Clinical trial NCT02985541: Mirena Extension Trial
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
Overall status: COMPLETED
Phase: PHASE3
Conditions: Contraception
Keywords: Birth Control
Heavy menstrual bleeding
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2016-12-07
Enrollment: 364
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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)

Primary outcomes:
measure: Number of Pregnancies Per 100 Women Years (Pearl Index [PI]) Within Years 6 Thru 8 of Mirena Use
timeFrame: Years 6 to 8 of Mirena use
Secondary outcomes:
measure: Menstrual Blood Loss (MBL) During a 30-day Period Starting at the Baseline Visit and at the End of Years 6, 7 and 8
timeFrame: Baseline and end of Years 6, 7 and 8 of Mirena use
measure: Number of Participants With Menstrual Blood Loss (MBL) (>= 80 ml Per 30 Days) at End of Year 6, 7 and 8 of Mirena Use
timeFrame: At end of Year 6, 7 and 8 of Mirena use
measure: Number of Participants With Treatment-emergent Adverse Events (TEAEs)
timeFrame: Years 6 to 8 of Mirena use
Other outcomes:
measure: Total LNG Concentrations in Plasma Estimated Based on the Final 8-year Population Pharmacokinetics (popPK) Model
timeFrame: At the beginning of Year 6 (baseline) and at the end of Years 6, 7, and 8 of Mirena use
measure: Participant's Satisfaction With Mirena by Visit
timeFrame: Baseline, at end of Year 6, 7 and 8 of Mirena use
Locations:
city: Mobile
country: United States
state: Alabama
city: Phoenix
country: United States
state: Arizona
city: Scottsdale
country: United States
state: Arizona
city: Tucson
country: United States
state: Arizona
city: Encinitas
country: United States
state: California
city: San Francisco
country: United States
state: California
city: Ventura
country: United States
state: California
city: Aurora
country: United States
state: Colorado
city: Atlanta
country: United States
state: Georgia
city: Idaho Falls
country: United States
state: Idaho
city: Fort Wayne
country: United States
state: Indiana
city: Newburgh
country: United States
state: Indiana
city: Frederick
country: United States
state: Maryland
city: Pikesville
country: United States
state: Maryland
city: Boston
country: United States
state: Massachusetts
city: Saginaw
country: United States
state: Michigan
city: Lincoln
country: United States
state: Nebraska
city: Las Vegas
country: United States
state: Nevada
city: Lebanon
country: United States
state: New Hampshire
city: Lawrenceville
country: United States
state: New Jersey
city: Neptune
country: United States
state: New Jersey
city: Albuquerque
country: United States
state: New Mexico
city: New York
country: United States
state: New York
city: Port Jefferson
country: United States
state: New York
city: Asheville
country: United States
state: North Carolina
city: Durham
country: United States
state: North Carolina
city: Greensboro
country: United States
state: North Carolina
city: Hickory
country: United States
state: North Carolina
city: Morehead City
country: United States
state: North Carolina
city: New Bern
country: United States
state: North Carolina
city: Winston-Salem
country: United States
state: North Carolina
city: Franklin
country: United States
state: Ohio
city: Mayfield Heights
country: United States
state: Ohio
city: Portland
country: United States
state: Oregon
city: Erie
country: United States
state: Pennsylvania
city: Philadelphia
country: United States
state: Pennsylvania
city: Philadelphia
country: United States
state: Pennsylvania
city: Chattanooga
country: United States
state: Tennessee
city: Austin
country: United States
state: Texas
city: Fort Worth
country: United States
state: Texas
city: Houston
country: United States
state: Texas
city: Draper
country: United States
state: Utah
city: Midlothian
country: United States
state: Virginia
city: North Chesterfield
country: United States
state: Virginia
city: Roanoke
country: United States
state: Virginia
city: Virginia Beach
country: United States
state: Virginia
city: Seattle
country: United States
state: Washington
city: Seattle
country: United States
state: Washington
city: Spokane
country: United States
state: Washington
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References: