Anticonceptie Contraceptive
Conditions
Interventions
The patch will be applied to the buttock while the subject is in a prone
position, after which the patch will be removed 1 week later. The patch will be
applied to an area that does not come in dire
Sponsors
Janssen-Cilag International NV
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1. Subject must be a woman of childbearing potential 18 to 45 years of age, inclusive, at screening 2. Subject has a body mass index (BMI) between 18 and 30 kg/m², inclusive, and body weight not less than 50 kg and not more than 100 kg at screening. 3. Subject must be healthy on the basis of physical examination, medical history, vital signs, and 12-lead electrocardiogram (ECG) performed at screening. This determination will be recorded in the source documents and signed by the investigator. 4. Subject must have a negative serum (Beta-human chorionic gonadotropin [Beta-hCG]) pregnancy test at screening and a negative urine pregnancy test on Day -1 of each treatment period. 5. Subject must be willing and able to adhere to the prohibitions and restrictions specified in this protocol (see Section 4.4, Prohibitions and Restrictions). 6. Subject must be surgically sterile with intact ovaries, sexually abstinent, or, if sexually active with a non-sterilized male partner, be using a highly effective method (ie, failure rate of 6 months, must not use nicotine-containing substances including tobacco products (eg, cigarettes, e-cigarettes, cigars, chewing tobacco, gum, patch), and tests negative for cotinine at screening and on Day -1 of each treatment period.
Exclusion criteria
Exclusion criteria: 1. Subject has a history of or current clinically significant medical illness including (but not limited to) cardiac arrhythmias or other cardiac disease, hematologic disease, coagulation disorders (including any abnormal bleeding or blood dyscrasias), lipid abnormalities, significant pulmonary disease, including bronchospastic respiratory disease, diabetes mellitus, renal or hepatic insufficiency, thyroid disease, neurologic or psychiatric disease, infection, cholelithiasis (gall stone disease), chronic idiopathic jaundice, family history of cholestatic jaundice, or any other illness that the investigator considers should exclude the subject or that could interfere with the interpretation of the study results. 2. Subject has clinically significant abnormal values for hematology, biochemistry, or urinalysis at screening as deemed appropriate by the investigator. 3. Subject has abnormal thyroid stimulating hormone level at screening. 4. Subject has clinically significant abnormal 12-lead ECG, vital signs, or physical examination at screening as deemed appropriate by the investigator. 5. Subject has a history or presence of disorders commonly accepted as contraindications to sex hormonal therapy including, but not limited to, the following: • Deep vein thrombophlebitis or thromboembolic disorders. • Cerebral vascular or coronary artery disease, chronic untreated hypertension, or migraines. • Benign or malignant liver tumor that developed during the use of oral contraceptives or other estrogen-containing products. • Known or suspected estrogen-dependent neoplasia. 6. Subject has presence of disorders commonly accepted as contraindications to combined oral contraceptives including, but not limited to, the following: • Undiagnosed abnormal vaginal bleeding. • Any neurovascular lesion of the eye or serious visual disturbance. • Any impairment of liver function or liver disease, or renal disease. 7. Subject has evidence of cervical dysplasia as documented by a CytoRich test or Papanicolaou (PAP) smear test within 10 months before screening. If a PAP smear has been done within 10 months prior to screening and results are available (documentation is available at the study site) a cervical smear does not need to be performed. 8. Subject has used oral hormonal contraception, ie, contraceptive pills, within 3 months before admission to the study site on Day -1 of Treatment Period 1. 9. Subject currently has a contraceptive implant such as Implanon* or Norplant® in place, or has had removal of contraceptive implant within the 3 months before admission to the study site on Day -1 of Treatment Period 1. 10. Subject currently has a contraceptive vaginal ring such as NuvaRing® in place, or has had removal of contraceptive vaginal ring within the 3 months before admission to the study site on Day 1 of Treatment Period 1. 11. Subject received hormone injections such as Depo Provera® or deposubQ Provera 104, within the 3 months before admission to the study site on Day 1 of Treatment Period 1. 12. Subject used a steroid hormone-containing IUD such as Mirena® within the screening period from Day 28 until admission to the study site on Day 1 of Treatment Period 1. 13. Subject used any prescription or nonprescription medication (including herbal supplements), that are known
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| - To determine the bioequivalence of the hormones (ie, NGMN and EE) from the transdermal contraceptive patch using the newly sourced adhesive component Oppanol N100 at EOSL as compared to the currently marketed EVRA patch using the adhesive component Oppanol B100 at BOSL. - To evaluate the adhesion of the transdermal contraceptive patch using the newly sourced adhesive component Oppanol N100 at EOSL as compared to the currently marketed EVRA patch using the adhesive component Oppanol B100 at BOSL. | — |
Secondary
| Measure | Time frame |
|---|---|
| To evaluate the irritation potential of the transdermal contraceptive patch using the newly sourced adhesive component Oppanol N100 at EOSL as compared to the currently marketed EVRA patch using the adhesive component Oppanol B100 at BOSL. To assess the safety and tolerability of the transdermal contraceptive patch using the newly sourced adhesive component Oppanol N100 at EOSL and the currently marketed EVRA patch using the adhesive component Oppanol B100 at BOSL. | — |
Countries
Netherlands
Outcome results
None listed