Mirena Extension Trial



Status:Active, not recruiting
Conditions:Contraception, Contraception
Therapuetic Areas:Reproductive
Healthy:No
Age Range:18 - 35
Updated:3/15/2019
Start Date:December 22, 2016
End Date:June 4, 2021

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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

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.


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)
We found this trial at
47
sites
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Mayfield Heights, OH
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Albuquerque, NM
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Asheville, NC
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Atlanta, GA
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Austin, TX
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Boston, MA
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Chattanooga, TN
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Denver, CO
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Draper, UT
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Durham, NC
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Encinitas, CA
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Erie, PA
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from
Fort Wayne, IN
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from
Fort Worth, TX
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420 West 12th Avenue
Franklin, Ohio 43210
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Franklin, OH
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from
Frederick, MD
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Greensboro, North Carolina 27401
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Greensboro, NC
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Hickory, NC
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Houston, TX
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Idaho Falls, ID
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Las Vegas, NV
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LawrenceVille, New Jersey 08648
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LawrenceVille, NJ
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from
Lebanon, NH
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from
Lincoln, NE
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from
Midlothian, VA
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from
Mobile, AL
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Morehead City, North Carolina 28557
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Morehead City, NC
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Neptune, NJ
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New Bern, NC
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New York, NY
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Newburgh, IN
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Norfolk, VA
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Philadelphia, PA
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Phoenix, AZ
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Pikesville, MD
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Port Jefferson, NY
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Portland, OR
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Richmond, VA
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Roanoke, VA
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Saginaw, MI
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San Francisco, CA
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Scottsdale, AZ
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Seattle, WA
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Spokane, WA
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from
Tucson, AZ
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from
Ventura, CA
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from
Winston-Salem, NC
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