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NCT07666997

Safety of a Contraceptive Copper Vaginal Ring

Sponsor: Elle, MD Biotechnologies Inc.

View on ClinicalTrials.gov

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.

Official title: Prospective Elavulation of the Safety of a Novel Copper Vaginal Contraceptive Ring (CVR)

Key Details

Gender

FEMALE

Age Range

18 Years - 50 Years

Study Type

INTERVENTIONAL

Enrollment

Start Date

2026-10-01

Completion Date

2027-04-30

Last Updated

2026-06-24

Healthy Volunteers

Yes

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

Inclusion Criteria: * 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 Exclusion Criteria: * 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 * Had an abortion or breastfeeding within 2 months before the start of the trial; * Presence of a significant medical condition or health concern that, in the opinion of the investigator, may impact the patient's safety or the study's outcomes; * A condition that, in the opinion of the investigator, precludes the patient from being able to provide informed consent; * Inability or unwillingness to refrain from using a tampon/menstrual cup for the duration of the study. * Known inability to tolerate products/devices in the vagina (i.e., tampons, menstrual cups, vaginal rings, etc.)