Reversible Prevention of PregnancyNCT02036203
A Study on the Safety and Efficacy of the SCu300A IUB Compared to the TCu380 Copper IUD
A study testing SCu300A IUB and TCu380A IUD in people with Reversible Prevention of Pregnancy, run by Ocon Medical Ltd. at 1 site in Israel.
Trial summary
This study aims to evaluate the safety and efficacy of the IUB SCu300A spherical copper IUD compared to the standard T shaped copper IUD, the TCu380. Participants will be followed for one year and quality of life measurements will be measured during this period as well. 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
- Reversible Prevention of Pregnancy
- What is being tested?
- SCu300A IUB and TCu380A IUD
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteIsrael
- Study dates
- 14 Jan 2014to 14 Jan 2014
- Phase
- Interventional
- 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 25 to 42 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Adult females aged 25-42
- 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%
- 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
- 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.
- Postpartum endometritis or post abortal endometritis in the past 3 month
Show all 22Show fewer
- Mucopurulent cervicitis
- Endometrial thickness more than 12 mm on insertion date
- Known anemia
- 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
1 site in 1 country.
About this study
Official title: A Prospective, Randomized, Single Blind, Two Arms Controlled Study of the Safety and Efficacy of the SCu300A IUB™ Spherical Copper Intrauterine Ball in Comparison to TCu 380 IUD Intra-uterine Contraceptive Device
This study aims to evaluate the safety and efficacy of the IUB SCu300A spherical copper IUD compared to the standard T shaped copper IUD, the TCu380.
Participants will be followed for one year and quality of life measurements will be measured during this period as well.
- Conditions
- Reversible Prevention of Pregnancy
- Being tested
- SCu300A IUB, TCu380A IUD
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SCu300A IUBDevice
Spherical copper contraceptive
TCu380A IUDDevice
T-shaped copper IUD
| Study group | Role | What they receive |
|---|---|---|
| SCu300A IUB | Experimental | Not described Receives: Device: SCu300A IUB |
| TCu380A | Active comparator | Not described Receives: Device: TCu380A IUD |
What is being measured
The primary outcome is the main question the study is designed to answer.
Perforation rate
Number of subjects with partial or complete perforation through the uterine wall
Measured: During device insertion
Device expulsion
Number of subjects with partially or fully ejected devices
Measured: 12 months
Efficacy in preventing pregnancy
Number of women who become pregnant during the trial period.
Measured: 12 months
Device malposition
Number of subjects with observed device malposition within the uterine cavity
Measured: 12 months
Secondary outcomes (1)
Menorrhagia and dysmenorrhea rates
Recording of menstrual pain, cramps and irregular bleeding as reported by subjects.
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 posted14 Jan 2014 (estimated)
- Study start14 Jan 2014
- Primary completion14 Jan 2014
- Study completion14 Jan 2014
Why it stopped: The study was withdrawn prior to patients enrolment due to sponsor's decision
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Reversible Prevention of PregnancyStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 0 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
- NCT02036203
- Sponsor's protocol ID
- AOS-2000-05
- Status last verified
- Jul 2018
- First submitted
- 23 Dec 2013
- Last updated
- 6 Jul 2018
- Results posted
- 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 of the Safety and Efficacy of the SCu300A IUB™ Spherical Copper Intrauterine Ball in Comparison to TCu 380 IUD Intra-uterine Contraceptive Device
- ClinicalTrials.gov ID
- NCT02036203
- Acronym / sponsor ID
- AOS-2000-05
- Conditions
- Reversible Prevention of Pregnancy
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: The study was withdrawn prior to patients enrolment due to sponsor's decision
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Ocon Medical Ltd.Industry (pharma, biotech, devices)
- Study start
- 14 Jan 2014 (actual)
- Primary completion
- 14 Jan 2014 (actual)
- Study completion
- 14 Jan 2014 (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.
This study aims to evaluate the safety and efficacy of the IUB SCu300A spherical copper IUD compared to the standard T shaped copper IUD, the TCu380.
Participants will be followed for one year and quality of life measurements will be measured during this period as well.
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 |
| TCu380A | Active comparator | Device: TCu380A IUD |
Who may qualify
- Ages
- 25 to 42 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Adult females aged 25-42
- 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%
Key exclusion criteria (22 listed)
- Use IUB/IUD as an emergency contraception
- A previously placed IUD that has not been removed
- Pregnancy or suspicion of pregnancy
- 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.
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 IUBSpherical copper contraceptive | Device | SCu300A IUB |
| TCu380A IUDT-shaped copper IUD | Device | TCu380A |
Primary outcome
Perforation rate
Time frame: During device insertion
Number of subjects with partial or complete perforation through the uterine wall
Device expulsion
Time frame: 12 months
Number of subjects with partially or fully ejected devices
Efficacy in preventing pregnancy
Time frame: 12 months
Number of women who become pregnant during the trial period.
Device malposition
Time frame: 12 months
Number of subjects with observed device malposition within the uterine cavity
1 secondary outcome
Menorrhagia and dysmenorrhea rates
Time frame: 12 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SCu300A IUB and TCu380A IUD in people with Reversible Prevention of Pregnancy, run by Ocon Medical Ltd. at 1 site in Israel.
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 22 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: withdrawn, 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 1 site in Israel. 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?
The study was withdrawn before enrolling participants, so there are no results.
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?
Perforation rate (time frame: During device insertion). 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.