The present study is designed to address the null hypothesis that there is no difference in the local and systemic immunomodulatory effects of buccally or vaginally administered misoprostol in healthy, reproductive-age women.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Enrollment
15
buccal administration
vaginal administration
Vanderbilt University Medical Center
Nashville, Tennessee, United States
Comparison of misoprostol drug levels in patients after vaginal and buccal administration
Peripheral blood collected at Days 0, 1, 28, and 29
Time frame: Peripheral blood collected at Days 0, 1, 28, and 29
Comparison of cytokine and chemokine levels in patients after vaginal and buccal administration
Peripheral blood collected at Days 0, 1, 28, and 29
Time frame: Peripheral blood collected at Days 0, 1, 28, and 29
Determination of immune cell activation state after vaginal and buccal administration
Peripheral blood collected at Days 0, 1, 28, and 29
Time frame: Peripheral blood collected at Days 0, 1, 28, and 29
Comparison of misoprostol drug levels in patients after vaginal and buccal administration
Cervicovaginal lavage at Days 0, 1, 28, and 29
Time frame: Cervicovaginal lavage at Days 0, 1, 28, and 29
Comparison of cytokine and chemokine levels in patients after vaginal and buccal administration
Cervicovaginal lavage at Days 0, 1, 28, and 29
Time frame: Cervicovaginal lavage at Days 0, 1, 28, and 29
Determination of immune cell activation state after vaginal and buccal administration
Cervical cytobrush at Days 0, 1, 28, and 29
Time frame: Cervical cytobrush at Days 0, 1, 28, and 29
Sequencing of 16S rRNA gene for microbial ecology studies after vaginal and buccal administration
Vaginal swab at Days 0, 1, 28, and 29
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Time frame: Vaginal swab at Days 0, 1, 28, and 29