Ignite Creation Date:
2024-05-05 @ 5:34 PM
Last Modification Date:
2024-10-26 @ 9:33 AM
Study NCT ID:
NCT00482963
Status:
COMPLETED
Last Update Posted:
2013-07-15
First Post:
2007-06-05
Brief Title:
A Study of the Drug Interactions Between a Hormonal Emergency Contraception and an HIV Medication
Sponsor:
University of Colorado Denver
Organization:
University of Colorado Denver
Study Overview
Official Title:
A Pilot Study of the Pharmacokinetic Interactions Between the Hormonal Emergency Contraception Plan B and Efavirenz
Status:
COMPLETED
Status Verified Date:
2013-07
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 study is to determine if blood levels of the hormonal emergency contraceptive agent Plan B are altered by concomitant use with the HIV medication efavirenz
Detailed Description:
The use of hormonal contraceptive pills in women with HIV is complex due to potential interactions between these agents and HIV medications HIV-infected women taking efavirenz have an even greater need for effective birth control as this medication may cause severe brain damage to a developing fetus The use of an emergency contraceptive agent in cases of unprotected sex or condom failure can prevent pregnancy This study seeks to establish that Plan B can be used effectively and safely in women taking efavirenz
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