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

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:

Drug Information available for: Misoprostol Mifepristone

U.S. FDA Resources

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 (Adult, Senior)
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:

Related Info This link exits the ClinicalTrials.gov site

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Winikoff B, Dzuba IG, Creinin MD, Crowden WA, Goldberg AB, Gonzales J, Howe M, Moskowitz J, Prine L, Shannon CS. Two distinct oral routes of misoprostol in mifepristone medical abortion: a randomized controlled trial. Obstet Gynecol. 2008 Dec;112(6):1303-10. doi: 10.1097/AOG.0b013e31818d8eb4.


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 Abortifacient Agents, Steroidal Abortifacient Agents Reproductive Control Agents Physiological Effects of Drugs 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 Abortifacient Agents, Nonsteroidal Anti-Ulcer Agents Gastrointestinal Agents Oxytocics

ClinicalTrials.gov processed this record on September 26, 2016