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Mirena Extension Trial (MET)

Primary Purpose

Contraception

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Levonorgestrel IUS (Mirena, BAY86-5028)
Sponsored by
Bayer
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Contraception focused on measuring Birth Control, Heavy menstrual bleeding

Eligibility Criteria

18 Years - 35 Years (Adult)FemaleDoes not accept healthy volunteers

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)

Sites / Locations

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Levonorgestrel IUS (Mirena, BAY86-5028)

Arm Description

Mirena during extended use (Years 6 to 8).

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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).
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.
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.

Full Information

First Posted
December 5, 2016
Last Updated
April 25, 2022
Sponsor
Bayer
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1. Study Identification

Unique Protocol Identification Number
NCT02985541
Brief Title
Mirena Extension Trial
Acronym
MET
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
Study Type
Interventional

2. Study Status

Record Verification Date
April 2022
Overall Recruitment Status
Completed
Study Start Date
December 22, 2016 (Actual)
Primary Completion Date
May 28, 2021 (Actual)
Study Completion Date
May 28, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bayer

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Contraception
Keywords
Birth Control, Heavy menstrual bleeding

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
364 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Levonorgestrel IUS (Mirena, BAY86-5028)
Arm Type
Experimental
Arm Description
Mirena during extended use (Years 6 to 8).
Intervention Type
Drug
Intervention Name(s)
Levonorgestrel IUS (Mirena, BAY86-5028)
Intervention Description
Levonorgestrel (LNG) intrauterine delivery system (IUS) with an initial in vitro release rate of 20 μg levonorgestrel per day.
Primary Outcome Measure Information:
Title
Number of Pregnancies Per 100 Women Years (Pearl Index [PI]) Within Years 6 Thru 8 of Mirena Use
Description
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.
Time Frame
Years 6 to 8 of Mirena use
Secondary Outcome Measure Information:
Title
Menstrual Blood Loss (MBL) During a 30-day Period Starting at the Baseline Visit and at the End of Years 6, 7 and 8
Description
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).
Time Frame
Baseline and end of Years 6, 7 and 8 of Mirena use
Title
Number of Participants With Menstrual Blood Loss (MBL) (>= 80 ml Per 30 Days) at End of Year 6, 7 and 8 of Mirena Use
Description
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.
Time Frame
At end of Year 6, 7 and 8 of Mirena use
Title
Number of Participants With Treatment-emergent Adverse Events (TEAEs)
Description
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.
Time Frame
Years 6 to 8 of Mirena use
Other Pre-specified Outcome Measures:
Title
Total LNG Concentrations in Plasma Estimated Based on the Final 8-year Population Pharmacokinetics (popPK) Model
Description
A population pharmacokinetic (popPK) analysis was performed including sparse data from the study.
Time Frame
At the beginning of Year 6 (baseline) and at the end of Years 6, 7, and 8 of Mirena use
Title
Participant's Satisfaction With Mirena by Visit
Description
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.
Time Frame
Baseline, at end of Year 6, 7 and 8 of Mirena use

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
No
Eligibility 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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bayer Study Director
Organizational Affiliation
Bayer
Official's Role
Study Director
Facility Information:
City
Mobile
State/Province
Alabama
ZIP/Postal Code
36608-6703
Country
United States
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85032
Country
United States
City
Scottsdale
State/Province
Arizona
ZIP/Postal Code
85251
Country
United States
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85712
Country
United States
City
Encinitas
State/Province
California
ZIP/Postal Code
92024
Country
United States
City
San Francisco
State/Province
California
ZIP/Postal Code
94110
Country
United States
City
Ventura
State/Province
California
ZIP/Postal Code
93003
Country
United States
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30342
Country
United States
City
Idaho Falls
State/Province
Idaho
ZIP/Postal Code
83404
Country
United States
City
Fort Wayne
State/Province
Indiana
ZIP/Postal Code
46825
Country
United States
City
Newburgh
State/Province
Indiana
ZIP/Postal Code
47630-8940
Country
United States
City
Frederick
State/Province
Maryland
ZIP/Postal Code
21702
Country
United States
City
Pikesville
State/Province
Maryland
ZIP/Postal Code
21208
Country
United States
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02118
Country
United States
City
Saginaw
State/Province
Michigan
ZIP/Postal Code
48604
Country
United States
City
Lincoln
State/Province
Nebraska
ZIP/Postal Code
68510
Country
United States
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89106
Country
United States
City
Lebanon
State/Province
New Hampshire
ZIP/Postal Code
03756-1000
Country
United States
City
Lawrenceville
State/Province
New Jersey
ZIP/Postal Code
08648
Country
United States
City
Neptune
State/Province
New Jersey
ZIP/Postal Code
07753
Country
United States
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87109
Country
United States
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
City
Port Jefferson
State/Province
New York
ZIP/Postal Code
11777
Country
United States
City
Asheville
State/Province
North Carolina
ZIP/Postal Code
28801
Country
United States
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27713
Country
United States
City
Greensboro
State/Province
North Carolina
ZIP/Postal Code
27408
Country
United States
City
Hickory
State/Province
North Carolina
ZIP/Postal Code
28602
Country
United States
City
Morehead City
State/Province
North Carolina
ZIP/Postal Code
28557
Country
United States
City
New Bern
State/Province
North Carolina
ZIP/Postal Code
28562
Country
United States
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27103-1749
Country
United States
City
Franklin
State/Province
Ohio
ZIP/Postal Code
45005-2593
Country
United States
City
Mayfield Heights
State/Province
Ohio
ZIP/Postal Code
44124
Country
United States
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States
City
Erie
State/Province
Pennsylvania
ZIP/Postal Code
16507
Country
United States
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States
City
Chattanooga
State/Province
Tennessee
ZIP/Postal Code
37404
Country
United States
City
Austin
State/Province
Texas
ZIP/Postal Code
78758
Country
United States
City
Fort Worth
State/Province
Texas
ZIP/Postal Code
76104-4145
Country
United States
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
City
Draper
State/Province
Utah
ZIP/Postal Code
84020-7163
Country
United States
City
Midlothian
State/Province
Virginia
ZIP/Postal Code
23114
Country
United States
City
North Chesterfield
State/Province
Virginia
ZIP/Postal Code
23235
Country
United States
City
Roanoke
State/Province
Virginia
ZIP/Postal Code
24013-2256
Country
United States
City
Virginia Beach
State/Province
Virginia
ZIP/Postal Code
23456
Country
United States
City
Seattle
State/Province
Washington
ZIP/Postal Code
98105
Country
United States
City
Seattle
State/Province
Washington
ZIP/Postal Code
98122
Country
United States
City
Spokane
State/Province
Washington
ZIP/Postal Code
99207-1240
Country
United States

12. IPD Sharing Statement

Links:
URL
https://clinicaltrials.bayer.com/
Description
Click here to find results for studies related to Bayer Healthcare products.

Learn more about this trial

Mirena Extension Trial

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