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PK, Safety Study of 90-Day Use of Vaginal Rings Containing Dapivirine and Levonorgestrel

NCT05041699 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2026-04-01

No results posted yet for this study

Summary

A double-blind, randomized trial (1:1) to characterize the local and systemic pharmacokinetics (PK) of two DPV-LNG vaginal ring formulations

Conditions

  • Pharmacokinetics
  • Safety Issues
  • Bleeding

Interventions

COMBINATION_PRODUCT

IPM Ring-105

DPV-LNG Ring containing xx mg of dapivirine + xx mg of levonorgestrel

COMBINATION_PRODUCT

IPM Ring-106

DPV-LNG Ring containing xx mg of dapivirine + xx mg of levonorgestrel

Sponsors & Collaborators

  • Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

    collaborator NIH

  • National Institutes of Health (NIH)

    collaborator NIH

  • International Partnership for Microbicides, Inc.

    lead INDUSTRY

Principal Investigators

  • John Steytler, MBChB · IPM SA NPC

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-06-20
Primary Completion
2024-10-07
Completion
2024-10-07
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05041699 on ClinicalTrials.gov