Mirena Extension Trial (MET)
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|ClinicalTrials.gov Identifier: NCT02985541|
Recruitment Status : Completed
First Posted : December 7, 2016
Results First Posted : April 28, 2022
Last Update Posted : April 28, 2022
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|Condition or disease||Intervention/treatment||Phase|
|Contraception||Drug: Levonorgestrel IUS (Mirena, BAY86-5028)||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||364 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||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|
|Actual Study Start Date :||December 22, 2016|
|Actual Primary Completion Date :||May 28, 2021|
|Actual Study Completion Date :||May 28, 2021|
Experimental: Levonorgestrel IUS (Mirena, BAY86-5028)
Mirena during extended use (Years 6 to 8).
Drug: Levonorgestrel IUS (Mirena, BAY86-5028)
Levonorgestrel (LNG) intrauterine delivery system (IUS) with an initial in vitro release rate of 20 μg levonorgestrel per day.
- Number of Pregnancies Per 100 Women Years (Pearl Index [PI]) Within Years 6 Thru 8 of Mirena Use [ Time Frame: Years 6 to 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.
- Menstrual Blood Loss (MBL) During a 30-day Period Starting at the Baseline Visit and at the End of Years 6, 7 and 8 [ Time Frame: Baseline and end of Years 6, 7 and 8 of Mirena use ]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).
- Number of Participants With Menstrual Blood Loss (MBL) (>= 80 ml Per 30 Days) at End of Year 6, 7 and 8 of Mirena Use [ Time Frame: 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.
- Number of Participants With Treatment-emergent Adverse Events (TEAEs) [ Time Frame: Years 6 to 8 of Mirena use ]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.
- Total LNG Concentrations in Plasma Estimated Based on the Final 8-year Population Pharmacokinetics (popPK) Model [ Time Frame: At the beginning of Year 6 (baseline) and at the end of Years 6, 7, and 8 of Mirena use ]A population pharmacokinetic (popPK) analysis was performed including sparse data from the study.
- Participant's Satisfaction With Mirena by Visit [ Time Frame: Baseline, at end of Year 6, 7 and 8 of Mirena use ]Participants were asked to evaluate their satisfaction with Mirena on a 5-point scale as very satisfied, somewhat satisfied, neither satisfied or dissatisfied, dissatisfied or very dissatisfied.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
|Ages Eligible for Study:||18 Years to 35 Years (Adult)|
|Sexes Eligible for Study:||Female|
|Accepts Healthy Volunteers:||No|
- 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
- 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)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02985541
|Study Director:||Bayer Study Director||Bayer|
Documents provided by Bayer:
|Other Study ID Numbers:||
|First Posted:||December 7, 2016 Key Record Dates|
|Results First Posted:||April 28, 2022|
|Last Update Posted:||April 28, 2022|
|Last Verified:||April 2022|
|Studies a U.S. FDA-regulated Drug Product:||Yes|
|Studies a U.S. FDA-regulated Device Product:||No|
Heavy menstrual bleeding
Contraceptive Agents, Hormonal
Reproductive Control Agents
Physiological Effects of Drugs
Contraceptive Agents, Female
Contraceptives, Oral, Synthetic