Study of Non-medicated Intravaginal Rings to Evaluate Use and Comfort in Sexually Active Women Aged 18 to 49 in Atlanta

What this Trial Is About

This trial investigates the performance and acceptability of three different non-medicated intravaginal rings IVRs among sexually active women aged 18 to 49. The study aims to understand how these IVRs, made from different materials, are perceived and tolerated during typical daily activities. The trial is an early phase 1, randomized open-label crossover study focusing on contraceptive usage without medication. Participants will test three types of non-medicated IVRstwo made of silicone and one made of EVAacross two one-day clinic visits. On the first day, women will handle and vaginally insert two rings, performing tasks simulating daily activities on the second day, they will test the third ring. The study evaluates acceptability using the Intravaginal Ring Acceptability Scale IVR-AS over a treatment period of about 13 weeks. Women taking part will undergo screening including medical and pelvic exams to confirm health status and eligibility. During the study, they will be assessed on how acceptable each ring is and how well they perform, with mean acceptability scores measured from enrollment until the end of treatment. Participants must attend all study visits and follow IVR use instructions. The study includes monitoring for safety and adherence, lasting about 13 weeks in total.

Assess Performance Attributes and Acceptability of Non-medicated Intravaginal Rings Among Sexually Active Women in Atlanta, GA