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

This study has been completed.
Sponsor:
Information provided by:
Gynuity Health Projects
ClinicalTrials.gov Identifier:
NCT00386867
First received: October 10, 2006
Last updated: June 1, 2007
Last verified: June 2007
  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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment

Resource links provided by NLM:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Additional Information:
No publications provided by Gynuity Health Projects

Additional 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
Study First Received: October 10, 2006
Last Updated: June 1, 2007
Health Authority: United States: Food and Drug Administration

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

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 July 20, 2014