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Mirena Extension Trial (MET)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02985541
Recruitment Status : Completed
First Posted : December 7, 2016
Results First Posted : April 28, 2022
Last Update Posted : April 28, 2022
Sponsor:
Information provided by (Responsible Party):
Bayer

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Contraception Drug: Levonorgestrel IUS (Mirena, BAY86-5028) Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 364 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
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.


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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).

  2. 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.

  3. 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.


Other Outcome Measures:
  1. 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.

  2. 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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 35 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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)
Contacts and Locations
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Information from the National Library of Medicine

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


Locations
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Sponsors and Collaborators
Bayer
Investigators
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Study Director: Bayer Study Director Bayer
  Study Documents (Full-Text)

Documents provided by Bayer:
Study Protocol  [PDF] September 20, 2017
Statistical Analysis Plan  [PDF] June 10, 2021

More Information
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Additional Information:

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Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT02985541    
Other Study ID Numbers: 18649
First Posted: December 7, 2016    Key Record Dates
Results First Posted: April 28, 2022
Last Update Posted: April 28, 2022
Last Verified: April 2022

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Bayer:
Birth Control
Heavy menstrual bleeding
Additional relevant MeSH terms:
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Menorrhagia
Uterine Hemorrhage
Uterine Diseases
Hemorrhage
Pathologic Processes
Menstruation Disturbances
Levonorgestrel
 Contraceptive Agents, Hormonal
Contraceptive Agents
Reproductive Control Agents
Physiological Effects of Drugs
Contraceptive Agents, Female
Contraceptives, Oral, Synthetic
Contraceptives, Oral