Acceptability and Feasibility of Medical Abortion Using Mifepristone and Buccal Misoprostol

Verified by: Gynuity Health Projects, November 2011
First Received: October 9, 2006 | Last Updated: November 28, 2011 | Phase: N/A | Start Date: September 2006
Overall Status: Completed | Estimated Enrollment: 1250
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This study will examine the acceptability and feasibility of introducing a mifepristone-misoprostol regimen of medical abortion into abortion services in two private clinics in Puerto Rico, 2 clinics in Baku, Azerbaijan, 3 clinics in Yerevan, Armenia, and 4 clinics in Mexico City. The study will also observe the efficacy and acceptability of buccal administration of 800 mcg of misoprostol...

Brief Summary

Official Title: “Acceptability and Feasibility of Medical Abortion in Mexico, Puerto Rico, Armenia and Azerbaijan: A Study of Buccal Misoprostol Administration Following Mifepristone 200 mg for Abortion up to 63 Days' Gestation”

This study will examine the acceptability and feasibility of introducing a mifepristone-misoprostol regimen of medical abortion into abortion services in two private clinics in Puerto Rico, 2 clinics in Baku, Azerbaijan, 3 clinics in Yerevan, Armenia, and 4 clinics in Mexico City. The study will also observe the efficacy and acceptability of buccal administration of 800 mcg of misoprostol following 200 mg of mifepristone.

  • Study Type: Interventional
  • Study Design: Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
  • Study Primary Completion Date: March 2011

Intervention(s) in this Clinical Trial

  • Drug: 200 mg mifepristone followed by 800 mcg buccal misoprostol
    • 200 mg mifepristone followed by 800 mcg buccal misoprostol 24-48 hours after the mifepristone.

Outcome Measures for this Clinical Trial

Primary Measures

  • efficacy
    • Time Frame: 15 days
      Safety Issue?: No

Secondary Measures

  • acceptability
    • Time Frame: 15 days
      Safety Issue?: No

Criteria for Participation in this Clinical Trial

Inclusion Criteria:

  • Gestation up to 63 days
  • General good health
  • Willingness to provide contact information for follow-up
  • Absence of conditions which contraindicate the use of mifepristone and misoprostol for pregnancy termination

Exclusion Criteria:

  • Ectopic pregnancy
  • Intrauterine device (IUD) in place

Gender Eligibility for this Clinical Trial: Female

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: Accepts Healthy Volunteers

Clinical Trial Investigator Information

Lead Investigator: Gynuity Health Projects Other

Overall Clinical Trial Officials and Contacts

Hector Diaz Martinez, MD Principal Investigator Clinica de Planificacion Familiar  

Additional Information

Information obtained from ClinicalTrials.gov on February 12, 2012

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00386282

Study ID Number: 1.1.4

ClinicalTrials.gov Identifier: NCT00386282

Health Authority: United States: Food and Drug Administration

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