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Mirena Efficiency and Tolerability During the First Year of Use

Information source: Bayer
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Medicated Intrauterine Devices; Contraception

Intervention: Mirena (BAY86-5028) (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: Bayer

Official(s) and/or principal investigator(s):
Bayer Study Director, Study Director, Affiliation: Bayer

Summary

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

Clinical Details

Official 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

Study design: Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Adverse event related to the product causing a subject to withdraw, or be withdrawn, from the study at any time up to 12 months from the insertion of Mirena

Secondary outcome: General safety assessment

Eligibility

Minimum age: 25 Years. Maximum age: 39 Years. Gender(s): Female.

Criteria:

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

Locations and Contacts

Amiens Cedex 01 80054, France
Additional Information

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Starting date: September 2003
Last updated: December 30, 2014

Page last updated: August 23, 2015

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