NCT00798980

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
224

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Feb 2007

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2007

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2008

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

November 26, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 27, 2008

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2009

Completed
Last Updated

April 22, 2015

Status Verified

April 1, 2015

Enrollment Period

1.3 years

First QC Date

November 26, 2008

Last Update Submit

April 21, 2015

Conditions

Nulliparous

Keywords

MirenaNulliparousIntrauterine Devices

Outcome Measures

Primary Outcomes (1)

  • Evaluation of the insertion procedure of Mirena in nulliparous women

    At the insertion time point

Secondary Outcomes (4)

  • Pain

    At the insertion time point

  • Continuation rate

    12-16 weeks post insertion

  • Bleeding Pattern

    12-16 weeks post insertion

  • Satisfaction

    12-16 weeks post insertion

Study Arms (1)

Arm 1

Drug: Mirena (BAY86-5028)

Interventions

Mirena (BAY86-5028)DRUG

Nulliparous Women

Arm 1

Eligibility Criteria

Age14 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Primary Care Clinic Patients

You may qualify if:

  • Nulliparous women Mirena insertion planned as contraceptive method

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Unknown Facility

Many Locations, Sweden

Location

Related Publications (1)

  • Marions L, Lovkvist L, Taube A, Johansson M, Dalvik H, Overlie I. Use of the levonorgestrel releasing-intrauterine system in nulliparous women--a non-interventional study in Sweden. Eur J Contracept Reprod Health Care. 2011 Apr;16(2):126-34. doi: 10.3109/13625187.2011.558222.

    PMID: 21417562RESULT

MeSH Terms

Interventions

Levonorgestrel

Intervention Hierarchy (Ancestors)

NorgestrelNorpregnenesNorpregnanesNorsteroidsSteroidsFused-Ring CompoundsPolycyclic Compounds

Study Officials

  • Bayer Study Director

    Bayer

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

November 26, 2008

First Posted

November 27, 2008

Study Start

February 1, 2007

Primary Completion

June 1, 2008

Study Completion

November 1, 2009

Last Updated

April 22, 2015

Record last verified: 2015-04

Locations

SE(1)