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Safety of a Contraceptive Copper Vaginal Ring

NCT07666997 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 8

Last updated 2026-06-24

No results posted yet for this study

Summary

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.

Conditions

  • Contraception
  • Birth Control
  • Pregnancy Prevention

Interventions

DEVICE

Vaginal Ring

The copper vaginal ring (CVR) is a non-hormonal vaginal ring designed for prevention of pregnancy

Sponsors & Collaborators

  • Elle, MD Biotechnologies Inc.

    lead INDUSTRY

Principal Investigators

  • Sukhbir Singh, MD · The Ottawa Hospital

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2026-10-01
Primary Completion
2027-02-28
Completion
2027-04-30

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07666997 on ClinicalTrials.gov