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Sponsored by: |
University of Pittsburgh |
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Information provided by: | University of Pittsburgh |
ClinicalTrials.gov Identifier: | NCT00330993 |
HYPOTHESIS: For women with pregnancies at <49, 50-56, and 57-63 days gestation who receive mifepristone 200 mg orally and misoprostol 800 mcg buccally at the same time, the complete abortion rate 24 hours after misoprostol administration will be 90% (95% CI 78%, 97%) within each gestational age group.
This is a prospective clinical trial. Women will be enrolled such that 40 women are in each of three gestational age ranges: ≤49, 50-56, and 57-63 days gestation on the day treatment is initiated. Once a gestational age range includes 40 subjects, enrollment in that group will be closed. Subjects will swallow mifepristone 200 mg and then place four 200 µg misoprostol tablets between the check and gum (2 tablets on each side). The women will be instructed to keep the tablets in place for 30 minutes; any remaining portions of the tablets will be swallowed after this time. Participants will follow-up 24 hours after receiving the misoprostol. Vaginal ultrasonography will be performed to assess for expulsion of the gestational sac. Women who have not aborted by the first follow-up visit will be given a dose of vaginal misoprostol and will return for a follow-up visit in one week. Subjects who have not aborted by the two-week follow-up will be offered a surgical abortion. At each visit, data will be collected on bleeding, cramping, other side effects, and medication use.
Condition | Intervention | Phase |
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Abortion, Induced |
Drug: mifepristone, misoprostol |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
Official Title: | Oral Mifepristone and Buccal Misoprostol Administered Simultaneously for Abortion Through 63 Days Gestation |
Estimated Enrollment: | 120 |
Study Start Date: | March 2006 |
Estimated Study Completion Date: | August 2006 |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:Healthy females: 1) 18 years of age or older, 2) requesting an elective termination of pregnancy by medical abortion, 3) with an intrauterine pregnancy no more than 63 days gestation on the day of mifepristone administration as documented by endovaginal ultrasound, 4) willing and able to sign informed consent, 5) willing to comply with the study protocol and visit schedule, 6) willing to have a surgical abortion/D&C if indicated, and 7) with easy and ready access to a telephone.
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Exclusion Criteria:1) ultrasound evidence at the evaluation(s) prior to mifepristone treatment of an early pregnancy failure, 2) contraindication to mifepristone (known allergy to mifepristone, chronic corticosteroid administration, adrenal disease), 3) contraindication to misoprostol (glaucoma, mitral stenosis, sickle cell anemia, poorly controlled seizure disorder, or known allergy to prostaglandin), 4) known or suspected extrauterine pregnancy, 5) known or suspected pelvic infection, 6) hemoglobin <10 mg/dL, 7) known clotting defect or receiving anticoagulants, 8) cardiovascular disease (angina, valvular disease, arrhythmia, or cardiac failure), 9) current breastfeeding, 10) pregnancy with an IUD in situ, 11) current use of any experimental drug, 12) suspected or confirmed endometrial arteriovenous malformation, 13) active oral herpes lesions per subject report, 14) prior participation in this research study, or 15) current participation in another research study that, in the opinion of the investigator, would interfere with the conduct of this study.
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United States, Pennsylvania | |
Office of Family Planning Research, Magee-Womens Hospital | |
Pittsburgh, Pennsylvania, United States, 15213 |
Principal Investigator: | Patricia A. Lohr, MD | University of Pittsburgh |
Study ID Numbers: | 0601001 |
Study First Received: | May 26, 2006 |
Last Updated: | January 24, 2007 |
ClinicalTrials.gov Identifier: | NCT00330993 |
Health Authority: | United States: Food and Drug Administration |
mifepristone misoprostol medical abortion 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 |