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Pharmacokinetics of Misoprostol With Titrated Oral Administration

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01271257
First Posted: January 6, 2011
Last Update Posted: January 28, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Shi-Yann Cheng, China Medical University Hospital
  Purpose
The AUC240, AUC360, and AUC480 of titrated oral misoprostol are greater than traditional oral misoprostol.

Condition Intervention Phase
Hypotonic; Labor Drug: Misoprostol Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Phase 1 Study of Titrated Oral Misoprostol

Resource links provided by NLM:


Further study details as provided by Shi-Yann Cheng, China Medical University Hospital:

Primary Outcome Measures:
  • AUC480 (the area under the curve of serum concentration of misoprostol acid against time up to 480 minutes) [ Time Frame: 480 min post start of oral misoprostol administration ]

Secondary Outcome Measures:
  • AUC240 (the area under the curve of serum concentration of misoprostol acid against time up to 240 minutes) [ Time Frame: 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) [ Time Frame: 360 min post start of oral misoprostol administration ]

Enrollment: 10
Study Start Date: January 2011
Study Completion Date: December 2014
Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: hourly misoprostol
20 microgram misoprostol intake per hour
Drug: Misoprostol
20 microgram PO per hour for 8 doses or 80 microgram PO per 4 hours for 2 doses
Other Name: cytotec
Active Comparator: traditional misoprostol
80 microgram misoprostol intake per 4 hours
Drug: Misoprostol
20 microgram PO per hour for 8 doses or 80 microgram PO per 4 hours for 2 doses
Other Name: cytotec

Detailed Description:
The primary outcomes measures of the study are the area under the curve of serum concentration of misoprostol acid against time up to 240, 360 and 480 minutes.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 20-40 Y/O healthy and non-pregnant woman

Exclusion Criteria:

  • heart, liver or kidney disease, anaphylaxis to misoprostol
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01271257


Locations
Taiwan
China Medical University Beigang Hospital
Yunlin Xian, Taiwan, 651
Sponsors and Collaborators
China Medical University Hospital
Investigators
Principal Investigator: Shi-Yann Cheng, M.D. China Medical University Beigang Hospital
  More Information

Additional Information:
Publications:
Responsible Party: Shi-Yann Cheng, Director of Department of Obstetrics and Gynecology, China Medical University Hospital
ClinicalTrials.gov Identifier: NCT01271257     History of Changes
Other Study ID Numbers: CMUBH R990011
DMR-IRB-242 ( Other Identifier: China Medical University Hospital )
First Submitted: January 5, 2011
First Posted: January 6, 2011
Last Update Posted: January 28, 2016
Last Verified: January 2016

Keywords provided by Shi-Yann Cheng, China Medical University Hospital:
misoprostol, pharmacokinetics

Additional relevant MeSH terms:
Misoprostol
Abortifacient Agents, Nonsteroidal
Abortifacient Agents
Reproductive Control Agents
Physiological Effects of Drugs
Anti-Ulcer Agents
Gastrointestinal Agents
Oxytocics