Acceptability and Feasibility of Medical Abortion Using Mifepristone and Buccal Misoprostol

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Gynuity Health Projects
ClinicalTrials.gov Identifier:
NCT00386282
First received: October 9, 2006
Last updated: July 29, 2014
Last verified: July 2014
  Purpose

This study examined 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. It was hypothesized that the study regimen would be both acceptable and efficacious.


Condition Intervention
Abortion, First Trimester
Drug: mifepristone-misoprostol treatment

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Gynuity Health Projects:

Primary Outcome Measures:
  • efficacy [ Time Frame: 15 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • acceptability [ Time Frame: 15 days ] [ Designated as safety issue: No ]

Enrollment: 1250
Study Start Date: September 2006
Study Completion Date: March 2011
Primary Completion Date: March 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
mifepristone-misoprostol treatment
200 mg mifepristone followed by 800 mcg buccal misoprostol 24-48 hours after the mifepristone
Drug: mifepristone-misoprostol treatment
200 mg mifepristone followed by 800 mcg buccal misoprostol 24-48 hours after the mifepristone.
Other Name: medical abortion

Detailed Description:

The study recruited women with pregnancies up to 63 days gestation. Eligible women took 200 mg mifepristone, followed by 800 buccal misoprostol. They later underwent clinic follow-up to determine if their medical abortions were complete. The study assessed the acceptability and feasibility of the above regimen and sought to determine the efficacy and acceptability of buccal administration of misoprostol as well as the acceptability of side effects experienced by women.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00386282

Locations
Armenia
Institute of Perinatology, Obstetrics and Gynecology
Yerevan, Armenia
Center for Family Planning and Sexual Health
Yerevan, Armenia
State Medical University
Yerevan, Armenia
Azerbaijan
Scientific Research Institute of Obstetrics and Gynecology
Baku, Azerbaijan
Family Planning Center
Baku, Azerbaijan
Mexico
H.G. Enrique Cabrera
Mexico City, Federal District, Mexico
H.M.I Inguaran
Mexico City, Federal District, Mexico
C.S. Beatriz Velasco Aleman
Mexico City, Federal District, Mexico
C.S. Santa Catarina
Mexico City, Federal District, Mexico
Puerto Rico
Clinica de Planificacion Familiar
Lomas Verdes, Bayamon, Puerto Rico, 00956
Woman's Metropolitan Center
San Juan, Puerto Rico, 00921
Sponsors and Collaborators
Gynuity Health Projects
Investigators
Principal Investigator: Hector Diaz Martinez, MD Clinica de Planificacion Familiar
Principal Investigator: Angela Arredondo, MD Woman's Metropolitan Center
Principal Investigator: Beverly Winikoff, MD, MPH Gynuity Health Projects
Principal Investigator: Gulnara Rzaeva, MD Scientific Research Institute of Obstetrics & Gynecology
Principal Investigator: Besti Muradova, MD Family Planning Center
Principal Investigator: Susanna Fildjyan, MD Institute of Perinatology, Obstetrics and Gynecology
Principal Investigator: Armine Harutyunyan, MD Center for Family Planning and Sexual Health
Principal Investigator: Anna Aghajanyan, MD State Medical University
Principal Investigator: Ranulfo Rios, MD H G Enrique Cabrera
Principal Investigator: Laura Garcia Martinez, MD H.M.I Inguaran
Principal Investigator: Antonio E Flores, MD C S Beatriz Velasco Aleman
Principal Investigator: Elba Margarita Lugo Hernandez, MD C S Santa Catarina
  More Information

No publications provided

Responsible Party: Gynuity Health Projects
ClinicalTrials.gov Identifier: NCT00386282     History of Changes
Other Study ID Numbers: 1.1.4
Study First Received: October 9, 2006
Last Updated: July 29, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Gynuity Health Projects:
Mifepristone
Misoprostol
Buccal administration

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

ClinicalTrials.gov processed this record on August 28, 2014