Ignite Creation Date:
2024-05-05 @ 4:58 PM
Last Modification Date:
2024-10-26 @ 9:26 AM
Study NCT ID:
NCT00357981
Status:
WITHDRAWN
Last Update Posted:
2013-08-29
First Post:
2006-07-26
Brief Title:
Continuous Use of the Contraceptive Patch and the Personal Economic Impact
Sponsor:
University of California San Francisco
Organization:
University of California San Francisco
Study Overview
Official Title:
Patient Experiences Using Evra for Management of Menstrual Related Symptoms
Status:
WITHDRAWN
Status Verified Date:
2013-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Both sponsor and UCSF decided this study was not clinical relevant at this time
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Dr Eleanor Drey in the Department of Obstetrics Gynecology and Reproductive Sciences UCSF is conducting a study to examine the personal and economic impact of continuous use of ORTHO EVRA the contraceptive patch on menstrual related symptoms for women who report having severe menstrual related symptoms
Detailed Description:
30 adult women 18-40 years of age will be recruited to participate in a six month study The focus of recruitment will be on women with menstrual-related symptoms who are currently working in physically demanding low autonomous service jobs
The approximate first two months of womens participation will be spent documenting baseline information about their health and well-being work patterns and performance and the economic impact of their menstruation Subjects will then initiate two two month intervals of continuous use of ORTHO EVRA
Over this four month treatment period subjects will document their health and well-being work patterns and performance and the economic impact of their menstruation while being treated with ORTHO EVRA This will allow us to compare subjects experiences pre- and post-treatment The studys instruments will focus on eliciting information on the personal and economic costs of menstruation such as measuring time missed from work changes in productivity and work satisfaction and impact on quality of life
The approximate first two months of womens participation will be spent documenting baseline information about their health and well-being work patterns and performance and the economic impact of their menstruation Subjects will then initiate two two month intervals of continuous use of ORTHO EVRA
Over this four month treatment period subjects will document their health and well-being work patterns and performance and the economic impact of their menstruation while being treated with ORTHO EVRA This will allow us to compare subjects experiences pre- and post-treatment The studys instruments will focus on eliciting information on the personal and economic costs of menstruation such as measuring time missed from work changes in productivity and work satisfaction and impact on quality of life
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