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
  Purpose

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%


Condition Intervention Phase
Medical Abortion
Drug: mifepristone and misoprostol
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Multicenter, Randomized Comparison of Mifepristone and Misoprostol Administered Simultaneously Versus 24 Hours Apart for Abortion Through 63 Days

Resource links provided by NLM:


Further study details as provided by University of Pittsburgh:

Primary Outcome Measures:
  • complete abortion rate [ Time Frame: 5 weeks after treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 1128
Study Start Date: June 2004
Study Completion Date: April 2006
Primary Completion Date: April 2006 (Final data collection date for primary outcome measure)
Detailed Description:

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%.

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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

Exclusion Criteria:abnormal pregnancy diagnosed by ultrasound

-

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00269568

Locations
United States, California
University of Southern California
Los Angeles, California, United States, 90033
United States, Illinois
Northwestern University
Chicago, Illinois, United States, 60611
United States, Oregon
Oregon Health Sciences University
Portland, Oregon, United States, 97201
United States, Pennsylvania
Magee-Womens Hospital
Pittsburgh, Pennsylvania, United States, 15213
Sponsors and Collaborators
University of Pittsburgh
Anonymous
Investigators
Principal Investigator: Mitchell D Creinin, MD Universtity of Pittsburgh
  More Information

Publications:
Responsible Party: Mitchell Creinin, MD, University of Pittsburgh
ClinicalTrials.gov Identifier: NCT00269568     History of Changes
Other Study ID Numbers: pittirb0404133
Study First Received: September 12, 2005
Last Updated: October 20, 2008
Health Authority: United States: Food and Drug Administration

Keywords provided by University of Pittsburgh:
medical abortion
mifepristone
misoprostol

Additional relevant MeSH terms:
Mifepristone
Misoprostol
Contraceptives, Oral, Synthetic
Contraceptives, Oral
Contraceptive Agents, Female
Contraceptive Agents
Reproductive Control Agents
Physiological Effects of Drugs
Pharmacologic Actions
Therapeutic Uses
Contraceptives, Postcoital, Synthetic
Contraceptives, Postcoital
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Luteolytic Agents
Menstruation-Inducing Agents
Abortifacient Agents, Steroidal
Abortifacient Agents
Anti-Ulcer Agents
Gastrointestinal Agents
Oxytocics
Abortifacient Agents, Nonsteroidal

ClinicalTrials.gov processed this record on April 17, 2014