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Completed

NCT Number: NCT02855346

PK and Safety Study of Vaginal Rings Containing Dapivirine and Levonorgestrel

PK and Safety Study of Vaginal Ring Containing Dapivirine and Levonorgestrel

Completed

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Key information

Conditions

HIV Prevention

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 1

Primary location

University of Alabama Hospital, Birmingham, Alabama, United States

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About this study

A Phase 1, Randomized, Double-Blind Pharmacokinetic and Safety Study of Dapivirine/Levonorgestrel

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Healthy women

Exclusion criteria

  • HIV infected women

Treatment and study plan

200 mg of DPV + 320 mg LNG

Combination Product

DPV VR, containing 200 mg DPV

Other names: Dapivirine

200 mg of DPV

Combination Product

DPV-LNG VR, containing 200 mg of DPV + 320 mg LNG

Other names: Dapivirine/Levonorgestrel

Primary outcomes

  1. Dapivirine and levonorgestrel concentrations in blood and Vaginal fluid

    Time frame: 14 days

    To characterize the local and systemic pharmacokinetics of one dapivirine vaginal ring formulation and one dapivirine-levonorgestrel vaginal ring formulations used continuously for 14 days

Secondary outcomes

  1. Grade 2 or higher Genitourinary adverse event and Grade 3 or higher adverse event as defined by DAIDS

    Time frame: 14 days

    To evaluate the safety of one dapivirine vaginal ring formulation and one dapivirine-levonorgestrel vaginal ring formulations used continuously for 14 days

Sponsors and collaborators

Lead sponsor

International Partnership for Microbicides, Inc.

Industry

Collaborators

  • National Institutes of Health (NIH)

Registry information

Official study title

A Phase 1, Randomized, Double-Blind Pharmacokinetic and Safety Study of Dapivirine/Levonorgestrel Vaginal Rings

Acronym: DAP/LNG

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
Aug 4, 2016
Registry last updated
May 22, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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