Dapivirine + Levonorgestrel Vaginal Rings for Bleeding, Pharmacokinetics, and Safety Concerns

Recruiting in Palo Alto (17 mi)

+1 other location

Age: 18 - 65

Sex: Female

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1 & 2

Waitlist Available

Sponsor: International Partnership for Microbicides, Inc.

No Placebo Group

Trial Summary

What is the purpose of this trial?This trial tests two types of vaginal rings that release medications. It focuses on healthy, HIV-negative women to see if the rings are safe and effective. The rings release one medication to help prevent HIV and another to control menstrual bleeding and prevent pregnancy.

Eligibility Criteria

This trial is for individuals assigned female at birth, aged 18-45, who are in good health and not currently pregnant or breastfeeding. Participants must have regular menstrual cycles, be HIV-negative with an intact uterus and at least one ovary, and agree to avoid certain medications that interact with the study drugs. They should not use hormonal contraceptives recently or have a history of significant allergies to the study products.

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

Able and willing to provide written informed consent to be screened for and enrolled in the CCN019B study

You consistently and correctly use male condoms during sexual activity.

+19 more

Exclusion Criteria

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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

Known adverse reaction to any component of the study product (ever)

+24 more

Participant Groups

The trial is testing two different vaginal ring formulations containing Dapivirine and Levonorgestrel (IPM Ring-105 and IPM Ring-106) over a period of 90 days. It's designed to measure how these rings affect local tissues as well as their overall safety when used consistently.

2Treatment groups

Experimental Treatment

Active Control

Group I: IPM Ring-105Experimental Treatment1 Intervention

Ring-105 (xx mg dapivirine + xxx mg levonorgestrel)

Group II: IPM Ring-106.Active Control1 Intervention

Ring-106 (xx mg dapivirine + xxx mg levonorgestrel)