Non-interventional, Real Life Study on Satisfaction With LNG-IUS in Spanish Young Women (18-30 Years Old) With Different Parity Status and Menstrual Bleeding Pattern

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

587 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-04-25

Study Completion Date

2021-03-15

Brief Summary

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

The aim of this non-interventional study (NIS) is to assess, under real-life conditions, woman's satisfaction with Levonogestrel IntraUterine System (LNG-IUS) in a young (18-30 years old (y.o.)) Spanish population taking into account their parity status.

Furthermore, the study is aimed to evaluate the impact of: menstrual bleeding pattern and satisfaction with it at baseline, LNG-IUS chosen, previously used contraceptive method and reasons for change to/ choice of a LNG-IUS on overall satisfaction with LNG-IUS use.

Related Clinical Trials

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

The Aim of This Study is to Estimate the Discontinuation Rate of Low-dose Levonorgestrel-releasing Intrauterine System Due to Self-reported Unacceptable Menstrual Bleeding Pattern in Spanish Women Who Are Using it for the First Time How Intrauterine System for Long Acting Contraception

NCT04785950

Hormonal Intrauterine Contraception

COMPLETED

LCS12 vs Combined Oral Contraceptive (COC) User Satisfaction Study

NCT01254292

Contraception

COMPLETED PHASE3

Assessment of the Transfer of Using Levonorgestrel Intrauterine System (LNG IUS) as a Contraceptive to Using it as Part of Hormone Replacement Therapy (HRT).

NCT00185458

Menopause

COMPLETED PHASE3

KYleena Satisfaction Study / Observational Study on User Satisfaction With the Levonorgestrel Intrauterine Delivery System Kyleena (LNG-IUS 12) in New Contraceptive Users and After Switching From Another Contraceptive Method

NCT03182140

Contraception

COMPLETED

LCS16 vs. COC User Satisfaction and Tolerability Study

NCT03074045

Contraception

COMPLETED PHASE3

Detailed Description

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

Conditions

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

Contraception

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

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Levonogestrel IntraUterine System (LNG-IUS)

Women in childbearing age between 18 to 30 years old and who have freely chosen a LNG-IUS for contraception after being adequately counselled and informed of all contraceptive options by their physician at the routine clinical practice setting in Spain

Levonogestrel IntraUterine System (LNG-IUS)

Intervention Type DRUG

At the routine clinical practice. Jaydess, Mirena, Kyleena Or any other levonogestrel intrauterine system (LNG-IUS) commercialized in Spain at the start of the study, only for contraception indication.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Levonogestrel IntraUterine System (LNG-IUS)

At the routine clinical practice. Jaydess, Mirena, Kyleena Or any other levonogestrel intrauterine system (LNG-IUS) commercialized in Spain at the start of the study, only for contraception indication.

Intervention Type DRUG

Eligibility Criteria

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

Inclusion Criteria

* Women in childbearing age, between 18-30 years old.
* Women who have chosen a LNG-IUS as contraceptive method, after been adequately counselled by the physician about all contraceptive possible options.
* Women who have chosen a LNG-IUS mainly for contraceptive reasons, not due to heavy menstrual bleeding.
* Women with no desire to conceive for at least within the next 12 months.
* Women capable of reading and writing

Exclusion Criteria

* Women whose main reason to use a LNG-IUS is not a contraceptive reason.
* Women with contraindication for LNG-IUS.
* Women with previous experience with a IUS.
* Women who have been diagnosed with heavy menstrual bleeding.
* Women with degenerative or other kind of diseases that could directly negatively impact their daily life.
* Women who have undergone a hysterectomy or irreversible contraceptive method.
* Women participating in a clinical trial.
* Women with a mental illness and unable to make decisions and follow instructions.
* Women with amenorrhea
* Women with clinical history of severe dysmenorrhea
* Women with concomitant medication that may lead changes in bleeding pattern (e.g. antiplatelets and/or anticoagulants)

Minimum Eligible Age

18 Years

Maximum Eligible Age

30 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes