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 32-year-old woman comes to the hospital with vaginal spotting.  Her last menstrual period was 10 weeks ago. She has regular menses lasting for 6 days and repeating every 29 days. Medical history is significant for appendectomy and several complicated UTIs. She has multiple male partners, and she is inconsistent with using barrier contraceptives. Vital signs are normal.  Serum β-hCG level is 1800 mIU/mL, and a repeat level after 2 days shows an abnormal rise to 2100 mIU/mL.  Pelvic ultrasound reveals a thin endometrium with no gestational sac in the uterus.

Patient description (patient's own words): I just turned 32 and last morning I woke up with strange blood stains on my underwear. My last periods were more than 2 months ago, which is unusual for me because I used to have regular periods lasting for 6 days every 29 days, more or less. I had several UTIs in the past. I also had appendicitis. I'm currently seeing several men and, to be honest, some of them do struggle to wear a condom. I went to the hospital to check myself up and they told me that my vitals were normal. I also had a blood test on Monday, and my β-hCG level was 1800 mIU/mL, and then on Wednesday, it went up to 2100 mIU/mL. The gynecologist also did an ultrasound and she told me that, hopefully, there was no ovule.

Does the patient match the trial criteria? Contradiction