Prevention of Pregnancy MedDRA version: 12.1 Level: LLT Classification code 10060346 Term: Transdermal contraception
Conditions
Interventions
Product Name: Treatment A
Product Code: material no. 80876395
Pharmaceutical Form: Transdermal patch
INN or Proposed INN: ETHINYLESTRADIOL
CAS Number: 57-63-6
Concentration unit: mg milligram(s)
Conce
Sponsors
Bayer HealthCare AG
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1.Healthy female subject 2.Age: 18 to 35 years (inclusive) at the first screening visit 3.Body mass index (BMI): = 18 kg/m² 4.Ability to understand and follow study-related instructions 5.Willingness to use non-hormonal methods of contraception during the entire study 6.Signed informed consent before any study specific tests or procedures are done 7.Confirmation of the subject’s health insurance coverage prior to the first screening examination 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.Incompletely cured pre-existing diseases for which it can be assumed that the absorption, distribution, metabolism, elimination and effects of the study drugs will not be normal 2.Known or suspected malignant tumors (including after treatment) 3.Known or suspected benign tumors of the liver, pituitary and adrenal gland (including after treatment) 4.Known or suspected liver disorders, including disturbances of bilirubin metabolism (e.g. Dubin-Johnson and Rotor syndromes) and bile secretion/flow (cholestasis, also history of it) 5.Conditions/diseases known to occur or deteriorate with both pregnancy and COC use. 6.Presence or history of pancreatitis 7.Presence or history of venous or arterial thrombotic/thromboembolic events (e.g. deep vein thrombosis, pulmonary embolism, myocardial infarction) or of a cerebrovascular accident, including prodromi (e.g. transient ischaemic attack, angina pectoris) and conditions that could increase the risk to suffer from any of the above mentioned disorders, e.g. a family history indicating hereditary predisposition 8.Diseases associated with adverse vascular events (e.g. diabetes mellitus, chronic inflammatory diseases like Crohn’s disease or colitis ulcerosa, severe disorders of lipid metabolism, sickle-cell anemia) 9.Severe renal insufficiency or acute renal failure 14.Skin diseases with suspected alteration of dermal resorption and/or increased risk for dermal intolerance (e.g. psoriasis, neurodermitis, urticaria) 16.Regular use of medicines other than contraceptives 17.Use of systemic or topical medicines or substances which oppose the study objectives or which might influence them within 4 weeks before the first study drug administration 18.Use of sex hormones (oral, transdermal, intravaginal) during the cycle preceding the pre-treatment cycle 19.Use of any long-acting injectable or implant hormonal therapy within 40 weeks prior to the first study drug administration 20.Use of an intra-uterine system (IUS) releasing hormones during the cycle preceding the pre-treatment cycle (non-hormonal intra-uterine devices are acceptable) 22.Smokers: at the age of 18 to 30 years inclusive (at first screening visit) with a daily consumption of > 10 cigarettes or at the age of 31 to 35 years inclusive (at first screening visit); former smokers who have stopped smoking at least 3 months prior to the first screening visit may be included 23.Donation of blood or plasmapheresis after signing the informed consent 24.Systolic blood pressure below 90 or above 140 mmHg (after at least 3 min in sitting position) 25.Diastolic blood pressure below 45 or above 90 mmHg (after at least 3 min in sitting position) 27.Clinically relevant findings in the physical examination (e.g. pronounced varicosis, thrombophlebitis, evidence of peripheral circulatory disturbances, skin abnormalities in the application area) 28.Clinically relevant findings in the gynecological examination including transvaginal ultrasound 29.Cervical cytological smear classified higher than II according to Papanicolaou (grading I - V) 30.Genital bleeding of unknown origin 31.Menstrual disorders suspicious of ovarian failure (e.g. oligomenorrhea, amenorrhea, hypomenorrhea) 32.Delivery, abortion or lactation less than 3 months before the first screening examination 33.Positive urine pregnancy test 34.Positive results for hepatitis B virus surface antigen (HBsAg), hepatitis C virus antibodies (anti-HCV), human immune deficiency virus antibodies (anti-HIV 1+2
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of this study is to evaluate the inhibition of ovulation in treatment cycles 2 and 3 after dermal application of 3 different patch formulations containing ethinylestradiol (EE) / gestodene (GSD) for 3 treatment cycles;Secondary Objective: •Course of gonadotropins (FSH, LH) and ovarian steroids (E2, P) •Endometrial thickness •Pharmacokinetics of EE, GSD and SHBG •Follicle size ;Primary end point(s): The primary pharmacodynamic variable will be the proportion of volunteers with ovulation in at least one of the treatment cycles 2 and 3. | — |
Countries
Germany, Netherlands
Outcome results
None listed