Clinical trial: A Study Run at Multiple Study Sites to Test Whether the SAMANTA Questionnaire That is Used to Diagnose Heavy Menstrual Bleeding (HMB), Can Also be Used to Assess Changes of Severity of HMB in Women With HMB Who Are Treated During 12 Months With a Chronic Hormonal Treatment (NCT03751800)

Eligibility criteria:
Inclusion Criteria:

          -  Women in childbearing age, ≥18 years old, not intending to become pregnant during the
             next year.

          -  Women diagnosed with heavy menstrual bleeding or idiopathic menorrhagia according to
             medical criteria and based on clinical judgment.

          -  Women for whom the clinician decides, in agreement with the patient, to prescribe any
             of the available chronic hormonal treatments with the therapeutic indication of HMB in
             Spain (Mirena, Qlaira or Progevera).

          -  Women capable of reading and writing.

          -  Women who signed the informed consent.

        Exclusion Criteria:

          -  Women with amenorrhea or menopause.

          -  Women with contraindications and warnings with the chronic hormonal treatment
             prescribed for HMB as per the summary of product characteristics (interaction with
             concomitant medication, etc.).

          -  Women receiving contraceptive hormonal therapy or using a copper intrauterine device.

          -  Women on hormone replacement therapy.

          -  Women with a history of malignancy.

          -  Women with degenerative diseases that could directly negatively impact their daily
             life.

          -  Women who have given birth within the previous 6 months.

          -  Women who are pregnant.

          -  Women participating in an investigational program with interventions outside of
             routine clinical practice.

          -  Women with psychiatric disorders who are unable to make decisions and follow
             instructions.

          -  Women with concomitant medication that may lead to changes in the bleeding pattern
             (e.g. antiplatelet and/ or anticoagulants).
Female
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.


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? 1