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A Randomized Trial of Buccal Compared to Oral Misoprostol Following Mifepristone for Medical Abortion up to 63 Days LMP

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ClinicalTrials.gov Identifier: NCT00386867
Recruitment Status : Completed
First Posted : October 12, 2006
Last Update Posted : June 5, 2007
Sponsor:
Information provided by:
Gynuity Health Projects

Brief Summary:
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 or disease Intervention/treatment
Abortion, Induced Drug: 800 mcg misoprostol via oral or buccal administration

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1200 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Study Start Date : October 2006
Estimated Study Completion Date : March 2007

Resource links provided by the National Library of Medicine

Drug Information available for: Misoprostol
U.S. FDA Resources




Primary Outcome Measures :
  1. efficacy

Secondary Outcome Measures :
  1. acceptability


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes 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.

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): 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

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00386867     History of Changes
Other Study ID Numbers: 1.1.3
First Posted: October 12, 2006    Key Record Dates
Last Update Posted: June 5, 2007
Last Verified: June 2007

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

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