Ignite Creation Date:
2024-05-05 @ 11:55 AM
Last Modification Date:
2024-10-26 @ 9:16 AM
Study NCT ID:
NCT00177333
Status:
COMPLETED
Last Update Posted:
2016-01-29
First Post:
2005-09-12
Brief Title:
Serum Levels of Doxycycline at the Time of Abortion With Two Dosing Regimens
Sponsor:
University of Pittsburgh
Organization:
University of Pittsburgh
Study Overview
Official Title:
Serum Levels of Doxycycline at the Time of Abortion With Two Dosing Regimens
Status:
COMPLETED
Status Verified Date:
2016-01
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:
This is a randomized double-blind controlled trial comparing two regimens of pre-abortion doxycycline The aims of the study are to determine the serum levels of doxycycline when administered pre-operatively 4 hours or approximately 18 hours before a dilation and evacuation D E abortion The hypotheses being tested are that subjects who receive doxycycline with food the night before an abortion will have adequate serum levels but less nausea and vomiting compared to women who take the doxycycline on an empty stomach on the morning of the abortion Subjects will either take 200mg doxycycline on the night before and 2 caps placebo with a sip of water on the morning of surgery or 2 caps placebo the night before and 200mg doxycycline on the morning of surgery with a sip of water All capsules will look identical Diaries questionnaires and a 10cc sample of blood for doxycycline levels will be collected from the subjects at the time of surgery
Detailed Description:
This is a randomized double-blind controlled trial comparing two regimens of pre-abortion doxycycline The aims of the study are to determine the serum levels of doxycycline when administered pre-operatively 4 hours or approximately 18 hours before a dilation and evacuation D E abortion The hypotheses being tested are that subjects who receive doxycycline with food the night before an abortion will have adequate serum levels but less nausea and vomiting compared to women who take the doxycycline on an empty stomach on the morning of the abortion Subjects will either take 200mg doxycycline on the night before and 2 caps placebo with a sip of water on the morning of surgery or 2 caps placebo the night before and 200mg doxycycline on the morning of surgery with a sip of water All capsules will look identical Diaries questionnaires and a 10cc sample of blood for doxycycline levels will be collected from the subjects at the time of surgery
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