Contraception
Conditions
Sponsors
Schering AG
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Healthy female volunteers requiring contraception - Age between 18 and 50 years (inclusive) at Visit 1, smokers not older than 30 years and with a daily cigarette consumption not exceeding 10 - Non-suspicious cervical smear taken at Visit 1 or within the last 6 months before Visit 1 - Signed and dated informed consent. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: - Pregnancy, lactation - Occurrence of less than 3 menstrual cycles before Visit 1 following delivery, abortion, or lactation - Amenorrhoea - Known hypersensitivity to any ingredient of the study drugs - Any known diseases or conditions that compromise the function of the body systems and could result in altered absorption, excessive accumulation, impaired metabolism, or altered excretion of the study medication - Any known severe systemic disease that might interfere with the conduct of the study or the interpretation of the results - Known thyroid disorders - Clinically significant depression (current or in the last year) - Any known abnormal clinically significant findings which, according to the assessment of the Investigator, may worsen under hormonal treatment - Laboratory values outside the inclusion range at Screening - Participation in another clinical study or administration of an investigational drug within 1 month prior to Visit 1 - Operations scheduled in the study period Known liver diseases: - Previous, acute and chronic progressive liver diseases, e.g., disturbances of bilirubin excretion in the bile (Dubin-Johnson and Rotor syndromes), disturbances of bile secretion, disturbances of bile flow (cholestasis, also a history thereof, idiopathic icterus or pruritus during a former pregnancy or estrogen-progestin treatment) - Between the subsidence of a viral hepatitis (normalization of liver parameters) and the beginning of the study there must be an interval of at least 6 months - Previous or current liver tumors. Known vascular and metabolic diseases: - Existing or previous venous thromboembolic diseases (deep vein thrombosis, pulmonary embolism), existing or previous arterial thromboembolic diseases (myocardial infarction, stroke), as well as any condition increasing the disposition to any of the above, e.g., coagulation disorders with tendency to blood clot formation, hereditary anti-thrombin III deficiency, protein-C and/or protein-S deficiency, any venous thromboembolic event occurred in a close relative (parent or sibling) at a young age ( 140 mmHg and/or diastolic blood pressure > 90 mmHg) - Known diabetes mellitus, impaired glucose tolerance - Known disturbances of lipid metabolism. Known sickle-cell anemia - Known or suspected malignant or premalignant disease, in particular steroid- hormone dependent malignant or premalignant diseases (e.g., endometrial cancer, breast cancer), also a history thereof Known other diseases: - Pemphigoid gestationis during a previous pregnancy, middle-ear deafness (otosclerosis), endometrial hyperplasia, genital bleeding of unknown origin, migraine with neurological symptoms (complicated migraine), manifest kidney disease with impaired renal function, porphyria Known alcohol, drug, or medicine abuse (e.g., laxatives) Prohibited concomitant medication: - Additional sex steroids, hydantoins (e.g., phenytoin), barbiturates (e.g., primidone), carbamazepine, rifampicin, griseofulvin, phenylbutazone, the herbal remedy St. John´s Wort, continuous use of antibiotics (e.g., ampicillin, tetracycline) for >10 days, any anticoagulatory drugs (e.g, heparin, coumarin) Sex hormones prior to start of treatme
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To confirm the safety of SH T00658ID with regard to plasma lipids, haemostatic variables, and carbohydrate metabolism ;Secondary Objective: The effects on thyroid parameters, sex hormone-binding globulin (SHBG), and cortisol-binding globulin (CBG) will also be investigated.;Primary end point(s): Lipid profile: Intraindividual relative changes (in percent) between Treatment Cycle 7 (Visit 4) and Baseline (Visit 2) in: - High-density lipoprotein (HDL)-cholesterol - Low-density lipoprotein (LDL)-cholesterol (calculated according to Friedewald) | — |
Countries
Germany
Outcome results
None listed