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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:
Gynuity Health Projects
Information provided by:
Gynuity Health Projects
ClinicalTrials.gov Identifier:
NCT00386867
First received: October 10, 2006
Last updated: June 1, 2007
Last verified: June 2007
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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 Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Treatment |
Resource links provided by NLM:
Further study details as provided by Gynuity Health Projects:
Eligibility| 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
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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
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:
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 |
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 |
ClinicalTrials.gov processed this record on August 22, 2017