Ignite Creation Date:
2024-05-05 @ 12:05 PM
Last Modification Date:
2024-10-26 @ 9:20 AM
Study NCT ID:
NCT00236769
Status:
COMPLETED
Last Update Posted:
2010-11-17
First Post:
2005-10-07
Brief Title:
A Study of Efficacy and Safety With the Transdermal Contraceptive System
Sponsor:
Johnson Johnson Pharmaceutical Research Development LLC
Organization:
Johnson Johnson Pharmaceutical Research Development LLC
Study Overview
Official Title:
An Open-label Study to Evaluate Contraceptive Efficacy and Safety of the Transdermal Contraceptive System of 17deacetyl-norgestimate and Ethinyl Estradiol
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 is to evaluate the contraceptive efficacy safety cycle control and compliance with the transdermal contraceptive system
Detailed Description:
This is an open-label multicenter global study to evaluate the contraceptive efficacy cycle control safety compliance and subject satisfaction of the transdermal contraceptive system Sixteen hundred healthy women will wear the contraceptive patch for either 6 or 13 cycles The first 530 subjects will wear the patch for 13 cycles and all subsequent subjects will wear the patch for 6 cycles At admission Visit 1 study drug plus 3 reserve patches and diary cards are dispensed for Cycle 1 first patch application will be on the first day of menses Study drug and diary cards are dispensed on day 28 of Cycle 1 Visit 2 for Cycles 2 and 3 on day 28 of Cycle 3 Visit 3 for Cycles 4 to 6 on day 28 of Cycle 6 Visit 4 for Cycles 7 to 9 and on day 28 of Cycle 9 Visit 5 for Cycles10 to13 At each of these visits diary cards and empty medication packages are collected Final study visits are on day 28 of Cycles 6 and 13 Diary card information is used to record compliance and bleeding information to assess cycle control Contraceptive efficacy is assessed by means of the Pearl Index and life table analysis gross cumulative probability of pregnancy Safety evaluations are based on adverse events which are collected throughout the study and changes in gynecologic examinations vital signs and laboratory results from admission to final visit Each transdermal contraceptive patch containing 6 mg NGM and 075 mg EE and delivering 250 ug 17-dNGM and 25 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 The patch can be worn on upper arm or torso buttock or abdomen
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