ContraceptionNCT07666997
Safety of a Contraceptive Copper Vaginal Ring
A study testing Vaginal Ring in people with Contraception and Birth Control, run by Elle, MD Biotechnologies Inc..
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Contraception, Birth Control, Pregnancy Prevention
- What is being tested?
- Vaginal Ring
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- No sites listed yet
- Study dates
- 15 Nov 2026to 30 Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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.
Show all 20Show fewer
- 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.)
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Prospective Evaluation of the Safety of a Novel Copper Vaginal Contraceptive Ring (CVR)
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 up to 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.
Read the detailed description
Current contraceptive options have a variety of unwanted risks and side effects. Hormonal options are among the most effective and widely used contraceptives but come with a long list of potential risks. Hormonal birth control can lead to impaired glucose metabolism, reduced bone mineral density, headaches, poor libido, irregular periods, depression and suicide. High efficacy contraceptive options (such as intrauterine devices; IUDs) have their own drawbacks. While IUDs are generally safe, they pose more serious risks such as infection, perforation of the uterine wall during insertion, or the IUD being expelled from the uterus. They also involve a medical procedure to insert and remove. Therefore, many women prefer less invasive options when considering birth control methods. There is a gap in the current options for non-hormonal birth control methods that are minimally invasive and pose few serious risks.
The copper vaginal ring (CVR) is a novel contraceptive device for the prevention of pregnancy. The copper ring utilizes a non-hormonal design and is anticipated to have fewer side effects than the copper IUD due to its placement further from the uterus, its shorter duration of use, and the fact that insertion does not require an invasive procedure.
The primary objective of this study is to determine the safety of a copper-containing vaginal ring in women. The secondary objectives of this study are to assess the fit, tolerability and adherence to copper vaginal ring instructions for use, and to determine what concentration of copper accumulates in the cervical mucus and vaginal fluid during use of the ring.
The study will enroll up to 8 women of childbearing age. All of the participants will use the study device for a duration of 28 days. Participants will come back to the clinic on day 5 of their cycle for a baseline assessment and to insert the ring. After 28 days of continuous use, all the participants will have their vaginal rings removed.
The study involves undergoing pelvic examinations, collection of vaginal fluid using vaginal swabs, collection of blood samples and cervical mucus before the trial starts (baseline), followed by pelvic exams, vaginal swabs, cervical mucus and blood collection occurring again at each of the 8 in-person visits. Visits occur at baseline, and on days 1, 2, 7, 14, 21, 28 and 35. On day 28, immediately after removal of the ring, biopsy samples from both the vagina and the endometrium will be taken.
At the end of the 28-day cycle, during the removal visit, all the participants will complete a survey with questions about the usability, tolerability, acceptability and adherence to use of the copper vaginal ring.
- Conditions
- Contraception, Birth Control, Pregnancy Prevention
- Being tested
- Vaginal Ring
- Keywords
- Non-hormonal, Vaginal ring
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vaginal RingDevice
The copper vaginal ring (CVR) is a non-hormonal vaginal ring designed for prevention of pregnancy
| Study group | Role | What they receive |
|---|---|---|
| CVR | Experimental | Participants in the CVR arm will use the Copper Vaginal Ring for 28 days Receives: Device: Vaginal Ring |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From enrollment to the end of study participation on Day 35
Secondary outcomes (2)
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.
Measured: Assessed during device use up to Day 28 upon removal of the device
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.
Measured: Assessed during device use up to Day 28 upon removal of the device
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2026
- Study start15 Nov 2026 (estimated)
- Primary completion30 Apr 2027 (estimated)
- Study completion30 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ContraceptionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 8 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Elle, MD Biotechnologies Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Ottawa Hospital Research Institute, National Research Council Canada
- Responsible party
- Sponsor
- Investigators
- Sukhbir Singh, MD, Principal investigator, The Ottawa Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07666997
- Sponsor's protocol ID
- EMD-CIP-001
- Status last verified
- Oct 2026
- First submitted
- 16 Jun 2026
- Last updated
- 19 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: This is an industry sponsored study and the results will be used to inform whether future studies of the device are warranted. IPD is unlikely to be shared with other researchers.
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Evaluation of the Safety of a Novel Copper Vaginal Contraceptive Ring (CVR)
- ClinicalTrials.gov ID
- NCT07666997
- Acronym / sponsor ID
- EMD-CIP-001
- Conditions
- Contraception, Birth Control, Pregnancy Prevention
- Keywords
- Non-hormonal, Vaginal ring
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 8 participants (estimated)
- Lead sponsor
- Elle, MD Biotechnologies Inc.Industry (pharma, biotech, devices)
- Collaborators
- Ottawa Hospital Research Institute, National Research Council Canada
- Study start
- 15 Nov 2026 (estimated)
- Primary completion
- 30 Apr 2027 (estimated)
- Study completion
- 30 Jun 2027 (estimated)
- First posted
- 24 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 up to 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.
Detailed description
Current contraceptive options have a variety of unwanted risks and side effects. Hormonal options are among the most effective and widely used contraceptives but come with a long list of potential risks. Hormonal birth control can lead to impaired glucose metabolism, reduced bone mineral density, headaches, poor libido, irregular periods, depression and suicide. High efficacy contraceptive options (such as intrauterine devices; IUDs) have their own drawbacks. While IUDs are generally safe, they pose more serious risks such as infection, perforation of the uterine wall during insertion, or the IUD being expelled from the uterus. They also involve a medical procedure to insert and remove. Therefore, many women prefer less invasive options when considering birth control methods. There is a gap in the current options for non-hormonal birth control methods that are minimally invasive and pose few serious risks.
The copper vaginal ring (CVR) is a novel contraceptive device for the prevention of pregnancy. The copper ring utilizes a non-hormonal design and is anticipated to have fewer side effects than the copper IUD due to its placement further from the uterus, its shorter duration of use, and the fact that insertion does not require an invasive procedure.
The primary objective of this study is to determine the safety of a copper-containing vaginal ring in women. The secondary objectives of this study are to assess the fit, tolerability and adherence to copper vaginal ring instructions for use, and to determine what concentration of copper accumulates in the cervical mucus and vaginal fluid during use of the ring.
The study will enroll up to 8 women of childbearing age. All of the participants will use the study device for a duration of 28 days. Participants will come back to the clinic on day 5 of their cycle for a baseline assessment and to insert the ring. After 28 days of continuous use, all the participants will have their vaginal rings removed.
The study involves undergoing pelvic examinations, collection of vaginal fluid using vaginal swabs, collection of blood samples and cervical mucus before the trial starts (baseline), followed by pelvic exams, vaginal swabs, cervical mucus and blood collection occurring again at each of the 8 in-person visits. Visits occur at baseline, and on days 1, 2, 7, 14, 21, 28 and 35. On day 28, immediately after removal of the ring, biopsy samples from both the vagina and the endometrium will be taken.
At the end of the 28-day cycle, during the removal visit, all the participants will complete a survey with questions about the usability, tolerability, acceptability and adherence to use of the copper vaginal ring.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CVR | Experimental | Device: Vaginal RingParticipants in the CVR arm will use the Copper Vaginal Ring for 28 days |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (20 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vaginal RingThe copper vaginal ring (CVR) is a non-hormonal vaginal ring designed for prevention of pregnancy | Device | CVR |
Primary outcome
Adverse Events [Safety]
Time frame: From enrollment to the end of study participation on Day 35
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.
2 secondary outcomes
Acceptability/Tolerability of the Device
Time frame: Assessed during device use up to Day 28 upon removal of the device
Device Malfunctions and Complications [Safety]
Time frame: Assessed during device use up to Day 28 upon removal of the device
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2026.
- Individual participant dataSharing planned: No. This is an industry sponsored study and the results will be used to inform whether future studies of the device are warranted. IPD is unlikely to be shared with other researchers.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Sukhbir Singh, MD principal investigator
The Ottawa Hospital
Questions about this trial
What is this clinical trial studying?
A study testing Vaginal Ring in people with Contraception and Birth Control, run by Elle, MD Biotechnologies Inc..
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 19 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Devan Pancura, MSc ((902)233-7534, devan@ellemd.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adverse Events [Safety] (time frame: From enrollment to the end of study participation on Day 35). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Oct 2026.