Source: org_study_id
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