Safety of a Contraceptive Copper Vaginal Ring
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-50
SponsorElle, MD Biotechnologies Inc.
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
This trial accepts healthy volunteersQualifiers
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
Design model
Single group
Treatments tested in this trial
Vaginal Ring
DeviceThe copper vaginal ring (CVR) is a non-hormonal vaginal ring designed for prevention of pregnancy
Treatment groups
8 Participants
are divided into 1 treatment groupGroup A: CVRExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Adverse Events [Safety]
Safety of the CVR will be assessed by recording all adverse events (AEs). AEs will be recorded and categorized based on their relationship to the study device and their expectedness. Serious Adverse Events (SAEs) and Unanticipated Adverse Device Affects (UADEs) will be tracked and represent the key metrics for an "unsafe" outcome with device use. These outcomes will be obtained by patient reports.
Time frame
From enrollment to the end of treatment on Day 35Secondary outcomes
1
Acceptability/Tolerability of the Device
Acceptability and tolerability of device use, including ease of insertion, aspects liked most and least about the device, and comfort by both partners during intercourse with the device inserted will be assessed using a validated Vaginal Ring tolerability questionnaire. The questionnaire consists of 20 questions and all answers are scored on a 5-point likert scale. Higher scores equate to higher acceptability/tolerability of the ring.
Time frame
Assessed on Day 28 upon removal of the device2
Device Malfunctions and Complications [Safety]
Device malfunctions include problems with the ring's structural integrity, copper component dimensional/tolerance failures, material degradation, or problems with the packaging. Device-related complications refer to problems that are mechanical or physical in nature (such as expulsion), local tissue effects, copper-specific problems, partner/coitus-related complications, or infection attributable to the ring. These outcomes will be obtained by the principle investigator during physical exams and by patient reports.
Time frame
From enrollment to the end of treatment on Day 35Locations
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: