Surveillance Study of the Contraceptive Intrauterine Device UT380®

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-07-26

Study Completion Date

2024-09-23

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Study of a Levonorgestrel 52 mg Intrauterine System for the Treatment of Heavy Menstrual Bleeding

NCT03642210

Menorrhagia

COMPLETED PHASE3

Evaluation of the Impact of an Oral and Practical Presentation of Intrauterine Devices by a Health Professional on Women's Opinion as a Possible Contraceptive Method

NCT05317715

Acceptance Processes

UNKNOWN NA

Multivariate Assessment of the IUB Intrauterine Device Compared With a T380A IUD

NCT02036177

To Assess the Safety, Effectiveness and User Experience of the Scu 300A IUB

COMPLETED PHASE4

Study Assessing the Reduction of Pain Felt During Installation Intra- Uterine Device by Direct Technique

NCT02595125

Contraception

COMPLETED NA

Effectiveness of Prolonged Use of IUD/Implant for Contraception

NCT02267616

Contraception

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Contraceptive; Complications, Intrauterine

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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®

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No