Clinical trial: Dexamethasone for Excessive Menstruation (NCT01769820)

Eligibility criteria:
Inclusion Criteria:

          -  Complaint of HMB, including women with fibroids

          -  Pre-menopausal

          -  Age 18 years and over

          -  Describing menstrual cycles every 21- 42 days

          -  Provide written informed consent prior to any study related procedures

          -  If of childbearing potential either agree to practice a non-hormonal method of
             contraception for duration of study or have a partner with a vasectomy

          -  Workup (Study 1 or 2)- MBL for single screening period is >= 50mL

          -  Adaptive Trial (Study 3)- average MBL for two screening menstrual collections is >=
             50mL

        Exclusion Criteria:

          -  Currently breast-feeding

          -  History or current uterus, cervix, ovarian or breast cancer

          -  Known severe coagulation disorder

          -  Glucocorticoid treatment or sex steroid administration by any route in previous 1
             month

          -  Taking prohibited medication -

          -  Thyroid, renal or liver dysfunction

          -  Diabetes mellitus

          -  Treated moderate/severe hypertension

          -  Psychotic depressive illness

          -  Rare hereditary galactose intolerance, lactase deficiency or glucose galactose
             malabsorption (due to lactose content of trial medication)

          -  Has a problem with alcohol or drug abuse

          -  Has a mental condition rendering her unable to understand the nature and scope of the
             study

          -  Participation in treatment phase in any earlier DexFEM study (1 or 2)

          -  Is currently enrolled in an investigational drug or device study or participated in
             such a study within the previous 30 days and is still in exclusion period

          -  workup study 1, only, an additional exclusion criterion of any contra-indication to
             MRI
Female
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
Subject must be at most 60 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