ContraceptionIUBNCT01973777
A Pilot Study of Early Expulsion Rates of the IUB™ SCu380A
A study testing IUB in people with Contraception, run by Wiebe, Ellen, M.D. at 1 site in Canada.
Trial summary
The IUB (Intrauterine ball) is a copper releasing intrauterine contraceptive device consisting of copper beads on a flexible NiTinol wire. It was designed to reduce the pain and bleeding caused by traditional T-shaped copper IUDs and to reduce expulsions. 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
- What is being tested?
- IUB
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 51 participants
- Where
- 1 siteCanada
- Study dates
- Dec 2013to Aug 2019
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- requesting non-hormonal intrauterine contraception
- able to return for ultrasound in 6-8 weeks
Who cannot join
- History of recent pelvic inflammatory disease
- Known anemia
- Dysfunctional uterine bleeding
- Malignancy or suspected malignant disease of female inner or outer genitalia
- Known intolerance or allergy to copper and/or copper IUDs
- Any other significant disease or condition that could interfere with the subject's ability to complete the protocol
- Pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Pilot Study of Early Expulsion Rates of the IUB™ SCu380A Spherical Copper Intrauterine Contraceptive Device.
The IUB (Intrauterine ball) is a copper releasing intrauterine contraceptive device consisting of copper beads on a flexible NiTinol wire. It was designed to reduce the pain and bleeding caused by traditional T-shaped copper IUDs and to reduce expulsions. In an initial pilot of 15 women, there were no complications during the 12 months. This observational pilot study of 50 women will determine that the early expulsion rate is not greater than 10% and that there is patient and physician acceptance, so that we can plan a larger randomized controlled trial for efficacy and safety.
- Conditions
- Contraception
- Being tested
- IUB
- Keywords
- intrauterine device, contraception
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IUBDevice
Also called SCu380A IUB™
intrauterine contraceptive device
| Study group | Role | What they receive |
|---|---|---|
| IUB | Experimental | There is one arm of women who will have IUBs inserted Receives: Device: IUB |
What is being measured
The primary outcome is the main question the study is designed to answer.
Expulsion Rate
The device being expelled from the uterus as documented by ultrasound or by seeing the actual device outside the uterus
Measured: at 6-8 weeks
Secondary outcomes (2)
Complication
infection, perforation, pregnancy
Measured: 12 months
Acceptability
patient-reported acceptability
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2013 (estimated)
- Study startDec 2013
- Primary completionMay 2015
- Study completionAug 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- intrauterine contraceptive device IUB
- Masking
- None (open label)
- Enrolment
- 51 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wiebe, Ellen, M.D.
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01973777
- Sponsor's protocol ID
- 130928 IUB
- Acronym
- IUB
- Status last verified
- Aug 2019
- First submitted
- 26 Oct 2013
- Last updated
- 6 Sep 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study of Early Expulsion Rates of the IUB™ SCu380A Spherical Copper Intrauterine Contraceptive Device.
- ClinicalTrials.gov ID
- NCT01973777
- Acronym / sponsor ID
- IUB / 130928 IUB
- Conditions
- Contraception
- Keywords
- intrauterine device, contraception
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 51 participants (actual)
- Lead sponsor
- Wiebe, Ellen, M.D.University, hospital or other
- Study start
- Dec 2013 (actual)
- Primary completion
- May 2015 (actual)
- Study completion
- Aug 2019 (actual)
- First posted
- 1 Nov 2013 (estimated)
- Results
- Posted 2 Feb 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The IUB (Intrauterine ball) is a copper releasing intrauterine contraceptive device consisting of copper beads on a flexible NiTinol wire. It was designed to reduce the pain and bleeding caused by traditional T-shaped copper IUDs and to reduce expulsions. In an initial pilot of 15 women, there were no complications during the 12 months. This observational pilot study of 50 women will determine that the early expulsion rate is not greater than 10% and that there is patient and physician acceptance, so that we can plan a larger randomized controlled trial for efficacy and safety.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- intrauterine contraceptive device IUB
| Arm | Type | Receives |
|---|---|---|
| IUB | Experimental | Device: IUBThere is one arm of women who will have IUBs inserted |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- requesting non-hormonal intrauterine contraception
- able to return for ultrasound in 6-8 weeks
Key exclusion criteria (7 listed)
- History of recent pelvic inflammatory disease
- Known anemia
- Dysfunctional uterine bleeding
- Malignancy or suspected malignant disease of female inner or outer genitalia
- Known intolerance or allergy to copper and/or copper IUDs
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 |
|---|---|---|
| IUBAlso: SCu380A IUB™intrauterine contraceptive device | Device | IUB |
Primary outcome
Expulsion Rate
Time frame: at 6-8 weeks
The device being expelled from the uterus as documented by ultrasound or by seeing the actual device outside the uterus
2 secondary outcomes
Complication
Time frame: 12 months
Acceptability
Time frame: 12 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Sep 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing IUB in people with Contraception, run by Wiebe, Ellen, M.D. at 1 site in Canada.
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 2 inclusion and 7 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: finished, as of the sponsor's last update on 6 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Yes. Results are posted in the registry (first posted 2 Feb 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Expulsion Rate (time frame: at 6-8 weeks). 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 6 Sep 2019.