Clinical trial: GA Levonorgestrel Intrauterine Contraceptive System (LCS) Phase III Study China (NCT00884260)

Eligibility criteria:
Inclusion Criteria:

          -  Has, in the opinion of the investigator, suitable general and uterine conditions for
             inserting the LCS.

          -  Normal cervical smear (normal cervical smear within the last six months prior to visit
             1 presented in writing can be accepted. The cervical smear should be analyzed and
             reported according to the Bethesda System.)

          -  Has clinically normal safety laboratory results (i.e., inside the specified range for
             inclusion).

          -  Has regular menstrual cycles (length of cycle 21-35 days) (i.e., endogenous cyclicity
             without hormonal contraceptive use).

        Exclusion Criteria:

          -  Known or suspected pregnancy or is lactating.

          -  Vaginal delivery, cesarean delivery, or abortion within 6 weeks prior to visit 2.

        Note: Postpartum insertions should be postponed until uterus is fully involuted, however
        not earlier than 6 weeks after delivery. If involution is substantially delayed, consider
        waiting until 12 weeks postpartum. In case of a difficult insertion and/or exceptional pain
        or bleeding during or after insertion, physical examination and ultrasound should be
        performed immediately to exclude perforation.

          -  History of ectopic pregnancies. Note: For Korea only: History of ectopic pregnancies
             or high probability of ectopic gestation.

          -  Infected abortion within 3 months prior to visit 1. Note: For Korea only: Endometritis
             after delivery or infected abortion within 3 months prior to visit 1.

          -  Abnormal uterine bleeding of unknown origin.

          -  Any genital infection (until successfully treated).

          -  History of, or current, pelvic inflammatory disease

          -  Congenital or acquired uterine anomaly.

          -  Any distortion of the uterine cavity (by e.g., fibroids) likely to cause problems (in
             the opinion of the investigator) during insertion, retention or removal of the LCS.

          -  History of, diagnosed or suspected genital malignancy, and untreated cervical
             dysplasia.

          -  Current deep venous thrombosis or thrombophlebitis; history of deep venous thrombosis.

          -  Clinically significant endometrial polyp(s), which, in the opinion of the
             investigator, will interfere with the assessment of the bleeding profile during the
             study

          -  Clinically significant ovarian cyst(s)

          -  Use of any long-acting injectable sex-hormone preparations within 12 months prior to
             start of study medication, and if entering subset: any sex-hormone administration
             within one month prior to start of the study medication.
Female
Accepts Healthy Volunteers
Subject must be at least 18 Years old.
Subject must be at most 40 Years

Patient description (medical language): A 43-year-old woman, gravida 3 para 3, comes to the clinic complaining of recently painful menstrual cycles.  The patient's last menstrual period was 2 weeks ago. Urine β-hCG is negative. Menarche was at age 12, and menstrual periods occur every 28 days and lasts for 5 days.  She is sexually active with her husband and does not have pain with intercourse. BMI is 23 kg/m2 and Vital signs are normal.  On physical examination, the uterus is uniformly enlarged and tender. She is candidate for hysterectomy with the diagnosis of adenomyosis.

Patient description (patient's own words): I'm 43, and I paid a visit to my doctor because my last few periods were insanely painful. My last periods were 2 weeks ago. I already had three pregnancies that gave me the three lovely children. I did a urine test to check for potential pregnancy, and it came back negative. I started to have my periods at the age of 12, and I have been pretty regular with periods every 28 days for 5 days. I'm sexually active with my husband and I do not have any pain when we have sex. My BMI is 23 and my vitals were normal. The doctor performed a physical exam and found that my uterus was tender and enlarged. She proposed me a hysterectomy and diagnosed me with adenomyosis.

Does the patient match the trial criteria? Contradiction