Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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 : November 26, 2019
Sponsor:
Information provided by (Responsible Party):
Bayer

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.

Condition or disease Intervention/treatment Phase
Contraception Drug: Levonorgestrel IUS (Mirena, BAY86-5028) Phase 3

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 364 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : December 22, 2016
Estimated Primary Completion Date : June 4, 2021
Estimated Study Completion Date : June 4, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.
Drug: Levonorgestrel IUS (Mirena, BAY86-5028)
Levonorgestrel intrauterine delivery system (IUS) with an initial in vitro release rate of 20 μg Levonorgestrel per day




Primary Outcome Measures :
  1. Number of pregnancies per 100 women years. [ Time Frame: Up to 3 years ]

Secondary Outcome Measures :
  1. 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

  2. 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.

  3. Number of post-baseline adverse events. [ Time Frame: Up to 3 years ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 35 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02985541


  Show 49 Study Locations
Sponsors and Collaborators
Bayer
Investigators
Layout table for investigator information
Study Director: Bayer Study Director Bayer

Layout table for additonal information
Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT02985541     History of Changes
Other Study ID Numbers: 18649
First Posted: December 7, 2016    Key Record Dates
Last Update Posted: November 26, 2019
Last Verified: November 2019

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Bayer:
Birth Control
Heavy menstrual bleeding
Additional relevant MeSH terms:
Layout table for MeSH terms
Menorrhagia
Uterine Hemorrhage
Uterine Diseases
Genital Diseases, Female
Hemorrhage
Pathologic Processes
Menstruation Disturbances
Levonorgestrel
Contraceptive Agents, Female
Contraceptive Agents
Reproductive Control Agents
Physiological Effects of Drugs
Contraceptives, Oral, Synthetic
Contraceptives, Oral