Clinical trial: Uterine Balloon Treatment for Heavy Period Bleeding. (NCT00215618)

Eligibility criteria:
Inclusion Criteria:

          -  Female at least 30 years of age who is premenopausal and for whom childbearing is
             complete.

          -  Excessive menstrual bleeding documented by a diary score of at least 150.

          -  Have documented 3 months failed medical therapy or either a) contraindicated for or b)
             refused medical therapy.

          -  Have an anatomically normal uterine cavity sounding at least 4cm, but not greater than
             12cm.

          -  Have a normal pap smear and no unexplained abnormal pap smears within 1 year of the
             procedure.

          -  Agree not to switch from hormonal to non-hormonal contraception or vice versa during
             or just prior to the study.

          -  Agree to use reliable contraception throughout the study.

          -  Freely agree to participate in the study, including all study related procedures and
             evaluations, and document this agreement by signing informed consent documentation.

        Exclusion Criteria:

          -  Active pelvic inflammatory disease (PID) or recurrent chronic PID.

          -  Active genital or urinary tract infection at the time of the procedure.

          -  History of malignancy of the reproductive system within 5 years of the procedure or
             have ever had malignancy of the endometrium.

          -  Endometrial neoplasia, determined by endometrial biopsy taken within 6 months of
             procedure.

          -  Cavity distorting submucous myoma(s) determined by preoperative hysterogram,
             hysteroscopy, or transvaginal sonography within 6 months of the procedure.

          -  Previous endometrial ablation procedure.

          -  Previous uterine surgeries (such as full thickness myomectomy, subserosal myomectomy,
             uterine reconstruction, or any surgery in which thinning of the uterine musculature
             could occur) except for low transverse caesarean section.

          -  Pregnant or desirous of future pregnancy.

          -  Taken endometrial suppression medication, except for oral contraceptives, within 3
             months of the procedure.

          -  Concurrent open or laparoscopic surgery.
Female
No healthy subjects accepted to join the trial.
Subject must be at least 30 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? Contradiction