The trial will be performed in healthy female volunteers. The intended indication is female contraception.
Conditions
Sponsors
Bayer Schering Pharma AG
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Signed and dated informed consent 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. 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) F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Pregnancy, lactation (less than three menstrual cycles before Visit 1 following delivery, abortion, or lactation) 2. Obesity (BMI > 30.0 kg/m2) 3. Hypersensitivity to active substances or to any of the excipients 4. 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 Visit1) 5. Laboratory values outside inclusion range at Screening 6. Any diseases or conditions that can compromise the function of the body systems and could result in altered absorption, excessive accumulation, impaired metabolism, or altered excretion of the study medication 7. 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 tumors (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 8. Undiagnosed vaginal bleeding 9. Known alcohol, drug, or medicine abuse (e.g., laxatives) 10. Additional sex steroids (excluding topical use of Progestogel®), 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 (e.g., barbiturate derivatives, primidone); tuberculostatics (e.g., rifampicin); oral antimycotics (except for a so-called single shot treatment) [e.g., griseofulvin, ketoconazole, itraconazole, fluoconazole]; virostatic agents (except for topical use) (e.g., ritonavir); phenylbutazone; products containing St. John’s wort (Hypericum perforatum); and continuous systemic use of antibiotics for >10 days 11. 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 Vis
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of this study is to evaluate and compare the cycle control and bleeding patterns of six different regimens of the combination estradiol and drospirenone over 7 cycles of treatment.;Secondary Objective: A subjective assessment of treatment will be performed. Safety (adverse events, safety laboratory tests, general and gynecological findings) and compliance will also be assessed. ;Primary end point(s): To compare cycle control, bleeding patterns, and safety of 6 different regimens of the combination estradiol and drospirenone over 7 cycles | — |
Countries
Germany
Outcome results
None listed