Clinical trial: Therapeutic Equivalence Trial of Two Hormonal-IUDs in Patients With Heavy Menstrual Bleeding (NCT01695902)

Eligibility criteria:
Inclusion Criteria:

          -  Non-pregnant, non-planning pregnancy, non-lactating non-menopausal females at least 18
             years of age.

          -  Patients with a clinical diagnosis of functional Menorrhagia during the last 6 months.

          -  Patients who are eligible and able to participate in the trial and who consent to do
             so in writing after the purpose and nature of the investigation have been explained to
             them.

        Exclusion Criteria:

          -  History of endometrial ablation or dilatation and/or curettage within the 3 months
             prior to screening

          -  Copper - coiled-intrauterine device or LNG releasing IUS use within 2 months prior to
             screening

          -  Abnormal liver function or jaundice

          -  Renal insufficiency

          -  Other hormonal treatment (sexual steroids),

          -  Organic causes of abnormal uterine bleeding (presence of endometrial polyps, submucous
             myomas of any size, or myometrial myomas > than 3 cm, adenomyosis, atypical
             hyperplasia, carcinoma)

          -  Abnormal uterine morphology

          -  Presence of ovarian cyst > 3 cm

          -  Lower genital tract infection

          -  Current or recurrent PID (present or recurrent pelvis infection (including history of
             postpartum endometritis, infected miscarriage) during the past 3 months

          -  Uncontrolled hypertension

          -  Congenital or acquired valvular disease (including corrections with prosthetic valves)

          -  Known or suspected pregnancy

          -  Known or suspected hormone-dependent tumor

          -  BMI > 30

          -  Abnormal Pap smear test or other evidence of cervical/endometrial mancy

          -  Unexplained amenorrhea

          -  Known hypersensitivity to device material and/or Levonorgestrel
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? Entailment