Ignite Creation Date:
2024-05-05 @ 12:04 PM
Last Modification Date:
2024-10-26 @ 9:20 AM
Study NCT ID:
NCT00236795
Status:
COMPLETED
Last Update Posted:
2011-06-08
First Post:
2005-10-07
Brief Title:
A Study of Efficacy and Safety With the Transdermal Contraceptive System Versus Triphasil
Sponsor:
Johnson Johnson Pharmaceutical Research Development LLC
Organization:
Johnson Johnson Pharmaceutical Research Development LLC
Study Overview
Official Title:
An Open-label Study to Evaluate the Contraceptive Efficacy and Safety of the Transdermal Contraceptive System of 17-deacetylnorgestimate and Ethinyl Estradiol With the Oral Contraceptive Triphasil
Status:
COMPLETED
Status Verified Date:
2010-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of the study was to compare the contraceptive efficacy and safety of the transdermal patch to Triphasil
Detailed Description:
This is an open-label multicenter worldwide study to evaluate the contraceptive efficacy safety cycle control compliance and subject satisfaction of the transdermal patch compared with Triphasil Fourteen hundred healthy women will receive study medication for either 6 or 13 cycles The first 33 of subjects 265 transdermal patch subjects and 200 Triphasil subjects will be expected to complete 13 cycles of medication All subsequent subjects will be expected to complete 6 cycles The ratio of subjects assigned to the transdermal patch arm of the study and to the Triphasil arm will be 43 At admission Visit 1 study drug plus 3 reserve patches diary cards and subject instructions for Cycle 1 are dispensed The first patch will be applied and Triphasil pill will be taken on the first day of menses Study medication and diary cards will be issued on day 28 of Cycles 1 Visit 2 and 3 Visit 3 and those continuing for 13 cycles will receive study drug again plus 3 reserve patches on day 28 of Cycles 6 Visit 4 and 9 Visit 5 Diary cards and empty medication packages will be collected at every visit Final visits are on day 28 of Cycles 6 and 9 Diary card information is used to record compliance and bleeding information to assess cycle control Contraceptive efficacy was assessed by means of the Pearl Index and life table analysis gross cumulative probability of pregnancy Safety evaluations were based on adverse events which were collected throughout the study and changes in physical examinations gynecologic examinations vital signs and laboratory results from prestudy to final visit A transdermal patch containing 6 mg NGM and 075 mg EE delivering 250 ug NGM and 25 ug EE over 24 hours for 7 days is worn for 1 week and replaced for 3 consecutive weeksThe fourth week is patch-free A Triphasil pill is taken for 28 consecutive days at the same time each day
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