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

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ClinicalTrials.gov Identifier: NCT00482209
Recruitment Status : Completed
First Posted : June 5, 2007
Last Update Posted : October 12, 2009
Information provided by:
Gynuity Health Projects

Brief Summary:
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 or disease Intervention/treatment
Induced Abortion Drug: Mifepristone, misoprostol Drug: mifepristone, misoprostol

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?

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1220 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Treatment
Study Start Date : May 2007
Primary Completion Date : October 2009
Study Completion Date : October 2009

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. Side-effects, acceptability for women [ Time Frame: side effects and acceptability recorded at exit interview ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00482209

Maternity House #2
Tbilisi, Georgia
Maternity House #4
Tbilisi, Georgia
Zhordania Institute of Human Reproduction
Tbilisi, Georgia
Hocmon Hospital
Ho Chi Minh City, Vietnam
Sponsors and Collaborators
Gynuity Health Projects
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

Additional Information:
Responsible Party: Dr. Beverly Winikoff, Gynuity Health Projects
ClinicalTrials.gov Identifier: NCT00482209     History of Changes
Other Study ID Numbers: 1.1.6
First Posted: June 5, 2007    Key Record Dates
Last Update Posted: October 12, 2009
Last Verified: October 2009

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

Additional relevant MeSH terms:
Abortifacient Agents, Nonsteroidal
Abortifacient Agents
Reproductive Control Agents
Physiological Effects of Drugs
Anti-Ulcer Agents
Gastrointestinal Agents
Abortifacient Agents, Steroidal
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