NCT00931827

Brief Summary

The study examines the use of Mirena or Implanon for long-term contraception in women. The duration of therapy use is the key focus of the study. Also, any reasons for discontinuation and the safety profile will be examined. In addition, patients are asked to fill out a short questionnaire about their menstrual bleeding before and during therapy.

Trial Health

90
On Track

Trial Health Score

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

Enrollment
436

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2008

Longer than P75 for all trials

Geographic Reach
4 countries

4 active sites

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2008

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

June 30, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 2, 2009

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2011

Completed
Last Updated

December 24, 2013

Status Verified

December 1, 2013

Enrollment Period

3.8 years

First QC Date

June 30, 2009

Last Update Submit

December 22, 2013

Conditions

Contraception

Keywords

Contraception

Outcome Measures

Primary Outcomes (1)

  • Continuation rate

    At 24 months

Secondary Outcomes (5)

  • Continuation rate

    At 12 months

  • Bleeding intensity, dysmenorrhea, and user satisfaction (questionnaires completed by patient)

    Initial and after 3, 6, 12 and 24 months

  • Cumulative discontinuation rate for unintended pregnancy, bleeding problems, other medical reasons, for non-medical reasons

    At 24 months

  • Incidence of Adverse Events, Serious Adverse Events

    During 24 months

  • The return to fertility of women discontinuing the method for wish for pregnancy

    12 months after discontinuation

Study Arms (2)

Group 1

Drug: Levonorgestrel IUS (Mirena, BAY86-5028)

Group 2

Drug: Implanon (Etonogestrel)

Interventions

Levonorgestrel IUS (Mirena, BAY86-5028)DRUG

Patients under daily life treatment receiving Mirena according to local drug information.

Group 1
Implanon (Etonogestrel)DRUG

Patients under daily life treatment receiving Implanon according to local drug information.

Group 2

Eligibility Criteria

Age20 Years - 35 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Women aged 20-35 years switching from short-acting hormonal contraception

You may qualify if:

  • Women aged 20-35 in good general health requesting contraception
  • Women who have used short-acting hormonal contraception (combined or progestogen-only pills, vaginal ring or contraceptive patch) for at least 3 cycles immediately before entering the study and opting to change to either Mirena or Implanon for contraception
  • Women who have given a written informed consent to participate in the study (if applicable)

You may not qualify if:

  • The contraindications and warnings of the respective Summary of Product Characteristics (Mirena or Implanon) must be followed. The decision to start Mirena or Implanon has to be made clearly before the decision to include patients in the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Unknown Facility

Many Locations, France

Location

Unknown Facility

Many Locations, Ireland

Location

Unknown Facility

Many Locations, Slovakia

Location

Unknown Facility

Many Locations, United Kingdom

Location

MeSH Terms

Interventions

Levonorgestreletonogestrel

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
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 30, 2009

First Posted

July 2, 2009

Study Start

January 1, 2008

Primary Completion

November 1, 2011

Study Completion

November 1, 2011

Last Updated

December 24, 2013

Record last verified: 2013-12

Locations

SL(1)IE(1)GB(1)FR(1)