healthy volunteers requesting oral contraception
Conditions
Interventions
Trade Name: Yasminelle
Product Name: Yasmin 20
Product Code: SHT00186D
Pharmaceutical Form: Tablet
INN or Proposed INN: Ethinylestradiol as Betadex Clathrate
CAS Number: 256463-26-0
Current Sponsor co
Sponsors
Bayer Schering Pharma AG
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: General inclusion criteria - Signed and dated informed consent - Healthy volunteer requesting contraception - Age between 18 and 35 years (inclusive), smokers maximum age of 30 years (inclusive) at screening - Non-suspicious (normal) cervical smear taken at visit 1 or within the last 6 months prior to visit 1 (provided a corresponding report is available) Additional inclusion criteria subgroups - Mean ‘pretreatment’ BMD T-score > -1 at the lumbar spine (L1-L4) (for subgroup 1 ‘bone mineral density’) - Wash-out period of 2 months if sex hormones were used prior to start of study medication (for subgroup 1 and 2 ‘metabolic parameters, hormones, biopsies’) 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: General and gynecological exclusion criteria - Pregnancy, lactation (at least three cycles have to follow delivery, abortion, or lactation before start of treatment) - Body mass index (BMI) 30 - Hypersensitivity to any of the study drug ingredients - Any disease or condition 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 - Any disease that may worsen under hormonal treatment or might interfere with the conduct of the study or the interpretation of the results (e.g., herpes gestationis or idiopathic icterus during a previous pregnancy; middle-ear deafness (otosclerosis), Sydenham chorea, porphyria, disturbances in bile flow (presence or history of cholestasis, gallstones), systemic lupus erythematodes) - Diagnosed or suspected malignant or premalignant disease - Liver diseases: presence or history of severe hepatic diseases including benign or malignant tumors. There should be an interval of at least 3 months between the start of study medication intake and the return of liver function values to normal. - Vascular diseases and coagulation disorders: Presence or history of venous thromboembolic diseases (deep vein thrombosis, pulmonary embolism), presence or history of arterial thromboembolic diseases (e.g., myocardial infarction, stroke), and any condition which could increase the risk to suffer from any of the above mentioned disorders, e.g., a positive family history (event that occurred in a sibling or a parent at an early age) or a suspected hereditary predisposition. - Other diseases: chronic inflammatory bowel disease (Crohn's disease or ulcerative colitis), hemolytic uremic syndrome, migraine with focal neurologic symptoms (complicated migraine) - Undiagnosed vaginal bleeding - Uncontrolled thyroid disorders - Dyslipoproteinaemia - Pancreatitis or a history thereof if associated with severe hypertriglyceridaemia (fasting triglycerides = 200mg/dl; fasting total cholesterol = 260mg/dl) - Uncontrolled arterial hypertension (confirmed systolic blood pressure > 140 mmHg or confirmed diastolic blood pressure > 90 mmHg) - Diabetes mellitus with vascular involvement - Sickle-cell anemia - Current or history of clinically significant depression - Current or history of alcohol or drug abuse - Prohibited concomitant medication (as listed in protocol) - Laboratory test results with clinically relevant abnormalities - Intake of an experimental drug within 1 month prior to inclusion in the study (visit 1) - Other contraceptive methods such as sterilization or use of intrauterine devices (IUDs) - Less than six cycles following i.m. depot contraception, less than one cycle following the removal of hormone-containing implants or intrauterine devices with or without hormone release (visit 2) - Volunteers who previously discontinued the use of oral contraceptives due to intracyclic bleeding episodes - Volunteer is a dependant person, e.g., a relative / family member, a member of the investigator’s staff, and / or is a student of the investigational site Additional exclusion criteria for subgroup 1 ’bone mineral density‘ - BMI 30 - Inactivity or bed rest longer than three weeks within the past 12 months - Excessive physical training
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the safety and efficacy of 2 variations of an extended regimen of the oral contraceptive SH T 00186 D (0.02 mg EE as ß-CDC and 3 mg DRSP) compared to the standard 24 + 4-day regimen of the same oral contraceptive SH T 00186 D Primary efficacy parameter: -Total number of bleeding days during one year -The number of pregnancies occuring under treatment is considered as co- primary variable ;Secondary Objective: Secondary efficacy parameters: -Bleeding pattern and cycle control Subgroup 1: -Mean bone mineral density (BMD) loss (group B+C) -Assessment of bone markers and estradiol (group B+C) Other efficacy parameters: -Menstruation-related symptoms questionnaires in all volunteers -Volunteer satisfaction questionnaire (group A+B) -General Safety measurements: Subgroup 1: -Metabolic parameters (lipid profile, hemostatic variables, carbohydrate profile) -Assessment of hormones (E2, FSH, LH, SHBG, testosterone) -Endometrial biopsy (group A+B) -Transvaginal ultrasound for monitoring of endometrial thickness and ovarian morphology (cysts) Subgroup 2: -Endometrial biopsy (group A+B) -Transvaginal ultrasound for monitoring of endometrial thickness and ovarian morphology (cysts) -Pharmacokinetics (EE, DRSP, SHBG, corticosteroid –binding globulin (CBG)) (group B);Primary end point(s): For the primary efficacy variable (total number of bleeding days during one year) the hypothesis whether the means of the two treatments (group A and C) are equal will be tested. The number of pregnancies occuring under treatment is considered as co-primary target variable. This change does not imply any changes in evaluation of efficacy or bleeding | — |
Countries
Germany
Outcome results
None listed