PK and Safety Study of Vaginal Rings Containing Dapivirine and Levonorgestrel

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02855346

Acronym

DAP/LNG

Enrollment

Registered

2016-08-04

Start date

2017-05-03

Completion date

2017-08-18

Last updated

2018-05-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

HIV Prevention

Brief summary

PK and Safety Study of Vaginal Ring Containing Dapivirine and Levonorgestrel

Detailed description

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

Interventions

COMBINATION_PRODUCT200 mg of DPV + 320 mg LNG

DPV VR, containing 200 mg DPV

COMBINATION_PRODUCT200 mg of DPV

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

Study design

Allocation

RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

PREVENTION

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 45 Years

Healthy volunteers

Yes

Inclusion criteria

* Healthy women

Exclusion criteria

* HIV infected women

Design outcomes

Primary

Measure	Time frame	Description
Dapivirine and levonorgestrel concentrations in blood and Vaginal fluid	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

Measure	Time frame	Description
Grade 2 or higher Genitourinary adverse event and Grade 3 or higher adverse event as defined by DAIDS	14 days	To evaluate the safety of one dapivirine vaginal ring formulation and one dapivirine-levonorgestrel vaginal ring formulations used continuously for 14 days

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026