Clinical Trials Directory

Trials / Completed

CompletedNCT00177333

Serum Levels of Doxycycline at the Time of Abortion With Two Dosing Regimens

Status
Completed
Phase
Phase 4
Study type
Interventional
Enrollment
40 (actual)
Sponsor
University of Pittsburgh · Academic / Other
Sex
Female
Age
18 Years
Healthy volunteers
Accepted

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.

Conditions

Interventions

TypeNameDescription
DRUGDoxycycline

Timeline

Start date
2005-09-01
Primary completion
2006-05-01
Completion
2006-05-01
First posted
2005-09-15
Last updated
2016-01-29

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT00177333. Inclusion in this directory is not an endorsement.