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

Study Description

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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	Phase
Abortion, Induced	Drug: 800 mcg misoprostol via oral or buccal administration	Not Applicable

Study Design

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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
Study Completion Date :	March 2007

Arms and Interventions

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Outcome Measures

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :

1. efficacy

Secondary Outcome Measures :

1. acceptability

Eligibility Criteria

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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.

Contacts and Locations

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Additional Information:

Related Info 

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
First Posted:	October 12, 2006
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