check_circleStudy Completed

Contraception

Bayer Identifier:

18649

ClinicalTrials.gov Identifier:

NCT02985541

EudraCT Number:

Not Available

EU CT Number:

Not Available
Mirena extension trial

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.

Key Participants Requirements

Sex

Female

Age

18 - 35 Years
  • -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
  • -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
December 2016 - May 2021
Phase
Phase 3
Could I Receive a placebo
No
Products
Mirena (Levonorgestrel IUS, BAY86-5028)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Completed
Tucson, 85712, United States
Completed
Spokane, 99207-1240, United States
Completed
Mobile, 36608-6703, United States
Completed
Houston, 77030, United States
Completed
Las Vegas, 89106, United States
Completed
Fort Wayne, 46825, United States
Completed
Lincoln, 68510, United States
Completed
Lawrenceville, 08648, United States
Completed
Erie, 16507, United States
Completed
New Bern, 28562, United States
Completed
Chattanooga, 37404, United States
Withdrawn
Decatur, 30034, United States
Withdrawn
Moorestown, 08057, United States
Completed
Seattle, 98105, United States
Completed
Portland, 97239, United States
Withdrawn
New Brunswick, 08901, United States
Completed
Scottsdale, 85251, United States
Completed
Pikesville, 21208, United States
Completed
North Chesterfield, 23235, United States
Completed
Newburgh, 47630-8940, United States
Completed
Neptune, 07753, United States
Completed
Aurora, 80045, United States
Completed
Roanoke, 24013-2256, United States
Completed
Philadelphia, 19104, United States
Completed
Lebanon, 03756-1000, United States
Withdrawn
San Antonio, 78229, United States
Withdrawn
Atlanta, 30342, United States
Withdrawn
Gainesville, 32605, United States
Completed
Saginaw, 48604, United States
Completed
Frederick, 21702, United States
Withdrawn
San Antonio, 78229, United States
Completed
Ventura, 93003, United States
Completed
Tucson, 85712, United States
Completed
Albuquerque, 87109, United States
Completed
Greensboro, 27408, United States
Completed
Morehead City, 28557, United States
Completed
Greensboro, 27408, United States
Completed
Midlothian, 23114, United States
Withdrawn
Raleigh, 27607, United States
Completed
San Francisco, 94110, United States
Completed
Draper, 84020-7163, United States
Completed
Idaho Falls, 83404, United States
Completed
Port Jefferson, 11777, United States
Withdrawn
Charleston, 29406, United States
Completed
Virginia Beach, 23456, United States
Withdrawn
San Diego, 92111, United States
Completed
Durham, 27713, United States
Completed
Phoenix, 85032, United States
Withdrawn
Fishers, 46037, United States
Withdrawn
Loxahatchee, 33470, United States
Withdrawn
Jacksonville, 32207, United States
Completed
Hickory, 28602, United States
Completed
New York, 10032, United States
Completed
Idaho Falls, 83404, United States
Completed
Fort Worth, 76104-4145, United States
Withdrawn
Panama City, 32405, United States
Withdrawn
Shawnee, 66218, United States
Completed
Austin, 78758, United States
Completed
Seattle, 98122, United States
Completed
Franklin, 45005-2593, United States
Completed
Philadelphia, 19107, United States
Completed
Mayfield Heights, 44124, United States
Withdrawn
Miami, 33147, United States
Withdrawn
Providence, 02905, United States
Withdrawn
Seattle, 98195, United States
Completed
Winston Salem, 27103-1749, United States
Withdrawn
Irving, 75062, United States
Withdrawn
Miami, 33165, United States
Completed
Boston, 02118, United States
Completed
Asheville, 28801, United States
Completed
Atlanta, 30342, United States
Withdrawn
Dallas, 75231, United States
Withdrawn
Hixson, 37343, United States
Completed
Encinitas, 92024, United States
Withdrawn
Laguna Hills, 92653, United States
Withdrawn
Omaha, 68114, United States
Withdrawn
San Antonio, 78212, United States
Withdrawn
New York, 10038, United States
Withdrawn
Huntington Beach, 90255, United States
Withdrawn
Dallas, 75230, United States

Primary Outcome

  • 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.
    date_rangeTime Frame:
    Years 6 to 8 of Mirena use

Secondary Outcome

  • 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).
    date_rangeTime Frame:
    Baseline and end of Years 6, 7 and 8 of Mirena use
  • 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.
    date_rangeTime Frame:
    At end of Year 6, 7 and 8 of Mirena use
  • 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.
    date_rangeTime Frame:
    Years 6 to 8 of Mirena use

Trial design

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
Trial Type
Interventional
Intervention Type
Drug
Trial Purpose
Treatment
Allocation
N/A
Blinding
Open Label
Assignment
Single Group Assignment
Trial Arms
1

Additional Information

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