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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ClinicalTrials.gov
Last refreshed on: 19 February 2015
Main ID:  NCT00386282
Date of registration: 09/10/2006
Prospective Registration: No
Primary sponsor: Gynuity Health Projects
Public title: Acceptability and Feasibility of Medical Abortion Using Mifepristone and Buccal Misoprostol
Scientific 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
Date of first enrolment: September 2006
Target sample size: 1250
Recruitment status: Completed
URL:  http://clinicaltrials.gov/show/NCT00386282
Study type:  Interventional
Study design:  Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment  
Phase:  N/A
Countries of recruitment
Armenia Azerbaijan Mexico Puerto Rico
Contacts
Name:     Ranulfo Rios, MD
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Affiliation:  H G Enrique Cabrera
Name:     Anna Aghajanyan, MD
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Affiliation:  State Medical University
Name:     Beverly Winikoff, MD, MPH
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Affiliation:  Gynuity Health Projects
Name:     Laura Garcia Martinez, MD
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Affiliation:  H.M.I Inguaran
Name:     Gulnara Rzaeva, MD
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Affiliation:  Scientific Research Institute of Obstetrics & Gynecology
Name:     Armine Harutyunyan, MD
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Affiliation:  Center for Family Planning and Sexual Health
Name:     Hector Diaz Martinez, MD
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Affiliation:  Clinica de Planificacion Familiar
Name:     Elba Margarita Lugo Hernandez, MD
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Affiliation:  C S Santa Catarina
Name:     Angela Arredondo, MD
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Affiliation:  Woman's Metropolitan Center
Name:     Antonio E Flores, MD
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Affiliation:  C S Beatriz Velasco Aleman
Name:     Besti Muradova, MD
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Affiliation:  Family Planning Center
Name:     Susanna Fildjyan, MD
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Affiliation:  Institute of Perinatology, Obstetrics and Gynecology
Key inclusion & exclusion criteria

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



Age minimum: 18 Years
Age maximum: N/A
Gender: Female
Health Condition(s) or Problem(s) studied
Abortion, First Trimester
Intervention(s)
Drug: mifepristone-misoprostol treatment
Primary Outcome(s)
efficacy [Time Frame: 15 days]
Secondary Outcome(s)
acceptability [Time Frame: 15 days]
Secondary ID(s)
1.1.4
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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