Scandinavian Mirena Insertion Nulliparous Trial.

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

224 participants

Study Classification

OBSERVATIONAL

Study Start Date

2007-02-28

Study Completion Date

2009-11-30

Brief Summary

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

In this non-interventional study we investigate the nulliparous women individual evaluation of the insertion procedure of LNG-IUD and the follow-up period of 3 months post insertion.

Related Clinical Trials

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

Mirena Efficiency and Tolerability During the First Year of Use

NCT00696202

Medicated Intrauterine Devices Contraception

COMPLETED PHASE4

Mirena Extension Trial

NCT02985541

Contraception

COMPLETED PHASE3

Prospective, Non-interventional, Multi-center Safety Study of Mirena for Heavy Menstrual Bleeding and Dysmenorrhea

NCT02475356

Menorrhagia, Dysmenorrhea

COMPLETED

A Cross-sectional, Observational Multicenter Study to Assess the Reasons for Choosing the 3-year Hormonal IUD and Level of IUDs Knowledge Among Women Aged 18 to 29 Years

NCT02903888

Intrauterine Devices, Medicated

COMPLETED

A Study of a Levonorgestrel-Releasing Intrauterine System for Long-Term, Reversible Contraception

NCT00995150

Contraception

TERMINATED 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.

Nulliparous

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.

Arm 1

Mirena (BAY86-5028)

Intervention Type DRUG

Nulliparous Women

Interventions

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

Mirena (BAY86-5028)

Nulliparous Women

Intervention Type DRUG

Eligibility Criteria

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

Inclusion Criteria

* Nulliparous women Mirena insertion planned as contraceptive method

Exclusion Criteria

* Ongoing or suspected pregnancy;
* Ongoing or recidivating genital infection;
* Cervicitis;
* Cervical dysplasia;
* Malignancy in uterus or cervix;
* Confirmed or suspected hormone sensitive neoplasia including breast cancer
* Undiagnosed abnormal uterine bleeding;
* Uterine anomaly including myoma if the cavity of the uterus is restricted;
* Conditions that cause increased risk of infections;
* Acute liver disease or liver tumour;
* Allergy to the active substance or any component of the IUD

Minimum Eligible Age

14 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes