Clinical trial: CDB-2914 for Abnormal Uterine Bleeding in Premenopausal Women (NCT01493791)

Eligibility criteria:
-  INCLUSION CRITERIA:

          -  Female gender - to evaluate effects in the target population for clinical trials

          -  History of abnormal uterine bleeding documented by menorrhagia impact questionnaire
             (MIQ) and menstrual calendar

          -  Anovulatory and ovulatory women will be included

          -  In good health. Chronic medication use is acceptable except for glucocorticoid use.
             Other chronic medication use may be acceptable at the discretion of the research team.
             Interval use of over-the counter drugs is acceptable but must be recorded.

          -  Ovulatory women will be defined as those who have menstrual cycles of 24 35 days and a
             progesterone value > 3.0 pg/mL between 5 and 9 days after in-home documentation of an
             LH surge

          -  Anovulatory women will be defined as those without an in-house LH surge in whom
             progesterone values 3 and 4 weeks after menses are < 3.0 ng/mL

          -  Hemoglobin > 10 g/dL (for those wishing surgery); iron may be administered to improve
             red blood cell counts

          -  Willing and able to comply with study requirements

          -  Age 25-40

          -  Using mechanical (condoms, diaphragms), sterilization or abstinence methods of
             contraception for the duration of the study

          -  Negative urine pregnancy test

          -  BMI less than or equal to 33, if a surgical candidate or less than or equal to 35, if
             not a surgical candidate.

          -  Creatinine less than 1.3 mg/dL

          -  Liver function tests within 130 percent of upper limit

          -  Women who elect surgery must state that they do not desire further fertility.

          -  Endometrial biopsy without endometrial hyperplasia or neoplasia

          -  Normal cervical cytology screening within the last 12 months

        EXCLUSION CRITERIA:

          -  Significant abnormalities in the history, physical or laboratory examination

          -  Pregnancy

          -  Lactation

          -  Use of oral, injectable or inhaled glucocorticoids or megesterol within the last year

          -  History of malignancy within the past 5 years

          -  Vaginal Bleeding in context of anatomic abnormality, endometrial neoplasia or
             hyperplasia, cervical, vaginal, or vulvar neoplaisa or preneoplastic pathology

          -  Use of estrogen or progesterone-containing compounds, such as oral contraceptives and
             hormone replacement therapy, within 8 weeks of study entry, including transdermal,
             injectable, vaginal and oral preparations

          -  Current use of agents known to induce hepatic P450 enzymes; use of imidazoles

          -  Current use of GnRH analogs or other compounds that affect menstrual cyclicity

          -  Use of herbal medication having estrogenic or antiestrogenic effects within the past 3
             months

          -  FSH > 20 IU/mL

          -  Untreated cervical dysplasia

          -  Need for interval use of narcotics

          -  Abnormal adnexal/ovarian mass

          -  Contradiction to anesthesia, for women planning surgery

          -  Leiomyomata, polyps or other anatomic causes of vaginal bleeding

          -  Previous participation in the study

          -  Thrombocytopenia defined as platelets < 150,000

          -  Patients with known abnormal breast pathology
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 25 Years old.
Subject must be at most 50 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