A Randomized Open Label Crossover Trial to Assess Performance Attributes and Acceptability of Non-medicated Intravaginal Rings Among Sexually Active Women in Atlanta, GA
Population Council
Summary
A randomized open label crossover trial to assess performance attributes and acceptability of non-medicated intravaginal rings among sexually active women in Atlanta, GA
Eligibility
- Age range
- 18–49 years
- Sex
- Female
- Healthy volunteers
- Yes
Inclusion Criteria: * 1\. Cisgender female aged 18-49 years old, inclusive, at screening based on self-report. 2\. Sexually active, defined as having penile-vaginal sex at least once a week, on average, over the past three months with the same male partner, and intends to continue having sexual intercourse at the current frequency for at least three months. 3\. Healthy based on medical history, physical exam (including pelvic exam with visual inspection) at screening. 4\. Using effective non-vaginal method of contraception (oral contraception, injectable, patch, IUD, sterilization, m…
Interventions
- DevicePro-type IVR
Women will test three non-medicated IVRs on two one-day clinic visits (two on the first day, one on the second day) by manipulating them, vaginally inserting each ring and then performing a controlled set of tasks simulating routine daily activities with the ring in the vagina.
Location
- Emory UniversityAtlanta, Georgia