Mirena Efficiency and Tolerability During the First Year of Use

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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00696202

Enrollment

199

Registered

2008-06-12

Start date

2003-09-30

Completion date

2005-03-31

Last updated

2014-12-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Contraception, Medicated Intrauterine Devices

Keywords

Mirena, Levonorgestrel, Intrauterine device, Efficacy, Tolerability, First year of use

Brief summary

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

Interventions

DRUGMirena (BAY86-5028)

Intrauterine levonorgestrel containing device (market product)

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

25 Years to 39 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

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Adverse event related to the product causing a subject to withdraw, or be withdrawn, from the study at any time up to 12 months from the insertion of Mirena	within 12 months after randomization

Secondary

Measure	Time frame
General safety assessment	within 12 months after randomization

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026