Clinical trial: Copper IUD Treatment Observation Study (NCT02519231)

Eligibility criteria:
Inclusion Criteria:

          -  • Age ≥ 18 and < 49 years. We are including a wide range of ages because women of all
             ages request TCu380A. While we recognize that some women approaching menopause (median
             age = 51.4 years) may have changes in their baseline menstruation, we trust that
             clinicians enrolling the patients into the study will ensure that these women meet all
             inclusion (i.e., regular cycles) and exclusion criteria (i.e., do not have diagnosis
             of menorrhagia).

               -  Requesting to have TCu380A IUD inserted as contraceptive method.

               -  English-speaking.

               -  Regular menstrual cycles ranging 21-35 days apart.

               -  Generally healthy.

               -  Willing to attend a 4- to 6-week follow-up visit and complete surveys.

        Exclusion Criteria:

          -  Known or suspected pregnancy.

               -  Contraindications to NSAID use. This includes underlying heart failure, chronic
                  renal disease, chronic liver disease, peptic ulcer disease, or history of upper
                  gastrointestinal bleed, and allergy to NSAIDs.

               -  Current regular use of a NSAID.

               -  Unwilling to avoid use of NSAIDs (except for study medication) for the duration
                  of the study.

               -  Current diagnosis of menorrhagia, metrorrhagia, symptomatic uterine fibroids, or
                  endometrial polyps.

               -  Use of depot medroxyprogesterone acetate (DMPA) or levonorgestrel-releasing
                  intrauterine device (LNG IUD) within the previous 3 months.

               -  Postpartum in the past 4 weeks. The average day in which non-breastfeeding
                  postpartum women ovulate is 25 days after birth, indicating that menstrual cycles
                  can resume after the 4th postpartum week.

               -  Existing medical condition for which placement of TCu380A IUD is a
                  contraindication according to the Centers for Disease Control and Prevention
                  Medical Eligibility Criteria (MEC 4 medical conditions; see Appendix A).

               -  Currently breastfeeding.

               -  Previous use of the TCu380A.
Female
Accepts Healthy Volunteers
Subject must be at least 18 Years old.
Subject must be at most 49 Years

Patient description (medical language): A 23-year-old female has prolonged oral bleeding immediately after a tooth extraction.  Despite several interventions, the bleeding persists for hours and stops only after desmopressin (DDAVP) administration.  The patient has heavy menstrual cycles each month.  She has no other medical problems and takes no medications.  Her mother and grandmother have also had excessive bleeding during menstrual period.  Review of systems is positive for mild bruising on his legs. Laboratory findings reveal a normal platelet count and an abnormal ristocetin cofactor assay, as well as CB <= 0.30 IU/mL and FVIII:C <= 0.40 IU/mL.

Patient description (patient's own words): I'm a 23 woman and I went to the ER because of non-stop bleeding after my tooth extraction. I tried to make the bleeding stop but it just kept going for hours and it finally stopped when I took some medication called DDAVP. I usually have heavy periods, just like my mom and grandma had. I don't have any other medical condition and I don't take any other medication. The doctor noticed the bruises on my legs. I had to do some lab tests. I had a normal platelet count but an abnormal ristocetin cofactor assay. I had low CB and FVIII:C levels.

Does the patient match the trial criteria? Contradiction