Contraceptive Usage Clinical Trial
Official title:
Phase I, 90-Day Safety, Pharmacokinetic, And Pharmacodynamic Study Of Intravaginal Rings Releasing Tenofovir And Levonorgestrel
This multi-center Phase I study is designed to characterize the safety, PK, and PD of TFV/LNG IVR to assess systemic and genital tract bioavailability in healthy women. The IVRs to be used in the study are TFV/LNG IVR (8-10mg per day/20μg per day) or placebo IVR. Samples will be obtained before, during and after 90 days of continuous or interrupted IVR use.
The purpose of this multi-center Phase I protocol, titled Phase I, 90-Day Safety,
Pharmacokinetic, and Pharmacodynamic Study of Intravaginal Rings Releasing Tenofovir and
Levonorgestrel is to assess the safety, pharmacokinetics (PK), and pharmacodynamics (PD) of
the Tenofovir/Levonorgestrel Intravaginal Ring (TFV/LNG IVR).
The study will enroll healthy, non-pregnant, ovulatory, HIV-uninfected women aged 18 to 50
with a body mass index (BMI) less than 30 kg/m2, regular menstrual cycles (approximately
26-35 days) by participant report, and willing to use non-spermicidal condoms for sex and
follow other study restrictions. Women will be protected from pregnancy by abstinence from
vaginal intercourse or agreeing to consistently use condoms.
The enrollment goal is for approximately 60 participants to complete the study. A subset of
approximately 20 women will be selected for an in-depth interview to take place during the
first month of IVR use and again after 90 days of use.
Women will be randomized to one of four arms: TFV/LNG IVR (8-10mg per day/20μg per day) for
90 days (Continuous), TFV/LNG IVR (8-10mg per day/20μg per day) for 3x28 days (Interrupted),
placebo IVR for 90 days (Continuous), or placebo IVR for 3x28 days (Interrupted) and will
undergo blood, cervicovaginal and rectal fluid sample collections, and cervicovaginal tissue
collections for PK and PD assessments before, during and after 90 days of continuous or
interrupted IVR use.
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