Safety of a Contraceptive Copper Vaginal Ring

Sponsor
Elle, MD Biotechnologies Inc.
Study ID
NCT07666997
Status
Not Yet Recruiting

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Conditions

  • Birth Control
  • Contraception
  • Pregnancy Prevention

Eligibility Criteria

Sex
FEMALE
Age
18 Years - 50 Years
Healthy Volunteers
Accepted

Interventions

  • Vaginal Ring — DEVICE
    The copper vaginal ring (CVR) is a non-hormonal vaginal ring designed for prevention of pregnancy

Study Details

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.

Key Dates

First listed
Jun 24, 2026
Start date
Oct 1, 2026
Status verified
Jun 2026
Primary completion
Feb 28, 2027
Completion
Apr 30, 2027

Study Design

Enrollment
8 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER

Arms

  • Experimental: CVR
    Participants in the CVR arm will use the Copper Vaginal Ring for 28 days

Primary Outcome Measure

Adverse Events [Safety] [ Time Frame: From enrollment to the end of treatment on Day 35 ]

Central Contacts

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