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Study of Sublingual Versus Oral Misoprostol Administration Following Mifepristone 200 mg for Abortion up to 63 Days Gestation

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ClinicalTrials.gov Identifier: NCT00286208
Recruitment Status : Completed
First Posted : February 3, 2006
Last Update Posted : February 19, 2014
Sponsor:
Information provided by (Responsible Party):
Gynuity Health Projects

Tracking Information
First Submitted Date  ICMJE February 1, 2006
First Posted Date  ICMJE February 3, 2006
Last Update Posted Date February 19, 2014
Study Start Date  ICMJE August 2005
Actual Primary Completion Date January 2008   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 18, 2014)
Need for surgical completion for incomplete abortions or ongoing viable pregnancies at follow up visit Study day 15. [ Time Frame: 2 weeks after mifepristone administration ]
Original Primary Outcome Measures  ICMJE
 (submitted: February 1, 2006)
Need for surgical completion for incomplete abortions or ongoing viable pregnancies at follow up visit Study day 15.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 18, 2014)
  • Side effects [ Time Frame: 48 hours ]
  • Acceptability for women [ Time Frame: 2 weeks ]
Original Secondary Outcome Measures  ICMJE
 (submitted: February 1, 2006)
  • Side effects
  • Acceptability for women
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study of Sublingual Versus Oral Misoprostol Administration Following Mifepristone 200 mg for Abortion up to 63 Days Gestation
Official Title  ICMJE A Randomized Study of Sublingual Versus Oral Misoprostol Administration Following Mifepristone 200 mg for Abortion up to 63 Days Gestation
Brief Summary

This open-label, randomized study is being conducted to determine whether a dose of 400 mcg of sublingual misoprostol (i.e., under the tongue) taken 24 hours following administration of mifepristone 200 mg is effective and acceptable at inducing an abortion compared with misoprostol taken orally.

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

  1. Is a regimen of medical abortion with mifepristone using sublingual misoprostol at least as effective as using oral misoprostol up to 63 days since the last menstrual period (LMP)?
  2. Are the side effects with sublingual use tolerable for women?
  3. Is sublingual administration of misoprostol acceptable to women?
  4. Is one of the regimens (sublingual or oral) superior in terms of efficacy, safety (side-effects) or acceptability?
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Induced Abortion
Intervention  ICMJE Drug: Mifepristone, misoprostol
Study Arms  ICMJE
  • Active Comparator: Sublingual Misoprostol
    400 mcg of sublingual misoprostol
    Intervention: Drug: Mifepristone, misoprostol
  • Active Comparator: Oral Misoprostol
    Misoprostol administered orally
    Intervention: Drug: Mifepristone, misoprostol
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 18, 2014)
1443
Original Enrollment  ICMJE
 (submitted: February 1, 2006)
350
Actual Study Completion Date  ICMJE January 2008
Actual Primary Completion Date January 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Women presenting for medical abortion who consent to participate
  • Possibility of final gestational age of less than or equal to 63 days
  • General good health
  • Willing to provide contact information 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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE Child, Adult, Older Adult
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Moldova, Republic of,   Tunisia,   Turkey
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00286208
Other Study ID Numbers  ICMJE 1.1.5
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Gynuity Health Projects
Study Sponsor  ICMJE Gynuity Health Projects
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Sheila Raghavan, M.Sc. Gynuity Health Projects
Principal Investigator: Beverly Winikoff, MD, MPH Gynuity Health Projects
Study Director: Rasha Dabash, MPH Gynuity Health Projects
Principal Investigator: Selma Hajri, MD Reproductive Health Consultant
Principal Investigator: Ayse Akin, MD, MPH Baskent University
Study Director: Ilana Dzuba, MHS Gynuity Health Projects
PRS Account Gynuity Health Projects
Verification Date February 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP