ContraceptionNCT01590563
A Study to Evaluate the Safety and Initial Efficacy of a Novel Intrauterine Device
A study testing IUD in people with Contraception, run by Ocon Medical Ltd. at 1 site in Hungary.
Trial summary
Current intrauterine devices (IUD) pose such risks as uterine perforation during insertion, malposition and expulsion. The investigated device, the IUB(tm) SCu300A is an IUD which is inserted in a similar fashion into the uterus and takes a three dimensional spherical shape while curving away from the fundus. Read more about this study
- Who is it for?
- Ages 25 to 42 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Contraception
- What is being tested?
- IUD
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteHungary
- Study dates
- Apr 2012to Jul 2013
- 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 25 to 42 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Adult female aged 25-42
- Free willing to fully comply with treatment process
- Healthy women
- Married or in a steady relationship. Blood hemoglobin >11.5gr%
- Signed informed consent form
Who cannot join
- Pregnancy or suspicion of pregnancy
- Use of other contraception methods
- Abnormalities of the uterus resulting in distortion of the uterine cavity
- Acute current or past history of pelvic inflammatory disease, or current behavior suggesting a high risk for pelvic inflammatory disease
- Postpartum endometritis or postabortal endometritis in the past 3 months
- Known or suspected uterine or cervical malignancy
Show all 19Show fewer
- Genital bleeding of unknown etiology
- Mucopurulent cervicitis
- Wilson's disease
- Allergy to any component of IUB™
- A previously placed IUD that has not been removed
- Known intolerance or allergy to copper and/or copper IUDs
- Medication that may interfere with the subject's ability to complete the protocol
- Any other significant disease or condition that could interfere with the subject's ability to complete the protocol
- A history of alcohol or drug abuse
- known infection with human immunodeficiency virus (HIV), Hepatitis B or Hepatitis C
- Planned pregnancy during the follow-up period
- Participation in another clinical trial
- Anemia of any kind or blood hemoglobin lower than 11.5gr%.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Study to Evaluate the Safety and Initial Efficacy of a Spherical Copper Intrauterine Contraceptive Device the IUB(tm)
Current intrauterine devices (IUD) pose such risks as uterine perforation during insertion, malposition and expulsion. The investigated device, the IUB(tm) SCu300A is an IUD which is inserted in a similar fashion into the uterus and takes a three dimensional spherical shape while curving away from the fundus. Apart for an anticipated reduction in the rate of stated complications, its smaller size and mallable characteristics are also expected to improve user experience. The clinical trial is intended to evaluate the safety and initial efficacy of this novel device.
Read the detailed description
A copper IUD (intrauterine device or coil) is a type of intrauterine contraceptive device. Most IUDs have a plastic T-shaped frame which is wrapped in copper wire and sleeves. The device has to be fitted inside and removed from the uterine cavity by a doctor or qualified medical practitioner. It remains in place the entire time pregnancy is not desired.
The IUD is a long acting reversible contraceptive, with different IUDs intended to last for different lengths of time, usually between 3 and 10 years. The length of time that the device lasts depends mainly on the amount of exposed copper, which is indicated, in square millimeters, by a number in the name of each device (i.e., the Paragard T-380A has 380 square millimeters of exposed copper).
The IUD is the world's most widely used method of reversible birth control, currently used by over 175 million women.
The mechanism of IUDs is not well understood. It is known however that the presence of a device in the uterus prompts the release of leukocytes and prostaglandins by the endometrium. These substances are hostile to both sperm and eggs; the presence of copper increases the spermicidal effect. The general medical consensus is that spermicidal and ovicidal mechanisms are the only way in which IUDs work. Some physicians and medical texts have suggested they may have a secondary effect of interfering with the development of pre-implanted embryos; this secondary effect is considered more plausible when the IUD is used as emergency contraception.
Second-generation copper-T IUDs have failure rates of less than 1% per year, and cumulative 10-year failure rates of 2-6%. A copper IUD may also be used as emergency contraception. If an IUD is inserted within five days of unprotected intercourse, a woman's chance of pregnancy is reduced to that of ongoing IUD users.
IUDs do not protect against STDs or PID.
Made from a shape memory alloy of a specific size and shape, the SCu300A IUB™ is inserted through an insertion tube much like regular IUDs, however, when pushed out, in the uterus, it takes a spherical shape. An important feature includes its downwards curving opposite to the uterine fundus as it emerges out of the tube, minimizing the risk of perforation. The three dimensional shape's elasticity allows for better amenability to the uterus, nullifying the possibility of malposition and its final outer diameter reducing the probability of expulsion. Lacking rigid or protruding segments and being significantly smaller than other IUDs, the IUB™ is expected to reduce distortion and tissue irritation, possibly resulting in less bleeding, discomfort and pain, leading to lower discontinuation rates. A thread is attached to the IUB™ to allow easy removal.
The trialed IUB™ will be copper-based (Cu surface area of 300mm2).
This study aims to assess the IUB™'s safety and initial efficacy. Endpoints include the assessment of changes in discomfort, pain and menorrhea, changes in the endometrium discontinuation rates as well as user experience. These results will be used as regulatory evidence and will also help in reaffirming the assumption that the IUB™'s design contributes to lower complication and side effect rates.
- Conditions
- Contraception
- Being tested
- IUD
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IUDDevice
Also called SCu300A IUB(tm)
Insertion of a spherical IUD, one year follow-up
| Study group | Role | What they receive |
|---|---|---|
| SCu300A IUB | Experimental | Insertion of a spherical IUD (intrauterine device) with one year follow-up Receives: Device: IUD |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rates of Uterine Perforation
Uterine perforation is an established risk of IUD deployment which may cause certain health hazards. It is anticipated that the IUB(tm), through its form and deployment pattern, will reduce this risk.
Measured: During installation
Efficacy in Preventing Pregnancy
Prevention of pregnancy will be measured. Pregnancy rates are expected to be comparable to current IUDs.
Measured: 12 months
Secondary outcomes (1)
Occurrence of Malposition, Expulsion.
Expulsion and malposition are established risks involved with IUD use. Occurrence of these risks may drastically reduce effectiveness. It is expected that the IUB(tm) form will reduce these risks.
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 posted3 May 2012 (estimated)
- Study startApr 2012
- Primary completionJul 2013
- Study completionJul 2013
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.
- Publications (1)Papers the sponsor has linked to this study.
- 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 device
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ocon Medical Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Principal investigator, Dana Raveh Arbel, Ocon Medical Ltd.
- Investigators
- Beata Szoczei, MD, Principal investigator, Synexus Hungary Kft.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01590563
- Sponsor's protocol ID
- AOS-C1000-02
- Status last verified
- Sep 2020
- First submitted
- 20 Apr 2012
- Last updated
- 14 Oct 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Baram I, Weinstein A, Trussell J. The IUB, a newly invented IUD: a brief report. Contraception. 2014 Feb;89(2):139-41. doi: 10.1016/j.contraception.2013.10.017. Epub 2013 Nov 7.
PubMed 24309220
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study to Evaluate the Safety and Initial Efficacy of a Spherical Copper Intrauterine Contraceptive Device the IUB(tm)
- ClinicalTrials.gov ID
- NCT01590563
- Acronym / sponsor ID
- AOS-C1000-02
- Conditions
- Contraception
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Ocon Medical Ltd.Industry (pharma, biotech, devices)
- Study start
- Apr 2012
- Primary completion
- Jul 2013 (actual)
- Study completion
- Jul 2013 (actual)
- First posted
- 3 May 2012 (estimated)
- Results
- Posted 9 Nov 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Current intrauterine devices (IUD) pose such risks as uterine perforation during insertion, malposition and expulsion. The investigated device, the IUB(tm) SCu300A is an IUD which is inserted in a similar fashion into the uterus and takes a three dimensional spherical shape while curving away from the fundus. Apart for an anticipated reduction in the rate of stated complications, its smaller size and mallable characteristics are also expected to improve user experience. The clinical trial is intended to evaluate the safety and initial efficacy of this novel device.
Detailed description
A copper IUD (intrauterine device or coil) is a type of intrauterine contraceptive device. Most IUDs have a plastic T-shaped frame which is wrapped in copper wire and sleeves. The device has to be fitted inside and removed from the uterine cavity by a doctor or qualified medical practitioner. It remains in place the entire time pregnancy is not desired.
The IUD is a long acting reversible contraceptive, with different IUDs intended to last for different lengths of time, usually between 3 and 10 years. The length of time that the device lasts depends mainly on the amount of exposed copper, which is indicated, in square millimeters, by a number in the name of each device (i.e., the Paragard T-380A has 380 square millimeters of exposed copper).
The IUD is the world's most widely used method of reversible birth control, currently used by over 175 million women.
The mechanism of IUDs is not well understood. It is known however that the presence of a device in the uterus prompts the release of leukocytes and prostaglandins by the endometrium. These substances are hostile to both sperm and eggs; the presence of copper increases the spermicidal effect. The general medical consensus is that spermicidal and ovicidal mechanisms are the only way in which IUDs work. Some physicians and medical texts have suggested they may have a secondary effect of interfering with the development of pre-implanted embryos; this secondary effect is considered more plausible when the IUD is used as emergency contraception.
Second-generation copper-T IUDs have failure rates of less than 1% per year, and cumulative 10-year failure rates of 2-6%. A copper IUD may also be used as emergency contraception. If an IUD is inserted within five days of unprotected intercourse, a woman's chance of pregnancy is reduced to that of ongoing IUD users.
IUDs do not protect against STDs or PID.
Made from a shape memory alloy of a specific size and shape, the SCu300A IUB™ is inserted through an insertion tube much like regular IUDs, however, when pushed out, in the uterus, it takes a spherical shape. An important feature includes its downwards curving opposite to the uterine fundus as it emerges out of the tube, minimizing the risk of perforation. The three dimensional shape's elasticity allows for better amenability to the uterus, nullifying the possibility of malposition and its final outer diameter reducing the probability of expulsion. Lacking rigid or protruding segments and being significantly smaller than other IUDs, the IUB™ is expected to reduce distortion and tissue irritation, possibly resulting in less bleeding, discomfort and pain, leading to lower discontinuation rates. A thread is attached to the IUB™ to allow easy removal.
The trialed IUB™ will be copper-based (Cu surface area of 300mm2).
This study aims to assess the IUB™'s safety and initial efficacy. Endpoints include the assessment of changes in discomfort, pain and menorrhea, changes in the endometrium discontinuation rates as well as user experience. These results will be used as regulatory evidence and will also help in reaffirming the assumption that the IUB™'s design contributes to lower complication and side effect rates.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Intrauterine device
| Arm | Type | Receives |
|---|---|---|
| SCu300A IUB | Experimental | Device: IUDInsertion of a spherical IUD (intrauterine device) with one year follow-up |
Who may qualify
- Ages
- 25 to 42 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Adult female aged 25-42
- Free willing to fully comply with treatment process
- Healthy women
- Married or in a steady relationship. Blood hemoglobin >11.5gr%
- Signed informed consent form
Key exclusion criteria (19 listed)
- Pregnancy or suspicion of pregnancy
- Use of other contraception methods
- Abnormalities of the uterus resulting in distortion of the uterine cavity
- Acute current or past history of pelvic inflammatory disease, or current behavior suggesting a high risk for pelvic inflammatory disease
- Postpartum endometritis or postabortal endometritis in 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 |
|---|---|---|
| IUDAlso: SCu300A IUB(tm)Insertion of a spherical IUD, one year follow-up | Device | SCu300A IUB |
Primary outcome
Rates of Uterine Perforation
Time frame: During installation
Uterine perforation is an established risk of IUD deployment which may cause certain health hazards. It is anticipated that the IUB(tm), through its form and deployment pattern, will reduce this risk.
Efficacy in Preventing Pregnancy
Time frame: 12 months
Prevention of pregnancy will be measured. Pregnancy rates are expected to be comparable to current IUDs.
1 secondary outcome
Occurrence of Malposition, Expulsion.
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 14 Oct 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 24309220Baram I, Weinstein A, Trussell J. The IUB, a newly invented IUD: a brief report. Contraception. 2014 Feb;89(2):139-41. doi: 10.1016/j.contraception.2013.10.017. Epub 2013 Nov 7.
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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.
Beata Szoczei, MD principal investigator
Synexus Hungary Kft.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing IUD in people with Contraception, run by Ocon Medical Ltd. at 1 site in Hungary.
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 19 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 14 Oct 2020. 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 Hungary. 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 9 Nov 2015). 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?
Rates of Uterine Perforation (time frame: During installation). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01590563, which also lists 1 linked publication.
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 14 Oct 2020.