Clinical trial: Quality of Life Outcomes for Ulipristal Acetate and Tranexamic Acid in the Management of Heavy Menstrual Bleeding (NCT03027973)

Eligibility criteria:
Inclusion Criteria:

          -  Participants are female and have a uterus

          -  Participants are between the ages of 18 and 51 years at the time of consent

          -  Participants have heavy menstrual bleeding as evidenced by their symptoms of
             subjective increased bleeding volume and desire to seek treatment

          -  The symptom of heavy menstrual bleeding has been present for most of the last 6 months

          -  Participants have regular menstrual cycles between 24 -38 days in length

        Exclusion Criteria:

          -  Participants who are pregnant or have a positive urine β-hCG

          -  Participants whose bleeding is coming from a cervical, vaginal, urinary or
             gastrointestinal source

          -  Participants who are found to have or who have a previous diagnosis of uterine or
             cervical polyps, adenomyosis, or leiomyomas (fibroids)

          -  Participants who are found to have or who have had endometrial hyperplasia, cervical
             dysplasia or malignancy of any of the vulva, cervix, endometrium, breast or ovaries.

          -  Participants who have ovulatory dysfunction as defined by menstrual cycles that are
             irregular in frequency and regularity and are often punctuated with periods of
             amenorrhea

          -  Participants who are found to have or who have been diagnosed with a coagulopathy

          -  Participants who have a current genitourinary infection

          -  Participants who are desirous of becoming pregnant within the next four months

          -  Participants who have untreated or inadequately treated thyroid disease

          -  Participants who have a contraindication to either treatment including
             hypersensitivity

          -  Participants who are breastfeeding

          -  Participants with mild, moderate or severe hepatic impairment

          -  Participants with moderate or severe renal impairment

          -  Participants with severe asthma not controlled with oral glucocorticoids

          -  Participants with active disease, or history of deep vein thrombosis (DVT), pulmonary
             embolism (PE), cerebral thrombosis or with family history of thromboembolic disease

          -  Patients with subarachnoid hemorrhage

          -  Patients with acquired disturbances of colour vision

          -  Participants who are already on hormone based treatment including, progesterone only
             pills, combined oral contraceptive pill (COCP), Intrauterine System (IUS)
Female
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
Subject must be at most 51 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