Mifepristone at Same Time Multicenter Study (MAST)

This study has been completed.
Sponsor:
Collaborator:
Anonymous
Information provided by:
University of Pittsburgh
ClinicalTrials.gov Identifier:
NCT00269568
First received: September 12, 2005
Last updated: October 20, 2008
Last verified: October 2008

September 12, 2005
October 20, 2008
June 2004
April 2006   (final data collection date for primary outcome measure)
complete abortion rate [ Time Frame: 5 weeks after treatment ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
  • compare bleeding and side effect profiles [ Time Frame: up to 5 weeks after treatment ] [ Designated as safety issue: Yes ]
  • compare acceptability of the two regimens [ Time Frame: 2 weeks after treatment ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • measure time to first ovulation [ Time Frame: up to 10 weeks after treatment ] [ Designated as safety issue: No ]
  • compare elapsed time to ovulation between treatment regimens [ Time Frame: up to 10 weeks after treatment ] [ Designated as safety issue: No ]
  • evaluate continuation rates of combined hormonal contraceptives in women with immediate initiation versus traditional Sunday start [ Time Frame: up to 12 weeks after treatment ] [ Designated as safety issue: No ]
  • describe the prevalence of domestic violence in a medical abortion research population [ Time Frame: at time of enrollment ] [ Designated as safety issue: No ]
  • 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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Medical Abortion
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

-

Female
18 Years to 55 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00269568
pittirb0404133
No
Mitchell Creinin, MD, University of Pittsburgh
University of Pittsburgh
Anonymous
Principal Investigator: Mitchell D Creinin, MD Universtity of Pittsburgh
University of Pittsburgh
October 2008

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