Trial Search Results

Mirena Extension Trial

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.

Stanford is currently accepting patients for this trial.

Lead Sponsor:

Bayer

Stanford Investigator(s):

Intervention(s):

  • Drug: Levonorgestrel IUS (Mirena, BAY86-5028)

Phase:

Phase 3

Eligibility


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)

Ages Eligible for Study

18 Years - 35 Years

Genders Eligible for Study

Female

Now accepting new patients

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Kathryn Batham
650-724-7826
Recruiting