Clinical trial: Desmopressin Acetate 0.2 mg Tablets, Fasting (NCT00835211)

Eligibility criteria:
Inclusion Criteria:

          -  Healthy adult non-smoker (for at least 3 months) or light smoking (less than 10
             cigarettes per day for at least 3 months) male or female subjects, 18-55 years of age;

          -  Weighing at least 60 kg for males and 52 kg for females;

          -  Subjects who had a body mass index (BMI) less than 30;

          -  Medically healthy subjects with clinically normal laboratory profiles and ECGs;

        Females of childbearing potential should have either been sexually inactive (abstinent) for
        14 days prior to the first dose and throughout the study or have been using one of the
        following acceptable birth control methods:

          -  surgically sterile (tubal ligation, hysterectomy, bilateral oophorectomy) 6 months
             minimum. Proof was required for the hysterectomy and oophorectomy;

          -  IUD in place for at least 3 months;

          -  barrier methods (condom, diaphragm) with spermicide for at least 14 days prior to the
             first dose and throughout the study;

          -  surgical sterilization of the partner (vasectomy for 6 months minimum);

          -  hormonal contraceptives for at least 3 months prior to the first dose of the study.

        Other birth control methods were deemed acceptable. Postmenopausal women with amenorrhea
        for at least 2 years were eligible.

          -  Voluntarily consent to participate in the study.

        Exclusion Criteria:

          -  Female subjects who were pregnant or lactating.

          -  Subjects who had been on a special diet (for whatever reason) during the 28 days prior
             to the first dose and throughout the study.

          -  Any clinically significant illness within 4 weeks prior to dosing.

          -  Subjects with any medical condition requiring regular treatment with prescription
             drugs.

          -  The use of any pharmacological agents known to significantly induce or inhibit
             drug-metabolizing enzymes within 30 days prior to the first dose.

          -  Subjects who, through completion of the study, would have donated in excess of: 500 mL
             of blood and/or plasma in 14 days; 1500 mL of blood and/or plasma in 180 days; 2500 mL
             of blood and/or plasma in 1 year.

          -  Subjects who had donated plasma within 30 days prior to the first dose.

          -  Subjects who ahd participated in another clinical trial within 30 days prior to the
             first dose.

          -  Subjects who did not tolerate venipuncture.

          -  History or presence of significant cardiovascular, pulmonary, hepatic, renal,
             hematologic, gastrointestinal, endocrine, immunologic, dermatologic, neurologic, or
             psychiatric disease.

        In addition, the history or presence of:

          -  hypersensitivity or idiosyncratic reaction to desmopressin or any other synthetic
             anti-diuretic hormones;

          -  type IIB von Willebrand's disease;

          -  personal or family bleeding disorder;

          -  alcoholism or drug abuse within the past year.
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 18 Years old.
Subject must be at most 55 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? Entailment