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 43-year-old woman, gravida 3 para 3, comes to the clinic complaining of recently painful menstrual cycles.  The patient's last menstrual period was 2 weeks ago. Urine β-hCG is negative. Menarche was at age 12, and menstrual periods occur every 28 days and lasts for 5 days.  She is sexually active with her husband and does not have pain with intercourse. BMI is 23 kg/m2 and Vital signs are normal.  On physical examination, the uterus is uniformly enlarged and tender. She is candidate for hysterectomy with the diagnosis of adenomyosis.

Patient description (patient's own words): I'm 43, and I paid a visit to my doctor because my last few periods were insanely painful. My last periods were 2 weeks ago. I already had three pregnancies that gave me the three lovely children. I did a urine test to check for potential pregnancy, and it came back negative. I started to have my periods at the age of 12, and I have been pretty regular with periods every 28 days for 5 days. I'm sexually active with my husband and I do not have any pain when we have sex. My BMI is 23 and my vitals were normal. The doctor performed a physical exam and found that my uterus was tender and enlarged. She proposed me a hysterectomy and diagnosed me with adenomyosis.

Does the patient match the trial criteria? Contradiction