Official Title: “Acceptability and Feasibility of Medical Abortion in 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, and 3 clinics in Yerevan, Armenia. 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: Treatment, Non-Randomized, Open Label, Active Control, Single Group Assignment, Efficacy Study

Intervention(s) in this Clinical Trial

• Drug: 200 mg mifepristone followed by 800 mcg buccal misoprostol

Primary Measures

• efficacy

Secondary Measures

• acceptability

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

Lead Sponsor: Gynuity Health Projects

Overall Clinical Trial Officials and Contacts

Hector Diaz Martinez, MD Principal Investigator Clinica de Planificacion Familiar  

Overall Contact: Melanie Peña, MPH, MA 212-448-1230 mpena@gynuity.org

Information obtained from ClinicalTrials.gov on July 02, 2009

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