Mirena Efficiency and Tolerability During the First Year of Use

In this trial the efficacy and safety of Mirena was investigated during the first year of use

Completed

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Key information

Conditions

Medicated Intrauterine Devices Contraception

Age range

25 year–39 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

Amiens, 80054, France

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Women aged 25 to 39 years who sought effective contraception during the post-partum period (i.e. insertion of the device between 6 and 12 weeks after parturition).

Exclusion criteria

Standard exclusion criteria for use of intrauterine hormone devices

Treatment and study plan

Mirena (BAY86-5028)

Drug

Intrauterine levonorgestrel containing device (market product)

Primary outcomes

Adverse event related to the product causing a subject to withdraw, or be withdrawn, from the study at any time up to 12 months from the insertion of Mirena

Time frame: within 12 months after randomization

Secondary outcomes

General safety assessment

Time frame: within 12 months after randomization

Sponsors and collaborators

Lead sponsor

Bayer

Industry

Registry information

Official study title

A Multicentre, Open Label, Uncontrolled Study of the Tolerance, Acceptability and Contraceptive Efficacy of Mirena 52 mg®, an Intra-uterine Levonorgestrel Device, During the First Year After Insertion Post-partum

Important dates

Study start: 2003
Study completion: 2005
First posted: Jun 12, 2008
Registry last updated: Dec 31, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed