Mirena Extension Trial

Last updated: April 25, 2022
Sponsor: Bayer
Overall Status: Completed

Phase

3

Condition

Female Hormonal Deficiencies/abnormalities

Dysfunctional Uterine Bleeding

Heavy Bleeding / Heavy Periods

Treatment

N/A

Clinical Study ID

NCT02985541
18649
  • Ages 18-35
  • Female

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Signed and dated informed consent
  • Women, 18 to 35 years of age at the time of screening (visit 1) who are currentlyusing Mirena for contraception or for contraception and heavy menstrual bleeding. Theduration of use of the current Mirena has to be at least 4 years 6 months at the startof screening phase but not more than 5 years at visit 2 and the woman is willing tocontinue with its use and has a continuing need for contraception.
  • Normal or clinically insignificant cervical smear not requiring further follow up

Exclusion

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 successfullytreated and which, in the investigator's opinion, has not negatively affectedsubject's fertility
  • Congenital or acquired uterine anomaly if it distorts the uterine cavity
  • History of, diagnosed or suspected genital or other malignancy and untreated cervicaldysplasia
  • Any active acute liver disease or liver tumor (benign or malignant)
  • Clinically significant endometrial polyp(s)

Study Design

Total Participants: 364
Study Start date:
December 22, 2016
Estimated Completion Date:
May 28, 2021

Connect with a study center

  • Mobile, Alabama 36608-6703
    United States

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  • Phoenix, Arizona 85032
    United States

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  • Scottsdale, Arizona 85251
    United States

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  • Tucson, Arizona 85712
    United States

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  • Encinitas, California 92024
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    Huntington, California 90255
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    Huntington Beach, California 90255
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    Laguna Hills, California 92653
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    San Diego, California 92111
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  • San Francisco, California 94110
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  • Ventura, California 93003
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  • Aurora, Colorado 80045
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    Denver, Colorado 80230
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    Gainesville, Florida 32605
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    Jacksonville, Florida 32207
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    Loxahatchee, Florida 33470
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    Loxahatchee Groves, Florida 33470
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    Miami, Florida 33147
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    Panama City, Florida 32405
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  • Atlanta, Georgia 30342
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    Decatur, Georgia 30034
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  • Idaho Falls, Idaho 83404
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    Fishers, Indiana 46037
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  • Fort Wayne, Indiana 46825
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  • Newburgh, Indiana 47630-8940
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    Shawnee, Kansas 66218
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    Shawnee Mission, Kansas 66218
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  • Frederick, Maryland 21702
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  • Pikesville, Maryland 21208
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  • Boston, Massachusetts 02118
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    Kalamazoo, Michigan 49009
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  • Saginaw, Michigan 48604
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  • Lincoln, Nebraska 68510
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    Omaha, Nebraska 68114
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  • Las Vegas, Nevada 89106
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  • Lebanon, New Hampshire 03756-1000
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  • Lawrenceville, New Jersey 08648
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    Moorestown, New Jersey 08057
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  • Neptune, New Jersey 07753
    United States

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    Neptune City, New Jersey 07753
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    New Brunswick, New Jersey 08901
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  • Albuquerque, New Mexico 87109
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  • New York, New York 10032
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  • Port Jefferson, New York 11777
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  • Asheville, North Carolina 28801
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  • Durham, North Carolina 27713
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  • Greensboro, North Carolina 27408
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  • Hickory, North Carolina 28602
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  • Morehead City, North Carolina 28557
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  • New Bern, North Carolina 28562
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    Raleigh, North Carolina 27607
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  • Winston-Salem, North Carolina 27103-1749
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  • Franklin, Ohio 45005-2593
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  • Mayfield Heights, Ohio 44124
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  • Portland, Oregon 97239
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  • Erie, Pennsylvania 16507
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  • Philadelphia, Pennsylvania 19107
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    Providence, Rhode Island 02905
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    Charleston, South Carolina 29406
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    Summerville, South Carolina 29485
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  • Chattanooga, Tennessee 37404
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    Hixon, Tennessee 37343
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  • Austin, Texas 78758
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    Dallas, Texas 75231
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  • Fort Worth, Texas 76104-4145
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  • Houston, Texas 77030
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    Irving, Texas 75062
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    San Antonio, Texas 78229
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  • Draper, Utah 84020-7163
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    Murray, Utah 84123
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  • Midlothian, Virginia 23114
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    Norfolk, Virginia 23502
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  • North Chesterfield, Virginia 23235
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    Richmond, Virginia 23235
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  • Roanoke, Virginia 24013-2256
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  • Virginia Beach, Virginia 23456
    United States

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  • Seattle, Washington 98105
    United States

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  • Spokane, Washington 99207-1240
    United States

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