Clinical trial: Cycle Control and Safety of E2-DRSP (NCT00653614)

Eligibility criteria:
Inclusion Criteria:

          -  Healthy female volunteers

          -  Age: 18 - 35 years (inclusive), smokers must not be older than 30 years at inclusion

          -  History of regular cyclic menstrual periods (with a cycle length between 25 and 35
             days)

          -  Willingness to use barrier methods of contraception (condoms with spermicide,
             diaphragms with spermicide, spermicidal vaginal suppositories) or abstinence during
             the trial

        Exclusion Criteria:

          -  Pregnancy, lactation (less than three menstrual cycles before Visit 1 following
             delivery, abortion, or lactation) - Obesity (BMI > 30.0 kg/m2)

          -  Abnormal, suspicious or unclear cervical smear (a cervical smear has to be taken at
             Visit 1 or a normal result has to be documented within the last 6 months before Visit
             1)

          -  Laboratory values outside inclusion range at Screening - Any disease that may worsen
             under hormonal treatment or might interfere with the conduct of the study or the
             interpretation of the results, as e.g.: - Cardiovascular -- presence or a history of
             venous or arterial thrombotic/thromboembolic events (e.g., deep venous thrombosis,
             pulmonary embolism, myocardial infarction) or of a cerebrovascular accident, including
             prodromi (e.g., transient ischemic attack, angina pectoris) and conditions which could
             increase the risk to suffer from any of the above mentioned disorders, e.g., a family
             history indicating a hereditary predisposition. -- uncontrolled arterial hypertension
             (repeated measurements of systolic blood pressure > 140 mmHg and/or diastolic blood
             pressure > 90 mmHg)

          -  Liver -- presence or history of liver tumor (benign or malignant) -- presence or
             history of severe hepatic disease as long as liver function values have not returned
             to normal -- jaundice and/or pruritus related to cholestasis -- history of cholestatic
             jaundice associated with pregnancy or previous COC use

          -  Metabolic diseases -- uncontrolled diabetes mellitus with vascular involvement severe
             dyslipoproteinemia

          -  Other diseases: any known or suspected malignant or premalignant disease, uncontrolled
             thyroid disorder, chronic inflammatory bowel disease, severe renal insufficiency or
             acute renal failure, hemolytic uremic syndrome, sickle cell anemia, porphyria, history
             of hypertriglyceridemia-associated Pancreatitis, systemic lupus erythematodes,
             pemphigoid gestationis during a previous pregnancy, Sydenham chorea, herpes
             gestationis, otosclerosis-related hearing loss, history of migraine with focal
             neurologic symptoms, epilepsy, current or history of clinically significant
             depression, hereditary angioedema

          -  Additional sex steroids, other hormonal contraceptive methods (oral, transdermal)
             during treatment (blister in use at randomization should be finished); intra-uterine
             devices (IUD) with or without hormone release within 1 month prior to Visit 1,
             implants within 1 month prior Visit 1, depot progestins within 6 months prior to Visit
             1 - Surgical interventions scheduled in the study period
Female
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
Subject must be at most 35 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