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...
Date First Received: October 9, 2006
Last Updated: March 26, 2009
Verified by: Gynuity Health Projects, March 2009
Clinical Trial Phase: N/A | Start Date: September 2006
Overall Status: Recruiting
Estimated Enrollment: 1250
Brief Summary
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”
Condition Keyword(s):
Intervention(s):
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
Outcome Measures for this Clinical Trial
Primary Measures
- efficacy
Secondary Measures
- acceptability
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 Sponsor Information
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
Additional Information
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
Clinical Trials Authorship and Review
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