PK, Safety Study of 90-Day Use of Vaginal Rings Containing Dapivirine and Levonorgestrel (NCT05041699) | Clinical Trial Compass
CompletedPhase 1
PK, Safety Study of 90-Day Use of Vaginal Rings Containing Dapivirine and Levonorgestrel
United States40 participantsStarted 2022-06-20
Plain-language summary
A double-blind, randomized trial (1:1) to characterize the local and systemic pharmacokinetics (PK) of two DPV-LNG vaginal ring formulations
Who can participate
Age range18 Years – 45 Years
SexFEMALE
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Assigned female sex at birth Note: Participants who are female at birth, who now identify as male, will not be excluded so long as they are not currently or have not been on female-to-male transition therapy within 90 days prior to Enrollment
✓. Age 18 through 45 years (inclusive) at Screening
✓. Able and willing to provide written informed consent to be screened for and enrolled in the CCN019B study
✓. Able and willing to provide adequate locator/contact information
✓. Able to communicate in spoken and written English
✓. Available for all visits and able and willing to comply with all study procedures and requirements
✓. Willing to abstain from insertion of anything into the vagina (including receptive intercourse, tampons) for 24 hours preceding the Enrollment Visit and clinical visits where samples are taken
✓. Not at risk for pregnancy due to use of an effective nonhormonal method of contraception or practice per participant report at Enrollment, and intending to continue use of an effective, non-hormonal method for the duration of study participation. Effective methods and practices are defined as:
Exclusion criteria
✕. BMI greater than 40 kg/m2 at Screening visit
✕. Pregnant at Screening or Enrollment visits or plans to become pregnant during the study period Note: A documented negative pregnancy test performed by study staff is required for inclusion; however, a self-reported pregnancy is adequate for exclusion from the study.
✕. Diagnosed with symptomatic urinary tract infection (UTI) or reproductive tract infection (RTI) at Screening or Enrollment visits. Otherwise eligible participants diagnosed with symptomatic UTI/RTI during screening will be offered treatment. If treatment is complete and symptoms have resolved within the 90-day screening window, eligible participants may be enrolled.
✕. Diagnosed with an acute STI requiring treatment per current CDC guidelines (http://www.cdc.gov/std/treatment/) at Screening or Enrollment visits such as gonorrhea (GC), chlamydia, trichomonas, and/or pelvic inflammatory disease (PID) Note: Genital warts requiring treatment and greater than two disease flares of herpes simplex virus (HSV) within a year are considered exclusionary; however, infrequent HSV outbreaks are not. Genital warts requiring treatment are defined as those that cause undue burden or discomfort to the participant, including bulky size, unacceptable appearance, or physical discomfort. See IPM 056/CCN019B Study Manual for additional information.
✕. Has a clinically apparent Grade 2 or higher pelvic exam finding (observed by study staff) at Screening or Enrollment, as per the DAIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, Corrected Version 2.1, July 2017, and/or Addendum 1 (Female Genital Grading Table for Use in Microbicide Studies \[Dated November 2007\]) Note: Cervical bleeding associated with speculum insertion and/or specimen collection judged to be within the range of normal according to the clinical judgment of the IoR/designee is considered expected non-menstrual bleeding and is not exclusionary.
✕. Participant report and/or clinical evidence of any of the following:
✕. Known adverse reaction to any component of the study product (ever)
What they're measuring
1
Evaluate pharmacokinetics by assessing changes in baseline of DPV and LNG concentrations in plasma
Timeframe: 90 days (3 cycles, one cycle is approximately 30 days of continuous use)
2
Evaluate pharmacokinetics by assessing changes in baseline of DPV and LNG concentrations in cervicovaginal fluid
Timeframe: 90 days (3 cycles, one cycle is approximately 30 days of continuous use)
Trial details
NCT IDNCT05041699
SponsorInternational Partnership for Microbicides, Inc.