Clinical trial: Compare Two Copper IUDs: Mona Lisa NT Cu380 Mini and ParaGard (NCT03124160)

Eligibility criteria:
Inclusion Criteria:

          -  16-40 years

             o 16 and 17 year olds, where permissible by state regulations and local Institutional
             Review Board (IRB) approval

          -  Sexually active, anticipating at least one act of vaginal intercourse per menstrual
             cycle with a male partner and at risk for pregnancy

          -  seeking contraception, and willing to use the study IUD as the only contraception
             method

          -  willing to be randomized to one of the two copper IUDs

          -  has an intact uterus and at least one ovary

          -  has a history of regular menstrual cycles; defined as occurring every 21-35 days when
             not using hormones, and with a variation of typical cycle length of no more than 5
             days

          -  able and willing to provide written informed consent

          -  agrees to follow all study requirements

          -  not currently pregnant or at risk for luteal phase pregnancy based on history of
             unprotected intercourse

        Exclusion Criteria:

          -  abnormal Pap requiring treatment after enrollment

          -  known human immunodeficiency virus / acquired immunodeficiency syndrome (HIV/AIDS)
             infection

          -  intending to become pregnant in the 37 months after enrollment

          -  known infertility

          -  history of allergy or sensitivity to copper

          -  previous tubal sterilization

          -  has received an injectable contraceptive in the last 9 months and has not resumed
             regular menstrual cycles (as evidenced by 2 spontaneous menses)

          -  within 30 days of administration of mifepristone and/or misoprostol for medical
             abortion or for miscarriage management

          -  within 30 days of first, second, or third trimester abortion or miscarriage (note:
             potential abortion/miscarriage participants can be screened and return after 30 days
             for randomization and IUD insertion)

          -  within 30 days of delivery (for parous population)

          -  breastfeeding or recently breastfeeding women unless two consecutive normal menstrual
             periods have occurred after delivery and prior to enrollment.

          -  wants to use a copper IUD for emergency contraception

          -  has previously participated in the study

          -  participated in another clinical trial involving an investigational product within the
             last 30 days (before screening) or planning to participate in another clinical trial
             involving an intervention or treatment during this study

          -  not living in the catchment area of the study site or planning to move from the area
             within the year (unless known to be moving to the catchment area of another study
             site)

          -  known or suspected current alcohol or drug abuse

          -  planning to undergo major surgery during study participation

          -  current need for use of exogenous hormones or therapeutic anticoagulants (Note:
             subjects who start a therapeutic anticoagulant after enrolment will be allowed to
             continue in the study.)

          -  at high risk for sexually-transmitted infections or pelvic infection

          -  anticipated need for regular condom use (refer to Section 8.1).

          -  has any condition (social or medical) which in the opinion of the Investigator would
             make study participation unsafe or complicate data interpretation

          -  Reported medical contraindications (Medical Eligibility Criteria category 3 or 4)14 to
             copper IUDs, including:

               -  suspicious unexplained vaginal bleeding

               -  known cervical cancer

               -  known endometrial cancer

               -  known Wilson's disease

               -  Confirmed gestational trophoblastic disease with persistently elevated beta-hCG
                  levels or malignant disease, with evidence or suspicion of intrauterine disease

               -  anatomic abnormalities with distorted uterine cavity

               -  current pelvic inflammatory disease (PID)

               -  pelvic tuberculosis

               -  immediately post-septic abortion or puerperal sepsis

               -  current known purulent cervicitis or chlamydial infection or gonorrhea; Note: to
                  enroll, there must be no obvious signs of infection at the time of enrollment
                  based on pelvic exam. If lab results come back for positive infection after
                  enrollment, treatment should be provided but the IUD can be left in place.

               -  complicated solid organ transplantation

               -  systemic lupus erythematosus with severe thrombocytopenia
Female
Accepts Healthy Volunteers
Subject must be at least 16 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? 0