Scandinavian Mirena Insertion Nulliparous Trial.

April 21, 2015 updated by: Bayer

Scandinavian Mirena Insertion Nulliparous Trial of an Observational Study.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

224

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Sweden
      • Many Locations, Sweden

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (ADULT, OLDER_ADULT, CHILD)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

Primary Care Clinic Patients

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Arm 1
Drug: Mirena (BAY86-5028)
Nulliparous Women

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Evaluation of the insertion procedure of Mirena in nulliparous women
Time Frame: At the insertion time point
At the insertion time point

Secondary Outcome Measures

Outcome Measure
Time Frame
Pain
Time Frame: At the insertion time point
At the insertion time point
Continuation rate
Time Frame: 12-16 weeks post insertion
12-16 weeks post insertion
Bleeding Pattern
Time Frame: 12-16 weeks post insertion
12-16 weeks post insertion
Satisfaction
Time Frame: 12-16 weeks post insertion
12-16 weeks post insertion

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bayer

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2007

Primary Completion (ACTUAL)

June 1, 2008

Study Completion (ACTUAL)

November 1, 2009

Study Registration Dates

First Submitted

November 26, 2008

First Submitted That Met QC Criteria

November 26, 2008

First Posted (ESTIMATE)

November 27, 2008

Study Record Updates

Last Update Posted (ESTIMATE)

April 22, 2015

Last Update Submitted That Met QC Criteria

April 21, 2015

Last Verified

April 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 14015 (City of Hope Medical Center)
  • MA0710SE
  • SCAN 68/06
  • 2006/0601120

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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