Pharmacokinetics of Misoprostol With Titrated Oral Administration
Phase 1 Study of Titrated Oral Misoprostol
2 other identifiers
interventional
10
1 country
1
Brief Summary
The AUC240, AUC360, and AUC480 of titrated oral misoprostol are greater than traditional oral misoprostol.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1
Started Jan 2011
Longer than P75 for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2011
CompletedFirst Submitted
Initial submission to the registry
January 5, 2011
CompletedFirst Posted
Study publicly available on registry
January 6, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2014
CompletedJanuary 28, 2016
January 1, 2016
3.9 years
January 5, 2011
January 27, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
AUC480 (the area under the curve of serum concentration of misoprostol acid against time up to 480 minutes)
480 min post start of oral misoprostol administration
Secondary Outcomes (2)
AUC240 (the area under the curve of serum concentration of misoprostol acid against time up to 240 minutes)
240 min post start of oral misoprostol administration
AUC360 (the area under the curve of serum concentration of misoprostol acid against time up to 360 minutes)
360 min post start of oral misoprostol administration
Study Arms (2)
hourly misoprostol
EXPERIMENTAL20 microgram misoprostol intake per hour
traditional misoprostol
ACTIVE COMPARATOR80 microgram misoprostol intake per 4 hours
Interventions
20 microgram PO per hour for 8 doses or 80 microgram PO per 4 hours for 2 doses
Eligibility Criteria
You may qualify if:
- Y/O healthy and non-pregnant woman
You may not qualify if:
- heart, liver or kidney disease, anaphylaxis to misoprostol
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
China Medical University Beigang Hospital
Yunlin Xian, Taiwan, 651, Taiwan
Related Publications (2)
Tang OS, Schweer H, Seyberth HW, Lee SW, Ho PC. Pharmacokinetics of different routes of administration of misoprostol. Hum Reprod. 2002 Feb;17(2):332-6. doi: 10.1093/humrep/17.2.332.
PMID: 11821273BACKGROUNDZieman M, Fong SK, Benowitz NL, Banskter D, Darney PD. Absorption kinetics of misoprostol with oral or vaginal administration. Obstet Gynecol. 1997 Jul;90(1):88-92. doi: 10.1016/S0029-7844(97)00111-7.
PMID: 9207820BACKGROUND
Related Links
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Shi-Yann Cheng, M.D.
China Medical University Beigang Hospital
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- BASIC SCIENCE
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Director of Department of Obstetrics and Gynecology
Study Record Dates
First Submitted
January 5, 2011
First Posted
January 6, 2011
Study Start
January 1, 2011
Primary Completion
December 1, 2014
Study Completion
December 1, 2014
Last Updated
January 28, 2016
Record last verified: 2016-01