Sponsor study identifier
interventional
66
2 countries
2
Study Start
September 28, 2017
Actual (reported)Primary Completion
December 26, 2018
Actual (reported)Study Completion
December 26, 2018
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 26, 2018
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
August 23, 2017
Actual (reported)September 12, 2017
Actual (reported)September 28, 2017
Actual (reported)December 26, 2018
Actual (reported)December 26, 2018
Actual (reported)Percentage of women with Treatment-emergent adverse events
Treatment-emergent adverse events (TEAEs)
Day 90
Changes in systemic laboratory values
Systemic laboratory values
Change from Baseline at Day 90
Changes in cervicovaginal mucosa by visual inspection
Mucosal safety
Change from Baseline at Day 90
TFV/LNG IVR is an intravaginal ring 55.0 mm in diameter, consisting of two segments of polyurethane tubing with an outer cross-sectional diameter of 5.5 mm: a longer segment (135 mm) containing white to off-white TFV paste and a shorter one (34 mm) with a translucent LNG core. Used for 90 days (continuous).
TFV/LNG IVR is an intravaginal ring 55.0 mm in diameter, consisting of two segments of polyurethane tubing with an outer cross-sectional diameter of 5.5 mm: a longer segment (135 mm) containing white to off-white TFV paste and a shorter one (34 mm) with a translucent LNG core. Used for 90 days (3x28 days interrupted).
Used for 90 days (Continuous or Interrupted)
Used for 90 days (Continuous or Interrupted)
Eastern Virginia Medical School
Norfolk, Virginia, 23507-1627, United States
Profamilia
Santo Domingo, Dominican Republic
Thurman AR, Brache V, Cochon L, Ouattara LA, Chandra N, Jacot T, Yousefieh N, Clark MR, Peet M, Hanif H, Schwartz JL, Ju S, Marzinke MA, Erikson DW, Parikh U, Herold BC, Fichorova RN, Tolley E, Doncel GF. Randomized, placebo controlled phase I trial of the safety, pharmacokinetics, pharmacodynamics and acceptability of a 90 day tenofovir plus levonorgestrel vaginal ring used continuously or cyclically in women: The CONRAD 138 study. PLoS One. 2022 Oct 10;17(10):e0275794. doi: 10.1371/journal.pone.0275794. eCollection 2022.
Tolley EE, Zissette S, Taylor J, Hanif H, Ju S, Schwarz J, Thurman A, Tyner D, Brache V, Doncel GF. Acceptability of a Long-Acting, Multipurpose Vaginal Ring: Findings from a Phase I Trial in the U.S. and Dominican Republic. J Womens Health (Larchmt). 2022 Sep;31(9):1343-1352. doi: 10.1089/jwh.2021.0394. Epub 2022 Apr 1.
study director
CONRAD
66 participants (actual enrollment reported by the registry).
First Submitted
August 23, 2017
First Posted
September 12, 2017
Study Start
September 28, 2017
Actual (reported)PK Study of 90-Day Use of Vaginal Rings Containing Dapivirine and Levonorgestrel
Changes in soluble markers
Soluble markers in cervicovaginal fluid
Change from Baseline at Day 90
Changes in inflammatory markers in cervicovaginal tissue
Inflammatory markers in cervicovaginal tissue
Change from Baseline at Day 90
Changes in endogenous vaginal bacteria
Endogenous vaginal bacteria in cervicovaginal fluid
Change from Baseline at Day 90
Microbial growth
Microbial growth on returned IVRs
Day 90
Maximum Plasma Concentrations [Cmax]
Baseline, 8 hours post-IVR insertion, Day 2 or 3 or 4 (randomized time point), 10, 21, 28, 32, 42, 53, 59, 63, 73, 84, 90; and 48 or 72 hours or 5 days after IVR removal (randomized time point)
Maximum CV Fluid Concentrations
2 and 8 hours post-IVR insertion, Day 2 or 3 or 4 (randomized time point), 10, 21, 32, 42, 53, 63, 73, 84; and 48 or 72 hours or 5 days after IVR removal (randomized time point)
Maximum Rectal Fluid Concentrations
Day 2 or 3 or 4 (randomized time point), 21, 53, 84; and 48 or 72 hours or 5 days after IVR removal (randomized time point)
Maximum CV Tissue Concentrations
Changes from baseline at day 90; and 48 or 72 hours or 5 days after IVR removal (randomized time point)
Maximum CV Tissue Metabolite Concentrations
Changes from baseline at day 90; and 48 or 72 hours or 5 days after IVR removal (randomized time point)
Antiviral activity in Rectal Fluid--HIV
Changes from baseline at day 90
Antiviral activity in Rectal Fluid--HSV-2
Changes from baseline at day 90
Changes in Antiviral Activity--HSV-2
Changes from baseline at day 90
Intravaginal ring 55.0 mm in diameter, consisting of two segments of polyurethane tubing with an outer diameter of 5.5 mm containing no active experimental ingredients. Used for one month. Used for 90 days (continuous).
Intravaginal ring 55.0 mm in diameter, consisting of two segments of polyurethane tubing with an outer diameter of 5.5 mm containing no active experimental ingredients. Used for one month. Used for 90 days (3x28 days interrupted).
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
Thurman AR, Ravel J, Gajer P, Marzinke MA, Ouattara LA, Jacot T, Peet MM, Clark MR, Doncel GF. Vaginal Microbiota and Mucosal Pharmacokinetics of Tenofovir in Healthy Women Using a 90-Day Tenofovir/Levonorgestrel Vaginal Ring. Front Cell Infect Microbiol. 2022 Mar 8;12:799501. doi: 10.3389/fcimb.2022.799501. eCollection 2022.
Primary Completion
December 26, 2018
Actual (reported)Study Completion
December 26, 2018
Actual (reported)Last Updated
July 23, 2019
Record last verified: 2019-07
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Source: ClinicalTrials.gov.
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