Contraception
Conditions
Interventions
Product Name: FC-Patch
Product Code: SH P00331 F
Pharmaceutical Form: Transdermal patch
INN or Proposed INN: ethinylestradiol
CAS Number: 57-63-6
Current Sponsor code: ZK 4944
Concentration unit: mg m
Sponsors
Schering AG
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Signed informed consent 2. Healthy female volunteer requesting contraception 3. Age between 18 and 35 years (inclusive), smokers maximum age of 30 years at inclusion 4. a) Pap smear taken or b) Non-suspicious Pap smear within the last six months prior to start of the study can be presented in writing (see Section 7.5.1.2 ‘Safety’) 5. At least six free cycles have to follow depot contraception, at least one free cycle has to follow gestodene, norelgestromin/norgestimate containing oral or transdermal contraceptives or removal of hormonal implants, IUD or IUS (Time will be counted from previous use to screening blood sampling.) 6. At least three cycles have to follow delivery, abortion, or lactation before start of treatment 7. For biopsy group only: endometrial biopsy taken at admission visit with a non-suspicious biopsy result 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. Known hypersensitivity to any of the study drug ingredients 3. Any disease or condition that can compromise the function of body systems and which could result in altered absorption, excessive accumulation, impaired metabolism, or altered excretion of the study medication 4. Severe systemic disease that might interfere with the conduct of the study or the interpretation of the results 5. Uncontrolled thyroid disorders 6. Current or history of clinically significant depression in the last year 7. Abnormal, clinically significant findings which, according to the assessment of the investigator, could worsen under hormonal treatment 8. Application of an experimental drug within 30 days prior to inclusion in the study 9. Liver diseases: previous, acute and chronic progressive liver diseases, e. g., disturbances of the bilirubin excretion in the bile (Dubin-Johnson and Rotor syndromes), disturbances of the bile secretion, disturbances in the bile flow (a history of or current cholestasis), idiopathic icterus or pruritus during a former pregnancy or estrogen-progestogen treatment. There should be an interval of at least 6 months between the subsidence of a viral hepatitis (normalization of the liver parameters) and the beginning of study medication application 10. Vascular diseases and coagulation disorders: Existing or previous venous thromboembolic diseases (deep vein thrombosis, pulmonary embolism), existing or previous arterial thromboembolic diseases (myocardial infarction, stroke), and any condition which could increase the risk to suffer any of the above mentioned disorders, e. g. known coagulation disorders, hereditary AT-III, protein-C and/or protein-S deficiency, any venous thromboembolic event that occurred in a close relative at a younger age, specific heart diseases, cardiac or renal dysfunction, varicose veins, previous phlebitis, alterations in cerebral vessels 11. Uncontrolled arterial hypertension (confirmed systolic blood pressure ? 140 mmHg or confirmed diastolic blood pressure ? 90 mmHg) 12. Known skin disease with suspected alteration of dermal absorption (e.g. psoriasis) 13. Significant skin reaction to transdermal preparations or sensitivity to surgical / medical tape 14. Known diabetes mellitus, impaired glucose tolerance 15. Sickle-cell anemia 16. Known disturbances of lipid metabolism 17. Diagnosed or suspected malignant or premalignat disease 18. Other diseases: Pemphigoid gestationis during a previous pregnancy; middle-ear deafness (otosclerosis); endometrial hyperplasia; migraine with neurologic symptoms (complicated migraine); genital bleeding of unknown origin; endometriosis; uterus myomatosus confirmed by ultrasonography; manifest kidney disease with impaired renal function 19. Alcohol, drug, or medicine abuse 20. Prohibited concomitant medication: Use of systemic or topical medications or substances which oppose the study objectives or which might influence them, e.g. additional sex steroids, drugs known to induce (e.g. rifampicin, barbiturates, anticonvulsants, the herbal remedy St. John's Wort (hypericum perforatum)), or inhibit (e.g. ketoconazole, cimetidine, verapamil) liver enzymes, continuous use of antibiotics over a period of more than 10 days (see section 7.3.3) 21. Other contraceptive methods such as sterilization or IUD
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To describe the bleeding pattern of SH P00331F vs a contraceptive comparator patch ;Secondary Objective: To describe the cycle control, tolerability, and endometrial safety of SH P00331F vs a contraceptive comparator patch ;Primary end point(s): The bleeding pattern and the cycle control behavior of a substance are best described by a set of variables summarized with statistical parameters. category variable bleeding pattern number of bleeding/spotting days (presented by reference period) number of spotting-only days number, mean length, maximal length, range of length for bleeding/spotting episodes number, mean length, maximal length, and range of length for spotting-only episodes cycle control withdrawal bleeding (presented by cycle) withdrawal bleeding (yes/no) length of withdrawal bleeding episode maximal intensity of withdrawal bleeding episode onset of withdrawal bleeding episode intracyclic bleeding intracyclic bleeding (yes/no) number and maximal length of | — |
Countries
Finland, Spain
Outcome results
None listed