PK and Safety Study of Vaginal Rings Containing Dapivirine and Levonorgestrel

Phase 1CompletedNCT02855346

International Partnership for Microbicides, Inc.24 enrolled

Overview

PK and Safety Study of Vaginal Ring Containing Dapivirine and Levonorgestrel

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Enrollment

Conditions

HIV Prevention

Interventions

200 mg of DPV + 320 mg LNGCOMBINATION_PRODUCT

DPV VR, containing 200 mg DPV

200 mg of DPVCOMBINATION_PRODUCT

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

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 45 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Healthy women Exclusion Criteria: * HIV infected women

Locations (2)

University of Alabama Hospital

Birmingham, Alabama, United States

Magee Women's Hospital of UPMC

Pittsburgh, Pennsylvania, United States

Outcomes

Primary Outcomes

Dapivirine and levonorgestrel concentrations in blood and Vaginal fluid

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

Time frame: 14 days

Secondary Outcomes

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

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

Time frame: 14 days

Data from ClinicalTrials.gov

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