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Sponsored by: |
Gynuity Health Projects |
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Information provided by: | Gynuity Health Projects |
ClinicalTrials.gov Identifier: | NCT00386867 |
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 |
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Abortion, Induced |
Drug: 800 mcg misoprostol via oral or buccal administration |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Single Group Assignment, Efficacy Study |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
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 |
Principal Investigator: | Beverly Winikoff, MD, MPH | Gynuity Health Projects |
Study Director: | Ilana Dzuba, MHS | Gynuity Health Projects |
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 |
medical abortion mifepristone misoprostol buccal administration |
Misoprostol Mifepristone |
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 |