Ignite Creation Date:
2024-05-05 @ 5:31 PM
Last Modification Date:
2024-10-26 @ 9:33 AM
Study NCT ID:
NCT00475553
Status:
COMPLETED
Last Update Posted:
2009-12-18
First Post:
2007-05-16
Brief Title:
Management of Breakthrough Bleeding During Extended Therapy Use With NuvaRing
Sponsor:
Scott and White Hospital Clinic
Organization:
Scott and White Hospital Clinic
Study Overview
Official Title:
The Frequency and Management of Breakthrough Bleeding During Extended Therapy With the Transvaginal Contraceptive Ring
Status:
COMPLETED
Status Verified Date:
2009-12
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 this research study is to evaluate the best way to manage breakthrough spotting and bleeding during an extended use regimen of NuvaRing Ease of use and acceptability of a flexible regimen of NuvaRing will also be evaluated A comparison of cyclic mood symptoms pelvic pain and headaches will be made between a standard 217 regimen and an extended regimen
Detailed Description:
Hormonal contraception is undergoing a change away from a 217 day regimen where a woman utilizes a combination estrogen and progestin therapy for 21 days followed by 7 days of a hormone-free interval HFI It is well documented that women may experience a higher incidence of mood changes headaches and cramping that begin prior to and during this 7 day HFI By reducing the HFI and extending the active combination contraceptive therapy it is hoped that women will experience greater satisfaction with their contraceptive regimen and will experience fewer negative side effects associated with a HFI
The most common reason for discontinuation of an extended contraception regimen is irregular bleeding The purpose of this research study is to evaluate the best way to manage this breakthrough spotting and bleeding Ease of use and acceptability of a flexible regimen of NuvaRing will also be evaluated A comparison of cyclic mood symptoms pelvic pain and headaches will be made between a standard 217 regimen and an extended regimen
The contraceptive ring used in this study contains both an estrogen ethinyl estradiol and a progestin etonogestrel These are synthetic man-made hormones The amount of ethinyl estrogen released into the bloodstream each day is 120mcg and the amount of etonogestrel is 150mcg The NuvaRing by Organon is FDA approved for contraception but is not approved for use in an extended regimen Therefore its use in this study is considered investigational
The most common reason for discontinuation of an extended contraception regimen is irregular bleeding The purpose of this research study is to evaluate the best way to manage this breakthrough spotting and bleeding Ease of use and acceptability of a flexible regimen of NuvaRing will also be evaluated A comparison of cyclic mood symptoms pelvic pain and headaches will be made between a standard 217 regimen and an extended regimen
The contraceptive ring used in this study contains both an estrogen ethinyl estradiol and a progestin etonogestrel These are synthetic man-made hormones The amount of ethinyl estrogen released into the bloodstream each day is 120mcg and the amount of etonogestrel is 150mcg The NuvaRing by Organon is FDA approved for contraception but is not approved for use in an extended regimen Therefore its use in this study is considered investigational
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