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Mirena Extension Trial (MET)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02985541
Recruitment Status : Active, not recruiting
First Posted : December 7, 2016
Last Update Posted : October 29, 2019
Sponsor:
Information provided by (Responsible Party):
Bayer

Tracking Information
First Submitted Date  ICMJE December 5, 2016
First Posted Date  ICMJE December 7, 2016
Last Update Posted Date October 29, 2019
Actual Study Start Date  ICMJE December 22, 2016
Estimated Primary Completion Date June 4, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 5, 2016)
Number of pregnancies per 100 women years. [ Time Frame: Up to 3 years ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02985541 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: December 5, 2016)
  • Menstrual blood loss (MBL) is measured by the alkaline hematin method. [ Time Frame: Up to 3 years ]
    The assessment of this variable is restricted to women who had Mirena inserted for HMB
  • Categorized menstrual blood loss (MBL) (>= 80 ml per 30 days). [ Time Frame: Up to 3 years ]
    The assessment of this variable is restricted to women who had Mirena inserted for HMB.
  • Number of post-baseline adverse events. [ Time Frame: Up to 3 years ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Mirena Extension Trial
Official Title  ICMJE 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
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Contraception
Intervention  ICMJE Drug: Levonorgestrel IUS (Mirena, BAY86-5028)
Levonorgestrel intrauterine delivery system (IUS) with an initial in vitro release rate of 20 μg Levonorgestrel per day
Study Arms  ICMJE Experimental: Levonorgestrel IUS (Mirena, BAY86-5028)
Mirena, an Levonorgestrel intrauterine delivery system (IUS) with an initial in vitro release rate of 20 μg Levonorgestrel per day.
Intervention: Drug: Levonorgestrel IUS (Mirena, BAY86-5028)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: October 25, 2019)
364
Original Estimated Enrollment  ICMJE
 (submitted: December 5, 2016)
360
Estimated Study Completion Date  ICMJE June 4, 2021
Estimated Primary Completion Date June 4, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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)
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years to 35 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02985541
Other Study ID Numbers  ICMJE 18649
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Bayer
Study Sponsor  ICMJE Bayer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Bayer Study Director Bayer
PRS Account Bayer
Verification Date October 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP