About this trial
Many birth control options today come with unwanted side effects or risks. Hormonal methods can affect both mental and physical health, while devices like copper IUDs carry risks such as uterine perforation or infection. This study is testing a new option: a copper vaginal ring (CVR) - a non-hormonal, non-invasive contraceptive that can be self-inserted, similar to a other vaginal rings like NuvaRing or Annovera.
The main goal of this study is to assess whether the copper vaginal ring is safe to use. Researchers will also look at how comfortable and easy it is to use, whether participants follow the instructions, and how much copper accumulates in cervical mucus and vaginal fluid during use.
The study will enroll 8 women of childbearing age. Participants wear the ring continuously for 28 days, inserting it on Day 5 of their menstrual cycle. Over the course of the study, participants will attend 8 in-person clinic visits, which include pelvic exams, vaginal swabs, blood draws, and cervical mucus collection. On the day the ring is removed (Day 28), small tissue samples (biopsies) are taken from the vagina and uterine lining. At the end of the study, participants will complete a short survey about their experience with the ring.
Eligibility criteria
Qualifiers
Biological female
Age >18
Premenopausal women
Regular, normal, cyclic menses, with a usual length of 21 to 35 days
Disqualifiers
Use of oral contraceptives, Copper-IUD, hormonal-IUD, another intravaginal contraceptive device, or any other method of female birth control within 3 months prior to study enrollment
Postmenopausal
Biological male
Positive urine pregnancy test at screening visit
Trial design
Treatments tested in this trial
- Vaginal Ring