Mirena Efficiency and Tolerability During the First Year of Use

Phase 4CompletedNCT00696202

Bayer199 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

199

Conditions

Medicated Intrauterine Devices Contraception

Interventions

Mirena (BAY86-5028)DRUG

Intrauterine levonorgestrel containing device (market product)

Eligibility

Sex: FEMALEMin age: 25 YearsMax age: 39 YearsHealthy volunteers:

Medical Language ↔ Plain English

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 (1)

Unnamed facility

Amiens, France

Outcomes

Primary Outcomes

Adverse event related to the product causing a subject to withdraw, or be withdrawn, from the study at any time up to 12 months from the insertion of Mirena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

General safety assessment

Time frame: within 12 months after randomization

Data from ClinicalTrials.gov

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