Mirena Efficiency and Tolerability During the First Year of Use

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT00696202
• Date of registration: 10/06/2008
• Prospective Registration: No
• Primary sponsor: Bayer
• Public title: Mirena Efficiency and Tolerability During the First Year of Use
• Scientific 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
• Date of first enrolment: September 2003
• Target sample size: 199
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT00696202
• Study type: Interventional
• Study design: Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
• Phase: Phase 4

Countries of recruitment

France

Contacts

• Name: Bayer Study Director
• Affiliation: Bayer

Key inclusion & exclusion 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



Age minimum: 25 Years
Age maximum: 39 Years
Gender: Female

Health Condition(s) or Problem(s) studied

Contraception

Medicated Intrauterine Devices

Intervention(s)

Drug: Mirena (BAY86-5028)

Primary Outcome(s)

Adverse event related to the product causing a subject to withdraw, or be withdrawn, from the study at any time up to 12 months from the insertion of Mirena [Time Frame: within 12 months after randomization]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 Outcome(s)

General safety assessment [Time Frame: within 12 months after randomization]

Secondary ID(s)

91295

307702

Source(s) of Monetary Support

Please refer to primary and secondary sponsors