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 woman comes to the emergency department with a history of nosebleeds lasting for 1 hour. She has a history of heavy menses as well as occasional gum bleeding following dental procedures. Her mother also has a history of menorrhagia. Laboratory tests reveal increased bleeding time and slightly increased partial thromboplastin time. She has no other medical conditions and is otherwise healthy. Her coagulation study shows CB = 0.30 IU/mL and FVIII:C = 0.37 IU/mL. She is not smoking or using any kind of illicit drugs. She uses alcohol occasionally and is in ra elationship with her boyfriend for the past 2 years.

Patient description (patient's own words): I had to rush to the ER because of a non-stop nosebleed that had been on for 1 hour. As a 23-year-old, I always had heavy periods, and sometimes, my gums would bleed after going to the dentist or brushing my teeth. I thought that it was not very alarming since my mom also had heavy periods. I did some lab tests that showed that I had increased bleeding time and long clotting time. Otherwise, I'm pretty healthy, and I don't smoke or take any kind of drugs. I drink only at parties from time to time. I have been with my boyfriend for the last 2 years. I did a coagulation study and I got the following results: CB = 0.30 IU/mL and FVIII:C = 0.37 IU/mL.

Does the patient match the trial criteria? Entailment