Contraception
Conditions
Sponsors
Schering AG
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Healthy female volunteers requiring contraception 2. Age between 18 and 50 years (inclusive) with smoking habits regulated as follows - Between 18 and 30 years of age, daily cigarette consumption not above 10 - Above 30 years of age, no smoking 3. Non-suspicious cervical smear taken at Visit 1 or within the last 3 months before Visit 1 4. 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: 1. Pregnancy, lactation 2. Occurrence of less than three menstrual cycles before Visit 1 following delivery, abortion, or lactation 3. Known hypersensitivity to any ingredient of the study drug 4. 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 5. Any known severe systemic disease that might interfere with the conduct of the study or the interpretation of the results 6. Known uncontrolled thyroid disorders 7. Clinically significant depression (current or in the last year) 8. Any known abnormal clinically significant findings which, according to the assessment of the Investigator, may worsen under hormonal treatment 9. Laboratory values outside inclusion range at Screening 10. Participation in another clinical study or administration of an investigational drug within 1 month prior to study entry (Visit 1) (or 6 months in case of long-acting progestins) 11. Operations scheduled in the study period 12. 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 13. 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 sibling or a parent at an early age, valvular heart disease, atrial fibrillation, cardiac dysfunction (NYHA I-IV) , strong predisposition to varicosis veins, previous phlebitis. Known arterial hypertension (systolic blood pressure > 140 mmHg and/or diastolic blood pressure > 90 mmHg). Known diabetes mellitus, impaired glucose tolerance. Known disturbances of lipid metabolism 14. Known sickle-cell anemia 15. 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 16. Known other diseases: Pemphigoid gestationis during a previous pregnancy, middle-ear deafness (otosclerosis), endometrial hyperplasia, migraine with neurological symptoms (complicated migraine), genital bleeding of unknown origin, manifest kidney disease with impaired renal function, porphyria 17. Known alcohol, drug, or medicine abuse (e.g., laxatives) 18. Prohibited concomitant medication: Additional sex steroids except for switchers from another OC for the time until the end of one blister after randomization, anticoagulants (e.g., heparin, coumarin); antiepileptics (hydantoin derivatives [e.g., phenytoin] or carboxamide derivatives [e.g., carbamazepine, oxcarbamazepine], other antiepileptics [e.g., felbamate, topiramate]); hypnotics and sedatives
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate bleeding patterns, cycle control, and safety of SH T00658ID in comparison to a reference oral contraceptive (SH D 593 B) containing 0.02 mg ethinylestradiol and 0.1 mg levonorgestrel. Contraceptive reliability (number of unintended pregnancies), subjective assessment of treatment, and characterisation of the effects of the investigational product on general well-being and sex life will also be investigated.;Secondary Objective: (The protocol does not differentiate between primary and secondary objectives);Primary end point(s): There is no distinction between primary and secondary variables. The efficacy variables investigated in this study are: - Bleeding patterns - Cycle control - Cycle control for Cycles 2 – 7 - Number of unintended pregnancies - Subjective assessment of treatment by the volunteer - Mean change in the Psychological General Well-Being Index total score and subscale scores from Baseline to Treatment Cycles 4 and 7 - Change in the McCoy Female Sexuality Questionnaire subscale scores from Baseline to Treatment Cycles 4 and 7 . Due to technical reasons cycle control and bleeding patterns were categorised under the efficacy section; nonetheless, they are de facto safety parameters as mentioned in the CPMP Note for Guidance on Clinical Investigation of Steroid Contraceptives in Women (August 2000). | — |
Countries
Czech Republic, Germany
Outcome results
None listed