To Assess the Safety, Effectiveness and User Experience of the Scu 300A IUBPhase 4NCT02036177
Multivariate Assessment of the IUB Intrauterine Device Compared With a T380A IUD
A Phase 4 study testing SCu300A IUB intrauterine device and T380A IUD in people with To Assess the Safety, Effectiveness and User Experience of the Scu 300A IUB, run by Ocon Medical Ltd. at 2 sites in 2 countries.
Trial summary
The novel SCu300A IUB™ (hereafter IUB™) will be evaluated for safety and effectiveness in comparison with a market approved standard T shaped IUD containing 380sq.mm. of copper. The Primary Endpoints for comparison are based on the objective and subjective parameters. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- To Assess the Safety, Effectiveness and User Experience of the Scu 300A IUB
- What is being tested?
- SCu300A IUB intrauterine device and T380A IUD
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 366 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 12 Jun 2014to 15 Jul 2017
- Phase
- Phase 4
- Are there results?
- None posted in the registry
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 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Adult females aged 18-45
- Free and willing to fully comply with treatment process
- Healthy women seeking LARC
- Married or in a steady relationship (at least 1 year)
- Blood hemoglobin >11.5gr/dL
- Signed informed consent form
- If took COCP at least had one cycle after use of OC
Who cannot join
- Use IUB/IUD as an emergency contraception
- A previously placed IUD that has not been removed
- Pregnancy or suspicion of pregnancy
- Immediately post-abortion or post-partum - unless had at least one free cycle
- Use of other contraception method (condom for either male or female, oral contraceptives, diaphragms, spermicides, hormonal patches, injections or ring, cervical cap)
- History of pelvic inflammatory disease, recent or remote.
Show all 24Show fewer
- Postpartum endometritis or postabortal endometritis in the past 3 month
- Mucupurulent cervicitis
- Endometrial thickness more than 12 mm on insertion date
- Known anemia (except thalassemia, sickle cell, chronic anemia)
- Severe Mennorrhagia or severe Dysmenorrhea
- History of previous IUD complications
- Dysfunctional uterine bleeding
- Undiagnosed uterine bleeding
- Malignancy or suspected malignant disease of female inner or outer genitalia
- Distortions of the uterine cavity by uterine fibroids or known anatomical abnormalities
- Known intolerance or allergy to nitinol or copper and/or copper IUDs - Wilson's disease.
- Medication that may interfere with the subject's ability to complete the protocol
- Use of injectable contraception in the previous year
- 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
- Pregnancy or pregnancy planned during the year
- Enrollment (less than 30 days after completing another study) in or planned to be enrolled in another study
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
Romania1 site
Spitalul Clinic "Nicolae Malaxa", Sectia Obstetri-ca-Ginecologie
Bucharest
About this study
Official title: A Prospective, Randomized, Single Blind, Two Arms Controlled Study to Confirm the Safety and Verify Performance of the IUB™ SCu300A Intrauterine Device in Comparison to TCu380 IUD Intra-uterine Contraceptive Device
The novel SCu300A IUB™ (hereafter IUB™) will be evaluated for safety and effectiveness in comparison with a market approved standard T shaped IUD containing 380sq.mm. of copper.
The Primary Endpoints for comparison are based on the objective and subjective parameters.
Read more
The objective parameters are pregnancy rate, perforation, expulsion and mal -position rates, changes in the endometrial thickness, rate of complications such as infection and anemia and discontinuation rates after 2 years.
The subjective parameters including Quality of Life (QoL) are: pain during insertion, menstrual characteristics and pain, bleeding in correlation to the bleeding pattern prior to insertion.
The Secondary Endpoints are physician opinion (ease of use in insertion and removal) and subject satisfaction.
- Being tested
- SCu300A IUB intrauterine device, T380A IUD
- Keywords
- IUB
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SCu300A IUB intrauterine deviceDevice
Spherical copper IUD
T380A IUDDevice
T-shaped copper IUD
| Study group | Role | What they receive |
|---|---|---|
| SCu300A IUB | Experimental | Not described Receives: Device: SCu300A IUB intrauterine device |
| T380A copper IUD | Active comparator | Not described Receives: Device: T380A IUD |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pregnancy rate
Measured: 24 months
Safety issues
Perforations, expulsions, mal-position etc
Measured: 24 months
Discontinuation rate
Measured: 24 months
Patient experience
Recording of menstrual cramping, pain and bleeding irregularities during the trial period
Measured: 24 months
Secondary outcomes (1)
Physician opinion
Ease of use in insertion and removal
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2014 (estimated)
- Study start12 Jun 2014
- Primary completion15 Jul 2017
- Study completion15 Jul 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for To Assess the Safety, Effectiveness and User Experience of the Scu 300A IUBStudies 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 4
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 366 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ocon Medical Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02036177
- Sponsor's protocol ID
- AOS-C2000
- Status last verified
- Jul 2018
- First submitted
- 19 Dec 2013
- Last updated
- 6 Jul 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Randomized, Single Blind, Two Arms Controlled Study to Confirm the Safety and Verify Performance of the IUB™ SCu300A Intrauterine Device in Comparison to TCu380 IUD Intra-uterine Contraceptive Device
- ClinicalTrials.gov ID
- NCT02036177
- Acronym / sponsor ID
- AOS-C2000
- Keywords
- IUB
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 366 participants (actual)
- Lead sponsor
- Ocon Medical Ltd.Industry (pharma, biotech, devices)
- Study start
- 12 Jun 2014 (actual)
- Primary completion
- 15 Jul 2017 (actual)
- Study completion
- 15 Jul 2017 (actual)
- First posted
- 14 Jan 2014 (estimated)
- 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.
The novel SCu300A IUB™ (hereafter IUB™) will be evaluated for safety and effectiveness in comparison with a market approved standard T shaped IUD containing 380sq.mm. of copper.
The Primary Endpoints for comparison are based on the objective and subjective parameters.
The objective parameters are pregnancy rate, perforation, expulsion and mal -position rates, changes in the endometrial thickness, rate of complications such as infection and anemia and discontinuation rates after 2 years.
The subjective parameters including Quality of Life (QoL) are: pain during insertion, menstrual characteristics and pain, bleeding in correlation to the bleeding pattern prior to insertion.
The Secondary Endpoints are physician opinion (ease of use in insertion and removal) and subject satisfaction.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SCu300A IUB | Experimental | Device: SCu300A IUB intrauterine device |
| T380A copper IUD | Active comparator | Device: T380A IUD |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Adult females aged 18-45
- Free and willing to fully comply with treatment process
- Healthy women seeking LARC
- Married or in a steady relationship (at least 1 year)
- Blood hemoglobin >11.5gr/dL
Key exclusion criteria (24 listed)
- Use IUB/IUD as an emergency contraception
- A previously placed IUD that has not been removed
- Pregnancy or suspicion of pregnancy
- Immediately post-abortion or post-partum - unless had at least one free cycle
- Use of other contraception method (condom for either male or female, oral contraceptives, diaphragms, spermicides, hormonal patches, injections or ring, cervical cap)
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 |
|---|---|---|
| SCu300A IUB intrauterine deviceSpherical copper IUD | Device | SCu300A IUB |
| T380A IUDT-shaped copper IUD | Device | T380A copper IUD |
Primary outcome
Pregnancy rate
Time frame: 24 months
Safety issues
Time frame: 24 months
Perforations, expulsions, mal-position etc
Discontinuation rate
Time frame: 24 months
Patient experience
Time frame: 24 months
Recording of menstrual cramping, pain and bleeding irregularities during the trial period
1 secondary outcome
Physician opinion
Time frame: 24 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jul 2018.
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.
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing SCu300A IUB intrauterine device and T380A IUD in people with To Assess the Safety, Effectiveness and User Experience of the Scu 300A IUB, run by Ocon Medical Ltd. at 2 sites in 2 countries.
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 7 inclusion and 24 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 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Bulgaria, Romania. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Pregnancy rate (time frame: 24 months). The study lists 4 primary outcomes in all. 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 Jul 2018.