Mirena Extension Trial

Study Overview
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Brief Summary
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The study is performed to assess if Mirena is effective and safe as a birth control method beyond 5 years of use. Further the menstrual blood loss (in women that had Mirena inserted for the indication heavy menstrual bleeding [HMB]) and safety will be assessed.

Official Title
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Multi-center, Open-label, Uncontrolled Study to Assess Contraceptive Efficacy and Safety of Mirena During Extended Use Beyond 5 Years in Women 18 to 35 Years of Age Including a Subgroup Evaluation of Treatment Effect on Heavy Menstrual Bleeding

Conditions
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Contraception

Intervention / Treatment
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* Drug: Levonorgestrel IUS (Mirena, BAY86-5028)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Signed and dated informed consent Women, 18 to 35 years of age at the time of screening (visit 1) who are currently using Mirena for contraception or for contraception and heavy menstrual bleeding. The duration of use of the current Mirena has to be at least 4 years 6 months at the start of screening phase but not more than 5 years at visit 2 and the woman is willing to continue with its use and has a continuing need for contraception. Normal or clinically insignificant cervical smear not requiring further follow up Exclusion Criteria: Menopausal symptoms with Follicle-stimulating hormone>30 mIU/ml Pregnancy or suspicion of pregnancy Uterine bleeding of unknown etiology Untreated acute cervicitis or vaginitis or other lower genital tract infections Increased susceptibility to pelvic infection Acute pelvic inflammatory disease (PID) or a history of PID unless successfully treated and which, in the investigator's opinion, has not negatively affected subject's fertility Congenital or acquired uterine anomaly if it distorts the uterine cavity History of, diagnosed or suspected genital or other malignancy and untreated cervical dysplasia Any active acute liver disease or liver tumor (benign or malignant) Clinically significant endometrial polyp(s)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 35 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Levonorgestrel IUS (Mirena, BAY86-5028)<br>Mirena during extended use (Years 6 to 8). | Drug: Levonorgestrel IUS (Mirena, BAY86-5028)<br>* Levonorgestrel (LNG) intrauterine delivery system (IUS) with an initial in vitro release rate of 20 μg levonorgestrel per day.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Pregnancies Per 100 Women Years (Pearl Index [PI]) Within Years 6 Thru 8 of Mirena Use | The Pearl Index (PI) is defined as the number of pregnancies per 100 women years. The 3-year PI (Years 6 to 8) was obtained by dividing the number of pregnancies the occurred during that time (starting at Day 1 Year 6 and up to Day 365 of Year 8) by the time (in 100 women years) that the women were at risk of getting pregnant during that time. | Years 6 to 8 of Mirena use | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Menstrual Blood Loss (MBL) During a 30-day Period Starting at the Baseline Visit and at the End of Years 6, 7 and 8 | Menstrual blood loss (MBL) during a 30-day period starting at the baseline visit and at the end of Year 6, Year 7, and Year 8, measured by the alkaline hematin method. The assessment of this variable was restricted to women who had Mirena inserted for heavy menstrual bleeding (HMB). | Baseline and end of Years 6, 7 and 8 of Mirena use | 
| Number of Participants With Menstrual Blood Loss (MBL) (>= 80 ml Per 30 Days) at End of Year 6, 7 and 8 of Mirena Use | Categorized menstrual blood loss (MBL) (≥ 80 mL per 30 days) at end of Year 6, Year 7, and Year 8. The assessment of this variable was restricted to women who had Mirena inserted for HMB. | At end of Year 6, 7 and 8 of Mirena use | 
| Number of Participants With Treatment-emergent Adverse Events (TEAEs) | Adverse event (AE) was defined as any untoward medical occurrence (ie any unfavorable and unintended sign [including abnormal laboratory findings], symptom or disease) in a patient or clinical investigation subject after providing written informed consent for participation in the study. Serious adverse event (SAE) was defined as any untoward medical occurrence that, at any dose 1) resulted in death, 2) was life-threatening, 3) required inpatient hospitalization or prolongation of existing hospitalization, 4) resulted in persistent or significant disability/incapacity, 5) was a congenital anomaly/birth defect, or 6) was another medically important serious event as judged by the investigator. Treatment-emergent adverse event (TEAE) was defined as an AE that occurred on Day 1 Year 6 of Mirena use or later. | Years 6 to 8 of Mirena use | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Birth Control, Heavy menstrual bleeding