Oral Mifepristone and Buccal Misoprostol Administered Simultaneously for Abortion Through 63 Days Gestation

This study has been completed.
Sponsor:
Information provided by:
University of Pittsburgh
ClinicalTrials.gov Identifier:
NCT00330993
First received: May 26, 2006
Last updated: January 24, 2007
Last verified: September 2006
  Purpose

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
Abortion, Induced
Drug: mifepristone, misoprostol
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Oral Mifepristone and Buccal Misoprostol Administered Simultaneously for Abortion Through 63 Days Gestation

Resource links provided by NLM:


Further study details as provided by University of Pittsburgh:

Primary Outcome Measures:
  • To determine the complete abortion rate, at 24 hours after misoprostol administration, when using mifepristone 200 mg orally and misoprostol 800 mcg buccally simultaneously in women at <49, 50-56, and 57-63 days gestation.

Secondary Outcome Measures:
  • To compare the complete abortion rates, at 24 hours after misoprostol administration, by gestational age (up to and including 49, from 50-56, and 57-63 days gestation) with this medical abortion regimen.
  • To determine the complete medical abortion rate at approximately 14 days after treatment, among those women who receive a second dose of misoprostol.
  • To assess side effects (i.e. nausea, vomiting) and pain medication use after treatment.
  • To assess the acceptability of this medical abortion regimen.
  • To compare the accuracy of transvaginal and abdominal ultrasonography in gestational age dating and treatment failure in this cohort.

Estimated Enrollment: 120
Study Start Date: March 2006
Estimated Study Completion Date: August 2006
  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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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  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00330993

Locations
United States, Pennsylvania
Office of Family Planning Research, Magee-Womens Hospital
Pittsburgh, Pennsylvania, United States, 15213
Sponsors and Collaborators
University of Pittsburgh
Investigators
Principal Investigator: Patricia A. Lohr, MD University of Pittsburgh
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00330993     History of Changes
Other Study ID Numbers: 0601001
Study First Received: May 26, 2006
Last Updated: January 24, 2007
Health Authority: United States: Food and Drug Administration

Keywords provided by University of Pittsburgh:
mifepristone
misoprostol
medical abortion
buccal administration

Additional relevant MeSH terms:
Mifepristone
Misoprostol
Abortifacient Agents
Abortifacient Agents, Nonsteroidal
Abortifacient Agents, Steroidal
Anti-Ulcer Agents
Contraceptive Agents
Contraceptive Agents, Female
Contraceptives, Oral
Contraceptives, Oral, Synthetic
Contraceptives, Postcoital
Contraceptives, Postcoital, Synthetic
Gastrointestinal Agents
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Luteolytic Agents
Menstruation-Inducing Agents
Oxytocics
Pharmacologic Actions
Physiological Effects of Drugs
Reproductive Control Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on October 23, 2014