Mirena Extension Trial


I'm Interested

Trial ID: NCT02985541


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.

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

Stanford Investigator(s)

Paul D. Blumenthal, MD, MPH
Paul D. Blumenthal, MD, MPH

Professor of Obstetrics and Gynecology (Gynecology-Family Planning) at the Stanford University Medical Center, Emeritus


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

   - Any active acute liver disease or liver tumor (benign or malignant)

   - Clinically significant endometrial polyp(s)


drug: Levonorgestrel IUS (Mirena, BAY86-5028)


I'm Interested

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Kathryn Batham