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Study of 400mcg Versus 800mcg Buccal Misoprostol Following Mifepristone 200mg for Abortion up to 63 Days Gestation

This study has been completed.
Sponsor:
Information provided by:
Gynuity Health Projects
ClinicalTrials.gov Identifier:
NCT00482209
First received: June 4, 2007
Last updated: October 9, 2009
Last verified: October 2009
History of Changes
  Purpose

This double-blind, randomized study will compare the efficacy and acceptability of mifepristone 200mg followed in 36-48 hours by 400mcg or 800mcg of buccal misoprostol (i.e., in the cheeks) for termination of pregnancy in women up to 63 days LMP.


Condition Intervention
Induced Abortion
 Drug: Mifepristone, misoprostol
Drug: mifepristone, misoprostol

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver)
Primary Purpose: Treatment

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Gynuity Health Projects:

Primary Outcome Measures:
  • Need for surgical completion for ongoing viable pregnancies at follow up visit (Study day 12-15) or for incomplete abortion at extended follow up visit (Study day (19-22). [ Time Frame: Study day 12-15 for ongoing viable pregnancies or Study day 19-22 for incomplete abortion at extended follow up visit ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Side-effects, acceptability for women [ Time Frame: side effects and acceptability recorded at exit interview ] [ Designated as safety issue: No ]

Estimated Enrollment: 1220
Study Start Date: May 2007
Study Completion Date: October 2009
Primary Completion Date: October 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
200mg mifepristone followed by 400mcg misoprostol
 Drug: Mifepristone, misoprostol
200mg mifepristone followed by 400mcg misoprostol 36-48 hours later
Active Comparator: 2
200mg mifepristone followed by 800mcg misoprostol
 Drug: mifepristone, misoprostol
200mg mifepristone followed by 800mcg misoprostol 36-48 hours later

Detailed Description:

The goal of this study is to provide answers to the following four questions:

  1. Is a regimen of medical abortion with mifepristone using 400mcg buccal misoprostol as effective and acceptable as using 800mcg buccal misoprostol up to 63 days since the last menstrual period (LMP)?
  2. Are the side effects with buccal use tolerable for women?
  3. Is buccal administration of misoprostol acceptable to women?
  4. When given a choice, do women prefer to take misoprostol at home or in the clinic?
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Women 18 years or over presenting for abortion services who consent to participate
  • good general health
  • assessed by a clinician to have an intrauterine pregnancy less than 64 days LMP on Study Day 1 and to be eligible for medical abortion
  • Have ready access to a telephone and emergency transportation;
  • Be willing to provide an address and/or telephone number for purposes of follow-up

Exclusion Criteria:

  • Conditions which contraindicate the use of mifepristone or misoprostol
  • Women presenting for medical abortion who do not consent to participate
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00482209

Locations
Georgia
Zhordania Institute of Human Reproduction
Tbilisi, Georgia
Maternity House #2
Tbilisi, Georgia
Maternity House #4
Tbilisi, Georgia
Vietnam
Hocmon Hospital
Ho Chi Minh City, Vietnam
Sponsors and Collaborators
Gynuity Health Projects
Investigators
Principal Investigator: Beverly Winikoff, MD, MPH Gynuity Health Projects
Study Director: Erica Chong, MPH Gynuity Health Projects
Study Director: Tamuna Tsereteli, MD, MSc, PhD Gynuity Health Projects
  More Information

Additional Information:
Related Info  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Dr. Beverly Winikoff, Gynuity Health Projects
ClinicalTrials.gov Identifier: NCT00482209     History of Changes
Other Study ID Numbers: 1.1.6
Study First Received: June 4, 2007
Last Updated: October 9, 2009
Health Authority: United States: Institutional Review Board

Keywords provided by Gynuity Health Projects:
mifepristone, misoprostol, medical abortion

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

ClinicalTrials.gov processed this record on June 17, 2013