Ignite Creation Date:
2024-05-05 @ 12:11 PM
Last Modification Date:
2024-10-26 @ 9:21 AM
Study NCT ID:
NCT00261482
Status:
COMPLETED
Last Update Posted:
2010-11-16
First Post:
2005-12-02
Brief Title:
Evaluation of Womens Experience With EVRA Norelgestromin Ethinyl Estradiol Transdermal Contraceptive Patch Compared With Previous Methods of Contraception
Sponsor:
Janssen Pharmaceutica NV Belgium
Organization:
Janssen Pharmaceutica NV Belgium
Study Overview
Official Title:
An Open Label Multicentre Study of the EVRA Norelgestromin Ethinyl Estradiol Transdermal Contraceptive Patch in Europe Evaluation of Womens Experience With EVRA and Comparison With Previously Used Methods of Contraception
Status:
COMPLETED
Status Verified Date:
2010-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of the study is to evaluate user experience with the EVRAÂ Contraceptive Transdermal Patch specifically user satisfaction with the EVRAÂ Patch and if applicable user preference of the EVRAÂ Patch compared with the previous method of contraception The study also evaluates contraceptive efficacy safety and user compliance
Detailed Description:
EVRA is the first transdermal contraceptive patch to receive approval by Health Canada and Marketing Authorization throughout the European Union This is an open-label single-arm multicenter clinical study with a treatment duration of 24 weeks 6 treatment cycles of 4 weeks Four clinic visits are scheduled a screening Visit 1 in which subjects are asked to complete a set of questions about satisfaction with the current method of contraception and questions about overall health status Visits 2 3 and 4 follow after Cycles 1 3 and 6 respectively of EVRA treatment At Visits 3 and 4 the subjects are asked to answer questions about satisfaction with EVRA and about overall health status At Visit 4 final study visit the subjects are asked to compare EVRA with previously used contraceptive methods Compliance is assessed at all visits by returned boxes of study medication and a review of Diary Cards where subjects recorded the dates and sites of patch application and details of any patch detachment The study will generate the first large-scale European dataset on womens experience with EVRA including satisfaction safety efficacy and compliance These data will be compared with subjects experience with previously used methods of contraception Each EVRA patch containing 6 mg NGMN and 600 ug EE and delivering 150 microgram NGMN and 20 ug EE over 24 hours for 7 days is worn for 1 week and replaced for 3 consecutive weeks The fourth week is patch-free Subjects can wear EVRA on 1 of 4 areas buttock abdomen upper torso or upper arm
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None