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A Randomized Trial of Buccal Compared to Oral Misoprostol Following Mifepristone for Medical Abortion up to 63 Days LMP
This study has been completed.
Sponsored by: Gynuity Health Projects
Information provided by: Gynuity Health Projects
ClinicalTrials.gov Identifier: NCT00386867
  Purpose

This open-label, randomized study will compare the efficacy, safety, and acceptability of mifepristone 200 mg followed in 24-36 hours either by buccal (i.e., in the cheeks) or oral misoprostol 800 mcg for termination of pregnancy in women up to 63 days L.M.P.


Condition Intervention
Abortion, Induced
Drug: 800 mcg misoprostol via oral or buccal administration

MedlinePlus related topics: Abortion
Drug Information available for: Mifepristone Misoprostol
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Open Label, Active Control, Single Group Assignment, Efficacy Study

Further study details as provided by Gynuity Health Projects:

Primary Outcome Measures:
  • efficacy

Secondary Outcome Measures:
  • acceptability

Estimated Enrollment: 1200
Study Start Date: October 2006
Estimated Study Completion Date: March 2007
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • be willing and able to sign consent forms;
  • be eligible for medical abortion according to clinician’s assessment;
  • be willing to undergo a surgical completion if necessary;
  • have ready and easy access to a telephone and emergency transportation;
  • speak English, Spanish, or have a translator available to translate for all study procedures; and,
  • agree to comply with the study procedures and visit schedule.

Exclusion Criteria:

  • Confirmed or suspected ectopic pregnancy or undiagnosed adnexal mass;
  • IUD in place;
  • Chronic renal failure;
  • Concurrent long-term corticosteroid therapy;
  • History of allergy to mifepristone, misoprostol or other prostaglandin;
  • Hemorrhagic disorders or concurrent anticoagulant therapy;
  • Inherited porphyrias; or
  • Other serious physical or mental health conditions.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00386867

Locations
United States, Illinois
Family Planning Associates Medical Group
Chicago, Illinois, United States
United States, Massachusetts
Planned Parenthood League of Massachusetts (Boston clinic)
Boston, Massachusetts, United States
United States, New York
Columbia University Medical Center, Division of Obstetrics & Gynecology
New York, New York, United States
Institute for Urban Family Health
New York, New York, United States
Parkmed
New York, New York, United States
United States, Pennsylvania
University of Pittsburgh, Division of Obstetrics, Gynecology and Reproductive Sciences
Pittsburgh, Pennsylvania, United States
United States, Texas
Whole Women’s Health
Austin, Texas, United States
Planned Parenthood
Waco, Texas, United States
Sponsors and Collaborators
Gynuity Health Projects
Investigators
Principal Investigator: Beverly Winikoff, MD, MPH Gynuity Health Projects
Study Director: Ilana Dzuba, MHS Gynuity Health Projects
  More Information

Related Info  This link exits the ClinicalTrials.gov site

Publications indexed to this study:
Study ID Numbers: 1.1.3
Study First Received: October 10, 2006
Last Updated: June 1, 2007
ClinicalTrials.gov Identifier: NCT00386867  
Health Authority: United States: Food and Drug Administration

Keywords provided by Gynuity Health Projects:
medical abortion
mifepristone
misoprostol
buccal administration

Study placed in the following topic categories:
Misoprostol
Mifepristone

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

ClinicalTrials.gov processed this record on January 16, 2009