Safety of a Contraceptive Copper Vaginal Ring

NCT07666997 | Not Yet Recruiting

• 1 other identifier: EMD-CIP-001
• Study Type: interventional
• Target: 8
• Locations: 0 countries
• Sites: N/A

Brief 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

Keywords

Non-hormonal; Vaginal ring

Outcome Measures

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.

  From enrollment to the end of treatment on Day 35

Secondary Outcomes (2)

• Acceptability/Tolerability of the Device

  Assessed on Day 28 upon removal of the device

• Device Malfunctions and Complications [Safety]

  From enrollment to the end of treatment on Day 35

Study Arms (1)

CVR

EXPERIMENTAL

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

Device: Vaginal Ring

Interventions

Vaginal Ring DEVICE

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

CVR

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Biological female
• Age \>18
• Premenopausal women
• Regular, normal, cyclic menses, with a usual length of 21 to 35 days
• Willing to give voluntary consent, sign an informed consent form and comply with study procedures as required by the protocol

You may not qualify if:

• 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
• Use of hormone therapy; injectable within the past 6 months; implantable within the past 3 months;
• Presence of a vaginal/cervical/uterine anomaly or a diagnosed pathology that effects the vaginal cavity and may impair the ability to safely insert/remove a vaginal ring.
• The presence of certain conditions of relevance to vaginal ring use, such as cervicitis, vaginitis or bleeding cervical erosion; lichen sclerosis, lichen planus or vaginismus; Papanicolau (PAP) grade III-V cervical smear result; prolapse of uterine cervix, cystocele and/or rectocele; severe or chronic constipation, dyspareunia or other coital problems; .
• History or current diagnosis of any of the following:
• gynecological cancer
• fibroids
• polycystic ovary syndrome
• Past exposure to radiation therapy to the pelvis, or planned radiation therapy to the pelvis during the study;
• Current diagnosis of a sexually transmitted disease;
• Wilson's Disease;
• Known allergy to metal or silicone

Sponsors & Collaborators

• Elle, MD Biotechnologies Inc.: lead

MeSH Terms

Interventions

Contraceptive Devices, Female

Intervention Hierarchy (Ancestors)

Contraceptive Devices; Equipment and Supplies

Study Officials

• Sukhbir Singh, MD

  The Ottawa Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Teresa Flaxman, PhD

CONTACT

(613)738-8400; tflaxman@ohri.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 16, 2026
• First Posted: June 24, 2026
• Study Start (Estimated): October 1, 2026
• Primary Completion (Estimated): February 28, 2027
• Study Completion (Estimated): April 30, 2027
• Last Updated: June 24, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share