Trial Condition(s):

Contraception

Mirena extension trial (MET)

Bayer Identifier:

18649

ClinicalTrials.gov Identifier:

NCT02985541

EudraCT Number:

Not Available

Study Completed

Trial Purpose

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)

Trial Summary

Enrollment Goal
364
Trial Dates
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Phase
3
Could I receive a placebo?
No
Products
Mirena (Levonorgestrel IUS, BAY86-5028)
Accepts Healthy Volunteers
No

Where to Participate

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Locations
Status
LocationsStatus
Locations

Investigative Site

Tucson, United States, 85712

Status
Completed
 
Locations

Investigative Site

Spokane, United States, 99207-1240

Status
Completed
 
Locations

Investigative Site

Mobile, United States, 36608-6703

Status
Completed
 
Locations

Investigative Site

Houston, United States, 77030

Status
Completed
 
Locations

Investigative Site

Las Vegas, United States, 89106

Status
Completed
 
Locations

Investigative Site

Fort Wayne, United States, 46825

Status
Completed
 
Locations

Investigative Site

Lincoln, United States, 68510

Status
Completed
 
Locations

Investigative Site

Lawrenceville, United States, 08648

Status
Completed
 
Locations

Investigative Site

Erie, United States, 16507

Status
Completed
 
Locations

Investigative Site

New Bern, United States, 28562

Status
Completed
 
Locations

Investigative Site

Chattanooga, United States, 37404

Status
Completed
 
Locations

Investigative Site

Seattle, United States, 98105

Status
Completed
 
Locations

Investigative Site

Portland, United States, 97239

Status
Completed
 
Locations

Investigative Site

Scottsdale, United States, 85251

Status
Completed
 
Locations

Investigative Site

Pikesville, United States, 21208

Status
Completed
 
Locations

Investigative Site

North Chesterfield, United States, 23235

Status
Completed
 
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Investigative Site

Newburgh, United States, 47630-8940

Status
Completed
 
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Investigative Site

Neptune, United States, 07753

Status
Completed
 
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Investigative Site

Aurora, United States, 80045

Status
Completed
 
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Investigative Site

Roanoke, United States, 24013-2256

Status
Completed
 
Locations

Investigative Site

Philadelphia, United States, 19104

Status
Completed
 
Locations

Investigative Site

Lebanon, United States, 03756-1000

Status
Completed
 
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Investigative Site

Saginaw, United States, 48604

Status
Completed
 
Locations

Investigative Site

Frederick, United States, 21702

Status
Completed
 
Locations

Investigative Site

Ventura, United States, 93003

Status
Completed
 
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Investigative Site

Albuquerque, United States, 87109

Status
Completed
 
Locations

Investigative Site

Greensboro, United States, 27408

Status
Completed
 
Locations

Investigative Site

Morehead City, United States, 28557

Status
Completed
 
Locations

Investigative Site

Midlothian, United States, 23114

Status
Completed
 
Locations

Investigative Site

San Francisco, United States, 94110

Status
Completed
 
Locations

Investigative Site

Draper, United States, 84020-7163

Status
Completed
 
Locations

Investigative Site

Idaho Falls, United States, 83404

Status
Completed
 
Locations

Investigative Site

Port Jefferson, United States, 11777

Status
Completed
 
Locations

Investigative Site

Virginia Beach, United States, 23456

Status
Completed
 
Locations

Investigative Site

Durham, United States, 27713

Status
Completed
 
Locations

Investigative Site

Phoenix, United States, 85032

Status
Completed
 
Locations

Investigative Site

Hickory, United States, 28602

Status
Completed
 
Locations

Investigative Site

New York, United States, 10032

Status
Completed
 
Locations

Investigative Site

Fort Worth, United States, 76104-4145

Status
Completed
 
Locations

Investigative Site

Austin, United States, 78758

Status
Completed
 
Locations

Investigative Site

Seattle, United States, 98122

Status
Completed
 
Locations

Investigative Site

Franklin, United States, 45005-2593

Status
Completed
 
Locations

Investigative Site

Philadelphia, United States, 19107

Status
Completed
 
Locations

Investigative Site

Mayfield Heights, United States, 44124

Status
Completed
 
Locations

Investigative Site

Winston Salem, United States, 27103-1749

Status
Completed
 
Locations

Investigative Site

Boston, United States, 02118

Status
Completed
 
Locations

Investigative Site

Asheville, United States, 28801

Status
Completed
 
Locations

Investigative Site

Atlanta, United States, 30342

Status
Completed
 
Locations

Investigative Site

Encinitas, United States, 92024

Status
Completed
 

Trial Design