CompletedNot Applicable

Surveillance Study of the Contraceptive Intrauterine Device UT380®

France200 participantsStarted 2018-07-26

Plain-language summary

The study is a long term Post Market Surveillance Study involving women who will received UT 380® device as a contraceptive method.

Who can participate

Age range

18 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 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 Exclusion Criteria: * 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®

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Unintended pregnancy rate

Timeframe: 5 years

Device expulsion rate

Timeframe: 5 years

Discontinuation rate

Timeframe: 5 years

Trial details

NCT IDNCT03642171

SponsorQuanta Medical

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2023-07-26

View on ClinicalTrials.gov More Contraceptive; Complications, Intrauterine trials

Who can participate

Age range

18 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.