Patient description: A 45-year-old woman was referred to the emergency department with abdominal pain lasting about 4 days accompanied by nausea and 2 episodes of vomiting. The pain is localized to the epigastric region and radiates to the right upper quadrant. The pain is worsening after eating fatty food. The patient experienced similar pain twice in the past year. Her past medical history is remarkable for hypercholesterolemia and two C/sections. She has 2 children, and she is menopausal. She doesn't smoke, drink alcohol, or use illicit drugs. She is mildly febrile. Her BP is 150/85, HR 115, RR 15, T 38.2, SpO2 98% on RA. On palpation, she experiences epigastric tenderness and tenderness in the right upper quadrant without rebound. Bowel sounds are normal. Laboratory analysis is remarkable for elevated ESR and leukocytosis with a left shift. The ultrasound revealed several gallstones and biliary sludge. The largest gallstone is 0.7cm. Surgery consultation recommends elective cholecystectomy.

Clinical trial eligibility criteria: eligible ages (years): 18.0-45.0,  Bioequivalence Ethinylestradiol Gestodene Harmonet Healthy female subjects in childbearing age, between the ages of 18 and 45 years, inclusive (Healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, full physical examination, including blood pressure and pulse rate measurement, 12-lead ECG and clinical laboratory tests) The BMI Body Mass Index of the volunteers should be within the range of 18,5 to 24,9 (Dietary Guidelines for Americans) and it may vary up to 10% due to the upper limit (18,5 to 27,39) and total body weight >50kg Do not be a smoker (at least 3 months) Not be using hormone contraceptives for at least 28 days before the medication dosing Women with a regular menstrual cycle (menstrual cycle that occurs, in average, in each 28 days, varying from 25 to 35 days) Use lubricated condoms with spermicidal or diaphragm with spermicidal (in accordance with the volunteer's preference) Systolic Pressure up to 130mmHg Diastolic Pressure up to 85mmHg An informed consent document signed and dated by the subject or a legally acceptable representative. If the subject and/or legally acceptable representative cannot read, then the informed consent document may be signed by an impartial witness  Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing) The volunteer has a drug abuse history [subjects using marijuana and hashish will be excluded if they have used these drugs less than three months prior to the medical consult and for drugs such as cocaine, phencyclidine (PCP), crack and heroin, volunteers will be excluded that have used these drugs less than 1 year prior to the medical consult A positive exam for drugs in urine (Methamphetamine, Opiate, Morphine, Marijuana, Cannabis, Amphetamine, Coccaine, Benzoylecgogine, Benzodiazepine) or a positive test for alcohol before the internment in periods 1 and 2 History of regular alcohol consumption exceeding 7 drinks/week (1 drink = 150 mL of wine or 360 mL of beer or 45 mL of hard liquor) within 6 months of screening The volunteer is a smoker or having stopped smoking less than 3 months The volunteer has participated of any experimental trial or has ingested any experimental drug within the 6 months that precede the beginning of the study (ANVISA: Resolution RDC nº34, from June 3rd 2008) lead ECG demonstrating QTc >450 msec at screening. If QTc exceeds 450 msec, the ECG should be repeated two more times and the average of the three QTc values should be used to determine the subject's eligibility Pregnant or nursing females; females of childbearing potential who are unwilling or unable to use an acceptable method of non-hormonal contraception as outlined in this protocol from at least 14 days prior to the first dose of study medication Use of prescription or nonprescription drugs and dietary supplements within 7 days or 5 half-lives (whichever is longer) prior to the first dose of study medication. Herbal medicine, herbal supplements must be discontinued 28 days prior to the first dose of study medication. Limited use of non-prescription medications that are not believed to affect subject safety or the overall results of the study may be permitted on a case-by-case basis following approval by the sponsor Hormonal methods of contraception (including oral and transdermal contraceptives, injectable progesterone, progestin subdermal implants, progesterone-releasing IUDs, postcoital contraceptive methods) and hormone replacement therapy must be discontinued 28 days prior to the first dose of study medication