Mirena Efficiency and Tolerability During the First Year of Use

Bayer

Status and phase: Completed; Phase 4

Conditions: Contraception; Medicated Intrauterine Devices

Treatments: Drug: Mirena (BAY86-5028)

Study type: Interventional

Funder types: Industry

Identifiers

NCT00696202

307702

91295

Details and patient eligibility

About

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

Enrollment: 199 patients

Sex: Female

Ages: 25 to 39 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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199 participants in 1 patient group

Arm 1

Experimental group

Treatment:

Drug: Mirena (BAY86-5028)