NCT02235662

Phase I One-month Safety, PK, PD, and Acceptability Study of IVR Releasing TFV and LNG or TFV Alone

Phase I One-Month Safety, Pharmacokinetic, Pharmacodynamic, and Acceptability Study of Intravaginal Rings Releasing Tenofovir and Levonorgestrel or Tenofovir Alone

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 86 (actual)
• Sponsor: CONRAD · Academic / Other
• Sex: Female
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

The purpose of the study is to evaluate the safety of the TFV/LNG intravaginal ring (IVR), TFV-only IVR, and placebo IVR, evaluate pharmacokinetics (PK) of TFV and LNG, evaluate pharmacodynamic (PD) surrogates of contraceptive efficacy of LNG, and to evaluate acceptability of the IVRs.

Conditions

• HIV
• Contraception

Interventions

Type	Name	Description
DRUG	TFV IVR
DRUG	TFV/LNG IVR
OTHER	Placebo IVR

Timeline

• Start date: 2014-10-01
• Primary completion: 2015-12-01
• Completion: 2015-12-01
• First posted: 2014-09-10
• Last updated: 2016-01-11

Locations

2 sites across 2 countries: United States, Dominican Republic