Contraceptive; Complications, IntrauterineCCDDIUUTNCT03642171
Surveillance Study of the Contraceptive Intrauterine Device UT380®
An observational study of Contraceptive; Complications, Intrauterine, run by Quanta Medical at 1 site in France.
Trial summary
The study is a long term Post Market Surveillance Study involving women who will received UT 380® device as a contraceptive method. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Contraceptive; Complications, Intrauterine
- How many people
- 200 participants
- Where
- 1 siteFrance
- Study dates
- 26 Jul 2018to 23 Sep 2024
- Phase
- Observational
- 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: The patients will be recruited in France city privates practicing gynaecologist.
Who may be able to join
- Woman > 18 years old
- nulliparous, uniparous and multiparous
- not currently using a contraceptive method or are willing to switch to a new reversible contraceptive
- with an indication of implantation of a UT380® IUD
- agreeing to participate in the study
Who cannot join
- Patient with risk of post implantation bleeding or high level of bleeding during menstruation period
- Patient with a risk of infection
- Patient that meet any of the absolute contraindication of UT 380®
- Any other elements that the investigator may think relevant and cannot allow the use of UT380®
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Post Market Surveillance Study of the Performance and Safety of UT 380® Contraceptive Intra Uterine Device in Nulliparous, Uniparous and Multiparous Women
The study is a long term Post Market Surveillance Study involving women who will received UT 380® device as a contraceptive method.
Read the detailed description
Prospective data on contraceptive performance of the UT380® from a large number of women are not yet available. Here we describe a long term Post Market Surveillance Study involving women who will received UT 380® device as a contraceptive method. Reports of case series usually contain detailed information about the individual patients. This includes demographic information (e.g. age and gender) and information on diagnosis, treatment, response to treatment, follow-up after treatment and patients experience of the treatment. In addition, it also include the health care staff's experience of the use of the UT 380. The result of this study will be used for different purposes e.g. marketing activities such as posters, folders, or targeted journals and/or conferences.
- Keywords
- Contraception, Intrauterine Device, UT380
What is being measured
The primary outcome is the main question the study is designed to answer.
Unintended pregnancy rate
Unintended pregnancy rate
Measured: 5 years
Device expulsion rate
Device expulsion rate
Measured: 5 years
Discontinuation rate
Discontinuation rate
Measured: 5 years
Secondary outcomes (14)
Extra uterine pregnancy rate
Extra uterine pregnancy rate
Measured: 5 years
Assessment of physicians satisfaction regarding the use of the UT380 using 5 points likert scale (1: not at all satisfied 5: very satisfied)
Physicians satisfaction regarding the use of the UT 380 will be assessed at post implantation visit (2 visits the fisrt year, and one visit per years during the following 4 years) using 5 points likert scale (1: not at all satisfied 5: very satisfied)
Measured: 5 years
Assessment of patients satisfaction regarding the use of the UT 380® using 5 points likert scale (1: not at all satisfied 5: very satisfied)
Patients satisfaction regarding the use of the UT 380® will be assessed at post implantation visit (2 visits the fisrt year, and one visit per years during the following 4 years) using 5 points likert scale (1: not at all satisfied 5: very satisfied)
Measured: 5 years
Removal rate of the UT380® due to excessive bleeding
Measured: 5 years
Removal rate of the UT380® due to pain
Measured: 5 years
Removal rate of the UT380® due to pelvic inflammatory diseases
Measured: 5 years
Removal rate of the UT380® due to other disease relevant in the contexte of the trial
Measured: 5 years
Removal rate of the UT380® due to desired pregnancy
Measured: 5 years
Removal rate of the UT380® due to any other personal reason
Measured: 5 years
Removal rate of the UT380® due to investigator decision
Measured: 5 years
Safety data such as uterin perforation
Uterin perforation rate
Measured: 5 years
Safety data such as any issue occurring immediately after the implantation of the device
Rate of issue occurring immediately after the implantation of the device
Measured: 5 years
Safety data such as any issue occurring between two visits: Abdominopelvic or uterine pain outside the menstrual cycle, bleeding,
Rate of issue occurring between two visits
Measured: 5 years
Safety data such as any issue during the device removal (such as pain, breaking device, excessive pulling force…)
Rate of issue during the device removal
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2018
- Study start26 Jul 2018
- Primary completion26 Jul 2023
- Study completion23 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Contraceptive; Complications, IntrauterineStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Quanta Medical
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Prodimed S.A., CCD
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03642171
- Sponsor's protocol ID
- 2868
- Acronym
- CCDDIUUT
- Status last verified
- Mar 2024
- First submitted
- 16 Jul 2018
- Last updated
- 21 Mar 2025
- 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 21 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Post Market Surveillance Study of the Performance and Safety of UT 380® Contraceptive Intra Uterine Device in Nulliparous, Uniparous and Multiparous Women
- ClinicalTrials.gov ID
- NCT03642171
- Acronym / sponsor ID
- CCDDIUUT / 2868
- Keywords
- Contraception, Intrauterine Device, UT380
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Quanta MedicalIndustry (pharma, biotech, devices)
- Collaborators
- Prodimed S.A., CCD
- Study start
- 26 Jul 2018 (actual)
- Primary completion
- 26 Jul 2023 (actual)
- Study completion
- 23 Sep 2024 (actual)
- First posted
- 22 Aug 2018 (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.
The study is a long term Post Market Surveillance Study involving women who will received UT 380® device as a contraceptive method.
Detailed description
Prospective data on contraceptive performance of the UT380® from a large number of women are not yet available. Here we describe a long term Post Market Surveillance Study involving women who will received UT 380® device as a contraceptive method. Reports of case series usually contain detailed information about the individual patients. This includes demographic information (e.g. age and gender) and information on diagnosis, treatment, response to treatment, follow-up after treatment and patients experience of the treatment. In addition, it also include the health care staff's experience of the use of the UT 380. The result of this study will be used for different purposes e.g. marketing activities such as posters, folders, or targeted journals and/or conferences.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The patients will be recruited in France city privates practicing gynaecologist.
Key inclusion criteria (5 listed)
- Woman > 18 years old
- nulliparous, uniparous and multiparous
- not currently using a contraceptive method or are willing to switch to a new reversible contraceptive
- with an indication of implantation of a UT380® IUD
- agreeing to participate in the study
Key exclusion criteria (4 listed)
- Patient with risk of post implantation bleeding or high level of bleeding during menstruation period
- Patient with a risk of infection
- Patient that meet any of the absolute contraindication of UT 380®
- Any other elements that the investigator may think relevant and cannot allow the use of UT380®
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Unintended pregnancy rate
Time frame: 5 years
Unintended pregnancy rate
Device expulsion rate
Time frame: 5 years
Device expulsion rate
Discontinuation rate
Time frame: 5 years
Discontinuation rate
14 secondary outcomes
Extra uterine pregnancy rate
Time frame: 5 years
Assessment of physicians satisfaction regarding the use of the UT380 using 5 points likert scale (1: not at all satisfied 5: very satisfied)
Time frame: 5 years
Assessment of patients satisfaction regarding the use of the UT 380® using 5 points likert scale (1: not at all satisfied 5: very satisfied)
Time frame: 5 years
Removal rate of the UT380® due to excessive bleeding
Time frame: 5 years
Removal rate of the UT380® due to pain
Time frame: 5 years
Removal rate of the UT380® due to pelvic inflammatory diseases
Time frame: 5 years
Removal rate of the UT380® due to other disease relevant in the contexte of the trial
Time frame: 5 years
Removal rate of the UT380® due to desired pregnancy
Time frame: 5 years
Removal rate of the UT380® due to any other personal reason
Time frame: 5 years
Removal rate of the UT380® due to investigator decision
Time frame: 5 years
Safety data such as uterin perforation
Time frame: 5 years
Safety data such as any issue occurring immediately after the implantation of the device
Time frame: 5 years
Safety data such as any issue occurring between two visits: Abdominopelvic or uterine pain outside the menstrual cycle, bleeding,
Time frame: 5 years
Safety data such as any issue during the device removal (such as pain, breaking device, excessive pulling force…)
Time frame: 5 years
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 21 Mar 2025.
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?
An observational study of Contraceptive; Complications, Intrauterine, run by Quanta Medical at 1 site in France.
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 4 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 21 Mar 2025. 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 France. 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 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?
Unintended pregnancy rate (time frame: 5 years). The study lists 3 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 21 Mar 2025.