Clinical trial: A proof-of Concept, Randomized 3-month Study to Evaluate the Effects of Three Contraceptive Intrauterine Systems Delivering Copper and a Daily Dose of 5, 20 or 40 μg of Ulipristal Acetate (UPA) (NCT03230539)

Eligibility criteria:
Inclusion Criteria:

          -  Healthy women of reproductive age (21-38 years)

          -  Not at risk for pregnancy based on subject has undergone sterilization or subject is
             monogamous and her male partner has undergone sterilization

          -  Have regular menstrual cycles of 21-35 days duration

          -  Have an intact uterus and both ovaries

          -  Will be able to comply with the protocol

          -  Capable of giving informed consent

        Exclusion Criteria:

          -  Women participating in another clinical trial within 30 days of initiation of this
             clinical trial

          -  Women not living in the catchment area of the clinic

          -  Known hypersensitivity to progestins or antiprogestins

          -  Known hypersensitivity to copper

          -  Any known chronic disease including HIV/AIDS

          -  All contraindications to IUD use,

          -  Desire to get pregnant during the study Breastfeeding

          -  Undiagnosed vaginal discharge or vaginal lesions or abnormalities

          -  Women with a current abnormal Pap. In accordance with the Bethesda system of
             classification: smear suggestive of high-grade pre-cancerous lesion(s), including
             HGSIL, are excluded;

          -  Women with LGSIL or ASCUS/high-risk HPV positive may participate if further evaluated
             with colposcopy and biopsy and no evidence of a lesion with a severity > CIN I is
             present and/or endocervical curettage is negative.

          -  Women with a biopsy finding of CIN I should have follow up for this finding per
             standard of care; women are excluded it treatment is indicated.

          -  Known benign or malignant liver tumors; known active liver disease

          -  Cancer (past history of any carcinoma or sarcoma)

          -  Medically diagnosed severe depression currently or in the past

          -  Known or suspected alcoholism or drug abuse

          -  Abnormal, clinically significant, serum fasting clinical chemistry values

          -  Women with known abnormal thyroid status

          -  Women with known impaired hypothalamic-pituitary-adrenal reserve

          -  Average diastolic BP > 85 mm or systolic BP >135 mm Hg after 5-10 minutes rest

          -  Body mass index (BMI) > 30.0 (or ≤18) Kg/m2

          -  Women with uterine anomalies

          -  Use within the past 2 months of any implanted hormonal contraceptives including
             progestin-releasing intrauterine systems (IUS) or progestin-releasing subdermal
             implants. NOTE: Removal of implanted hormonal contraceptives must have been for
             personal reasons unrelated to the purpose of enrollment in this study.

          -  Current use of a non-hormone containing IUD. NOTE: Removal of an IUD must be for
             personal reasons unrelated to the purpose of enrollment in this study.

          -  Use of injectable contraceptives during the previous 3 months (e.g. Cyclofem) or 6
             months (e.g. DMPA).

          -  Women who do not have at least two progesterone measurements ≥10nmol/L during the
             baseline cycle will be excluded from further participation in the study (See Section
             13.4.1)

          -  Acute pelvic inflammatory disease or a history of pelvic inflammatory disease unless
             there has been a subsequent intrauterine pregnancy. Postpartum endometritis or
             infected abortion in the past 3 months.

          -  Genital bleeding of unknown etiology.

          -  Untreated acute cervicitis or vaginitis, including bacterial vaginosis or other lower
             genital tract infections until infection is controlled.

          -  Current behavior suggesting a high risk for pelvic inflammatory disease

          -  Mucopurulent cervicitis

          -  Wilson's disease

          -  Allergy to any component of the IUS
Female
Accepts Healthy Volunteers
Subject must be at least 21 Years old.
Subject must be at most 38 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? Entailment