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Mifepristone at Same Time Multicenter Study (MAST)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00269568
First Posted: December 23, 2005
Last Update Posted: January 29, 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):
University of Pittsburgh
September 12, 2005
December 23, 2005
January 29, 2016
June 2004
April 2006   (Final data collection date for primary outcome measure)
complete abortion rate [ Time Frame: 5 weeks after treatment ]
complete abortion rate
Complete list of historical versions of study NCT00269568 on ClinicalTrials.gov Archive Site
  • to compare complete abortion rates by gestational age [ Time Frame: 5 weeks after treatment ]
  • compare bleeding and side effect profiles [ Time Frame: up to 5 weeks after treatment ]
  • compare acceptability of the two regimens [ Time Frame: 2 weeks after treatment ]
  • compare the expression of EP3 receptor mRNA in cervical tissue 2 and 24 hours after mifepristone treatment to pretreatment control [ Time Frame: up to 24 hours after treatment ]
  • measure time to first ovulation [ Time Frame: up to 10 weeks after treatment ]
  • compare elapsed time to ovulation between treatment regimens [ Time Frame: up to 10 weeks after treatment ]
  • evaluate continuation rates of combined hormonal contraceptives in women with immediate initiation versus traditional Sunday start [ Time Frame: up to 12 weeks after treatment ]
  • describe the prevalence of domestic violence in a medical abortion research population [ Time Frame: at time of enrollment ]
  • to compare complete abortion rates by gestational age
  • compare bleeding and side effect profiles
  • compare acceptability of the two regimens
  • compare the expression of EP3 receptor mRNA in cervical tissue 2 and 24 hours after mifepristone treatment to pretreatment control
  • measure time to first ovulation
  • compare elapsed time to ovulation between treatment regimens
  • evaluate continuation rates of combined hormonal contraceptives in women with immediate initiation versus traditional Sunday start
  • describe the prevalence of domestic violence in a medical abortion research population
Not Provided
Not Provided
 
Mifepristone at Same Time Multicenter Study
A Multicenter, Randomized Comparison of Mifepristone and Misoprostol Administered Simultaneously Versus 24 Hours Apart for Abortion Through 63 Days
This is a multicenter, randomized study. 564 healthy women, age 18 years or older, with an intrauterine pregnancy, and requesting a medical abortion, will be recruited to participate in this prospective clinical trial. This study will provide an evaluation of oral mifepristone 200 mg and vaginal misoprostol 800 mcg administered simultaneously in women up to 63 days gestation. The aims of the study are to compare the complete abortion rates, at 7 and 14 days after misoprostol administration, when using mifepristone 200 mg orally and misoprostol 800 mcg vaginally are administered simultaneously and 24 hours apart in women up to 63 days gestation. Assessment of side effects (nausea, vomiting, pain) as well as acceptability will be done using pre and post-study questionnaires, and visual analogue scales. Complete abortion rate within 24 hours is expected to be 90%
This is a multicenter, randomized study. 564 healthy women, age 18 years or older, with an intrauterine pregnancy, and requesting a medical abortion, will be recruited to participate in this prospective clinical trial. This study will provide an evaluation of oral mifepristone 200 mg and vaginal misoprostol 800 mcg administered simultaneously in women up to 63 days gestation. The aims of the study are to compare the complete abortion rates, at 7 and 14 days after misoprostol administration, when using mifepristone 200 mg orally and misoprostol 800 mcg vaginally are administered simultaneously and 24 hours apart in women up to 63 days gestation. Assessment of side effects (nausea, vomiting, pain) as well as acceptability will be done using pre and post-study questionnaires, and visual analogue scales. Complete abortion rate within 24 hours is expected to be 90%.
Interventional
Phase 4
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Abortion Seekers
Drug: mifepristone and misoprostol
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
1128
April 2006
April 2006   (Final data collection date for primary outcome measure)

Inclusion Criteria:pregnancy equal to or less than 63 days at enrollment -

Exclusion Criteria:abnormal pregnancy diagnosed by ultrasound

Sexes Eligible for Study: Female
18 Years to 55 Years   (Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00269568
pittirb0404133
No
Not Provided
Plan to Share IPD: No
University of Pittsburgh
University of Pittsburgh
Not Provided
Principal Investigator: Mitchell D Creinin, MD Universtity of Pittsburgh
University of Pittsburgh
January 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP