Immune Modulation by Misoprostol | NCT02259309 | Trialant

Immune Modulation by Misoprostol | NCT02259309 | Trialant

Sponsor/Collaborators Module

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Misoprostol administration - buccal then vaginal	Experimental	Vaginal or buccal administration	Drug: Misoprostol - buccal Drug: Misoprostol - vaginal
Misoprostol administration - vaginal then buccal	Experimental	Vaginal or buccal administration	Drug: Misoprostol - buccal Drug: Misoprostol - vaginal

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Misoprostol - buccal	Drug	buccal administration	Misoprostol administration - buccal then vaginal Misoprostol administration - vaginal then buccal

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Comparison of misoprostol drug levels in patients after vaginal and buccal administration	Peripheral blood collected at Days 0, 1, 28, and 29	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	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	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	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	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	Cervical cytobrush at Days 0, 1, 28, and 29

Secondary Outcomes

Measure	Description	Time Frame
Sequencing of 16S rRNA gene for microbial ecology studies after vaginal and buccal administration	Vaginal swab at Days 0, 1, 28, and 29	Vaginal swab at Days 0, 1, 28, and 29

Contacts/Locations Module

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
2109195	Background	Moran M, Mozes MF, Maddux MS, Veremis S, Bartkus C, Ketel B, Pollak R, Wallemark C, Jonasson O. Prevention of acute graft rejection by the prostaglandin E1 analogue misoprostol in renal-transplant recipients treated with cyclosporine and prednisone. N Engl J Med. 1990 Apr 26;322(17):1183-8. doi: 10.1056/NEJM199004263221703.
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Intervention Browse Module