Mirena Efficiency and Tolerability During the First Year of Use

Contraception Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00696202
• Other study ID #: 91295
• Secondary ID: 307702
• Status: Completed
• Phase: Phase 4
• First received: June 10, 2008
• Last updated: December 30, 2014
• Start date: September 2003
• Est. completion date: March 2005

Study information

• Verified date: December 2014
• Source: Bayer
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 199
• Est. completion date: March 2005
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 25 Years to 39 Years

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Contraception
• Medicated Intrauterine Devices

Intervention

Drug:
• Mirena (BAY86-5028)
Intrauterine levonorgestrel containing device (market product)

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Bayer

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adverse event related to the product causing a subject to withdraw, or be withdrawn, from the study at any time up to 12 months from the insertion of Mirena		within 12 months after randomization	Yes
Secondary	General safety assessment		within 12 months after randomization	Yes

External Links

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